Vamorolone solid oral dosage forms

Abstract

The present disclosure relates to pharmaceutical compositions comprising vamorolone, wherein the pharmaceutical composition is a solid oral dosage form. The present disclosure also relates to processes for preparing the pharmaceutical compositions disclosed herein and methods of treating muscular dystrophy comprising administering the pharmaceutical compositions disclosed herein to a subject.

Description

VAMOROLONE SOLID ORAL DOSAGE FORMS JOINT RESEARCH AGREEMENT

[0001] The subject matter disclosed in this application was developed, and the claimed invention was made by, or on behalf of, Catalyst Pharmaceuticals, Inc. and Santhera Pharmaceuticals (Schweiz) AG, parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention. The claimed invention was made as a result of activities undertaken within the scope of the joint research agreement. BACKGROUND

[0002] Vamorolone, marketed under the trade name AGAMREE®, is a synthetic corticosteroid indicated for the treatment of Duchenne muscular dystrophy. Vamorolone is currently administered as an oral suspension to facilitate ready mg / kg dosing. There remains a need to develop solid oral dosage forms of vamorolone, e.g., tablets or capsules, which are easier to store and administer. BRIEF SUMMARY

[0003] In some aspects, the present disclosure provides a pharmaceutical composition comprising: a) an amorphous solid dispersion comprising amorphous vamorolone and a pharmaceutically acceptable polymer; and b) one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is a solid oral dosage form.

[0004] In some aspects, the amorphous solid dispersion comprises from about 15 wt% to about 95 wt% vamorolone and about 5 wt% to about 85 wt% of the polymer.

[0005] In some aspects, the amorphous solid dispersion comprises from about 20 wt% to about 50 wt% vamorolone and about 50 wt% to about 80 wt% of the polymer.

[0006] In some aspects, the pharmaceutically acceptable polymer is selected from the group consisting of hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone, copovidone, polyvinyl caprolactam-polyvinylacetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid), and combinations thereof.

[0007] In some aspects, the pharmaceutically acceptable polymer is selected from the group consisting of hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, cellulose acetate phthalate, methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), povidone, copovidone, and polyvinyl caprolactam- polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®).

[0008] In some aspects, the amorphous solid dispersion further comprises a plasticizer, a surfactant, a filler, or a combination of any of the foregoing.

[0009] In some aspects, the amorphous solid dispersion further comprises a plasticizer.

[0010] In some aspects, the plasticizer comprises a citrate ester, a fatty acid ester, a phthalate ester, poly(ethylene glycol), poly(propylene glycol), tocopherol polyethylene glycol succinate, dibutyl sebacate, triacetin, a polysorbate, a sugar alcohol, or a combination of any of the foregoing.

[0011] In some aspects, the plasticizer comprises poly(ethylene glycol).

[0012] In some aspects, the amorphous solid dispersion further comprises a surfactant.

[0013] In some aspects, the surfactant comprises sodium lauryl sulfate, a poloxamer, a polysorbate, tocopherol polyethylene glycol succinate, poly(ethylene glycol), a fatty acid triglyceride, or a combination of any of the foregoing.

[0014] In some aspects, the surfactant comprises a poloxamer.

[0015] In some aspects, the filler comprises microcrystalline cellulose, silicified microcrystalline cellulose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylmethyl cellulose, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, povidone, copovidone, lactose monohydrate, lactose anhydrous, mannitol, sucrose, dextrates (EMDEX® or CAMDEX®), maltodextrin, polydextrose, starch, pregelatinized starch, hydroxypropyl starch, carbomer, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate and maltodextrin, polycarbophil, or a combination of any of the foregoing.

[0016] In some aspects, the amorphous solid dispersion is provided as a plurality of granules or pellets.

[0017] In some aspects, the pharmaceutical composition comprises from about 20 wt% to about 95 wt% of the amorphous solid dispersion.

[0018] In some aspects, the pharmaceutical composition comprises from about 10 wt% to about 50 wt% of the amorphous solid dispersion.

[0019] In some aspects, the amorphous solid dispersion is prepared by hot melt extrusion, twin screw melt granulation, high shear melt granulation, or spray drying.

[0020] In some aspects, the solid oral dosage form is a tablet or capsule.

[0021] In some aspects, the one or more pharmaceutically acceptable excipients comprises one or more diluents, one or more disintegrants, one or more lubricants, one or more flow enhancers, or a combination of any of the foregoing.

[0022] In some aspects, the one or more diluents comprises microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, sucrose, starch, pregelatinized starch, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate, maltodextrin, or a combination of any of the foregoing.

[0023] In some aspects, the one or more diluents comprises microcrystalline cellulose, silicified microcrystalline cellulose, mannitol, or a combination of any of the foregoing.

[0024] In some aspects, the pharmaceutical composition comprises from about 5 wt% to about 85 wt% of the one or more diluents.

[0025] In some aspects, the one or more disintegrants comprises croscarmellose sodium, carmellose sodium, sodium starch glycolate, carboxymethylcellulose sodium, carboxymethylcellulose calcium, crospovidone, starch, microcrystalline cellulose, low- substituted hydroxypropyl cellulose, or a combination of any of the foregoing.

[0026] In some aspects, the one or more disintegrants comprises croscarmellose sodium, sodium starch glycolate, crospovidone, or a combination of any of the foregoing.

[0027] In some aspects, the pharmaceutical composition comprises from about 0.25 wt% to about 10 wt% of the one or more disintegrants.

[0028] In some aspects, the one or more lubricants comprises magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination of any of the foregoing.

[0029] In some aspects, the one or more lubricants comprises magnesium stearate or sodium stearyl fumarate.

[0030] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more lubricants.

[0031] In some aspects, the one or more flow enhancers comprises magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination of any of the foregoing.

[0032] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more flow enhancers.

[0033] In some aspects, the solid oral dosage form is a tablet, optionally wherein the tablet is coated with one or more film coating materials.

[0034] In some aspects, the one or more film coating materials is not optional and is hydroxypropyl methylcellulose, poly(vinyl acetate), hydroxypropyl cellulose, polyethylene glycol, or a combination of any of the foregoing.

[0035] In some aspects, the pharmaceutical composition comprises from about 1 wt% to about 10 wt% of the one or more film coating materials.

[0036] In some aspects, the solid oral dosage form is a powder for suspension.

[0037] In some aspects, the one or more pharmaceutically acceptable excipients comprises one or more suspending agents, one or more buffering agents, one or more wetting agents, one or more preservatives, one or more flavoring agents, one or more flow enhancers, or a combination of any of the foregoing.

[0038] In some aspects, the one or more suspending agents comprises hydroxypropyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, carbomer, xantham gum, starch, pregelatinized starch, sodium alginate, or a combination of any of the foregoing.

[0039] In some aspects, the pharmaceutical composition comprises from about 5 wt% to about 80 wt% of the one or more suspending agents.

[0040] In some aspects, the one or more buffering agents comprises a citrate buffer, a phosphate buffer, a carbonate buffer, or a combination of any of the foregoing.

[0041] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more buffering agents.

[0042] In some aspects, the one or more wetting agents comprises sodium lauryl sulfate, a poloxamer, a polysorbate, or a combination of any of the foregoing.

[0043] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 10 wt% of the one or more wetting agents.

[0044] In some aspects, the one or more preservatives comprises methyl paraben, propyl paraben, sodium benzoate, citric acid, ascorbic acid, or a combination of any of the foregoing.

[0045] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more preservatives.

[0046] In some aspects, the one or more flavoring agents comprises sucrose, aspartame, an artificial flavor, a natural flavor, or a combination of any of the foregoing.

[0047] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more flavoring agents.

[0048] In some aspects, the one or more flow enhancers comprises colloidal silicon dioxide, talc, glycerol monostearate, magnesium monostearate, or a combination thereof.

[0049] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more flow enhancers.

[0050] In some aspects, the present disclosure provides a process for preparing a pharmaceutical composition disclosed herein, comprising: a) admixing vamorolone, a polymer, and optionally one or more of a plasticizer, a surfactant, or a filler, to form a mixture; b) extruding the mixture to form an amorphous solid dispersion; c) pelletizing or milling the amorphous solid dispersion; and d) admixing the amorphous solid dispersion with one or more pharmaceutically acceptable excipients.

[0051] In some aspects, the present disclosure provides a process for preparing a pharmaceutical composition disclosed herein, comprising: a) admixing vamorolone, a polymer, and an organic solvent to form a mixture; b) spray drying the mixture to form an amorphous solid dispersion; and c) admixing the amorphous solid dispersion with one or more pharmaceutically acceptable excipients.

[0052] In some aspects, the present disclosure provides a pharmaceutical composition comprising: a) a plurality of coated particles, wherein each coated particle comprises: i) an inert core;ii) a first drug layer coated over the inert core, the first drug layer comprising amorphous vamorolone and a first polymer; and iii) a first encapsulation layer coated over the first drug layer, the first encapsulation layer comprising a second polymer; and b) optionally one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is a solid oral dosage form.

[0053] In some aspects, the inert core is a microcrystalline cellulose sphere, a sugar sphere, a silica sphere, dicalcium phosphate anhydrous, magnesium alumino-metasilicate, microcrystalline cellulose, or a combination of any of the foregoing.

[0054] In some aspects, the inert core comprises from about 5 wt% to about 90 wt% of a total mass of the coated particle

[0055] In some aspects, the first polymer comprises hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing.

[0056] In some aspects, the first drug layer is present comprises from about 30 wt% to about 80 wt% of the total mass of the coated particle.

[0057] In some aspects, the second polymer comprises hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing.

[0058] In some aspects, the first polymer and the second polymer are the same.

[0059] In some aspects, the first encapsulation layer comprises from about 30 wt% to about 80 wt % of the total mass of the coated particle.

[0060] In some aspects, the pharmaceutical composition comprises from about 20 wt% to about 95 wt% of the coated particles.

[0061] In some aspects, the particles are prepared by fluid bed drug layering.

[0062] In some aspects, the solid oral dosage form is a tablet or capsule.

[0063] In some aspects, the one or more pharmaceutically acceptable excipients comprises one or more diluents, one or more disintegrants, one or more lubricants, one or more flow enhancers, or a combination of any of the foregoing.

[0064] In some aspects, the one or more diluents comprises microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, sucrose, starch, pregelatinized starch, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate and maltodextrin, or a combination of any of the foregoing.

[0065] In some aspects, the pharmaceutical composition comprises from about 5 wt% to about 85 wt% of the one or more diluents.

[0066] In some aspects, the one or more disintegrants comprises croscarmellose sodium, carmellose sodium, sodium starch glycolate, carboxymethylcellulose sodium, carboxymethylcellulose calcium, crospovidone, starch, microcrystalline cellulose, low- substituted hydroxypropyl cellulose, or a combination of any of the foregoing.

[0067] In some aspects, the pharmaceutical composition comprises from about 0.25 wt% to about 10 wt% of the one or more disintegrants.

[0068] In some aspects, the one or more lubricants comprises magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination of any of the foregoing.

[0069] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more lubricants.

[0070] In some aspects, the one or more flow enhancers comprises magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination thereof.

[0071] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more flow enhancers.

[0072] In some aspects, the solid oral dosage form is a tablet, wherein the tablet is coated with one or more film coating materials.

[0073] In some aspects, the one or more film coating materials comprises hydroxypropyl methylcellulose, poly(vinyl acetate), hydroxypropyl cellulose, polyethylene glycol, or a combination thereof.

[0074] In some aspects, the pharmaceutical composition comprises from about 1 wt% to about 10 wt% of the one or more film coating materials.

[0075] In some aspects, the solid oral dosage form is a powder for suspension.

[0076] In some aspects, the one or more pharmaceutically acceptable excipients comprises one or more suspending agents, one or more buffering agents, one or morewetting agents, one or more preservatives, one or more flavoring agents, one or more flow enhancers, one or more antifoaming agents, or a combination of any of the foregoing.

[0077] In some aspects, the one or more suspending agents comprises hydroxypropyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, carbomer, xantham gum, starch, pregelatinized starch, sodium alginate, or a combination of any of the foregoing.

[0078] In some aspects, the pharmaceutical composition comprises from about 5 wt% to about 80 wt% of the one or more suspending agents.

[0079] In some aspects, the one or more buffering agents comprises a citrate buffer, a phosphate buffer, a carbonate buffer, or a combination of any of the foregoing.

[0080] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more buffering agents.

[0081] In some aspects, the one or more wetting agents comprises sodium lauryl sulfate, a poloxamer, a polysorbate, or a combination of any of the foregoing.

[0082] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 10 wt% of the one or more wetting agents.

[0083] In some aspects, the one or more preservatives comprises methyl paraben, propyl paraben, sodium benzoate, citric acid, ascorbic acid, or a combination of any of the foregoing.

[0084] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more preservatives.

[0085] In some aspects, the one or more flavoring agents comprises sucrose, aspartame, an artificial flavor, a natural flavor, or a combination of any of the foregoing.

[0086] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more flavoring agents.

[0087] In some aspects, the one or more flow enhancers comprises colloidal silicon dioxide, talc, glycerol monostearate, magnesium monostearate, or a combination of any of the foregoing.

[0088] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more flow enhancers.

[0089] In some aspects, the one or more antifoaming agents comprises simethicone (polydimethylsiloxane-silicon dioxide), an alcohol, an insoluble oil, a stearate, a polydimethylsiloxane, an ether, a glycol, or a combination of any of the foregoing.

[0090] In some aspects, the pharmaceutical composition comprises from about 0.01 wt% to about 10 wt% of the one or more antifoaming agents.

[0091] In some aspects, the present disclosure provides a pharmaceutical composition comprising: a) a plurality of coated particles, wherein each coated particle comprises: i) a core comprising amorphous vamorolone and a first polymer; and ii) a first encapsulation layer coated over the core, the first encapsulation layer comprising a second polymer; and b) optionally one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is a solid oral dosage form.

[0092] In some aspects, the present disclosure provides a pharmaceutical composition comprising crystalline vamorolone and one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is a solid oral dosage form.

[0093] In some aspects, the crystalline vamorolone is vamorolone crystalline Form I.

[0094] In some aspects, the one or more pharmaceutically acceptable excipients comprises one or more diluents, one or more binders, one or more disintegrants, one or more lubricants, or a combination of any of the foregoing.

[0095] In some aspects, the one or more diluents comprises microcrystalline cellulose, silicified microcrystalline cellulose, mannitol, lactose, starch, dicalcium phosphate dihydrate, or a combination of any of the foregoing.

[0096] In some aspects, the pharmaceutical composition comprises from about 20 wt% to about 85 wt% of the one or more diluents.

[0097] In some aspects, the one or more binders comprises povidone, copovidone, hydroxpropylmethyl cellulose, hydroxypropyl cellulose, or a combination of any of the foregoing.

[0098] In some aspects, the pharmaceutical composition comprises from about 0.5 wt% to about 10 wt% of the one or more binders.

[0099] In some aspects, the one or more disintegrants comprises crosscarmellose sodium, sodium starch glycolate (EXPLOTAB®), cross povidone, or a combination of any of the foregoing.

[0100] In some aspects, the pharmaceutical composition comprises from about 0.5 wt% to about 7 wt% of the one or more disintegrants.

[0101] In some aspects, the one or more lubricants comprises magnesium stearate, steric acid, glyceryl dibehenate, sodium steryl fumarate, or a combination of any of the foregoing.

[0102] In some aspects, the pharmaceutical composition comprises from about 0.1 wt% to about 4 wt% of the one or more lubricants.

[0103] In some aspects, the pharmaceutical composition further comprises an amorphous solid dispersion comprising amorphous vamorolone and a pharmaceutically acceptable polymer.

[0104] In some aspects, the amorphous solid dispersion comprises from about 15 wt% to about 95 wt% vamorolone and about 5 wt% to about 85 wt% of the polymer.

[0105] In some aspects, the pharmaceutically acceptable polymer is selected from the group consisting of hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone, copovidone, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid), and combinations thereof.

[0106] In some aspects, the amorphous solid dispersion further comprises a plasticizer, a surfactant, a filler, or a combination of any of the foregoing.

[0107] In some aspects, the plasticizer comprises a citrate ester, a fatty acid ester, a phthalate ester, poly(ethylene glycol), poly(propylene glycol), tocopherol polyethylene glycol succinate, dibutyl sebacate, triacetin, a polysorbate, a sugar alcohol, or a combination of any of the foregoing.

[0108] In some aspects, the amorphous solid dispersion further comprises a surfactant.

[0109] In some aspects, the surfactant comprises sodium lauryl sulfate, a poloxamer, a polysorbate, tocopherol polyethylene glycol succinate, poly(ethylene glycol), a fatty acid triglyceride, or a combination of any of the foregoing.

[0110] In some aspects, the filler comprises microcrystalline cellulose, silicified microcrystalline cellulose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylmethyl cellulose, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, povidone, copovidone, lactose monohydrate, lactose anhydrous, mannitol, sucrose, dextrates (EMDEX® or CAMDEX®), maltodextrin, polydextrose, starch, pregelatinized starch, hydroxypropyl starch, carbomer, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate and maltodextrin, polycarbophil, or a combination of any of the foregoing.

[0111] In some aspects, the amorphous solid dispersion is provided as a plurality of granules or pellets.

[0112] In some aspects, the pharmaceutical composition comprises from about 0.5 wt% to about 10 wt% of the amorphous solid dispersion.

[0113] In some aspects, the amorphous solid dispersion is prepared by hot melt extrusion, twin screw melt granulation, high shear melt granulation, or spray drying.

[0114] In some aspects, the pharmaceutical composition is prepared by direct blending.

[0115] In some aspects, the present disclosure provides a process for preparing a pharmaceutical composition disclosed herein, comprising admixing crystalline vamorolone with one or more pharmaceutically acceptable excipients.

[0116] In some aspects, the pharmaceutical composition has a total mass ranging from about 50 mg to about 800 mg.

[0117] In some aspects, the total mass of the pharmaceutical composition is about 150 mg.

[0118] In some aspects, the total mass of the pharmaceutical composition is about 300 mg.

[0119] In some aspects, the pharmaceutical composition has a friability of less than 1.0% as measured using USP<1216>.

[0120] In some aspects, the pharmaceutical composition has a disintegration time of less than 10 minutes.

[0121] In some aspects, the pharmaceutical composition has a hardness of from about 5 kp to about 20 kp.

[0122] In some aspects, when the pharmaceutical composition is administered to a subject with food, the composition provides a vamorolone Tmaxof from about 0.5 hours to about 5 hours.

[0123] In some aspects, when the pharmaceutical composition is administered to a subject with food, the composition provides a vamorolone median Tmaxof about 2 hours.

[0124] In some aspects, when the pharmaceutical composition is administered to a subject with food, the composition provides a vamorolone AUC24 of from about 2,600 ng∙h / mL to about 4,350 ng∙h / mL.

[0125] In some aspects, when the pharmaceutical composition is administered to a subject with food, the composition provides a vamorolone Cmax of from about 650 ng / mL to about 1,200 mg / mL.

[0126] In some aspects, the present disclosure provides a method of treating muscular dystrophy in a subject in need thereof, comprising orally administering a pharmaceutical composition disclosed herein.

[0127] In some aspects, the pharmaceutical composition is administered once, twice, or three times per day.

[0128] In some aspects, the pharmaceutical composition is administered with food.

[0129] In some aspects, the pharmaceutical composition is administered without food.

[0130] In some aspects, the muscular dystrophy is Duchenne muscular dystrophy, Becker muscular dystrophy, limb girdle muscular dystrophy, congenital muscular dystrophy, facioscapulohumeral muscular dystrophy, myotonic muscular dystrophy, oculopharyngeal muscular dystrophy, distal muscular dystrophy, or Emery-Dreifuss muscular dystrophy.

[0131] In some aspects, the muscular dystrophy is Duchenne muscular dystrophy.

[0132] In some aspects, a total daily dose of vamorolone of from about 2 mg / kg to about 6 mg / kg is administered to the subject.

[0133] In some aspects, the total daily dose of vamorolone is about 6 mg / kg.

[0134] In some aspects, the subject is at least two years of age.

[0135] In some aspects, the pharmaceutical composition comprises from about 5 mg to about 500 mg amorphous vamorolone.

[0136] In some aspects, the pharmaceutical composition comprises from about 30 mg to about 300 mg amorphous vamorolone.

[0137] In some aspects, the pharmaceutical composition comprises from about 100 mg to about 300 mg amorphous vamorolone.

[0138] Additional embodiments and advantages of the disclosure will be set forth, in part, in the description that follows, and will flow from the description, or can be learned by practice of the disclosure.

[0139] It is to be understood that both the foregoing summary and the following detailed description are exemplary and explanatory only, and do not restrict the scope of the claims. BRIEF DESCRIPTION OF THE FIGURES

[0140] FIG.1 is a flow chart depicting a procedure for preparing solid oral dosage forms using high shear granulation, as described in Example 9.

[0141] FIG.2 is a flow chart depicting a procedure for preparing solid oral dosage forms using top spray granulation, as described in Example 10.

[0142] FIG.3 is a flow chart depicting a procedure for preparing solid oral dosage forms using high shear granulation and a lipid binder, as described in Example 11.

[0143] FIG.4 is a flow chart depicting a procedure for preparing solid oral dosage forms using high shear granulation and a lipid carrier, as described in Example 12.

[0144] FIG.5 is a flow chart depicting a procedure for preparing solid oral dosage forms using high shear granulation and a cyclodextrin, as described in Example 13.

[0145] FIG.6 is a flow chart depicting a procedure for preparing solid oral dosage forms using drug layering, as described in Example 14.

[0146] FIG.7 is a flow chart depicting a procedure for preparing solid oral dosage forms using direct blending, as described in Example 15.

[0147] FIG.8 is a flow chart depicting a procedure for preparing solid oral dosage forms using wet granulation, as described in Example 16.

[0148] FIG.9 is a phase diagram depicting the solubility of vamorolone in KOLLIDON® VA64 and poloxamer P188.

[0149] FIG.10 is a phase diagram depicting the solubility of vamorolone in SOLUPLUS®.

[0150] FIG.11 is a phase diagram depicting the solubility of vamorolone in PVA 4-88 and poloxamer P188.

[0151] FIG.12 is a phase diagram depicting the solubility of vamorolone in HPMCAS MMP.

[0152] FIG.13 is a line graph depicting the release of vamorolone over time from a vamorolone oral suspension or loose hot melt extrudate (HME) granules comprising 30% vamorolone and 5% or 10% LABRASOL®.

[0153] FIG.14 is a line graph depicting release of vamorolone over time from a vamorolone oral suspension or loose HME granules comprising 10%, 20%, or 30% vamorolone, PVP K30 and 5% PEG4000.

[0154] FIG.15 is a line graph depicting release of vamorolone over time from a vamorolone oral suspension or loose HME granules comprising 10% vamorolone in i) KOLLIDON® VA64 and 5% poloxamer P188; ii) SOLUPLUS® and 5% poloxamer P188; iii) HPMCAS MMP and 5% poloxamer P188; or iv) PVP K30 and 5% PEG4000.

[0155] FIG.16 is a line graph depicting release of vamorolone over time from a vamorolone oral suspension or HME granules in capsules comprising 10% vamorolone in i) KOLLIDON® VA64 and 5% poloxamer P188; ii) SOLUPLUS® and 5% poloxamer P188; or iii) HPMCAS MMP.

[0156] FIG.17 is a line graph depicting release of vamorolone over time from a vamorolone oral suspension or HME granules in capsules comprising 10%, 20%, or 30% vamorolone in KOLLIDON® VA64 and 5% poloxamer P188.

[0157] FIG.18 is a line graph depicting release of vamorolone over time from a vamorolone oral suspension or a formulation comprising HME granules (comprising different polymers) and additional components filled in capsules as described in Example 6a.

[0158] FIG.19 is a line graph depicting release of vamorolone over time from a vamorolone oral suspension or a formulation comprising HME granules (comprising different loadings of vamolorone) and additional components filled in capsules as described in Example 6a.

[0159] FIG.20 is a line graph depicting release of vamorolone over time from a vamorolone oral suspension or tablets or granules comprising 20%, 30%, or 40% vamorolone in PVP K30 and 5% PEG4000.

[0160] FIG.21 is a line graph depicting release of vamorolone over time from a vamorolone oral suspension or tablets comprising 30% vamorolone in PVP K30 having different hardnesses.

[0161] FIG.22 is a line graph depicting release of vamorolone over time from a vamorolone oral suspension or tablets comprising 30% vamorolone in PVP K30 having different tablet weights.

[0162] FIG.23 is a line graph depicting release of vamorolone over time from a vamorolone oral suspension or 150 mg tablets comprising 30% vamorolone in PVP K30 or KOLLIDON® VA64.

[0163] FIG.24 is a line graph depicting release of vamorolone over time from a vamorolone oral suspension or 150 mg (30 mg vamorolone) or 750 mg (150 mg vamorolone) tablets comprising spray dried dispersions comprising 50% vamorolone and 50% cellulose acetate phthalate (CAP).

[0164] FIG.25 is a line graph depicting the compressibility of tablets having Formulations F134-F137 as prepared as described in Example 6d.

[0165] FIG.26 is a line graph depicting the compactibility of tablets having Formulations F134-F137 as prepared as described in Example 6d.

[0166] FIG.27 is a line graph depicting the tabletability of tablets having Formulations F134-F137 as prepared as described in Example 6d.

[0167] FIG.28 is a line graph depicting the disintegration time of tablets having Formulations F134-F137 as prepared as described in Example 6d.

[0168] FIG.29 is a line graph depicting the compressibility of tablets having Formulations F138-F140 (containing 30 mg vamolorone) as prepared as described in Example 6d.

[0169] FIG.30 is a line graph depicting the compactibility of tablets having Formulations F138-F140 (containing 30 mg vamolorone) as prepared as described in Example 6d.

[0170] FIG.31 is a line graph depicting the tabletability of tablets having Formulations F138-F140 (containing 30 mg vamolorone) as prepared as described in Example 6d.

[0171] FIG.32 is a line graph depicting the disintegration time of tablets having Formulations F138-F140 (containing 30 mg vamolorone) as prepared as described in Example 6d.

[0172] FIG.33 is a line graph depicting the compressibility of tablets having Formulations F138-F140 (containing 150 mg vamolorone) as prepared as described in Example 6d.

[0173] FIG.34 is a line graph depicting the compactibility of tablets having Formulations F138-F140 (containing 150 mg vamolorone) as prepared as described in Example 6d.

[0174] FIG.35 is a line graph depicting the tabletability of tablets having Formulations F138-F140 (containing 150 mg vamolorone) as prepared as described in Example 6d.

[0175] FIG.36 is a line graph depicting the disintegration time of tablets having Formulations F138-F140 (containing 150 mg vamolorone) as prepared as described in Example 6d.

[0176] FIG.37 is an X-ray powder diffraction (XPRD) pattern of crystalline vamorolone Form I. DETAILED DESCRIPTION

[0177] The headings provided herein are not limitations of the various embodiments of the disclosure, which can be defined by reference to the specification as a whole. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims. Definitions

[0178] For convenience, the meaning of some terms and phrases used in the specification, examples, and appended claims are provided below. Unless stated otherwise, or implicit from context, the following terms and phrases include the meanings provided below. The definitions are provided to aid in describing particular embodiments, and are not intended to limit the claimed technology, because the scope of the technology is limited only by the claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. If there is an apparent discrepancy between the usage of a term in the art and its definition provided herein, the definition provided within the specification will control.

[0179] The indefinite articles “a” and “an” to describe an element or component means that one or at least one of these elements or components is present. Although these articles are conventionally employed to signify that the modified noun is a singular noun, as used herein the articles “a” and “an” also include the plural, unless otherwise stated in specific instances. Similarly, the definite article “the,” as used herein, also signifies that the modified noun can be singular or plural, again unless otherwise stated in specific instances.

[0180] As used herein, the term “about” used with numerical values means “within 10% of the stated value,” unless expressly noted otherwise. For example, “about 5 wt%” means from 4.5 wt% to 5.5 wt%.

[0181] As used herein, the term “wt%” refers to the mass percentage of one component in a composition relative to the combined mass of all components in the composition. For example, the wt% of component A in a composition consisting of 1 g of component A, 4 g of component B, and 5 g of component C is 1 g / (1 g + 4 g + 5 g) x 100% = 10 wt%.

[0182] The term “pharmaceutically acceptable,” as applied to carriers, excipients, or other components that can be used in the compositions described herein, refer to carriers, excipients, or other components that are nontoxic to recipients at the dosages and concentrations employed.

[0183] As used herein, the terms “comprises,” “comprising,” “having,” “including,” “containing,” and the like are open-ended terms meaning “including, but not limited to.” To the extent a given aspect disclosed herein “comprises” certain elements, it should be understood that present disclosure also specifically contemplates and discloses aspects that “consist essentially of” those elements and that “consist of” those elements.

[0184] As used herein the terms “consists essentially of,” “consisting essentially of,” and the like are to be construed as a semi-closed terms, meaning that no other ingredients which materially affect the basic and novel characteristics of an aspect are included.

[0185] As used herein, the terms “consists of,” “consisting of,” and the like are to be construed as closed terms, such that an aspect “consisting of” a particular set of elements excludes any element, step, or ingredient not specified in the aspect.

[0186] The terms “treat,” “treating,” and “treatment” refer to any indicia of success in the treatment or amelioration of an injury, disease, or condition, including any objective or subjective parameter such as abatement; remission; diminishing of symptoms or making the injury, disease, or condition more tolerable to the patient; slowing in the rate of degeneration or decline; or improving a patient’s physical or mental well-being. The treatment or amelioration of symptoms can be based on objective or subject parameters, including the results of a physical examination, neuropsychiatric examinations, or psychiatric evaluation.

[0187] As used herein, the term “Cmax” refers to the maximum serum concentration achieved by a drug in a subject’s body after the drug has been administered to the subject.

[0188] As used herein, the term “Tmax” refers to the time after administration of a drug to a subject at which Cmaxis observed in the subject.

[0189] As used herein, the term “AUC24” refers to the definite integral, i.e., area under the curve, of a serum concentration of a drug in a subject’s body as a function of time from 0 to 24 hours, and is indicative of the subject’s drug exposure over 24 hours. Pharmaceutical Compositions Vamorolone

[0190] The present disclosure provides pharmaceutical compositions comprising vamorolone. Vamorolone is a synthetic corticosteroid and has the following structure:.

[0191] Vamorolone’s full chemical name is [17α,21-dihydroxy-16α-methyl-pregna- 1,4,9(11)-triene-3,20-dione]. Vamorolone is marketed under the trade name AGAMREE®. Other names for vamorolone include 16α-methyl-9,11-dehydro prednisolone and VBP-15. Vamorolone’s CAS registry number is 13209-41-1.

[0192] Vamorolone can be an amorphous solid or a crystalline solid. Crystalline forms of vamorolone include vamorolone Forms I-VIII. In some aspects, vamorolone can be vamorolone Form I. In some aspects, vamorolone Form I is characterized by an X-ray powder diffraction pattern comprising peaks, in terms of ° 2θ, at about 11.9, about 13.7, about 16.1, and about 18.3 when measured with Cu Kα radiation. In some aspects, vamorolone Form I is characterized by an X-ray powder diffraction pattern comprising peaks, in terms of ° 2θ, at about 11.9, about 13.7, about 14.4, about 14.8, about 16.1, about 17.0, and about 18.3 when measured with Cu Kα radiation. In some aspects, vamorolone Form I is characterized by an X-ray powder diffraction pattern substantially similar to FIG.37. Vamorolone Form I is disclosed in U.S. Patent No.11,382,922, which is incorporated herein by reference in its entirety. Vamorolone Forms II-VIII are disclosed in U.S. Application Publication No.2023 / 0002439, which is incorporated herein by reference in its entirety.Amorphous Solid Dispersions

[0193] Amorphous solid dispersions are compositions in which an amorphous active pharmaceutical ingredient, e.g., vamorolone, is dispersed throughout a polymer matrix. Amorphous solid dispersions can increase the solubility of the amorphous active pharmaceutical ingredient, which can lead to improved pharmacokinetic properties.

[0194] Amorphous solid dispersions can be prepared by numerous methods, including, but not limited to, hot melt extrusion, twin screw melt granulation, high shear melt granulation, or spray drying. These methods can provide the amorphous solid dispersion as a plurality of granules and / or pellets, which can be further blended with one or more pharmaceutically acceptable excipients and further processed, e.g., by compressing the mixture into a tablet or filling the mixture into a capsule, to provide a solid oral dosage form.

[0195] Accordingly, and in certain embodiments, the present disclosure provides a pharmaceutical composition comprising: a) an amorphous solid dispersion comprising amorphous vamorolone and a pharmacuetuically acceptable polymer; and b) one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is a solid oral dosage form.

[0196] In some aspects, the amorphous solid dispersion can further comprise crystalline vamorolone, i.e., vamorolone can be present as a mixture of amorphous and crystalline vamorolone. In some aspects, the crystalline vamorolone can comprise crystalline vamorolone Form I. In some aspects, the amorphous solid dispersion can comprise about 0.001 wt%, about 0.01 wt%, about 0.1 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 12 wt%, about 14 wt%, about 16 wt%, about 18 wt%, or about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, wherein the remaining vamorolone present in the amorphous solid dispersion is amorphous. In some aspects, the amorphous solid dispersion can comprise from about 0.001 wt% to about 0.01 wt%, from about 0.001 wt% to about 0.1 wt%, from about 0.001 wt% to about 1 wt%, from about 0.001 wt% to about 3 wt%, from about 0.001 wt% to about 5 wt%, from about 0.001 wt% to about 10 wt%, from about 0.001 wt% to about 15 wt%, from about 0.001 wt% to about 20 wt%, from about 0.01 wt% to about 0.1 wt%, from about 0.01 wt% to about 1 wt%, from about 0.01 wt% to about 3 wt%, from about 0.01 wt% to about 5 wt%, from about0.01 wt% to about 10 wt%, from about 0.01 wt% to about 15 wt%, from about 0.01 wt% to about 20 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 3 wt% to about 5 wt%, from about 3 wt% to about 10 wt%, from about 3 wt% to about 15 wt%, from about 3 wt% to about 20 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, or from about 15 wt% to about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, wherein the remaining vamorolone present in the amorphous solid dispersion is amorphous.

[0197] In certain aspects, the amorphous solid dispersion comprising amorphous vamorolone and the pharmaceutically acceptable polymer can futher comprise at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler.

[0198] In certain aspects, the amorphous solid dispersion comprising amorphous vamorolone, crystalline vamorolone, e.g., crystalline vamorolone Form I, and the pharmaceutically acceptable polymer can futher comprise at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler.

[0199] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, a polymer having a wt% as described below, and optionally at least one of a plasticizer having a wt% as described below, a surfactant having a wt% as described below, a solubilizing agent having a wt% as described below, and a filler having a wt% as described below. In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt%to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, with the remainder comprising the polymer, and optionally, at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler.

[0200] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, from about 0.001 wt% to about 0.01 wt%, from about 0.001 wt% to about 0.1 wt%, from about 0.001 wt% to about 1 wt%, from about 0.001 wt% to about 3 wt%, from about 0.001 wt% to about 5 wt%, from about 0.001 wt% to about 10 wt%, from about 0.001 wt% to about 15 wt%, from about 0.001 wt% to about 20 wt%, from about 0.01 wt% to about 0.1 wt%, from about 0.01 wt% to about 1 wt%, from about 0.01 wt% to about 3 wt%, from about 0.01 wt% to about 5 wt%, from about 0.01 wt% to about 10 wt%, from about 0.01 wt% to about 15 wt%, from about 0.01 wt% to about 20 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt%to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 3 wt% to about 5 wt%, from about 3 wt% to about 10 wt%, from about 3 wt% to about 15 wt%, from about 3 wt% to about 20 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, or from about 15 wt% to about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, a polymer having a wt% as described below, and optionally at least one of a plasticizer having a wt% as described below, a surfactant having a wt% as described below, a solubilizing agent having a wt% as described below, and a filler having a wt% as described below.

[0201] In some aspects, the amorphous solid dispersion can comprise about 80 wt% amorphous vamorolone with the remainder comprising the polymer, and optionally, at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler. In some aspects, the amorphous solid dispersion can comprise about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, about 90 wt%, or about 95 wt% amorphous vamorolone, with the remainder comprising the polymer, and optionally, at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler.

[0202] In some aspects, the amorphous solid dispersion can comprise about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, about 90 wt%, or about 95 wt% amorphous vamorolone and about 0.001 wt%, about 0.01 wt%, about 0.1 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 12 wt%, about 14 wt%, about 16 wt%, about 18 wt%, or about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, with the remainder comprising the polymer, and optionally, at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler.

[0203] In some aspects, the pharmaceutical composition can comprise from about 5 mg to about 300 mg amorphous vamorolone. In some aspects, the pharmaceuticalcomposition can comprise from about 5 mg to about 20 mg, from about 5 mg to about 30 mg, from about 5 mg to about 50 mg, from about 5 mg to about 75 mg, from about 5 mg to about 100 mg, from about 5 mg to about 150 mg, from about 5 mg to about 200 mg, from about 5 mg to about 250 mg, from about 5 mg to about 300 mg, from about 10 mg to about 30 mg, from about 10 mg to about 50 mg, from about 10 mg to about 75 mg, from about 10 mg to about 100 mg, from about 10 mg to about 150 mg, from about 10 mg to about 200 mg, from about 10 mg to about 250 mg, from about 10 mg to about 300 mg, from about 30 mg to about 50 mg, from about 30 mg to about 75 mg, from about 30 mg to about 100 mg, from about 30 mg to about 150 mg, from about 30 mg to about 200 mg, from about 30 mg to about 250 mg, from about 30 mg to about 300 mg, from about 50 mg to about 75 mg, from about 50 mg to about 100 mg, from about 50 mg to about 150 mg, from about 50 mg to about 200 mg, from about 50 mg to about 250 mg, from about 50 mg to about 300 mg, from about 75 mg to about 100 mg, from about 75 mg to about 150 mg, from about 75 mg to about 200 mg, from about 75 mg to about 250 mg, from about 75 mg to about 300 mg, from about 100 mg to about 150 mg, from about 100 mg to about 200 mg, from about 100 mg to about 250 mg, from about 100 mg to about 300 mg, from about 100 mg to about 350 mg, from about 100 mg to about 400 mg, from about 150 mg to about 200 mg, from about 150 mg to about 250 mg, from about 150 mg to about 300 mg, from about 200 mg to about 250 mg, from about 200 mg to about 300 mg, from about 200 mg to about 350 mg, from about 200 mg to about 400 mg, or from about 250 mg to about 300 mg amorphous vamorolone, with the remainder comprising the polymer, and optionally, at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler.

[0204] In some aspects, the pharmaceutical composition can comprise about 150 mg amorphous vamorolone with the remainder comprising the polymer, and optionally, at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler. In some aspects, the pharmaceutical composition can comprise about 5 mg, about 10 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg, about 60 mg, about 70 mg, about 80 mg, about 90 mg, about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, or about 300 mg amorphous vamorolone.

[0205] In some aspects, the amorphous solid dispersion can comprise from about 5 mg to about 300 mg amorphous vamorolone. In some aspects, the amorphous solid dispersion can comprise from about 5 mg to about 20 mg, from about 5 mg to about 30 mg, fromabout 5 mg to about 50 mg, from about 5 mg to about 75 mg, from about 5 mg to about 100 mg, from about 5 mg to about 150 mg, from about 5 mg to about 200 mg, from about 5 mg to about 250 mg, from about 5 mg to about 300 mg, from about 10 mg to about 30 mg, from about 10 mg to about 50 mg, from about 10 mg to about 75 mg, from about 10 mg to about 100 mg, from about 10 mg to about 150 mg, from about 10 mg to about 200 mg, from about 10 mg to about 250 mg, from about 10 mg to about 300 mg, from about 30 mg to about 50 mg, from about 30 mg to about 75 mg, from about 30 mg to about 100 mg, from about 30 mg to about 150 mg, from about 30 mg to about 200 mg, from about 30 mg to about 250 mg, from about 30 mg to about 300 mg, from about 50 mg to about 75 mg, from about 50 mg to about 100 mg, from about 50 mg to about 150 mg, from about 50 mg to about 200 mg, from about 50 mg to about 250 mg, from about 50 mg to about 300 mg, from about 75 mg to about 100 mg, from about 75 mg to about 150 mg, from about 75 mg to about 200 mg, from about 75 mg to about 250 mg, from about 75 mg to about 300 mg, from about 100 mg to about 150 mg, from about 100 mg to about 200 mg, from about 100 mg to about 250 mg, from about 100 mg to about 300 mg, from about 100 mg to about 350 mg, from about 100 mg to about 400 mg, from about 150 mg to about 200 mg, from about 150 mg to about 250 mg, from about 150 mg to about 300 mg, from about 200 mg to about 250 mg, from about 200 mg to about 300 mg, from about 200 mg to about 350 mg, from about 200 mg to about 400 mg, or from about 250 mg to about 300 mg amorphous vamorolone, with the remainder comprising the polymer, and optionally, at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler.

[0206] In some aspects, the amorphous solid dispersion can comprise about 150 mg amorphous vamorolone with the remainder comprising the polymer, and optionally, at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler. In some aspects, the amorphous solid dispersion can comprise about 5 mg, about 10 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg, about 60 mg, about 70 mg, about 80 mg, about 90 mg, about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, or about 300 mg amorphous vamorolone, with the remainder comprising the polymer, and optionally, at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler.

[0207] In some aspects, the polymer in the amorphous solid dispersion can be hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to ashypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA- 64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing.

[0208] In some aspects, as stated above, poly(ethylene oxide) can have any molecular weight, e.g., from about 3,000 to about 20,000,000. In some aspects, poly(ethylene oxide) can have a molecular weight of from about 2,000 to about 3,500, from about 2,000 to about 4,000, from about 2,000 to about 5,000, from about 2,000 to about 5,500, from about 2,000 to about 6,000, from about 2,000 to about 7,000, from about 2,000 to about 8,000, from about 2,000 to about 10,000, from about 2,000 to about 50,000, from about 2,000 to about 100,000, from about 2,000 to about 1,000,000, from about 2,000 to about 5,000,000, from about 2,000 to about 20,000,000, from about 3,000 to about 5,000, from about 3,000 to about 5,500, from about 3,000 to about 6,000, from about 3,000 to about 7,000, from about 3,000 to about 8,000, from about 3,000 to about 10,000, from about 3,000 to about 50,000, from about 3,000 to about 100,000, from about 3,000 to about 1,000,000, from about 3,000 to about 5,000,000, from about 3,000 to about 20,000,000, from about 5,000 to about 6,000, from about 5,000 to about 7,000, from about 5,000 to about 8,000, from about 5,000 to about 10,000, from about 5,000 to about 50,000, from about 5,000 to about 100,000, from about 5,000 to about 1,000,000, from about 5,000 to about 5,000,000, from about 5,000 to about 20,000,000, about 6,000 to about 8,000, from about 6,000 to about 10,000, from about 6,000 to about 50,000, from about 6,000 to about 100,000, from about 6,000 to about 1,000,000, from about 6,000 to about 5,000,000, from about 6,000 to about 20,000,000, from about 8,000 to about 10,000, from about 8,000 to about 50,000, from about 8,000 to about 100,000, from about 8,000 to about 1,000,000, from about 8,000 to about 5,000,000, from about 8,000 to about 20,000,000, from about10,000 to about 50,000, from about 10,000 to about 100,000, from about 10,000 to about 1,000,000, from about 10,000 to about 5,000,000, from about 10,000 to about 20,000,000, from about 100,000 to about 1,000,000, from about 100,000 to about 5,000,000, or from about 5,000,000 to about 20,000,000.

[0209] In some aspects, poly(ethylene oxide) can have a molecular weight of about 3,500. In some aspects, poly(ethylene oxide) can have a molecular weight of about 2,000, about 2,500, about 3,000, about 3,500, about 4,000, about 4,500, about 5,000, about 5,500, about 6,000, about 6,500, about 7,000, about 7,500, about 8,000, about 9,500, about 10,000, about 20,000, about 50,000, about 1,000,000, about 2,000,000, about 5,000,000, about 7,500,000, about 10,000,000, about 15,000,000, or about 20,000,000.

[0210] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 95 wt% to about 15 wt% of the polymer, and optionally, at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler. In particular, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone and from about 5 wt% to about 85 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose(HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA- 64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing. In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, or from about 45 wt% to about 55 wt% amorphous vamorolone and from about 45 wt% to about 85 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate- polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or any combination of the foregoing.

[0211] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 0.001 wt% to about 20 wt%, crystalline vamorolone, e.g., crystalline vamorolone Form I, from about 95 wt% to about 15 wt% of the polymer, and optionally, at least one of a plasticizer, a surfactant, a solubilizing agent, and a filler. In particular, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt%to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, from about 0.001 wt% to about 0.01 wt%, from about 0.001 wt% to about 0.1 wt%, from about 0.001 wt% to about 1 wt%, from about 0.001 wt% to about 3 wt%, from about 0.001 wt% to about 5 wt%, from about 0.001 wt% to about 10 wt%, from about 0.001 wt% to about 15 wt%, from about 0.001 wt% to about 20 wt%, from about 0.01 wt% to about 0.1 wt%, from about 0.01 wt% to about 1 wt%, from about 0.01 wt% to about 3 wt%, from about 0.01 wt% to about 5 wt%, from about 0.01 wt% to about 10 wt%, from about 0.01 wt% to about 15 wt%, from about 0.01 wt% to about 20 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 3 wt% to about 5 wt%, from about 3 wt% to about 10 wt%, from about 3 wt% to about 15 wt%, from about 3 wt% to about 20 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, or from about 15 wt% to about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, and from about 5 wt% to about 85 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetatephthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate- polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing.

[0212] In some aspects, the amorphous solid dispersion can comprise from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA- 64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer(SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing.

[0213] In some aspects, the amorphous solid dispersion can comprise about 80 wt% amorphous vamorolone and about 20 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA- 64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing. In some aspects, the amorphous solid dispersion can comprise about 15 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, or about 90 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing.

[0214] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 95 wt% amorphous vamorolone and from about 5 wt% to about 85 wt% of a polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate- polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing.

[0215] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 0.001 wt% to about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, and from about 5 wt% to about 85 wt% of a polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, celluloseacetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate- polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing.

[0216] In some aspects, the pharmaceutical composition can comprise an amorphous solid dispersion comprising from about 5 mg to about 20 mg, from about 5 mg to about 30 mg, from about 5 mg to about 50 mg, from about 5 mg to about 75 mg, from about 5 mg to about 100 mg, from about 5 mg to about 150 mg, from about 5 mg to about 200 mg, from about 5 mg to about 250 mg, from about 5 mg to about 300 mg, from about 10 mg to about 30 mg, from about 10 mg to about 50 mg, from about 10 mg to about 75 mg, from about 10 mg to about 100 mg, from about 10 mg to about 150 mg, from about 10 mg to about 200 mg, from about 10 mg to about 250 mg, from about 10 mg to about 300 mg, from about 30 mg to about 50 mg, from about 30 mg to about 75 mg, from about 30 mg to about 100 mg, from about 30 mg to about 150 mg, from about 30 mg to about 200 mg, from about 30 mg to about 250 mg, from about 30 mg to about 300 mg, from about 50 mg to about 75 mg, from about 50 mg to about 100 mg, from about 50 mg to about 150 mg, from about 50 mg to about 200 mg, from about 50 mg to about 250 mg, from about 50 mg to about 300 mg, from about 75 mg to about 100 mg, from about 75 mg to about 150 mg, from about 75 mg to about 200 mg, from about 75 mg to about 250 mg, from about 75 mg to about 300 mg, from about 100 mg to about 150 mg, from about 100 mg to about 200 mg, from about 100 mg to about 250 mg, from about 100 mg to about 300 mg, from about 100 mg to about 350 mg, from about 100 mg to about 400 mg, from about 150 mg to about 200 mg, from about 150 mg to about 250 mg, from about 150 mg to about 300 mg, from about 200 mg to about 250 mg, from about 200 mg to about 300 mg, from about 200 mg to about 350 mg, from about 200 mg to about 400 mg, or from about 250 mg to about 300 mg amorphous vamorolone, which can be from about 1 wt% to about 5 wt%, from about 1 wt% to about 15 wt%, from about 5 wt% to about 15 wt%,from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% of the total mass of the amorphous solid dispersion, and from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the polymer relative to the total mass of the amorphous solid dispersion, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropylmethylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate- polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing.

[0217] In some aspects, the amorphous solid dispersion can further comprise a plasticizer. In some aspects, the plasticizer can comprise a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing.

[0218] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, about 95 wt% to about 15 wt % of the polymer and about 0.1 wt% to about 25 wt% of the plasticizer. In some aspects, the amorphous solid dispersion can comprise from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 25 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 25 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 25 wt%, from about 15 wt% to about 20 wt%, from about 15 wt% to about 25 wt%, or from about 20 wt% to about 25 wt% of the plasticizer.

[0219] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropylmethylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate- polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, and from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 25 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 25 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 25 wt%, from about 15 wt% to about 20 wt%, from about 15 wt% to about 25 wt%, or from about 20 wt% to about 25 wt% of the plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing. In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, or from about 45 wt% to about 55 wt% amorphous vamorolone, from about 45wt% to about 85 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or any combination of the foregoing, and from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, or from about 5 wt% to about 10 wt% of the plasticizer, wherein the plasticizer is poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500.

[0220] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, from about 0.001 wt% to about 0.01 wt%, from about 0.001 wt% to about 0.1 wt%, from about 0.001 wt% to about 1 wt%, from about 0.001 wt% to about 3 wt%, from about 0.001 wt% to about 5 wt%, from about 0.001 wt% to about 10 wt%, from about 0.001 wt% to about 15 wt%, from about 0.001 wt% to about 20 wt%, from about 0.01 wt% to about 0.1 wt%, from about 0.01 wt% to about 1 wt%, from about 0.01 wt%to about 3 wt%, from about 0.01 wt% to about 5 wt%, from about 0.01 wt% to about 10 wt%, from about 0.01 wt% to about 15 wt%, from about 0.01 wt% to about 20 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 3 wt% to about 5 wt%, from about 3 wt% to about 10 wt%, from about 3 wt% to about 15 wt%, from about 3 wt% to about 20 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, or from about 15 wt% to about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, and from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 25 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 25 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 25 wt%, from about 15 wt% to about 20 wt%, from about 15 wt% to about 25 wt%, or from about 20 wt% to about 25 wt% of the plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing.

[0221] In some aspects, the amorphous solid dispersion can comprise about 10 wt% of the plasticizer. In some aspects, the amorphous solid dispersion can comprise about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 11 wt%, about 12 wt%, about 13 wt%, about 14 wt%, about 15 wt%, about 16 wt%, about 17 wt%, about 18 wt%, about 19 wt%, about 20 wt%, about 21 wt%, about 22 wt%, about 23 wt%, about 24 wt%, or about 25 wt% of the plasticizer.

[0222] In some aspects, the amorphous solid dispersion can comprise about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%,about 80 wt%, about 85 wt%, about 90 wt%, or about 95 wt% amorphous vamorolone, about 15 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, or about 90 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA- 64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, and about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 11 wt%, about 12 wt%, about 13 wt%, about 14 wt%, about 15 wt%, about 16 wt%, about 17 wt%, about 18 wt%, about 19 wt%, about 20 wt%, about 21 wt%, about 22 wt%, about 23 wt%, about 24 wt%, or about 25 wt% of the plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing.

[0223] In some aspects, the amorphous solid dispersion can comprise about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%,about 80 wt%, about 85 wt%, about 90 wt%, or about 95 wt% amorphous vamorolone, about 0.001 wt%, about 0.01 wt%, about 0.1 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 12 wt%, about 14 wt%, about 16 wt%, about 18 wt%, or about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, about 15 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, or about 90 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K- 17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam- polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid- ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, and about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 11 wt%, about 12 wt%, about 13 wt%, about 14 wt%, about 15 wt%, about 16 wt%, about 17 wt%, about 18 wt%, about 19 wt%, about 20 wt%, about 21 wt%, about 22 wt%, about 23 wt%, about 24 wt%, or about 25 wt% of the plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing.

[0224] In some aspects, the amorphous solid dispersion can comprise 15 wt% to about 95 wt% amorphous vamorolone, about 95 wt% to about 15 wt % of the polymer, about 0.1 wt% to 25 wt% of the plasticizer, and can further comprise a surfactant. In some aspects, the surfactant can comprise sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; a polysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing.

[0225] In some aspects, the amorphous solid dispersion can comprise about 15 wt% to about 95 wt% amorphous vamorolone, about 95 wt% to about 15 wt % of the polymer, about 0.1 wt% to 25 wt% of the plasticizer, and from about 0.1 wt% to about 10 wt% of the surfactant. In some aspects, the amorphous solid dispersion can comprise from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2.5 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of the surfactant.

[0226] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, fromabout 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate- polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), orany combination of the foregoing, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 25 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 25 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 25 wt%, from about 15 wt% to about 20 wt%, from about 15 wt% to about 25 wt%, or from about 20 wt% to about 25 wt% of the plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing, and from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2.5 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of the surfactant, wherein the surfactant is sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; a polysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing.

[0227] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt%to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, from about 0.001 wt% to about 0.01 wt%, from about 0.001 wt% to about 0.1 wt%, from about 0.001 wt% to about 1 wt%, from about 0.001 wt% to about 3 wt%, from about 0.001 wt% to about 5 wt%, from about 0.001 wt% to about 10 wt%, from about 0.001 wt% to about 15 wt%, from about 0.001 wt% to about 20 wt%, from about 0.01 wt% to about 0.1 wt%, from about 0.01 wt% to about 1 wt%, from about 0.01 wt% to about 3 wt%, from about 0.01 wt% to about 5 wt%, from about 0.01 wt% to about 10 wt%, from about 0.01 wt% to about 15 wt%, from about 0.01 wt% to about 20 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 3 wt% to about 5 wt%, from about 3 wt% to about 10 wt%, from about 3 wt% to about 15 wt%, from about 3 wt% to about 20 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, or from about 15 wt% to about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt%to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA- 64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 25 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 25 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 25 wt%, from about 15 wt% to about 20 wt%, from about 15 wt% to about 25 wt%, or from about20 wt% to about 25 wt% of the plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing, and from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2.5 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of the surfactant, wherein the surfactant is sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; a polysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing.

[0228] In some aspects, the amorphous solid dispersion can comprise about 5 wt% of the surfactant. In some aspects, the amorphous solid dispersion can comprise about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, or about 10 wt% of the surfactant.

[0229] In some aspects, the amorphous solid dispersion can comprise about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, about 90 wt%, or about 95 wt% amorphous vamorolone, about 15 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, or about 90 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade,e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA- 64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 11 wt%, about 12 wt%, about 13 wt%, about 14 wt%, about 15 wt%, about 16 wt%, about 17 wt%, about 18 wt%, about 19 wt%, about 20 wt%, about 21 wt%, about 22 wt%, about 23 wt%, about 24 wt%, or about 25 wt% of the plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing, and about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, or about 10 wt% of the surfactant, wherein the surfactant is sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; a polysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing.

[0230] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45wt%, from about 15 wt% to about 55 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, or from about 45 wt% to about 55 wt% amorphous vamorolone, from about 45 wt% to about 85 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate- polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or any combination of the foregoing, and from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2.5 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of the surfactant, wherein the surfactant is a poloxamer, e.g., P188 or P407; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing.

[0231] In some aspects, the amorphous solid dispersion can comprise about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, about 90 wt%, or about 95 wt% amorphous vamorolone, about 0.001 wt%, about 0.01 wt%, about 0.1 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 12 wt%, about 14 wt%, about 16 wt%, about 18 wt%, or about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, about 15 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, or about 90 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K- 17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam- polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid- ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 11 wt%, about 12 wt%, about 13 wt%, about 14 wt%, about 15 wt%, about 16 wt%, about 17 wt%, about 18 wt%, about 19 wt%, about 20 wt%, about 21 wt%, about 22 wt%, about 23 wt%, about 24 wt%, or about 25 wt% of the plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing, and about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, or about 10 wt% of the surfactant, wherein the surfactant is sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; a polysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® orGELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing.

[0232] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 5 wt% to about 85 wt% of a polymer, optionally from about 0.1 wt% to about 25 wt% of a plasticizer, and optionally from about 0.1 wt% to about 10 wt% of a surfactant. In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 50 wt% amorphous vamorolone, from about 40 wt% to about 70 wt% of a polymer, optionally from about 0.1 wt% to about 25 wt% of a plasticizer, and optionally from about 0.1 wt% to about 10 wt% of a surfactant.

[0233] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 0.001 wt% to about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, from about 5 wt% to about 85 wt% of a polymer, optionally from about 0.1 wt% to about 25 wt% of a plasticizer, and optionally from about 0.1 wt% to about 10 wt% of a surfactant.

[0234] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 50 wt% amorphous vamorolone, from about 0.001 wt% to about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, from about 40 wt% to about 70 wt% of a polymer, optionally from about 0.1 wt% to about 25 wt% of a plasticizer, and optionally from about 0.1 wt% to about 10 wt% of a surfactant.

[0235] In some aspects, the pharmaceutical composition can comprise an amorphous solid dispersion comprising from about 5 mg to about 300 mg amorphous vamololone, which can be from 1 wt% to about 90 wt% of the total mass of the amorphous solid dispersion, from about 5 wt% to about 85 wt% of a polymer relative to the total mass of the amorphous solid dispersion, optionally from about 0.1 wt% to about 25 wt% of a plasticizer relative to the total mass of the amorphous solid dispersion, and optionally from about 0.1 wt% to about 10 wt% of a surfactant relative to the total mass of the amorphous solid dispersion.

[0236] In some aspects, the amorphous solid dispersion can further comprise a solubilizing agent, such as a cyclodextrin.

[0237] In some aspects, the amorphous solid dispersion can comprise from about 1 wt% to about 40 wt% of the solubilizing agent. In some aspects, the amorphous solid dispersion can comprise from about 1 wt% to about 5 wt%, from about 1 wt% to about 10wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 30 wt%, %, from about 5 wt% to about 10 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 30 wt%, from about 5 wt% to about 40 wt%,%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 30 wt%, from about 10 wt% to about 40 wt%,%, from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, or from about 30 wt% to about 40 wt% of a solubilizing agent.

[0238] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt%to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate- polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 25 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 25 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 25 wt%, from about 15 wt% to about 20 wt%, from about 15 wt% to about 25 wt%, or from about 20 wt% to about 25 wt% of the plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, orerythriol; or a combination of any of the foregoing, from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2.5 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of the surfactant, wherein the surfactant is sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; a polysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing, and from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 30 wt%, %, from about 5 wt% to about 10 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 30 wt%, from about 5 wt% to about 40 wt%,%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 30 wt%, from about 10 wt% to about 40 wt%,%, from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, or from about 30 wt% to about 40 wt% of the solubilizing agent, e.g., a cyclodextrin.

[0239] In some aspects, the amorphous solid dispersion can comprise about 10 wt% of a solubilizing agent. In some aspects, the amorphous solid dispersion can comprise about 1 wt%, about 5 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, or about 40 wt% of a solubilizing agent.

[0240] In some aspects, the amorphous solid dispersion can comprise about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, about 90 wt%, or about 95 wt% amorphous vamorolone, about 15 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, or about 90 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade,e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA- 64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 11 wt%, about 12 wt%, about 13 wt%, about 14 wt%, about 15 wt%, about 16 wt%, about 17 wt%, about 18 wt%, about 19 wt%, about 20 wt%, about 21 wt%, about 22 wt%, about 23 wt%, about 24 wt%, or about 25 wt% of the plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing, about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, or about 10 wt% of the surfactant, wherein the surfactant is sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; a polysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing, and about 1 wt%, about 5 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, or about 40 wt% of the solubilizing agent, e.g., a cyclodextrin.

[0241] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 5 wt% to about 85 wt% of a polymer, optionally from about 0.1 wt% to about 25 wt% of a plasticizer, optionally from about 0.1 wt% to about 10 wt% of a surfactant, and optionally from about 1 wt% to about 40 wt% of a solubilizing agent.

[0242] In some aspects, the pharmaceutical composition can comprise an amorphous solid dispersion comprising from about 5 mg to about 300 mg amorphous vamorolone, which can be from about 1 wt% to about 90 wt% of the total mass of the amorphous solid dispersion, from about 5 wt% to about 85 wt% of a polymer relative to the total mass of the amorphous solid dispersion, optionally from about 0.1 wt% to about 25 wt% of a plasticizer relative to the total mass of the amorphous solid dispersion, optionally from about 0.1 wt% to about 10 wt% of a surfactant relative to the total mass of the amorphous solid dispersion, and optionally from about 1 wt% to about 40 wt% of a solubilizing agent relative to the total mass of the amorphous solid dispersion.

[0243] In some aspects, the amorphous solid dispersion can further comprise a filler. In some aspects, the filler can comprise microcrystalline cellulose (e.g., standard (PH grades), fibrous (KG grades), or mixed (UF grades)), silicified microcrystalline cellulose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylmethyl cellulose, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, povidone, copovidone, lactose monohydrate, lactose anhydrous, mannitol, sucrose, dextrates (EMDEX® or CAMDEX®), maltodextrin, polydextrose, starch, pregelatinized starch (partially or fully gelatinized), hydroxypropyl starch, carbomer, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate and maltodextrin, polycarbophil, or a combination of any of the foregoing.

[0244] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% of a filler. In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 20 wt%, from about 10 wt% to about 30 wt%, from about 10 wt% to about 40 wt%, from about 10 wt% to about 50 wt%, from about 10 wt% to about 60 wt%, from about 10 wt% to about 70 wt%, from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, fromabout 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 30 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, or from about 70 wt% to about 80 wt% of a filler.

[0245] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt%to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate- polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 25 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 25 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 25 wt%, from about 15 wt% to about 20 wt%, from about 15 wt% to about 25 wt%, or from about 20 wt% to about 25 wt% of the plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, orerythriol; or a combination of any of the foregoing, from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2.5 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of the surfactant, wherein the surfactant is sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; a polysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing, optionally from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 30 wt%, %, from about 5 wt% to about 10 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 30 wt%, from about 5 wt% to about 40 wt%,%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 30 wt%, from about 10 wt% to about 40 wt%,%, from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, or from about 30 wt% to about 40 wt% of the solubilizing agent, e.g., a cyclodextrin, and from about 10 wt% to about 20 wt%, from about 10 wt% to about 30 wt%, from about 10 wt% to about 40 wt%, from about 10 wt% to about 50 wt%, from about 10 wt% to about 60 wt%, from about 10 wt% to about 70 wt%, from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 30 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, or from about 70 wt% to about 80 wt% of a filler, wherein the filler is microcrystalline cellulose (e.g., standard (PH grades),fibrous (KG grades), or mixed (UF grades)), silicified microcrystalline cellulose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylmethyl cellulose, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, povidone, copovidone, lactose monohydrate, lactose anhydrous, mannitol, sucrose, dextrates (EMDEX® or CAMDEX®), maltodextrin, polydextrose, starch, pregelatinized starch (partially or fully gelatinized), hydroxypropyl starch, carbomer, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate and maltodextrin, polycarbophil, or a combination of any of the foregoing.

[0246] In some aspects, the amorphous solid dispersion can comprise about 20 wt% of a filler. In some aspects, the amorphous solid dispersion can comprise about 10 wt%, about 15 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, or about 80 wt% of a filler.

[0247] In some aspects, the amorphous solid dispersion can comprise about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, about 90 wt%, or about 95 wt% amorphous vamorolone, about 15 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, or about 90 wt% of the polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA- 64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particularaspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 11 wt%, about 12 wt%, about 13 wt%, about 14 wt%, about 15 wt%, about 16 wt%, about 17 wt%, about 18 wt%, about 19 wt%, about 20 wt%, about 21 wt%, about 22 wt%, about 23 wt%, about 24 wt%, or about 25 wt% of the plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing, about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, or about 10 wt% of the surfactant, wherein the surfactant is sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; a polysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing, optionally about 1 wt%, about 5 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, or about 40 wt% of the solubilizing agent, e.g., a cyclodextrin, and about 10 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, or about 80 wt% of a filler, wherein the filler is microcrystalline cellulose (e.g., standard (PH grades), fibrous (KG grades), or mixed (UF grades)), silicified microcrystalline cellulose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylmethyl cellulose, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, povidone, copovidone, lactose monohydrate, lactose anhydrous, mannitol, sucrose, dextrates (EMDEX® or CAMDEX®), maltodextrin, polydextrose, starch, pregelatinized starch (partially or fully gelatinized), hydroxypropyl starch, carbomer, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphateanhydrous, coprocessed dicalcium phosphate and maltodextrin, polycarbophil, or a combination of any of the foregoing.

[0248] In some aspects, the amorphous solid dispersion can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 5 wt% to about 85 wt% of a polymer, optionally from about 0.1 wt% to about 25 wt% of a plasticizer, optionally from about 0.1 wt% to about 10 wt% of a surfactant, optionally from about 1 wt% to about 40 wt% of a solubilizing agent, and optionally from about 10 wt% to about 80 wt% of a filler.

[0249] In some aspects, the pharmaceutical composition can comprise an amorphous solid dispersion comprising from about 5 mg to about 300 mg amorphous vamorolone, which can be from about 1 wt% to about 90 wt% of the total mass of the amorphous solid dispersion, from about 5 wt% to about 85 wt% of a polymer relative to the total mass of the amorphous solid dispersion, optionally from about 0.1 wt% to about 25 wt% of a plasticizer relative to the total mass of the amorphous solid dispersion, optionally from about 0.1 wt% to about 10 wt% of a surfactant relative to the total mass of the amorphous solid dispersion, optionally from about 1 wt% to about 40 wt% of a solubilizing agent relative to the total mass of the amorphous solid dispersion, and optionally from about 10 wt% to about 80 wt% of a filler relative to the total mass of the amorphous solid dispersion.

[0250] In some aspects, any of the amorphous solid dispersions described above can be provided as a plurality of granules or pellets. In some aspects, the amorphous solid dispersion is provided as a plurality of granules or pellets and can comprise from about 15 wt% to about 95 wt% amorphous vamorolone and from about 95 wt% to about 15 wt% of a polymer. In some aspects, the amorphous solid dispersion is provided as a plurality of granules or pellets and can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 95 wt% to about 15 wt% of a polymer, and from about 0.1 wt% to about 25 wt% of a plasticizer. In some aspects, the amorphous solid dispersion is provided as a plurality of granules or pellets and can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 95 wt% to about 15 wt% of a polymer, from about 0.1 wt% to about 25 wt% of a plasticizer, and from about 0.1 wt% to about 10 wt % of a surfactant. In some aspects, the amorphous solid dispersion is provided as a plurality of granules or pellets and can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 95 wt% to about 15 wt% of a polymer, from about0.1 wt% to about 25 wt% of a plasticizer, from about 0.1 wt% to about 10 wt % of a surfactant, and from about 1 wt% to about 40 wt% of a solubilizing agent. In some aspects, the amorphous solid dispersion is provided as a plurality of granules or pellets and can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 95 wt% to about 15 wt% of a polymer, from about 0.1 wt% to about 25 wt% of a plasticizer, from about 0.1 wt% to about 10 wt % of a surfactant, from about 1 wt% to about 40 wt% of a solubilizing agent, and from about 10 wt% to about 80 wt% of a filler.

[0251] In some aspects, the amorphous solid dispersion is provided as a plurality of granules or pellets and can comprise from about 15 wt% to about 95 wt% amorphous vamorolone and from about 95 wt% to about 15 wt% of a polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA- 64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing.

[0252] In some aspects, the amorphous solid dispersion is provided as a plurality of granules or pellets and can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 95 wt% to about 15 wt% of a polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA-64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, and from about 0.1 wt% to about 25 wt% of a plasticizer, wherein the plasticizer is a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing.

[0253] In some aspects, the amorphous solid dispersion is provided as a plurality of granules or pellets and can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, from about 95 wt% to about 15 wt% of a polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS, which can have any grade, e.g., L, M, or H), hydroxypropyl methylcellulose (HPMC, also referred to as hypromellose, which can have any grade, e.g., E3, E5, or E15), hydroxypropyl cellulose (HPC or KLUCEL™, which can have any molecular weight, e.g., 40,000), hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone (which can have any grade, e.g., K-12, K-17, K-25, K-30), copovidone (e.g., KOLLIDON® VA- 64), polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide) (which can have any molecular weight, e.g., from about 3,000 to about 20,000,000, and in particular aspects from about 3,000 to about 8,000), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid) (e.g., APINOVEX™ LV), or any combination of the foregoing, from about 0.1 wt% to about 25 wt% of a plasticizer, wherein the plasticizer is a citrate ester,e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing, optionally from about 0.1 wt% to about 10 wt % of a surfactant, wherein the surfactant is sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; a polysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing, optionally from about 1 wt% to about 40 wt% of a solubilizing agent, e.g., cyclodextrin,, and optionally from about 10 wt% to about 80 wt% of a filler, wherein the filler is microcrystalline cellulose (e.g., standard (PH grades), fibrous (KG grades), or mixed (UF grades)), silicified microcrystalline cellulose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylmethyl cellulose, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, povidone, copovidone, lactose monohydrate, lactose anhydrous, mannitol, sucrose, dextrates (EMDEX® or CAMDEX®), maltodextrin, polydextrose, starch, pregelatinized starch (partially or fully gelatinized), hydroxypropyl starch, carbomer, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate and maltodextrin, polycarbophil, or a combination of any of the foregoing.

[0254] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the amorphous solid dispersion, optionally one or more diluents having a wt% as described below, optionally one or more disintegrants having a wt% as described below, optionally one or more lubricants having a wt% as described below, optionally one or more flow enhancers having a wt% as described below, optionally one or more suspending agents having a wt% as described below, optionally one or more buffering agents having a wt% as described below, optionally one or more wetting agents having a wt% as described below, optionally one or more preservatives having a wt% as described below, and optionally one or more flavoring agents having a wt% as described below. In some aspects, the pharmaceutical composition can comprise from about 20 wt%to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 20 wt% to about 90 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 80 wt%, from about 30 wt% to about 90 wt%, from about 30 wt% to about 95 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 40 wt% to about 90 wt%, from about 40 wt% to about 95 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 50 wt% to about 90 wt%, from about 50 wt% to about 95 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, from about 60 wt% to about 90 wt%, from about 60 wt% to about 95 wt%, from about 70 wt% to about 80 wt%, from about 70 wt% to about 90 wt%, from about 70 wt% to about 95 wt%, from about 80 wt% to about 90 wt%, from about 80 wt% to about 95 wt%, or from about 90 wt% to about 95 wt% of the amorphous solid dispersion.

[0255] In some aspects, the pharmaceutical composition can comprise about 80 wt% of the amorphous solid dispersion. In some aspects, the pharmaceutical composition can comprise about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 85 wt%, about 90 wt%, or about 95 wt% of the amorphous solid dispersion.

[0256] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the amorphous solid dispersion and optionally from about 5 wt% to about 85 wt% of one or more diluents. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the amorphous solid dispersion, optionally from about 5 wt% to about 85 wt% of one or more diluents, and optionally from about 0.25 wt% to about 10 wt% of one or more disintegrants. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the amorphous solid dispersion, optionally from about 5 wt% to about 85 wt% of one or more diluents, optionally from about 0.25 wt% to about 10 wt% of one or more disintegrants, and optionally from about 0.1 wt% to about 5 wt% of one or more lubricants. In some aspects, the pharmaceutical composition can comprise from about 20wt% to about 95 wt% of the amorphous solid dispersion, optionally from about 5 wt% to about 85 wt% of one or more diluents, optionally from about 0.25 wt% to about 10 wt% of one or more disintegrants, optionally from about 0.1 wt% to about 5 wt% of one or more lubricants, and optionally from about 0.1 wt% to about 5 wt% of one or more flow enhancers.

[0257] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the amorphous solid dispersion and optionally from about 5 wt% to about 80 wt% of one or more suspending agents. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the amorphous solid dispersion, optionally from about 5 wt% to about 80 wt% of one or more suspending agents, and optionally from about 0.1 wt% to about 5 wt% of one or more buffering agents. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the amorphous solid dispersion, optionally from about 5 wt% to about 80 wt% of one or more suspending agents, optionally from about 0.1 wt% to about 5 wt% of one or more buffering agents, and optionally from about 0.1 wt% to about 10 wt% of one or more wetting agents. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the amorphous solid dispersion, optionally from about 5 wt% to about 80 wt% of one or more suspending agents, optionally from about 0.1 wt% to about 5 wt% of one or more buffering agents, optionally from about 0.1 wt% to about 10 wt% of one or more wetting agents, and optionally from about 0.1 wt% to about 5 wt% of one or more preservatives. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the amorphous solid dispersion, optionally from about 5 wt% to about 80 wt% of one or more suspending agents, optionally from about 0.1 wt% to about 5 wt% of one or more buffering agents, optionally from about 0.1 wt% to about 10 wt% of one or more wetting agents, optionally from about 0.1 wt% to about 5 wt% of one or more preservatives, and from about 0.1 wt% to about 5 wt% of one or more flavoring agents. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the amorphous solid dispersion, optionally from about 5 wt% to about 80 wt% of one or more suspending agents, optionally from about 0.1 wt% to about 5 wt% of one or more buffering agents, optionally from about 0.1 wt% to about 10 wt% of one or more wetting agents, optionally from about 0.1 wt% to about 5 wt% of one or morepreservatives, from about 0.1 wt% to about 5 wt% of one or more flavoring agents, and from about 0.1 wt% to about 5 wt% of one or more flow enhancers.

[0258] In some aspects, the amorphous solid dispersion can be prepared by hot melt extrusion, twin screw melt granulation, high shear melt granulation, or spray drying. In some aspects, the amorphous solid dispersion can be prepared using methods similar to those described in Examples 1-4b below.

[0259] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone, from about 10 wt% to about 80 wt% HPMCAS, optionally from about 0.1 wt% to about 10 wt% of a plasticizer, e.g., triethyl citrate and / or polyethylene glycol (e.g., PEG 400), optionally from about 0.1 wt% to about 5 wt% of a surfactant, e.g., sodium lauryl sulfate, poloxamer (e.g., poloxamer 188), and / or polysorbate 80.

[0260] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 30 wt% amorphous vamorolone, from about 70 wt% to about 90 wt% HPMCAS, and from about 0.1 wt% to about 5 wt% of a surfactant, e.g., poloxamer (e.g., poloxamer 188). In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 30 wt% amorphous vamorolone, from about 0.001 wt% to about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, from about 70 wt% to about 90 wt% HPMCAS, and from about 0.1 wt% to about 5 wt% of a surfactant, e.g., poloxamer (e.g., poloxamer 188).

[0261] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone, from about 10 wt% to about 80 wt% HPMC, optionally from about 0.1 wt% to about 10 wt% of a plasticizer, e.g., triethyl citrate and / or polyethylene glycol (e.g., PEG 400), optionally from about 0.1 wt% to about 5 wt% of a surfactant, e.g., sodium lauryl sulfate, poloxamer (e.g., poloxamer 188), and / or polysorbate 80.

[0262] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone, from about 10 wt% to about 80 wt% povidone (e.g., K-30), optionally from about 0.1 wt% to about 10 wt% of a plasticizer, e.g., triethyl citrate and / or polyethylene glycol (e.g., PEG 400), optionally from about 0.1 wt% to about 5 wt% of a surfactant, e.g., sodium lauryl sulfate, poloxamer (e.g., poloxamer 188), and / or polysorbate 80.

[0263] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 50 wt% amorphous vamorolone, from about 50 wt% to about 90 wt% povidone (e.g., K-30), and about 1 wt% to about 10 wt% of a plasticizer, e.g., polyethylene glycol (e.g., PEG 4000).

[0264] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone, from about 10 wt% to about 80 wt% copovidone (e.g., KOLLIDON® VA64), optionally from about 0.1 wt% to about 10 wt% of a plasticizer, e.g., triethyl citrate and / or polyethylene glycol (e.g., PEG 400), optionally from about 0.1 wt% to about 5 wt% of a surfactant, e.g., sodium lauryl sulfate, poloxamer (e.g., poloxamer 188), and / or polysorbate 80.

[0265] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 50 wt% amorphous vamorolone, from about 50 wt% to about 90 wt% copovidone (e.g., KOLLIDON® VA64), and from about 1 wt% to about 10 wt% of a plasticizer, e.g., polyethylene glycol (e.g., PEG 4000). In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 50 wt% amorphous vamorolone, from about 0.001 wt% to about 20 wt% crystalline vamorolone, from about 50 wt% to about 90 wt% copovidone (e.g., KOLLIDON® VA64), and from about 1 wt% to about 10 wt% of a plasticizer, e.g., polyethylene glycol (e.g., PEG 4000).

[0266] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 50 wt% amorphous vamorolone, from about 50 wt% to about 90 wt% copovidone (e.g., KOLLIDON® VA64), and from about 1 wt% to about 10 wt% of a surfactant, e.g., LABRASOL®, GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01), or a poloxamer, e.g., P188 or P407. In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 50 wt% amorphous vamorolone, from about 0.001 wt% to about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, from about 50 wt% to about 90 wt% copovidone (e.g., KOLLIDON® VA64), and from about 1 wt% to about 10 wt% of a surfactant, e.g., LABRASOL®, GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01), or a poloxamer, e.g., P188 or P407.

[0267] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone, from about 10 wt% to about 80 wt% polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (e.g., SOLUPLUS®), optionally from about 0.1 wt% to about 10 wt% of a plasticizer, e.g., triethyl citrateand / or polyethylene glycol (e.g., PEG 400), optionally from about 0.1 wt% to about 5 wt% of a surfactant, e.g., sodium lauryl sulfate, poloxamer (e.g., poloxamer 188), and / or polysorbate 80.

[0268] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 40 wt% amorphous vamorolone, from about 60 wt% to about 90 wt% polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (e.g., SOLUPLUS®), and from about 1 wt% to about 10 wt% of a surfactant, e.g., LABRASOL®, GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01), or a poloxamer, e.g., P188 or P407. In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 40 wt% amorphous vamorolone, from about 0.001 wt% to about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, from about 60 wt% to about 90 wt% polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (e.g., SOLUPLUS®), and from about 1 wt% to about 10 wt% of a surfactant, e.g., LABRASOL®, GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01), or a poloxamer, e.g., P188 or P407.

[0269] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone, from about 10 wt% to about 80 wt% methacrylic acid-methyl methacrylate copolymer (1:1) (e.g., EUDRAGIT® L100-55), optionally from about 0.1 wt% to about 10 wt% of a plasticizer, e.g., triethyl citrate and / or polyethylene glycol (e.g., PEG 400), optionally from about 0.1 wt% to about 5 wt% of a surfactant, e.g., sodium lauryl sulfate, poloxamer (e.g., poloxamer 188), and / or polysorbate 80.

[0270] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone, from about 10 wt% to about 80 wt% methacrylic acid-methyl methacrylate copolymer (1:1) (e.g., EUDRAGIT® L100), optionally from about 0.1 wt% to about 10 wt% of a plasticizer, e.g., triethyl citrate and / or polyethylene glycol (e.g., PEG 400), optionally from about 0.1 wt% to about 5 wt% of a surfactant, e.g., sodium lauryl sulfate, poloxamer (e.g., poloxamer 188), and / or polysorbate 80.

[0271] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 40 wt% amorphous vamorolone, from about 0.001 wt% to about 20 wt% crystalline vamorolone, e.g., crystalline vamorolone Form I, from about 10 wt% to about 80 wt% methacrylic acid-methyl methacrylate copolymer (1:1) (e.g., EUDRAGIT® EPO), and from about 1 wt% to about 10 wt % of a solubilizer, e.g., stearic acid. In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 40 wt% amorphous vamorolone, from about 10 wt% to about 80 wt% methacrylic acid- methyl methacrylate copolymer (1:1) (e.g., EUDRAGIT® E PO), and from about 1 wt% to about 10 wt % of a solubilizer, e.g., stearic acid.

[0272] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone and from about 10 wt% to about 80 wt% poly(ethylene glycol) (e.g., PEG 3000, PEG 6000, or PEG 8000). In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone and from about 10 wt% to about 80 wt% tocopherol polyethylene glycol succinate. In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone and from about 10 wt% to about 80 wt% povidone (e.g., K-30). In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone and from about 10 wt% to about 80 wt% copovidone (e.g., KOLLIDON® VA64). In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone and from about 10 wt% to about 80 wt% hydroxypropyl cellulose (e.g., KLUCEL™ ELF).

[0273] In some aspects, the amorphous solid dispersion can comprise from about 10 wt% to about 80 wt% amorphous vamorolone, from about 10 wt% to about 80 wt% poly(ethylene glycol) (e.g., PEG 3000, PEG 6000, or PEG 8000), and optionally from about 10 wt% to about 80 wt% of a filler, e.g., microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, starch, pregelatinized starch, and / or dicalcium phosphate. Drug-Layered Particles

[0274] In certain embodiments, the present disclosure also provides a pharmaceutical composition comprising: a) a plurality of coated particles, wherein each coated particle comprises: i) an inert core; ii) a first drug layer coated over the inert core, the first drug layer comprising amorphous vamorolone and a first polymer; andiii) a first encapsulation layer coated over the first drug layer, the first encapsulation layer comprising a second polymer; and b) optionally one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is a solid oral dosage form.

[0275] In some aspects, the inert core can be a microcrystalline cellulose sphere, a sugar sphere, a silica sphere, dicalcium phosphate anhydrous, magnesium alumino-metasilicate, microcrystalline cellulose, or a combination of any of the foregoing.

[0276] In some aspects, the first drug layer can comprise from about 15 wt% to about 95 wt% amorphous vamorolone relative to the total mass of the coated particle. In some aspects, the first drug layer can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone relative to the total mass of the coated particle.

[0277] In some aspects, the first drug layer can comprise about 80 wt% amorphous vamorolone relative to the total mass of the coated particle. In some aspects, the first drug layer can comprise about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, about 90 wt%, or about 95 wt% amorphous vamorolone relative to the total mass of the coated particle.

[0278] In some aspects, the first drug layer can comprise from about 0.1 wt% to about 95 wt% amorphous vamorolone relative to the total mass of the pharmaceutical composition. In some aspects, the first drug layer can comprise from about 0.01 wt% to about 0.1 wt%, from about 0.01 wt% to about 0.5 wt%, from about 0.01 wt% to about 1 wt%, from about 0.01 wt% to about 10 wt%, from about 0.01 wt% to about 25 wt%, from about 0.01 wt% to about 50 wt%, from about 0.01 wt% to about 75 wt%, from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 25 wt%, from about 0.1 wt% to about 50 wt%, from about 0.1 wt% to about 75 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 10 wt%, from about 0.5 wt% to about 25 wt%, from about 0.5 wt% to about 50 wt%, from about 0.5 wt% to about 75 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 25 wt%, from about 1 wt% to about 50 wt%, from about 1 wt% to about 75 wt%, from about 10 wt% to about 25 wt%, from about 10 wt% to about 50 wt%, from about 10 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone relative to the total mass of the pharmaceutical composition.

[0279] In some aspects, the first drug layer can comprise about 80 wt% amorphous vamorolone relative to the total mass of the pharmaceutical composition. In some aspects, the first drug layer can comprise about 15 wt%, about 20 wt%, about 25 wt%, about 30wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, about 90 wt%, or about 95 wt% amorphous vamorolone relative to the total mass of the pharmaceutical composition.

[0280] In some aspects, the inert core can comprise from about 5 wt% to about 90 wt% of a total mass of the coated particle. In some aspects, the inert core can comprise from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 5 wt% to about 85 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 15 wt% to about 90 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 90 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 90 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 90 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 90 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 90 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 90 wt%, or from about 85 wt% to about 90 wt% of the total mass of the coated particle.

[0281] In some aspects, the inert core can comprise about 80 wt% of the total mass of the coated particle. In some aspects, the inert core can comprise about 5 wt%, about 10 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 85 wt%, or about 90 wt% of the total mass of the coated particle.

[0282] In some aspects, the first drug layer can comprise from about 15 wt% to about 95 wt% amorphous vamorolone and the inert core can comprise from about 5 wt% to about 90 wt% of the total mass of the coated particle.

[0283] In some aspects, the first polymer can comprise hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing.

[0284] In some aspects, the first drug layer can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone relative to the total mass of the coated particle and from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% of the first polymer relative to the total mass of the coated particle, wherein the first polymer can comprise hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing.

[0285] In some aspects, the first drug layer can comprise from about 30 wt% to about 80 wt% of the total mass of the coated particle. In some aspects, the first drug layer can comprise from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, or from about 70 wt% to about 80 wt% of the total mass of the coated particle.

[0286] In some aspects, the first drug layer can comprise about 50 wt% of the total mass of the coated particle. In some aspects, the first drug layer can comprise about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, or about 80 wt% of the total mass of the coated particle.

[0287] In some aspects, the first drug layer can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, the inert core can comprise from about 5 wt% to about 90 wt% of a total mass of the coated particle, and the first drug layer can comprise from about 30 wt% to about 80 wt% of the total mass of the coated particle.

[0288] In some aspects, the second polymer can comprise hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer(SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing.

[0289] In some aspects, the first polymer and the second polymer can be the same. In some aspects, the first polymer and the second polymer can be different.

[0290] In some aspects, the first encapsulation layer can comprises from about 30 wt% to about 80 wt % of the total mass of the coated particle.

[0291] In some aspects, the first encapsulation layer can comprise from about 30 wt% to about 80 wt% of the total mass of the coated particle. In some aspects, the first encapsulation layer can comprise from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, or from about 70 wt% to about 80 wt% of the total mass of the coated particle.

[0292] In some aspects, the first encapsulation layer can comprise about 50 wt% of the total mass of the coated particle. In some aspects, the first encapsulation layer can comprise about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, or about 80 wt% of the total mass of the coated particle.

[0293] In some aspects, the first drug layer can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone relative to the total mass of the coated particle, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% of the first polymer relative to the total mass of the coated particle, wherein the first polymer can comprise hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing, and from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, fromabout 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% of the second polymer relative to the total mass of the coated particle, wherein the second polymer can comprise hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing.

[0294] In some aspects, the first drug layer can comprise from about 15 wt% to about 95 wt% amorphous vamorolone, the inert core can comprise from about 5 wt% to about 90 wt% of a total mass of the coated particle, the first drug layer can comprise from about 30 wt% to about 80 wt% of the total mass of the coated particle, and the first encapsulation layer can comprise from about 30 wt% to about 80 wt% of the total mass of the coated particle.

[0295] In some aspects, the plurality of coated particles can further comprise additional drug layers, i.e., a second drug layer, a third drug layer, a fourth drug layer, etc., and / or additional encapsulation layers, i.e., a second encapsulation layer, a third encapsulation layer, a fourth encapsulation layer, etc. These layers can have any of compositions described above for the first drug layer and first encapsulation layer, respectively.

[0296] In some aspects, the inert core can be a microcrystalline cellulose sphere, the inert core can comprise from about 10 wt% to about 80 wt% of a total mass of the coated particle and the first drug layer can comprise from about 10 wt% to about 60 wt% amorphous vamorolone and from about 10 wt% to about 80 wt% of the first polymer, e.g., HPMCAS, HPMC, HPC, povidone, copovidone, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), or methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L100).

[0297] In some aspects, the inert core can be a microcrystalline cellulose sphere, a sugar sphere, a silica sphere, dicalcium phosphate anhydrous, magnesium alumino-metasilicate, microcrystalline cellulose, or a combination of any of the foregoing, the inert core can comprise from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, fromabout 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 5 wt% to about 85 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 15 wt% to about 90 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 90 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 90 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 90 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 90 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 90 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 90 wt%, or from about 85 wt% to about 90 wt% of the total mass of the coated particle, the first drug layer can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt%to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone relative to the total mass of the coated particle and from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% of the first polymer relative to the total mass of the coated particle, wherein the first polymer can comprise hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing, and the first encapsulation layer can comprise from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, or from about 70 wt% to about 80 wt% of the total mass of the coated particle, wherein the first encapsulation layer can comprise from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt%to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% of the second polymer relative to the total mass of the coated particle, wherein the second polymer can comprise hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing,.

[0298] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the coated particles, optionally one or more diluents having a wt% as described below, optionally one or more disintegrants having a wt% as described below, optionally one or more lubricants having a wt% as described below, optionally one or more flow enhancers having a wt% as described below, optionally one or more suspending agents having a wt% as described below, optionally one or more buffering agents having a wt% as described below, optionally one or more wetting agents having a wt% as described below, optionally one or more preservatives having a wt% as described below, optionally one or more flavoring agents having a wt% as described below, and optionally one or more flow enhancers having a wt% as described below. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 20 wt% to about 90 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 80 wt%, from about 30 wt%to about 90 wt%, from about 30 wt% to about 95 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 40 wt% to about 90 wt%, from about 40 wt% to about 95 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 50 wt% to about 90 wt%, from about 50 wt% to about 95 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, from about 60 wt% to about 90 wt%, from about 60 wt% to about 95 wt%, from about 70 wt% to about 80 wt%, from about 70 wt% to about 90 wt%, from about 70 wt% to about 95 wt%, from about 80 wt% to about 90 wt%, from about 80 wt% to about 95 wt%, or from about 90 wt% to about 95 wt% of the coated particles.

[0299] In some aspects, the pharmaceutical composition can comprise about 80 wt% of the coated particle. In some aspects, the pharmaceutical composition can comprise about 5 wt%, about 10 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 85 wt%, about 90 wt%, or about 95 wt% of the coated particles.

[0300] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 20 wt% to about 90 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 80 wt%, from about 30 wt% to about 90 wt%, from about 30 wt% to about 95 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 40 wt% to about 90 wt%, from about 40 wt% to about 95 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 50 wt% to about 90 wt%, from about 50 wt% to about 95 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, from about 60 wt% to about 90 wt%, from about 60 wt% to about 95 wt%, from about 70 wt% to about 80 wt%, from about 70 wt% to about 90 wt%, from about 70 wt% to about 95 wt%, from about 80 wt% to about 90 wt%, from about 80 wt% to about 95 wt%, or from about 90 wt% to about 95 wt% of the coated particles, and from about 5 wt% to about 15 wt%, about 5 wt% to about 25 wt%, about 5wt% to about 35 wt%, about 5 wt% to about 45 wt%, about 5 wt% to about 55 wt%, about 5 wt% to about 65 wt%, about 5 wt% to about 75 wt%, about 15 wt% to about 25 wt%, about 15 wt% to about 35 wt%, about 15 wt% to about 45 wt%, about 15 wt% to about 55 wt%, about 15 wt% to about 65 wt%, about 15 wt% to about 75 wt%, about 15 wt% to about 85 wt%, about 25 wt% to about 35 wt%, about 25 wt% to about 45 wt%, about 25 wt% to about 55 wt%, about 25 wt% to about 65 wt%, about 25 wt% to about 75 wt%, about 25 wt% to about 85 wt%, about 35 wt% to about 45 wt%, about 35 wt% to about 55 wt%, about 35 wt% to about 65 wt%, about 35 wt% to about 75 wt%, about 35 wt% to about 85 wt%, about 45 wt% to about 55 wt%, about 45 wt% to about 65 wt%, about 45 wt% to about 75 wt%, about 45 wt% to about 85 wt%, about 55 wt% to about 65 wt%, about 55 wt% to about 75 wt%, about 55 wt% to about 85 wt%, about 65 wt% to about 75 wt%, about 65 wt% to about 85 wt%, or about 75 wt% to about 85 wt% of one or more diluents, wherein the one or more diluents can comprise microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, sucrose, starch, pregelatinized starch (partially or fully gelatinized), dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate, maltodextrin, or a combination of any of the foregoing.

[0301] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 20 wt% to about 90 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 80 wt%, from about 30 wt% to about 90 wt%, from about 30 wt% to about 95 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 40 wt% to about 90 wt%, from about 40 wt% to about 95 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 50 wt% to about 90 wt%, from about 50 wt% to about 95 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, from about 60 wt% to about 90 wt%, from about 60 wt% to about 95 wt%, from about 70 wt% to about 80 wt%, from about 70 wt% to about 90 wt%, from about 70 wt% to about 95 wt%, from about 80 wt% to about 90 wt%, from about 80 wt% to about 95 wt%, or from about 90 wt% to about 95 wt% of the coatedparticles, from about 5 wt% to about 15 wt%, about 5 wt% to about 25 wt%, about 5 wt% to about 35 wt%, about 5 wt% to about 45 wt%, about 5 wt% to about 55 wt%, about 5 wt% to about 65 wt%, about 5 wt% to about 75 wt%, about 15 wt% to about 25 wt%, about 15 wt% to about 35 wt%, about 15 wt% to about 45 wt%, about 15 wt% to about 55 wt%, about 15 wt% to about 65 wt%, about 15 wt% to about 75 wt%, about 15 wt% to about 85 wt%, about 25 wt% to about 35 wt%, about 25 wt% to about 45 wt%, about 25 wt% to about 55 wt%, about 25 wt% to about 65 wt%, about 25 wt% to about 75 wt%, about 25 wt% to about 85 wt%, about 35 wt% to about 45 wt%, about 35 wt% to about 55 wt%, about 35 wt% to about 65 wt%, about 35 wt% to about 75 wt%, about 35 wt% to about 85 wt%, about 45 wt% to about 55 wt%, about 45 wt% to about 65 wt%, about 45 wt% to about 75 wt%, about 45 wt% to about 85 wt%, about 55 wt% to about 65 wt%, about 55 wt% to about 75 wt%, about 55 wt% to about 85 wt%, about 65 wt% to about 75 wt%, about 65 wt% to about 85 wt%, or about 75 wt% to about 85 wt% of one or more diluents, wherein the one or more diluents can comprise microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, sucrose, starch, pregelatinized starch (partially or fully gelatinized), dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate, maltodextrin, or a combination of any of the foregoing, and from about 0.25 wt% to about 0.5 wt%, from about 0.25 wt% to about 1 wt%, from about 0.25 wt% to about 2.5 wt%, from about 0.25 wt% to about 5 wt%, from about 0.25 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of one or more disintegrants, wherein the one or more disintegrants can comprise croscarmellose sodium, carmellose sodium, sodium starch glycolate (e.g., type A or B), carboxymethylcellulose sodium, carboxymethylcellulose calcium, crospovidone, starch, microcrystalline cellulose, low- substituted hydroxypropyl cellulose (e.g., LH-21), or a combination of any of the foregoing.

[0302] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 20 wt% to about 90 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 80 wt%, from about 30 wt% to about 90 wt%, from about 30 wt% to about 95 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 40 wt% to about 90 wt%, from about 40 wt% to about 95 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 50 wt% to about 90 wt%, from about 50 wt% to about 95 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, from about 60 wt% to about 90 wt%, from about 60 wt% to about 95 wt%, from about 70 wt% to about 80 wt%, from about 70 wt% to about 90 wt%, from about 70 wt% to about 95 wt%, from about 80 wt% to about 90 wt%, from about 80 wt% to about 95 wt%, or from about 90 wt% to about 95 wt% of the coated particles, from about 5 wt% to about 15 wt%, about 5 wt% to about 25 wt%, about 5 wt% to about 35 wt%, about 5 wt% to about 45 wt%, about 5 wt% to about 55 wt%, about 5 wt% to about 65 wt%, about 5 wt% to about 75 wt%, about 15 wt% to about 25 wt%, about 15 wt% to about 35 wt%, about 15 wt% to about 45 wt%, about 15 wt% to about 55 wt%, about 15 wt% to about 65 wt%, about 15 wt% to about 75 wt%, about 15 wt% to about 85 wt%, about 25 wt% to about 35 wt%, about 25 wt% to about 45 wt%, about 25 wt% to about 55 wt%, about 25 wt% to about 65 wt%, about 25 wt% to about 75 wt%, about 25 wt% to about 85 wt%, about 35 wt% to about 45 wt%, about 35 wt% to about 55 wt%, about 35 wt% to about 65 wt%, about 35 wt% to about 75 wt%, about 35 wt% to about 85 wt%, about 45 wt% to about 55 wt%, about 45 wt% to about 65 wt%, about 45 wt% to about 75 wt%, about 45 wt% to about 85 wt%, about 55 wt% to about 65 wt%, about 55 wt% to about 75 wt%, about 55 wt% to about 85 wt%, about 65 wt% to about 75 wt%, about 65 wt% to about 85 wt%, or about 75 wt% to about 85 wt% of one or more diluents, wherein the one or more diluents can comprise microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, sucrose, starch, pregelatinized starch (partially or fully gelatinized), dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocesseddicalcium phosphate, maltodextrin, or a combination of any of the foregoing, from about 0.25 wt% to about 0.5 wt%, from about 0.25 wt% to about 1 wt%, from about 0.25 wt% to about 2.5 wt%, from about 0.25 wt% to about 5 wt%, from about 0.25 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of one or more disintegrants, wherein the one or more disintegrants can comprise croscarmellose sodium, carmellose sodium, sodium starch glycolate (e.g., type A or B), carboxymethylcellulose sodium, carboxymethylcellulose calcium, crospovidone, starch, microcrystalline cellulose, low- substituted hydroxypropyl cellulose (e.g., LH-21), or a combination of any of the foregoing, and from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1 wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of one or more lubricants, wherein the one or more lubricants can comprise magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination of any of the foregoing.

[0303] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 20 wt% to about 90 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 80 wt%, from about 30 wt% to about 90 wt%, from about 30 wt% to about 95 wt%, from about 40 wt%to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 40 wt% to about 90 wt%, from about 40 wt% to about 95 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 50 wt% to about 90 wt%, from about 50 wt% to about 95 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, from about 60 wt% to about 90 wt%, from about 60 wt% to about 95 wt%, from about 70 wt% to about 80 wt%, from about 70 wt% to about 90 wt%, from about 70 wt% to about 95 wt%, from about 80 wt% to about 90 wt%, from about 80 wt% to about 95 wt%, or from about 90 wt% to about 95 wt% of the coated particles, from about 5 wt% to about 15 wt%, about 5 wt% to about 25 wt%, about 5 wt% to about 35 wt%, about 5 wt% to about 45 wt%, about 5 wt% to about 55 wt%, about 5 wt% to about 65 wt%, about 5 wt% to about 75 wt%, about 15 wt% to about 25 wt%, about 15 wt% to about 35 wt%, about 15 wt% to about 45 wt%, about 15 wt% to about 55 wt%, about 15 wt% to about 65 wt%, about 15 wt% to about 75 wt%, about 15 wt% to about 85 wt%, about 25 wt% to about 35 wt%, about 25 wt% to about 45 wt%, about 25 wt% to about 55 wt%, about 25 wt% to about 65 wt%, about 25 wt% to about 75 wt%, about 25 wt% to about 85 wt%, about 35 wt% to about 45 wt%, about 35 wt% to about 55 wt%, about 35 wt% to about 65 wt%, about 35 wt% to about 75 wt%, about 35 wt% to about 85 wt%, about 45 wt% to about 55 wt%, about 45 wt% to about 65 wt%, about 45 wt% to about 75 wt%, about 45 wt% to about 85 wt%, about 55 wt% to about 65 wt%, about 55 wt% to about 75 wt%, about 55 wt% to about 85 wt%, about 65 wt% to about 75 wt%, about 65 wt% to about 85 wt%, or about 75 wt% to about 85 wt% of one or more diluents, wherein the one or more diluents can comprise microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, sucrose, starch, pregelatinized starch (partially or fully gelatinized), dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate, maltodextrin, or a combination of any of the foregoing, from about 0.25 wt% to about 0.5 wt%, from about 0.25 wt% to about 1 wt%, from about 0.25 wt% to about 2.5 wt%, from about 0.25 wt% to about 5 wt%, from about 0.25 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%,from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of one or more disintegrants, wherein the one or more disintegrants can comprise croscarmellose sodium, carmellose sodium, sodium starch glycolate (e.g., type A or B), carboxymethylcellulose sodium, carboxymethylcellulose calcium, crospovidone, starch, microcrystalline cellulose, low- substituted hydroxypropyl cellulose (e.g., LH-21), or a combination of any of the foregoing, from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1 wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of one or more lubricants, wherein the one or more lubricants can comprise magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination of any of the foregoing, and from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1 wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of one or more flow enhancers, wherein the one or more flow enhancers can comprise magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination of any of the foregoing.

[0304] In some aspects, the pharmaceutical composition can be prepared by fluid bed drug layering.

[0305] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the plurality of coated particles and optionally from about 5 wt% to about 85 wt% of one or more diluents. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the plurality of coated particles, optionally from about 5 wt% to about 85 wt% of one or more diluents, and optionally from about 0.25 wt% to about 10 wt% of one or more disintegrants. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the plurality of coated particles, optionally from about 5 wt% to about 85 wt% of one or more diluents, optionally from about 0.25 wt% to about 10 wt% of one or more disintegrants, and optionally from about 0.1 wt% to about 5 wt% of one or more lubricants. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the plurality of coated particles, optionally from about 5 wt% to about 85 wt% of one or more diluents, optionally from about 0.25 wt% to about 10 wt% of one or more disintegrants, optionally from about 0.1 wt% to about 5 wt% of one or more lubricants, and optionally from about 0.1 wt% to about 5 wt% of one or more flow enhancers.

[0306] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the plurality of coated particles and optionally from about 5 wt% to about 80 wt% of one or more suspending agents. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the plurality of coated particles, optionally from about 5 wt% to about 80 wt% of one or more suspending agents, and optionally from about 0.1 wt% to about 5 wt% of one or more buffering agents. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the plurality of coated particles, optionally from about 5 wt% to about 80 wt% of one or more suspending agents, optionally from about 0.1 wt% to about 5 wt% of one or more buffering agents, and optionally from about 0.1 wt% to about 10 wt% of one or more wetting agents. In some aspects, the pharmaceutical composition comp can comprise from about 20 wt% to about 95 wt% of the plurality of coated particles, optionally from about 5 wt% to about 80 wt% of one or more suspending agents, optionally from about 0.1 wt% to about 5 wt% of one or more buffering agents, optionally from about 0.1 wt% to about 10 wt% of one or more wetting agents, and optionally from about 0.1 wt% to about 5 wt% of one or more preservatives. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95wt% of the plurality of coated particles, optionally from about 5 wt% to about 80 wt% of one or more suspending agents, optionally from about 0.1 wt% to about 5 wt% of one or more buffering agents, optionally from about 0.1 wt% to about 10 wt% of one or more wetting agents, optionally from about 0.1 wt% to about 5 wt% of one or more preservatives, and from about 0.1 wt% to about 5 wt% of one or more flavoring agents. In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 95 wt% of the plurality of coated particles, optionally from about 5 wt% to about 80 wt% of one or more suspending agents, optionally from about 0.1 wt% to about 5 wt% of one or more buffering agents, optionally from about 0.1 wt% to about 10 wt% of one or more wetting agents, optionally from about 0.1 wt% to about 5 wt% of one or more preservatives, from about 0.1 wt% to about 5 wt% of one or more flavoring agents, and from about 0.1 wt% to about 5 wt% of one or more flow enhancers.

[0307] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 20 wt% to about 90 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 80 wt%, from about 30 wt% to about 90 wt%, from about 30 wt% to about 95 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 40 wt% to about 90 wt%, from about 40 wt% to about 95 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 50 wt% to about 90 wt%, from about 50 wt% to about 95 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, from about 60 wt% to about 90 wt%, from about 60 wt% to about 95 wt%, from about 70 wt% to about 80 wt%, from about 70 wt% to about 90 wt%, from about 70 wt% to about 95 wt%, from about 80 wt% to about 90 wt%, from about 80 wt% to about 95 wt%, or from about 90 wt% to about 95 wt% of the coated particles and from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt%to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 80 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 80 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 80 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 80 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 80 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 80 wt%, or from about 75 wt% to about 80 wt% of one or more suspending agents, wherein the one or more suspending agents can comprise hydroxypropyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, carbomer, xantham gum, starch, pregelatinized starch, sodium alginate, or a combination of any of the foregoing.

[0308] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 20 wt% to about 90 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 80 wt%, from about 30 wt% to about 90 wt%, from about 30 wt% to about 95 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 40 wt% to about 90 wt%, from about 40 wt% to about 95 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 50 wt% to about 90 wt%, from about 50 wt% to about 95 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, from about 60 wt% to about 90 wt%, from about 60 wt% to about 95 wt%, from about 70 wt% to about 80 wt%, from about 70 wt% to about 90 wt%, from about 70 wt% to about 95 wt%, from about 80 wt% to about 90 wt%, from about 80 wt% to about 95 wt%, or from about 90 wt% to about 95 wt% of the coated particles, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%,from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 80 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 80 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 80 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 80 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 80 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 80 wt%, or from about 75 wt% to about 80 wt% of one or more suspending agents, wherein the one or more suspending agents can comprise hydroxypropyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, carbomer, xantham gum, starch, pregelatinized starch, sodium alginate, or a combination of any of the foregoing, and from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1 wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of one or more buffering agents, wherein the one or more buffering agents can comprise a citrate buffer, a phosphate buffer, a carbonate buffer, or a combination of any of the foregoing.

[0309] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 20 wt% to about 90 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 80 wt%, from about 30 wt% to about 90 wt%, from about 30 wt% to about 95 wt%, from about 40 wt%to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 40 wt% to about 90 wt%, from about 40 wt% to about 95 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 50 wt% to about 90 wt%, from about 50 wt% to about 95 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, from about 60 wt% to about 90 wt%, from about 60 wt% to about 95 wt%, from about 70 wt% to about 80 wt%, from about 70 wt% to about 90 wt%, from about 70 wt% to about 95 wt%, from about 80 wt% to about 90 wt%, from about 80 wt% to about 95 wt%, or from about 90 wt% to about 95 wt% of the coated particles, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 80 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 80 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 80 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 80 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 80 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 80 wt%, or from about 75 wt% to about 80 wt% of one or more suspending agents, wherein the one or more suspending agents can comprise hydroxypropyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, carbomer, xantham gum, starch, pregelatinized starch, sodium alginate, or a combination of any of the foregoing, from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of one or more buffering agents, wherein the one or more buffering agents can comprise a citrate buffer, a phosphate buffer, a carbonate buffer, or a combination of any of the foregoing, and from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2.5 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of one or more wetting agents, wherein the one or more wetting agents can comprise sodium lauryl sulfate, a poloxamer, a polysorbate, or a combination of any of the foregoing.

[0310] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 20 wt% to about 90 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 80 wt%, from about 30 wt% to about 90 wt%, from about 30 wt% to about 95 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 40 wt% to about 90 wt%, from about 40 wt% to about 95 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 50 wt% to about 90 wt%, from about 50 wt% to about 95 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, from about 60 wt% to about 90 wt%, from about 60 wt% to about 95 wt%, from about 70 wt% to about 80 wt%, from about 70 wt% to about 90 wt%, from about 70 wt% to about 95 wt%, from about 80 wt% to about 90 wt%, from about 80 wt% to about 95 wt%, or from about 90 wt% to about 95 wt% of the coated particles, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, fromabout 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 80 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 80 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 80 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 80 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 80 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 80 wt%, or from about 75 wt% to about 80 wt% of one or more suspending agents, wherein the one or more suspending agents can comprise hydroxypropyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, carbomer, xantham gum, starch, pregelatinized starch, sodium alginate, or a combination of any of the foregoing, from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1 wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of one or more buffering agents, wherein the one or more buffering agents can comprise a citrate buffer, a phosphate buffer, a carbonate buffer, or a combination of any of the foregoing, from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2.5 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% toabout 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of one or more wetting agents, wherein the one or more wetting agents can comprise sodium lauryl sulfate, a poloxamer, a polysorbate, or a combination of any of the foregoing, and from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1 wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of one or more preservatives, wherein the one or more preservatives can comprise methyl paraben, propyl paraben, sodium benzoate, citric acid, ascorbic acid, or a combination of any of the foregoing.

[0311] In some aspects, the pharmaceutical composition can comprise from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 20 wt% to about 90 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 80 wt%, from about 30 wt% to about 90 wt%, from about 30 wt% to about 95 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 40 wt% to about 90 wt%, from about 40 wt% to about 95 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 50 wt% to about 90 wt%, from about 50 wt% to about 95 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, from about 60 wt% to about 90 wt%, from about 60 wt% to about 95 wt%, from about 70 wt% to about 80 wt%, from about 70 wt% to about 90 wt%, from about 70 wt% to about 95 wt%, from about 80 wt% to about 90 wt%, from about 80 wt% to about 95 wt%, or from about 90 wt% to about 95 wt% of the coatedparticles, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 80 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 80 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 80 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 80 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 80 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 80 wt%, or from about 75 wt% to about 80 wt% of one or more suspending agents, wherein the one or more suspending agents can comprise hydroxypropyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, carbomer, xantham gum, starch, pregelatinized starch, sodium alginate, or a combination of any of the foregoing, from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1 wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of one or more buffering agents, wherein the one or more buffering agents can comprise a citrate buffer, a phosphate buffer, a carbonate buffer, or a combination of any of the foregoing, from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2.5 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of one or more wetting agents, wherein the one or more wetting agents can comprise sodium lauryl sulfate, a poloxamer, a polysorbate, or a combination of any of the foregoing, from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1 wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of one or more preservatives, wherein the one or more preservatives can comprise methyl paraben, propyl paraben, sodium benzoate, citric acid, ascorbic acid, or a combination of any of the foregoing, and from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1 wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of one or more flavoring agents, wherein the one or more flavoring agents can comprise sucrose, aspartame, an artificial flavor (e.g, peppermint, bubblegum, or grape), a natural flavor, or a combination of any of the foregoing.

[0312] The present disclosure also provides pharmaceutical compositions comprising: a) a plurality of coated particles, wherein each coated particle comprises: i) a core comprising amorphous vamorolone and a first polymer; andii) a first encapsulation layer coated over the core, the first encapsulation layer comprising a second polymer; and b) optionally one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is a solid oral dosage form.

[0313] In some aspects, the core comprising amorphous vamorolone and a first polymer can be an amorphous solid dispersion in the form of a granule or pellet, e.g., one of the amorphous solid dispersions described above. In some aspects, the core comprising amorphous vamorolone and a first polymer can be an amorphous solid dispersion in the form of a granule or pellet comprising from about 15 wt% to about 95 wt% amorphous vamorolone, from about 5 wt% to about 85 wt% of the first polymer, optionally from about 0.1 wt% to about 25 wt% of a plasticizer, optionally from about 0.1 wt% to about 10 wt% of a surfactant, optionally from about 1 wt% to about 40 wt% of a solubilizing agent, and optionally from about 10 wt% to about 80 wt% of a filler.

[0314] In some aspects, the core comprising amorphous vamorolone and a first polymer can be an amorphous solid dispersion in the form of a granule or pellet comprising from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone and from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the first polymer, wherein the first polymer can comprise hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate- polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing.

[0315] In some aspects, the core comprising amorphous vamorolone and a first polymer can be an amorphous solid dispersion in the form of a granule or pellet comprising from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt%to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the first polymer, wherein the first polymer can comprise hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing, and from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 25 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 25 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 25 wt%, from about 15 wt% to about 20 wt%, from about 15 wt% to about 25 wt%, or from about 20 wt% to about 25 wt% of a plasticizer, wherein the plasticizer can comprise a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g.,diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing.

[0316] In some aspects, the core comprising amorphous vamorolone and a first polymer can be an amorphous solid dispersion in the form of a granule or pellet comprising from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the first polymer, wherein the first polymer can comprise hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 25 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 25 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 25 wt%, from about 15 wt% to about 20 wt%, from about 15 wt% to about 25 wt%, or from about 20 wt% to about 25 wt% of a plasticizer, wherein the plasticizer can comprise a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing, and from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2.5 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of a surfactant, wherein the surfactant can comprise sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; apolysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing.

[0317] In some aspects, the core comprising amorphous vamorolone and a first polymer can be an amorphous solid dispersion in the form of a granule or pellet comprising from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the first polymer, wherein the first polymer can comprise hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 25 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 25 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 25 wt%, from about 15 wt% to about 20 wt%, from about 15 wt% to about 25 wt%, or from about 20 wt% to about 25 wt% of a plasticizer, wherein the plasticizer can comprise a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing, from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2.5 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of a surfactant, wherein the surfactant can comprise sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; apolysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing, and from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 30 wt%, %, from about 5 wt% to about 10 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 30 wt%, from about 5 wt% to about 40 wt%,%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 30 wt%, from about 10 wt% to about 40 wt%,%, from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, or from about 30 wt% to about 40 wt% of a solubilizing agent, such as a cyclodextrin.

[0318] In some aspects, the core comprising amorphous vamorolone and a first polymer can be an amorphous solid dispersion in the form of a granule or pellet comprising from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15 wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 25 wt% to about 95 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 35 wt% to about 95 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 45 wt% to about 95 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 55 wt% to about 95 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, from about 65 wt% to about 95 wt%, from about 75 wt% to about 85 wt%, from about 75 wt% to about 95 wt%, or from about 85 wt% to about 95 wt% amorphous vamorolone, from about 5 wt% to about 15 wt%, from about 5 wt% to about 25 wt%, from about 5 wt% to about 35 wt%, from about 5 wt% to about 45 wt%, from about 5 wt% to about 55 wt%, from about 5 wt% to about 65 wt%, from about 5 wt% to about 75 wt%, from about 15 wt% to about 25 wt%, from about 15 wt% to about 35 wt%, from about 15 wt% to about 45 wt%, from about 15 wt% to about 55 wt%, from about 15wt% to about 65 wt%, from about 15 wt% to about 75 wt%, from about 15 wt% to about 85 wt%, from about 25 wt% to about 35 wt%, from about 25 wt% to about 45 wt%, from about 25 wt% to about 55 wt%, from about 25 wt% to about 65 wt%, from about 25 wt% to about 75 wt%, from about 25 wt% to about 85 wt%, from about 35 wt% to about 45 wt%, from about 35 wt% to about 55 wt%, from about 35 wt% to about 65 wt%, from about 35 wt% to about 75 wt%, from about 35 wt% to about 85 wt%, from about 45 wt% to about 55 wt%, from about 45 wt% to about 65 wt%, from about 45 wt% to about 75 wt%, from about 45 wt% to about 85 wt%, from about 55 wt% to about 65 wt%, from about 55 wt% to about 75 wt%, from about 55 wt% to about 85 wt%, from about 65 wt% to about 75 wt%, from about 65 wt% to about 85 wt%, or from about 75 wt% to about 85 wt% of the first polymer, wherein the first polymer can comprise hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 10 wt%, from about 0.1 wt% to about 15 wt%, from about 0.1 wt% to about 20 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 15 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 25 wt%, from about 5 wt% to about 10 wt%, from about 5 wt% to about 15 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 25 wt%, from about 10 wt% to about 15 wt%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 25 wt%, from about 15 wt% to about 20 wt%, from about 15 wt% to about 25 wt%, or from about 20 wt% to about 25 wt% of a plasticizer, wherein the plasticizer can comprise a citrate ester, e.g., triethyl citrate, tributyl citrate, acetyl triethyl citrate, or acetyl tributyl citrate; a fatty acid ester, e.g., butyl stearate, glycerol monostearate, or stearyl alcohol; a phthalate ester, e.g., diethyl phthalate or dibutyl phthalate; poly(ethylene glycol), e.g., having a molecular weight of from about 400 to about 3,500; poly(propylene glycol); tocopherol polyethylene glycol succinate; dibutyl sebacate; triacetin; a polysorbate; a sugar alcohol, e.g., sorbitol, xylitol, lactitol, or erythriol; or a combination of any of the foregoing, from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2.5 wt%, from about 0.1 wt% to about 5 wt%, from about 0.1 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%,from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of a surfactant, wherein the surfactant can comprise sodium lauryl sulfate; a poloxamer, e.g., P188 or P407; a polysorbate, e.g., T80; tocopherol polyethylene glycol succinate; poly(ethylene glycol), e.g., having a molecular weight of from about 3,350 to about 8,000; a fatty acid triglyceride, e.g., LABRASOL® or GELUCIRE® (e.g., grade 48 / 16, 59 / 14, 50 / 13, 44 / 14, or 43 / 01); or a combination of any of the foregoing, optionally from about 1 wt% to about 5 wt%, from about 1 wt% to about 10 wt%, from about 1 wt% to about 20 wt%, from about 1 wt% to about 30 wt%, %, from about 5 wt% to about 10 wt%, from about 5 wt% to about 20 wt%, from about 5 wt% to about 30 wt%, from about 5 wt% to about 40 wt%,%, from about 10 wt% to about 20 wt%, from about 10 wt% to about 30 wt%, from about 10 wt% to about 40 wt%,%, from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, or from about 30 wt% to about 40 wt% of a solubilizing agent, such as a cyclodextrin, and from about 10 wt% to about 20 wt%, from about 10 wt% to about 30 wt%, from about 10 wt% to about 40 wt%, from about 10 wt% to about 50 wt%, from about 10 wt% to about 60 wt%, from about 10 wt% to about 70 wt%, from about 20 wt% to about 30 wt%, from about 20 wt% to about 40 wt%, from about 20 wt% to about 50 wt%, from about 20 wt% to about 60 wt%, from about 20 wt% to about 70 wt%, from about 20 wt% to about 80 wt%, from about 30 wt% to about 40 wt%, from about 30 wt% to about 50 wt%, from about 30 wt% to about 60 wt%, from about 30 wt% to about 70 wt%, from about 30 wt% to about 30 wt%, from about 40 wt% to about 50 wt%, from about 40 wt% to about 60 wt%, from about 40 wt% to about 70 wt%, from about 40 wt% to about 80 wt%, from about 50 wt% to about 60 wt%, from about 50 wt% to about 70 wt%, from about 50 wt% to about 80 wt%, from about 60 wt% to about 70 wt%, from about 60 wt% to about 80 wt%, or from about 70 wt% to about 80 wt% of a filler, wherein the filler can comprise microcrystalline cellulose (e.g., standard (PH grades), fibrous (KG grades), or mixed (UF grades)), silicified microcrystalline cellulose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylmethyl cellulose, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethylcellulose, povidone, copovidone, lactose monohydrate, lactose anhydrous, mannitol, sucrose, dextrates (EMDEX® or CAMDEX®), maltodextrin, polydextrose, starch, pregelatinized starch (partially or fully gelatinized), hydroxypropyl starch, carbomer, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate and maltodextrin, polycarbophil, or a combination of any of the foregoing. Tablet or Capsule Solid Oral Dosage Forms

[0319] In some aspects, the solid oral dosage forms described above can be a tablet or a capsule. For example, the amorphous solid dispersions or coated particles described above can be blended with one or more pharmaceutical excipients, e.g., excipients appropriate for a tablet or capsule solid oral dosage form, and then can be compressed into a table or filled into, for example, a hard or soft gelatin capsule.

[0320] In some aspects, the one or more pharmaceutically acceptable excipients can comprise one or more diluents, one or more disintegrants, one or more lubricants, one or more flow enhancers, or a combination of any of the foregoing.

[0321] In some aspects, the one or more pharmaceutically acceptable excipients can comprise one or more diluents. In some aspects, the one or more diluents can comprise microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, sucrose, starch, pregelatinized starch (partially or fully gelatinized), dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate, maltodextrin, or a combination of any of the foregoing.

[0322] In some aspects, the pharmaceutical composition can comprise from about 5 wt% to about 85 wt% of the one or more diluents. In some aspects, the pharmaceutical composition can comprise from about 5 wt% to about 15 wt%, about 5 wt% to about 25 wt%, about 5 wt% to about 35 wt%, about 5 wt% to about 45 wt%, about 5 wt% to about 55 wt%, about 5 wt% to about 65 wt%, about 5 wt% to about 75 wt%, about 15 wt% to about 25 wt%, about 15 wt% to about 35 wt%, about 15 wt% to about 45 wt%, about 15 wt% to about 55 wt%, about 15 wt% to about 65 wt%, about 15 wt% to about 75 wt%, about 15 wt% to about 85 wt%, about 25 wt% to about 35 wt%, about 25 wt% to about 45 wt%, about 25 wt% to about 55 wt%, about 25 wt% to about 65 wt%, about 25 wt% to about 75 wt%, about 25 wt% to about 85 wt%, about 35 wt% to about 45 wt%, about 35wt% to about 55 wt%, about 35 wt% to about 65 wt%, about 35 wt% to about 75 wt%, about 35 wt% to about 85 wt%, about 45 wt% to about 55 wt%, about 45 wt% to about 65 wt%, about 45 wt% to about 75 wt%, about 45 wt% to about 85 wt%, about 55 wt% to about 65 wt%, about 55 wt% to about 75 wt%, about 55 wt% to about 85 wt%, about 65 wt% to about 75 wt%, about 65 wt% to about 85 wt%, or about 75 wt% to about 85 wt% of the one or more diluents.

[0323] In some aspects, the pharmaceutical composition can comprise about 20 wt% of the one or more diluents. In some aspects, the pharmaceutical composition can comprise about 5 wt%, about 10 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, or about 85 wt% of the one or more diluents.

[0324] In some aspects, the one or more pharmaceutically acceptable excipients can comprise one or more disintegrants. In some aspects, the one or more disintegrants can comprise croscarmellose sodium, carmellose sodium, sodium starch glycolate (e.g., type A or B), carboxymethylcellulose sodium, carboxymethylcellulose calcium, crospovidone, starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose (e.g., LH-21), or a combination of any of the foregoing.

[0325] In some aspects, the pharmaceutical composition can comprise from about 0.25 wt% to about 10 wt% of the one or more disintegrants. In some aspects, the pharmaceutical composition can comprise from about 0.25 wt% to about 0.5 wt%, from about 0.25 wt% to about 1 wt%, from about 0.25 wt% to about 2.5 wt%, from about 0.25 wt% to about 5 wt%, from about 0.25 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of the one or more disintegrants.

[0326] In some aspects, the pharmaceutical composition can comprise about 5 wt% of the one or more disintegrants. In some aspects, the pharmaceutical composition can comprise about 0.25 wt%, about 0.5 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%,about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, or about 10 wt% of the one or more disintegrants.

[0327] In some aspects, the pharmaceutical composition can comprise from about 5 wt% to about 15 wt%, about 5 wt% to about 25 wt%, about 5 wt% to about 35 wt%, about 5 wt% to about 45 wt%, about 5 wt% to about 55 wt%, about 5 wt% to about 65 wt%, about 5 wt% to about 75 wt%, about 15 wt% to about 25 wt%, about 15 wt% to about 35 wt%, about 15 wt% to about 45 wt%, about 15 wt% to about 55 wt%, about 15 wt% to about 65 wt%, about 15 wt% to about 75 wt%, about 15 wt% to about 85 wt%, about 25 wt% to about 35 wt%, about 25 wt% to about 45 wt%, about 25 wt% to about 55 wt%, about 25 wt% to about 65 wt%, about 25 wt% to about 75 wt%, about 25 wt% to about 85 wt%, about 35 wt% to about 45 wt%, about 35 wt% to about 55 wt%, about 35 wt% to about 65 wt%, about 35 wt% to about 75 wt%, about 35 wt% to about 85 wt%, about 45 wt% to about 55 wt%, about 45 wt% to about 65 wt%, about 45 wt% to about 75 wt%, about 45 wt% to about 85 wt%, about 55 wt% to about 65 wt%, about 55 wt% to about 75 wt%, about 55 wt% to about 85 wt%, about 65 wt% to about 75 wt%, about 65 wt% to about 85 wt%, or about 75 wt% to about 85 wt% of the one or more diluents, wherein the one or more diluents can comprise microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, sucrose, starch, pregelatinized starch (partially or fully gelatinized), dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate, maltodextrin, or a combination of any of the foregoing, and from about 0.25 wt% to about 0.5 wt%, from about 0.25 wt% to about 1 wt%, from about 0.25 wt% to about 2.5 wt%, from about 0.25 wt% to about 5 wt%, from about 0.25 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of the one or more disintegrants, wherein the one or more disintegrants can comprise croscarmellose sodium, carmellose sodium, sodium starch glycolate (e.g., type A or B), carboxymethylcellulose sodium, carboxymethylcellulose calcium, crospovidone, starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose (e.g., LH-21), or a combination of any of the foregoing.

[0328] In some aspects, the pharmaceutical composition can comprise one or more lubricants. In some aspects, the one or more lubricants can comprise magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination of any of the foregoing.

[0329] In some aspects, the pharmaceutical composition can comprise from about 0.1 wt% to about 5 wt% of the one or more lubricants. In some aspects, wherein the pharmaceutical composition can comprise from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1 wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of the one or more lubricants.

[0330] In some aspects, the pharmaceutical composition can comprise about 3 wt% of the one or more lubricants. In some aspects, the pharmaceutical composition can comprise about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 1.5 wt%, about 2 wt%, about 2.5 wt%, about 3.5 wt%, about 4 wt%, about 4.5 wt%, or about 5 wt% of the one or more lubricants.

[0331] In some aspects, the pharmaceutical composition can comprise from about 5 wt% to about 15 wt%, about 5 wt% to about 25 wt%, about 5 wt% to about 35 wt%, about 5 wt% to about 45 wt%, about 5 wt% to about 55 wt%, about 5 wt% to about 65 wt%, about 5 wt% to about 75 wt%, about 15 wt% to about 25 wt%, about 15 wt% to about 35 wt%, about 15 wt% to about 45 wt%, about 15 wt% to about 55 wt%, about 15 wt% to about 65 wt%, about 15 wt% to about 75 wt%, about 15 wt% to about 85 wt%, about 25 wt% to about 35 wt%, about 25 wt% to about 45 wt%, about 25 wt% to about 55 wt%, about 25 wt% to about 65 wt%, about 25 wt% to about 75 wt%, about 25 wt% to about 85 wt%, about 35 wt% to about 45 wt%, about 35 wt% to about 55 wt%, about 35 wt% to about 65 wt%, about 35 wt% to about 75 wt%, about 35 wt% to about 85 wt%, about 45 wt% to about 55 wt%, about 45 wt% to about 65 wt%, about 45 wt% to about 75 wt%,about 45 wt% to about 85 wt%, about 55 wt% to about 65 wt%, about 55 wt% to about 75 wt%, about 55 wt% to about 85 wt%, about 65 wt% to about 75 wt%, about 65 wt% to about 85 wt%, or about 75 wt% to about 85 wt% of the one or more diluents, wherein the one or more diluents can comprise microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, sucrose, starch, pregelatinized starch (partially or fully gelatinized), dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate, maltodextrin, or a combination of any of the foregoing, from about 0.25 wt% to about 0.5 wt%, from about 0.25 wt% to about 1 wt%, from about 0.25 wt% to about 2.5 wt%, from about 0.25 wt% to about 5 wt%, from about 0.25 wt% to about 7.5 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2.5 wt%, from about 0.5 wt% to about 5 wt%, from about 0.5 wt% to about 7.5 wt%, from about 0.5 wt% to about 10 wt%, from about 1 wt% to about 2.5 wt%, from about 1 wt% to about 5 wt%, from about 1 wt% to about 7.5 wt%, from about 1 wt% to about 10 wt%, from about 2.5 wt% to about 5 wt%, from about 2.5 wt% to about 7.5 wt%, from about 2.5 wt% to about 10 wt%, from about 5 wt% to about 7.5 wt%, from about 5 wt% to about 10 wt%, or from about 7.5 wt% to about 10 wt% of the one or more disintegrants, wherein the one or more disintegrants can comprise croscarmellose sodium, carmellose sodium, sodium starch glycolate (e.g., type A or B), carboxymethylcellulose sodium, carboxymethylcellulose calcium, crospovidone, starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose (e.g., LH-21), or a combination of any of the foregoing, and from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1 wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of the one or more lubricants, wherein the one or more lubricants can comprise magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination of any of the foregoing.

[0332] In some aspects, the pharmaceutical composition can comprise one or more flow enhancers (also referred to as a glidant). In some aspects, the one or more flow enhancers can comprise magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination of any of the foregoing.

[0333] In some aspects, the pharmaceutical composition can comprise from about 0.1 wt% to about 5 wt% of the one or more flow enhancers. In some aspects, wherein the pharmaceutical composition can comprise from about 0.1 wt% to about 0.5 wt%, from about 0.1 wt% to about 1 wt%, from about 0.1 wt% to about 2 wt%, from about 0.1 wt% to about 3 wt%, from about 0.1 wt% to about 4 wt%, from about 0.5 wt% to about 1 wt%, from about 0.5 wt% to about 2 wt%, from about 0.5 wt% to about 3 wt%, from about 0.5 wt% to about 4 wt%, from about 0.5 wt% to about 5 wt%, from about 1 wt% to about 2 wt%, from about 1 wt% to about 3 wt%, from about 1 wt% to about 4 wt%, from about 1 wt% to about 5 wt%, from about 2 wt% to about 3 wt%, from about 2 wt% to about 4 wt%, from about 2 wt% to about 5 wt%, from about 3 wt% to about 4 wt%, from about 3 wt% to about 5 wt%, or from about 4 wt% to about 5 wt% of the one or more flow enhancers.

[0334] In some aspects, the pharmaceutical composition can comprise about 3 wt% of the one or more flow enhancers. In some aspects, the pharmaceutical composition can comprise about 0.1 wt%, about 0.5 wt%, about 1 wt%, about 1.5 wt%, about 2 wt%, about 2.5 wt%, about 3.5 wt%, about 4 wt%, about 4.5 wt%, or about 5 wt% of the one or more flow enhancers.

[0335] In some aspects, the pharmaceutical composition can comprise from about 5 wt% to about 15 wt%, about 5 wt% to about 25 wt%, about 5 wt% to about 35 wt%, about 5 wt% to about 45 wt%, about 5 wt% to about 55 wt%, about 5 wt% to about 65 wt%, about 5 wt% to about 75 wt%, about 15 wt% to about 25 wt%, about 15 wt% to about 35 wt%, about 15 wt% to about 45 wt%, about 15 wt% to about 55 wt%, about 15 wt% to about 65 wt%, about 15 wt% to about 75 wt%, about 15 wt% to about 85 wt%, about 25 wt% to about 35 wt%, about 25 wt% to about 45 wt%, about 25 wt% to about 55 wt%, about 25 wt% to about 65 wt%, about 25 wt% to about 75 wt%, about 25 wt% to about 85 wt%, about 35 wt% to about 45 wt%, about 35 wt% to about 55 wt%, about 35 wt% to about 65 wt%, about 35 wt% to about 75 wt%, about 35 wt% to about 85 wt%, about 45 wt% to about 55 wt%, about 45 wt% to about 65 wt%, about 45 wt% to about 75 wt%,about 45 wt% to about 85 wt%, about 55 wt% to about 65 wt%, about 55 wt% to about 75 wt%, about 55 wt% to about 85 wt%, about 65 wt% to about 75 wt%, about 65 wt% to about 85 wt%, or about 75 wt% to about 85 wt% of the one or more diluents, wherein the one or more diluents can comprise microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, sucrose, starch, pregelatinized starch (partially or fully gelatinized), dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate, maltodextrin, or a combination of any of the foregoing, from about 0.25 wt% to about 0.5 wt%, from about 0.25 wt% to about 1 wt%, from about 0.25 wt% to about 2.5 wt%, from about 0.25 wt% to about 5 wt%, from ab...

Claims

WHAT IS CLAIMED IS:

1. A pharmaceutical composition comprising: a) an amorphous solid dispersion comprising amorphous vamorolone and a pharmaceutically acceptable polymer; and b) one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is a solid oral dosage form.

2. The pharmaceutical composition of claim 1, wherein the amorphous solid dispersion comprises from about 15 wt% to about 95 wt% vamorolone and about 5 wt% to about 85 wt% of the polymer.

3. The pharmaceutical composition of claim 2, wherein the amorphous solid dispersion comprises from about 20 wt% to about 50 wt% vamorolone and about 50 wt% to about 80 wt% of the polymer.

4. The pharmaceutical composition of any one of claims 1-3, wherein the pharmaceutically acceptable polymer is selected from the group consisting of hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone, copovidone, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid), and combinations thereof.

5. The pharmaceutical composition of claim 4, wherein the pharmaceutically acceptable polymer is selected from the group consisting of hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, cellulose acetate phthalate, methacrylic acid- methyl methacrylate copolymer (1:1) (EUDRAGIT® L), povidone, copovidone, and polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®).

6. The pharmaceutical composition of any one of claims 1-5, wherein the amorphous solid dispersion further comprises a plasticizer, a surfactant, a filler, or a combination of any of the foregoing.

7. The pharmaceutical composition of claim 6, wherein the amorphous solid dispersion further comprises a plasticizer.

8. The pharmaceutical composition of claim 6 or 7, wherein the plasticizer comprises a citrate ester, a fatty acid ester, a phthalate ester, poly(ethylene glycol), poly(propylene glycol), tocopherol polyethylene glycol succinate, dibutyl sebacate, triacetin, a polysorbate, a sugar alcohol, or a combination of any of the foregoing.

9. The pharmaceutical composition of claim 8, wherein the plasticizer comprises poly(ethylene glycol).

10. The pharmaceutical composition of any one of claims 6-9, wherein the amorphous solid dispersion further comprises a surfactant.

11. The pharmaceutical composition of any one of claims 6-10, wherein the surfactant comprises sodium lauryl sulfate, a poloxamer, a polysorbate, tocopherol polyethylene glycol succinate, poly(ethylene glycol), a fatty acid triglyceride, or a combination of any of the foregoing.

12. The pharmaceutical composition of claim 11, wherein the surfactant comprises a poloxamer.

13. The pharmaceutical composition of any one of claims 6-12, wherein the filler comprises microcrystalline cellulose, silicified microcrystalline cellulose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylmethyl cellulose, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, povidone, copovidone, lactose monohydrate, lactose anhydrous, mannitol, sucrose, dextrates (EMDEX® or CAMDEX®), maltodextrin, polydextrose, starch, pregelatinized starch, hydroxypropyl starch, carbomer, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate and maltodextrin, polycarbophil, or a combination of any of the foregoing.

14. The pharmaceutical composition of any one of claims 1-13, wherein the amorphous solid dispersion is provided as a plurality of granules or pellets.

15. The pharmaceutical composition of any one of claims 1-14, wherein the pharmaceutical composition comprises from about 20 wt% to about 95 wt% of the amorphous solid dispersion.

16. The pharmaceutical composition of claim 15, wherein the pharmaceutical composition comprises from about 10 wt% to about 50 wt% of the amorphous solid dispersion.

17. The pharmaceutical composition of any one of claims 1-16, wherein the amorphous solid dispersion is prepared by hot melt extrusion, twin screw melt granulation, high shear melt granulation, or spray drying.

18. The pharmaceutical composition of any one of claims 1-17, wherein the solid oral dosage form is a tablet or capsule.

19. The pharmaceutical composition of claim 18, wherein the one or more pharmaceutically acceptable excipients comprises one or more diluents, one or more disintegrants, one or more lubricants, one or more flow enhancers, or a combination of any of the foregoing.

20. The pharmaceutical composition of claim 19, wherein the one or more diluents comprises microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, sucrose, starch, pregelatinized starch, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate, maltodextrin, or a combination of any of the foregoing.

21. The pharmaceutical composition of claim 20, wherein the one or more diluents comprises microcrystalline cellulose, silicified microcrystalline cellulose, mannitol, or a combination of any of the foregoing.

22. The pharmaceutical composition of any one of claims 19-21, wherein the pharmaceutical composition comprises from about 5 wt% to about 85 wt% of the one or more diluents.

23. The pharmaceutical composition of any one of claims 19-22, wherein the one or more disintegrants comprises croscarmellose sodium, carmellose sodium, sodium starch glycolate, carboxymethylcellulose sodium, carboxymethylcellulose calcium,crospovidone, starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, or a combination of any of the foregoing.

24. The pharmaceutical composition of claim 23, wherein the one or more disintegrants comprises croscarmellose sodium, sodium starch glycolate, crospovidone, or a combination of any of the foregoing.

25. The pharmaceutical composition of any one of claims 19-24, wherein the pharmaceutical composition comprises from about 0.25 wt% to about 10 wt% of the one or more disintegrants.

26. The pharmaceutical composition of any one of claims 19-25, wherein the one or more lubricants comprises magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination of any of the foregoing.

27. The pharmaceutical composition of claim 26, wherein the one or more lubricants comprises magnesium stearate or sodium stearyl fumarate.

28. The pharmaceutical composition of any one of claims 19-27, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more lubricants.

29. The pharmaceutical composition of any one of claims 19-28, wherein the one or more flow enhancers comprises magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination of any of the foregoing.

30. The pharmaceutical composition of any one of claims 19-29, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more flow enhancers.

31. The pharmaceutical composition of any one of claims 18-30, wherein the solid oral dosage form is a tablet, optionally wherein the tablet is coated with one or more film coating materials.

32. The pharmaceutical composition of claim 31, wherein the one or more film coating materials is not optional and is hydroxypropyl methylcellulose, poly(vinyl acetate), hydroxypropyl cellulose, polyethylene glycol, or a combination of any of the foregoing.

33. The pharmaceutical composition of claim 31 or 32, wherein the pharmaceutical composition comprises from about 1 wt% to about 10 wt% of the one or more film coating materials.

34. The pharmaceutical composition of any one of claims 1-17, wherein the solid oral dosage form is a powder for suspension.

35. The pharmaceutical composition of claim 34, wherein the one or more pharmaceutically acceptable excipients comprises one or more suspending agents, one or more buffering agents, one or more wetting agents, one or more preservatives, one or more flavoring agents, one or more flow enhancers, or a combination of any of the foregoing.

36. The pharmaceutical composition of claim 35, wherein the one or more suspending agents comprises hydroxypropyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, carbomer, xantham gum, starch, pregelatinized starch, sodium alginate, or a combination of any of the foregoing.

37. The pharmaceutical composition of claim 35 or 36, wherein the pharmaceutical composition comprises from about 5 wt% to about 80 wt% of the one or more suspending agents.

38. The pharmaceutical composition of any one of claims 35-37, wherein the one or more buffering agents comprises a citrate buffer, a phosphate buffer, a carbonate buffer, or a combination of any of the foregoing.

39. The pharmaceutical composition of any one of claims 35-38, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more buffering agents.

40. The pharmaceutical composition of any one of claims 35-39, wherein the one or more wetting agents comprises sodium lauryl sulfate, a poloxamer, a polysorbate, or a combination of any of the foregoing.

41. The pharmaceutical composition of any one of claims 35-40, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 10 wt% of the one or more wetting agents.

42. The pharmaceutical composition of any one of claims 35-41, wherein the one or more preservatives comprises methyl paraben, propyl paraben, sodium benzoate, citric acid, ascorbic acid, or a combination of any of the foregoing.

43. The pharmaceutical composition of any one of claims 35-42, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more preservatives.

44. The pharmaceutical composition of any one of claims 35-43, wherein the one or more flavoring agents comprises sucrose, aspartame, an artificial flavor, a natural flavor, or a combination of any of the foregoing.

45. The pharmaceutical composition of any one of claims 35-44, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more flavoring agents.

46. The pharmaceutical composition of any one of claims 35-45, wherein the one or more flow enhancers comprises colloidal silicon dioxide, talc, glycerol monostearate, magnesium monostearate, or a combination thereof.

47. The pharmaceutical composition of any one of claims 35-46, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more flow enhancers.

48. A process for preparing the pharmaceutical composition of any one of claims 1-47, comprising: a) admixing vamorolone, a polymer, and optionally one or more of a plasticizer, a surfactant, or a filler, to form a mixture; b) extruding the mixture to form an amorphous solid dispersion; c) pelletizing or milling the amorphous solid dispersion; and d) admixing the amorphous solid dispersion with one or more pharmaceutically acceptable excipients.

49. A process for preparing the pharmaceutical composition of any one of claims 1-47, comprising: a) admixing vamorolone, a polymer, and an organic solvent to form a mixture; b) spray drying the mixture to form an amorphous solid dispersion; and c) admixing the amorphous solid dispersion with one or more pharmaceutically acceptable excipients.

50. A pharmaceutical composition comprising: a) a plurality of coated particles, wherein each coated particle comprises: i. an inert core; ii. a first drug layer coated over the inert core, the first drug layer comprising amorphous vamorolone and a first polymer; and iii. a first encapsulation layer coated over the first drug layer, the first encapsulation layer comprising a second polymer; and b) optionally one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is a solid oral dosage form.

51. The pharmaceutical composition of claim 50, wherein the inert core is a microcrystalline cellulose sphere, a sugar sphere, a silica sphere, dicalcium phosphate anhydrous, magnesium alumino-metasilicate, microcrystalline cellulose, or a combination of any of the foregoing.

52. The pharmaceutical composition of claim 51, wherein the inert core comprises from about 5 wt% to about 90 wt% of a total mass of the coated particle 53. The pharmaceutical composition of any one of claims 50-52, wherein the first polymer comprises hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing.

54. The pharmaceutical composition of any one of claims 50-53, wherein the first drug layer is present comprises from about 30 wt% to about 80 wt% of the total mass of the coated particle.

55. The pharmaceutical composition of any one of claims 50-54, wherein the second polymer comprises hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), or a combination of any of the foregoing.

56. The pharmaceutical composition of any one of claims 50-55, wherein the first polymer and the second polymer are the same.

57. The pharmaceutical composition of any one of claims 50-56, wherein the first encapsulation layer comprises from about 30 wt% to about 80 wt % of the total mass of the coated particle.

58. The pharmaceutical composition of any one of claims 50-57, wherein the pharmaceutical composition comprises from about 20 wt% to about 95 wt% of the coated particles.

59. The pharmaceutical composition of any one of claims 50-58, wherein the particles are prepared by fluid bed drug layering.

60. The pharmaceutical composition of any one of claims 50-59, wherein the solid oral dosage form is a tablet or capsule.

61. The pharmaceutical composition of claim 60, wherein the one or more pharmaceutically acceptable excipients comprises one or more diluents, one or more disintegrants, one or more lubricants, one or more flow enhancers, or a combination of any of the foregoing.

62. The pharmaceutical composition of claim 61, wherein the one or more diluents comprises microcrystalline cellulose, silicified microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol, sucrose, starch, pregelatinized starch, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate and maltodextrin, or a combination of any of the foregoing.

63. The pharmaceutical composition of claim 61 or 62, wherein the pharmaceutical composition comprises from about 5 wt% to about 85 wt% of the one or more diluents.

64. The pharmaceutical composition of any one of claims 61-63, wherein the one or more disintegrants comprises croscarmellose sodium, carmellose sodium, sodium starch glycolate, carboxymethylcellulose sodium, carboxymethylcellulose calcium, crospovidone, starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, or a combination of any of the foregoing.

65. The pharmaceutical composition of any one of claims 61-64, wherein the pharmaceutical composition comprises from about 0.25 wt% to about 10 wt% of the one or more disintegrants.

66. The pharmaceutical composition of any one of claims 61-65, wherein the one or more lubricants comprises magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination of any of the foregoing.

67. The pharmaceutical composition of any one of claims 61-65, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more lubricants.

68. The pharmaceutical composition of any one of claims 61-67, wherein the one or more flow enhancers comprises magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl dibehenate, talc, colloidal silicon dioxide, or a combination thereof.

69. The pharmaceutical composition of any one of claims 61-68, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more flow enhancers.

70. The pharmaceutical composition of any one of claims 60-69, wherein the solid oral dosage form is a tablet, wherein the tablet is coated with one or more film coating materials.

71. The pharmaceutical composition of claim 70, wherein the one or more film coating materials comprises hydroxypropyl methylcellulose, poly(vinyl acetate), hydroxypropyl cellulose, polyethylene glycol, or a combination thereof.

72. The pharmaceutical composition of claim 70 or 71, wherein the pharmaceutical composition comprises from about 1 wt% to about 10 wt% of the one or more film coating materials.

73. The pharmaceutical composition of any one of claims 50-59, wherein the solid oral dosage form is a powder for suspension.

74. The pharmaceutical composition of claim 73, wherein the one or more pharmaceutically acceptable excipients comprises one or more suspending agents, one or more buffering agents, one or more wetting agents, one or more preservatives, one or more flavoring agents, one or more flow enhancers, one or more antifoaming agents, or a combination of any of the foregoing.

75. The pharmaceutical composition of claim 74, wherein the one or more suspending agents comprises hydroxypropyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, carbomer, xantham gum, starch, pregelatinized starch, sodium alginate, or a combination of any of the foregoing.

76. The pharmaceutical composition of claim 74 or 75, wherein the pharmaceutical composition comprises from about 5 wt% to about 80 wt% of the one or more suspending agents.

77. The pharmaceutical composition of any one of claims 74-76, wherein the one or more buffering agents comprises a citrate buffer, a phosphate buffer, a carbonate buffer, or a combination of any of the foregoing.

78. The pharmaceutical composition of any one of claims 74-77, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more buffering agents.

79. The pharmaceutical composition of any one of claims 74-78, wherein the one or more wetting agents comprises sodium lauryl sulfate, a poloxamer, a polysorbate, or a combination of any of the foregoing.

80. The pharmaceutical composition of any one of claims 74-79, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 10 wt% of the one or more wetting agents.

81. The pharmaceutical composition of any one of claims 74-80, wherein the one or more preservatives comprises methyl paraben, propyl paraben, sodium benzoate, citric acid, ascorbic acid, or a combination of any of the foregoing.

82. The pharmaceutical composition of any one of claims 74-81, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more preservatives.

83. The pharmaceutical composition of any one of claims 74-82, wherein the one or more flavoring agents comprises sucrose, aspartame, an artificial flavor, a natural flavor, or a combination of any of the foregoing.

84. The pharmaceutical composition of any one of claims 74-83, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more flavoring agents.

85. The pharmaceutical composition of any one of claims 74-84, wherein the one or more flow enhancers comprises colloidal silicon dioxide, talc, glycerol monostearate, magnesium monostearate, or a combination of any of the foregoing.

86. The pharmaceutical composition of any one of claims 74-85, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 5 wt% of the one or more flow enhancers.

87. The pharmaceutical composition of any one of claims 74-86, wherein the one or more antifoaming agents comprises simethicone (polydimethylsiloxane-silicon dioxide), an alcohol, an insoluble oil, a stearate, a polydimethylsiloxane, an ether, a glycol, or a combination of any of the foregoing.

88. The pharmaceutical composition of any one of claims 74-87, wherein the pharmaceutical composition comprises from about 0.01 wt% to about 10 wt% of the one or more antifoaming agents.

89. A pharmaceutical composition comprising: a) a plurality of coated particles, wherein each coated particle comprises: i. a core comprising amorphous vamorolone and a first polymer; and ii. a first encapsulation layer coated over the core, the first encapsulation layer comprising a second polymer; and b) optionally one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is a solid oral dosage form.

90. A pharmaceutical composition comprising crystalline vamorolone and one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is a solid oral dosage form.

91. The pharmaceutical composition of claim 90, wherein the crystalline vamorolone is vamorolone crystalline Form I.

92. The pharmaceutical composition of claim 90 or 91, wherein the one or more pharmaceutically acceptable excipients comprises one or more diluents, one or more binders, one or more disintegrants, one or more lubricants, or a combination of any of the foregoing.

93. The pharmaceutical composition of claim 92, wherein the one or more diluents comprises microcrystalline cellulose, silicified microcrystalline cellulose, mannitol, lactose, starch, dicalcium phosphate dihydrate, or a combination of any of the foregoing.

94. The pharmaceutical composition of claim 92 or 93, wherein the pharmaceutical composition comprises from about 20 wt% to about 85 wt% of the one or more diluents.

95. The pharmaceutical composition of any one of claims 92-94, wherein the one or more binders comprises povidone, copovidone, hydroxpropylmethyl cellulose, hydroxypropyl cellulose, or a combination of any of the foregoing.

96. The pharmaceutical composition of any one of claims 92-95, wherein the pharmaceutical composition comprises from about 0.5 wt% to about 10 wt% of the one or more binders.

97. The pharmaceutical composition of any one of claims 92-96, wherein the one or more disintegrants comprises crosscarmellose sodium, sodium starch glycolate (EXPLOTAB®), cross povidone, or a combination of any of the foregoing.

98. The pharmaceutical composition of any one of claims 92-97, wherein the pharmaceutical composition comprises from about 0.5 wt% to about 7 wt% of the one or more disintegrants.

99. The pharmaceutical composition of any one of claims 92-98, wherein the one or more lubricants comprises magnesium stearate, steric acid, glyceryl dibehenate, sodium steryl fumarate, or a combination of any of the foregoing.

100. The pharmaceutical composition of any one of claims 92-99, wherein the pharmaceutical composition comprises from about 0.1 wt% to about 4 wt% of the one or more lubricants.

101. The pharmaceutical composition of any one of claims 90-100, wherein the pharmaceutical composition further comprises an amorphous solid dispersion comprising amorphous vamorolone and a pharmaceutically acceptable polymer.

102. The pharmaceutical composition of claim 101, wherein the amorphous solid dispersion comprises from about 15 wt% to about 95 wt% vamorolone and about 5 wt% to about 85 wt% of the polymer.

103. The pharmaceutical composition of claim 101 or 102, wherein the pharmaceutically acceptable polymer is selected from the group consisting of hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, povidone, copovidone, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (SOLUPLUS®), methacrylic acid-ethyl acrylate copolymer (1:1) (EUDRAGIT® L-55), methacrylic acid-methyl methacrylate copolymer (1:1) (EUDRAGIT® L), methacrylic acid-methyl methacrylate copolymer (1:2) (EUDRAGIT® S), amino methacrylate copolymer (EUDRAGIT® E), poly(ethylene glycol), poly(ethylene oxide), poly(vinyl acetate), polyvinyl alcohol, poly(acrylic acid), and combinations thereof.

104. The pharmaceutical composition of any one of claims 101-103, wherein the amorphous solid dispersion further comprises a plasticizer, a surfactant, a filler, or a combination of any of the foregoing.

105. The pharmaceutical composition of claim 104, wherein the plasticizer comprises a citrate ester, a fatty acid ester, a phthalate ester, poly(ethylene glycol), poly(propylene glycol), tocopherol polyethylene glycol succinate, dibutyl sebacate, triacetin, a polysorbate, a sugar alcohol, or a combination of any of the foregoing.

106. The pharmaceutical composition of claim 104 or 105, wherein the amorphous solid dispersion further comprises a surfactant.

107. The pharmaceutical composition of claim 106, wherein the surfactant comprises sodium lauryl sulfate, a poloxamer, a polysorbate, tocopherol polyethylene glycol succinate, poly(ethylene glycol), a fatty acid triglyceride, or a combination of any of the foregoing.

108. The pharmaceutical composition of any one of claims 104-107, wherein the filler comprises microcrystalline cellulose, silicified microcrystalline cellulose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylmethyl cellulose, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, povidone, copovidone, lactose monohydrate, lactose anhydrous, mannitol, sucrose, dextrates (EMDEX® or CAMDEX®), maltodextrin, polydextrose, starch, pregelatinized starch, hydroxypropyl starch, carbomer, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, tricalcium phosphate anhydrous, coprocessed dicalcium phosphate and maltodextrin, polycarbophil, or a combination of any of the foregoing.

109. The pharmaceutical composition of any one of claims 101-108, wherein the amorphous solid dispersion is provided as a plurality of granules or pellets.

110. The pharmaceutical composition of any one of claims 101-109, wherein the pharmaceutical composition comprises from about 0.5 wt% to about 10 wt% of the amorphous solid dispersion.

111. The pharmaceutical composition of any one of claims 101-110, wherein the amorphous solid dispersion is prepared by hot melt extrusion, twin screw melt granulation, high shear melt granulation, or spray drying.

112. The pharmaceutical composition of any one of claims 90-111, wherein the pharmaceutical composition is prepared by direct blending.

113. A process for preparing the pharmaceutical composition of any one of claims 1-112, comprising admixing crystalline vamorolone with one or more pharmaceutically acceptable excipients.

114. The pharmaceutical composition of any one of claims 1-113, wherein the pharmaceutical composition has a total mass ranging from about 50 mg to about 800 mg.

115. The pharmaceutical composition of claim 114, wherein the total mass of the pharmaceutical composition is about 150 mg.

116. The pharmaceutical composition of claim 114, wherein the total mass of the pharmaceutical composition is about 300 mg.

117. The pharmaceutical composition of any one of claims 1-116, wherein the pharmaceutical composition has a friability of less than 1.0% as measured using USP<1216>.

118. The pharmaceutical composition of any one of claims 1-117, wherein the pharmaceutical composition has a disintegration time of less than 10 minutes.

119. The pharmaceutical composition of any one of claims 1-118, wherein the pharmaceutical composition has a hardness of from about 5 kp to about 20 kp.

120. The pharmaceutical composition of any one of claims 1-119, wherein, when the pharmaceutical composition is administered to a subject with food, the composition provides a vamorolone Tmax of from about 0.5 hours to about 5 hours.

121. The pharmaceutical composition of any one of claims 1-119, wherein, when the pharmaceutical composition is administered to a subject with food, the composition provides a vamorolone median Tmax of about 2 hours.

122. The pharmaceutical composition of any one of claims 1-121, wherein, when the pharmaceutical composition is administered to a subject with food, the composition provides a vamorolone AUC24 of from about 2,600 ng∙h / mL to about 4,350 ng∙h / mL.

123. The pharmaceutical composition of any one of claims 1-122, wherein, when the pharmaceutical composition is administered to a subject with food, the composition provides a vamorolone Cmax of from about 650 ng / mL to about 1,200 mg / mL.

124. A method of treating muscular dystrophy in a subject in need thereof, comprising orally administering the pharmaceutical composition of any one of claims 1-123 to the subject.

125. The method of claim 124, wherein the pharmaceutical composition is administered once, twice, or three times per day.

126. The method of claim 124 or 125, wherein the pharmaceutical composition is administered with food.

127. The method of claim 124 or 125, wherein the pharmaceutical composition is administered without food.

128. The method of any one of claims 124-127, wherein the muscular dystrophy is Duchenne muscular dystrophy, Becker muscular dystrophy, limb girdle muscular dystrophy, congenital muscular dystrophy, facioscapulohumeral muscular dystrophy, myotonic muscular dystrophy, oculopharyngeal muscular dystrophy, distal muscular dystrophy, or Emery-Dreifuss muscular dystrophy.

129. The method of claim 128, wherein the muscular dystrophy is Duchenne muscular dystrophy.

130. The method of any one of claims 124-129, wherein a total daily dose of vamorolone of from about 2 mg / kg to about 6 mg / kg is administered to the subject.

131. The method of claim 130, wherein the total daily dose of vamorolone is about 6 mg / kg.

132. The method of any one of claims 124-131, wherein the subject is at least two years of age.

133. The method of any one of claims 124-131, wherein the pharmaceutical composition comprises from about 5 mg to about 500 mg amorphous vamorolone.

134. The method of claim 133, wherein the pharmaceutical composition comprises from about 30 mg to about 300 mg amorphous vamorolone.

135. The method of claim 134, wherein the pharmaceutical composition comprises from about 100 mg to about 300 mg amorphous vamorolone.

136. The pharmaceutical composition of any one of claims 1-123, wherein the pharmaceutical composition comprises from about 5 mg to about 500 mg amorphous vamorolone.

137. The pharmaceutical composition of claim 136, wherein the pharmaceutical composition comprises from about 30 mg to about 300 mg amorphous vamorolone.

138. The pharmaceutical composition of claim 137, wherein the pharmaceutical composition comprises from about 100 mg to about 300 mg amorphous vamorolone.

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