Compositions for nail conditions and uses thereof
The compositions address the challenges of topical delivery for nail disorders by using film-forming polymers and permeation enhancers to improve retention and penetration, enhancing treatment efficacy and safety.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2025-08-29
- Publication Date
- 2026-03-05
AI Technical Summary
Existing treatments for nail disorders, such as onychomycosis and nail psoriasis, face challenges with topical delivery, including retention on the nail surface, penetration through the nail plate, safety, and patient compliance, often using irritating solvents and having low permeability.
Compositions comprising an active pharmaceutical ingredient, film-forming polymers like Hypromellose derivatives and polymethacrylates, plasticizers, and permeation enhancers like lactic acid, formulated in a way that forms a durable film on the nail surface, enhancing penetration and retention.
The compositions provide effective treatment by improving nail appearance and ensuring the active ingredients remain on the nail surface despite washing, with enhanced permeability and safety.
Smart Images

Figure CN2025117969_05032026_PF_FP_ABST
Abstract
Description
COMPOSITIONS FOR NAIL CONDITIONS AND USES THEREOFCROSS-REFERENCEThis application claims the benefit of PCT Application No. PCT / CN2024 / 115875 filed August 30, 2024, which is incorporated by reference herein in its entirety.BACKGROUND OF THE DISCLOSURENail Diseases, such as onychomycosis and nail psoriasis, severely impact a person’s quality of life, and also lead to feelings of self-consciousness and depression in severe cases for these diseases can cause physical changes. Many medications have been developed for treatment of these nail diseases. However, most of those medications cause unexpected systemic toxicity. To date, topical formulation is the best option for the therapy. However, there are challenges for topical delivery through nails, including keeping active ingredients on the surface of nails, penetration of active ingredients through nail plates, as well as safety and patient compliance. Different dosage forms are reported to be applied to nail diseases, such as solution, cream, and gel, of which film-form lacquer seems better. Some commercial products are on the market, such asfor onychomycosis. But most of these products contain irritating solvents such as ethyl acetate. Additionally, the film-formed cannot stay for a long time on the nail surface and can be easily removed by washing hand. Moreover, the permeabilities of those commercial products are low. Therefore, there is a need for a drug delivery system for treatment of nail disorders.BRIEF SUMMARYProvided herein are compositions, comprising: an active pharmaceutical ingredient (API) in an amount of no more than 20% (w / v) ; a film forming polymer, wherein the film-forming polymer is present in an amount of 5-15% (w / v) ; a plasticizer, wherein the plasticizer is in an amount of no more than 5 % (w / v) ; a volatile solvent, wherein the volatile solvent is ethanol; and a non-volatile solvent. Further provided herein are compositions, wherein the film-forming polymer comprises Hypromellose derivatives, polymethacrylates, polyurethane, or any combinations thereof. Further provided herein are compositions, wherein the film-forming polymer comprises a Hypromellose derivative, a polymethacrylate, or any combinations thereof. Further provided herein are compositions, wherein the Hypromellose derivative is hydroxypropyl methylcellulose acetate succinate (HPMC-AS) . Further provided herein are compositions, wherein the HPMC-AS is present in an amount of about 0.5% (w / v) to about 1%(w / v) . Further provided herein are compositions, wherein the polymethacrylate is an Eudragit. Further provided herein are compositions, wherein the Eudragit is present in an amount of about 5-15% (w / v) . Further provided herein are compositions, wherein the Eudragit is present in an amount of about 10% (w / v) . Further provided herein are compositions, wherein the compositions further comprise at least one solubilizer. Further provided herein are compositions, wherein the at least one solubilizer comprises propylene, glycol, transcutol, polyethylene glycol, or any combinations thereof. Further provided herein are compositions, wherein the at least one solubilizer comprises transcutol. Further provided herein are compositions, wherein the compositions further comprise a plasticizer. Further provided herein are compositions, wherein the plasticizer is polyethylene glycol 6000. Further provided herein are compositions, wherein the compositions further comprise a permeation enhancer. Further provided herein are compositions, wherein the permeation enhancer is selected from the group consisting of a hydrating agent, a keratolytic agent, an acid, a disulfide bond break agent, a chelating agent, or any combinations thereof. Further provided herein are compositions, wherein the permeation enhancer is acid. Further provided herein are compositions, wherein the acid is lactic acid. Further provided herein are compositions, wherein the lactic acid is present in an amount of about 3% (w / v) to about 30% (w / v) . Further provided herein are compositions, wherein the lactic acid is present in an amount of about 10% (w / v) . Further provided herein are compositions, wherein the compositions further comprise at least one thickener. Further provided herein are compositions, wherein the at least one thickener comprises PEG400. Further provided herein are compositions, wherein the compositions further comprise a color substance. Further provided herein are compositions, wherein the color substance comprises a pigment, a dye, a colorant, or any combinations thereof.Provided herein are methods of treating a nail disorder comprising topically applying a composition provided herein. Further provided herein are methods, wherein the nail disorder is selected from the group consisting of eczema, atopic dermatitis, onycholysis, subungual hyperkeratosis, discoloration, onychauxis, psoriatic nail, onychorrhexis, onychoschizia, lamellar splitting, onychomadesis, brittle nail syndrome, transverse grooves, nail pitting, soft nails, nail dystrophy, nail fragility of intact or damaged nails, nail tumor, and any combination thereof. Further provided herein are methods, wherein the nail disorder is onychomycosis. Further provided herein are methods, wherein the nail disorder is nail psoriasis.Provided herein are methods of improving an appearance of a nail of a subject comprising topically applying a composition provided herein to the nail. Further provided herein are methods, wherein the method improves a color, a surface smoothness, a shape, and / or a thickness of the nail. Further provided herein are methods, wherein topically applying the composition is carried out at least once per week. Further provided herein are methods, wherein topically applying the composition is carried out at least once per day.Provided herein are methods for making a film-forming formulation comprising: providing a solvent comprising a volatile solvent, wherein the volatile solvent is present in an amount of 60%to 100%by volume in the solvent; adjusting a pH of the solvent from pH 8 to pH 11; dissolving an active ingredient and at least one polymer in the solvent after adjusting the pH; and adding a plasticizer, thereby forming the film-forming formulation. Further provided herein are methods, wherein the volatile solvent comprises ethanol, propanol, isopropanol, ethyl acetate, or a mixture thereof. Further provided herein are methods, wherein the volatile solvent is ethanol. Further provided herein are methods, wherein the polymer is selected from Hypromellose derivatives, polymethacrylates, and combinations thereof. Further provided herein are methods, wherein the active ingredient is selected from an anti-bacterial substance, an anti-viral substance, an anti-fungal substance, an anti-inflammation substance, and an anti-nail tumor substance, in an amount of 0.01-20%by weight. Further provided herein are methods, wherein the anti-bacterial substance comprises at least one selected from penicillin, sulfonamides, Streptogramins, polypeptides, tetracycline, doxycycline, amoxicillin, carbapenems, cephalosporins, fluoroquinolones, glycopeptides and lipoglycopeptides, macrolides, monobactams, and any combinations thereof. Further provided herein are methods, wherein the anti-fungal substance comprises efinaconazole, tavaborole, ciclopirox, amorolfine, luliconazole, terbinafine, miconazole, ketoconazole, intraconazole, fluconazole, econazole, oxiconazole, clotrimazole, naftifine, voriconazole, isavuconazole, fenticonazole, tavaborole, amorolfine, anidulafungin, caspofungin, micafungin, rezafungin, Amphotericin B, terbinafine, or any combinations thereof. Further provided herein are methods, wherein the anti-inflammation substance comprises a JAK inhibitor, a PDE4 inhibitor, a corticosteroid, vitamin A, vitamin D3, an anti-IL-17 agent, an anti-IL-23 agent, an anti-TNFα agent, an anti-IL-4 agent, an S1PR inhibitor, a PI3Kδ inhibitor, or a TYK2 inhibitor. Further provided herein are methods, wherein the anti-tumor substance comprises a checkpoint inhibitor, an anti-IL-7 agent, 5-fluorouracil (F-FU) , or any combinations thereof. Further provided herein are methods, wherein the methods further comprise adding at least one solubilizer. Further provided herein are methods, wherein the at least one solubilizer is propylene glycol, transcutol, or polyethylene glycol (PEG) . Further provided herein are methods, wherein the methods further comprise adding a permeation enhancer. Further provided herein are methods, wherein the permeation enhancer comprises at least one selected from cyclodextrin and its derivatives, urea and its derivatives, lactic acid and its derivatives, sodium sulfite and its derivatives, EDTA, cysteine and its derivatives, and any combinations thereof. Further provided herein are methods, wherein the permeation enhancer is an acid. Further provided herein are methods, wherein the acid is lactic acid. Further provided herein are methods, wherein the methods further comprise adding at least one thickener. Further provided herein are methods, wherein the at least one thickener comprises PEG400. Further provided herein are methods, wherein the methods further comprise adding a color substance. Further provided herein are methods, wherein the color substance comprises a pigment, a dye, a colorant, or any combinations thereof.Provided herein are compositions comprising: an active pharmaceutical ingredient (API) , wherein the active pharmaceutical ingredient is selected from an anti-bacterial substance, an anti-viral substance, an anti-fungal substance, an anti-inflammation substance, and an anti-tumor substance, in an amount of 0.01% (w / v) to 20% (w / v) ; film-forming polymers comprising HPMC-AS and Eudragit L100, wherein the HPMC-AS is present in an amount of 0.5% (w / v) to 4% (w / v) and the Eudragit L100 is present in an amount of 5% (w / v) to 15% (w / v) ; a plasticizer, wherein the plasticizer is PEG 6000 present in an amount of 0.5 %(w / v) to 4 % (w / v) ; a solubilizer, wherein the solubilizer is propylene glycol or transcutol; and a volatile solvent, wherein the volatile solvent is ethanol. Further provided herein are compositions, wherein the anti-bacterial substance comprises at least one selected from a group consisting of penicillin, sulfonamides, Streptogramins, polypeptides, tetracycline, doxycycline, amoxicillin, carbapenems, cephalosporins, fluoroquinolones, glycopeptides and lipoglycopeptides, macrolides, monobactams, and any combinations thereof. Further provided herein are compositions, wherein the anti-fungal substance comprises efinaconazole, tavaborole, ciclopirox, amorolfine, luliconazole, terbinafine, miconazole, ketoconazole, intraconazole, fluconazole, econazole, oxiconazole, clotrimazole, naftifine, voriconazole, isavuconazole, fenticonazole, tavaborole, amorolfine, anidulafungin, caspofungin, micafungin, rezafungin, Amphotericin B, terbinafine, or any combinations thereof. Further provided herein are compositions, wherein the anti-inflammation substance comprises a JAK inhibitor, a PDE4 inhibitor, a corticosteroid, vitamin A, vitamin D3, an anti-IL-17 agent, an anti-IL-23 agent, an anti-TNFα agent, an anti-IL-4 agent, an S1PR inhibitor, a PI3Kδ inhibitor, or a TYK2 inhibitor. Further provided herein are compositions, wherein the anti-tumor substance comprises a checkpoint inhibitor, an anti-IL-7 agent, 5-fluorouracil (F-FU) , or any combinations thereof. Further provided herein are compositions, wherein the API is terbinafine HCl. Further provided herein are compositions, wherein the HPMC-AS is present in an amount of 0.5% (w / v) to 4%(w / v) . Further provided herein are compositions, wherein the HPMC-AS is present in an amount of 0.5% (w / v) . Further provided herein are compositions, wherein the Eudragit L100 is present in an amount of 5-15% (w / v) . Further provided herein are compositions, wherein the Eudragit L100 is present in an amount of 10% (w / v) . Further provided herein are compositions, wherein the PEG 6000 is present in an amount of 2 % (w / v) to 4 % (w / v) . Further provided herein are compositions, wherein solubilizer is present in an amount of 3% (w / v) to 5% (w / v) . Further provided herein are compositions, wherein the compositions further comprise water. Further provided herein are compositions, wherein the volume ratio of ethanol to water is from 9: 1 to 6: 4. Further provided herein are compositions, wherein the volume ratio of ethanol to water is from 9: 1 to 8: 2. Further provided herein are compositions, wherein the compositions further comprise a permeation enhancer, wherein the permeation enhancer is selected from the group consisting of a hydrating agent, a keratolytic agent, an acid, a disulfide bond break agent, a chelating agent, or any combinations thereof. Further provided herein are compositions, wherein the permeation enhancer is an acid. Further provided herein are compositions, wherein the acid is lactic acid. Further provided herein are compositions, wherein the lactic acid is present in an amount of about 3%to about 30%. Further provided herein are compositions, wherein the lactic acid is present in an amount of 10%. Further provided herein are compositions, wherein the compositions further comprise a pigment. Further provided herein are compositions, wherein the pigment is present in an amount of about 0.1%.Provided herein are compositions, comprising: terbinafine or terbinafine HCl in an amount of 0.5-20%by weight; a film forming polymer, wherein the film forming polymer present in an amount of 5-15%by weight; a plasticizer, wherein the plasticizer is in an amount of 0.5-5 %by weight; a permeation enhancer, wherein the permeation enhancer is lactic acid present in an amount of 2%to 30%by weight, a volatile solvent, wherein the volatile solvent comprises ethanol; and a non-volatile solvent. Further provided herein are compositions, wherein the composition is in a topical form. Further provided herein are compositions, wherein film forming polymer is selected from Hypromellose derivatives, polymethacrylates, or any combinations thereof. Further provided herein are compositions, wherein the film forming polymer comprises Eudragit L100 and HPMC-AS-LF. Further provided herein are compositions, wherein the HPMC-AS is present in an amount of 0.5% (w / v) to 4% (w / v) and the Eudragit L100 is present in an amount of 5% (w / v) to 15% (w / v) . Further provided herein are compositions, wherein the HPMC-AS is present in an amount of 0.5% (w / v) and the Eudragit L100 is present in an amount of 10% (w / v) . Further provided herein are compositions, wherein the plasticizer is PEG 6000. Further provided herein are compositions, wherein PEG 6000 is present in an amount of equal to or less than 4%. Further provided herein are compositions, wherein PEG 6000 is present in an amount of 4%. Further provided herein are compositions, wherein the volatile solvent is ethanol, and the non-volatile solvent is an aqueous solution. Further provided herein are compositions, wherein the compositions further comprise a solubilizer. Further provided herein are compositions, wherein the solubilizer is Transcutol or PEG 400. Further provided herein are compositions, wherein the solubilizer is Transcutol. Further provided herein are compositions, wherein the Transcutol is present in an amount of equal to or less than 5%. Further provided herein are compositions, wherein the lactic acid is present in an amount of about 3%to about 10%. Further provided herein are compositions, wherein the lactic acid is present in an amount of about 10%. Further provided herein are compositions, wherein the volume ratio of the ethanol to the non-volatile solvent is from 9: 1 to 6: 4. Further provided herein are compositions, wherein the non-volatile solvent is water. Further provided herein are compositions, wherein the volume ratio of the ethanol to water is 4:1.Provided herein are compositions, comprising: terbinafine or terbinafine HCl; a film forming polymer, wherein the film forming polymer present in an amount of 5-15%by weight; a plasticizer, wherein the plasticizer is in an amount of 0.5-5 %by weight; lactic acid, wherein the ratio of terbinafine and the lactic acid is from 1: 10 (w: w) to 1: 2 (w: w) , and wherein the lactic acid is present in an amount sufficient for permeation enhancement of the terbinafine; a volatile solvent, wherein the volatile solvent comprises ethanol; and a non-volatile solvent. Further provided herein are compositions, wherein the terbinafine is present in an amount of 0.5-15%by weight. Further provided herein are compositions, wherein the composition is in a topical form. Further provided herein are compositions, wherein film forming polymer is selected from Hypromellose derivatives, polymethacrylates, or any combinations thereof. Further provided herein are compositions, wherein the film forming polymer comprises Eudragit L100 and HPMC-AS-LF. Further provided herein are compositions, wherein the HPMC-AS is present in an amount of 0.5% (w / v) to 4% (w / v) and the Eudragit L100 is present in an amount of 5% (w / v) to 15% (w / v. Further provided herein are compositions, wherein the HPMC-AS is present in an amount of 0.5% (w / v) and the Eudragit L100 is present in an amount of 10% (w / v) . Further provided herein are compositions, wherein the plasticizer is PEG 6000. Further provided herein are compositions, wherein PEG 6000 is present in an amount of equal to or less than 4%. Further provided herein are compositions, wherein PEG 6000 is present in an amount of 4%. Further provided herein are compositions, wherein the volatile solvent is ethanol, and the non-volatile solvent is an aqueous solution. Further provided herein are compositions, wherein the compositions further comprise a solubilizer. Further provided herein are compositions, wherein the solubilizer is Transcutol or PEG 400. Further provided herein are compositions, wherein the solubilizer is Transcutol. Further provided herein are compositions, wherein the Transcutol is present in an amount of equal to or less than 5%. Further provided herein are compositions, wherein the lactic acid is present in an amount of about 3%to about 10%. Further provided herein are compositions, wherein the lactic acid is present in an amount of about 10%. Further provided herein are compositions, wherein the volume ratio of the ethanol to the non-volatile solvent is from 9: 1 to 6: 4. Further provided herein are compositions, wherein the non-volatile solvent is water. Further provided herein are compositions, wherein the volume ratio of the ethanol to water is 4: 1.Provided herein are methods for treating a nail disorder comprising contacting the nail with an effective amount of a composition provided herein. Further provided herein are methods, wherein after contacting the nail, the composition forms a film on the nail surface in less than 2 minutes. Further provided herein are methods, wherein the film is resistant to hand washing.BRIEF DESCRIPTION OF THE FIGURESThe features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:FIGURE 1 is an image showing films from different formulations.FIGURE 2 is a plot graph showing X-Ray diffraction (XRPD) patterns of films prepared from film-forming solutions at varying concentrations of terbinafine HCl, an active pharmaceutical ingredient (API) . Y axis represents the relative X-ray intensity of peaks (counts) . X axis represents the angle of diffraction.FIGURE 3 is a plot graph showing XRPD patterns of dry films prepared from film-forming solutions at varying concentrations of propylene glycol or transcutol. Y axis represents the relative X-ray intensity of peaks (counts) . X axis represents the angle of diffraction.FIGURE 4 is a plot graph showing XRPD patterns of films after contacting water prepared from film-forming solutions at varying concentrations of propylene glycol or transcutol. Y axis represents the relative X-ray intensity of peaks (counts) . X axis represents the angle of diffraction.FIGURES 5A-5E are images showing the polarizing microscope crystal status of films after contacting water prepared from different film-forming formulations under a. The film-forming formulations are prepared (a) without solubilizer (FIG. 5A) , (b) with 3%transcutol (FIG. 5B) , (c) with 5%transcutol (FIG. 5C) , (d) with 3%propylene glycol (FIG. 5D) , or (e) with 5%propylene glycol (FIG. 5E) .FIGURE 6 is a plot graph showing the permeation analysis of film-forming formulations at varying concentrations of transcutol. Y axis represents the API concentration. X axis represents time.FIGURE 7 is a plot graph showing the permeation analysis of film-forming formulations at varying concentrations of transcutol or propylene glycol. Y axis represents the API concentration. X axis represents time (hour) .FIGURE 8 shows the procedure of ex vivo ungual permeation with bovine nails or human nails.FIGURES 9A-9B are plots showing API permeation in bovine nail 48 hours after administration (FIG. 9A) and API deposition in bovine nail plate (FIG. 9B) for formulations with or without a permeation enhancer. Y axis represents the amount of API. X axis represents different formulations.FIGURES 10A-10B are plots showing API permeation in bovine nail 48 hours after administration (FIG. 10A) and API deposition in bovine nail plate (FIG. 10B) for formulations in presence of 10%cyclodextrin HP-β-CD, 10%urea, 10%acetylcysteine, saturated EDTA, or 10%lactic acid. Y axis represents the amount of API. X axis represents different formulations.FIGURES 11A-11B are plots showing API permeation in bovine nail 48 hours after administration (FIG. 11A) and API deposition in bovine nail plate (FIG. 11B) for formulations in presence of lactic acid and different solvents. Y axis represents the amount of API. X axis represents different formulations.FIGURES 12A-12B are plots showing API permeation in bovine nail 48 hours after administration (FIG. 12A) and API deposition in bovine nail plate (FIG. 12B) for formulations in presence of different solvents without water. Y axis represents the amount of API. X axis represents different formulations.FIGURES 13A-13D are plots showing API permeation in bovine nail 48 hours after administration (FIGS. 13A-13B) and API deposition in bovine nail plate (FIGS. 13C-13D) for formulations with or without a solubilizer. Y axis represents the amount of API. X axis represents different formulations.FIGURES 14A-14B are plots showing API permeation in bovine nail 48 hours after administration (FIG. 14A) and API deposition in bovine nail plate (FIG. 14B) for different formulations.FIGURES 15A-15B are plots showing API permeation curve (FIG. 15A) and API deposition in bovine nail plate (FIG. 15B) for formulations with 2.5%or 5%terbinafine HCl as compared to conventional formulations in presence of 10%or 33%lactic acid. Y axis represents the amount of API. X axis represents different formulations.FIGURES 16A-16B are plots showing API permeation curve (FIG. 16A) and API deposition in human nail plate (FIG. 16B) for formulations in presence of different concentration of terbinafine HCl as compared to a commercial formulation. Y axis represents the amount of API. X axis represents different formulations.FIGURES 17A-17B are plots showing API permeation curve (FIG. 17A) and API deposition in human nail plate (FIG. 17B) for an exemplary nail film solution as compared to conventional formulations.FIGURES 18A-18F are plots showing API permeation in bovine nail 48 hours after application of exemplary solutions containing different APIs or commercial products (FIGS. 18A-18C) and the corresponding API deposition in bovine nail plate (FIG. 18D-18F) .FIGURES 19A-19D are plots showing API permeation in bovine nail 67 hours after application of exemplary solutions containing different APIs (FIGS. 19A-19B) and the corresponding API deposition in bovine nail plate (FIGS. 19C-19D) .FIGURES 20A-20B are plots showing API permeation curve (FIG. 20A) and API deposition in human nail plate (FIG. 20B) for formulations in presence of different concentration of lactic acid as compared to conventional formulations.DETAILED DESCRIPTIONThe present disclosure is generally directed to compositions for treating nail disorders using film-forming compositions comprising active ingredients, polymers and volatile solvents and non-volatile solvents. In particular, provided herein are compositions and methods for treating nail disorders using film-forming compositions based on volatile solvents such as ethanol with the benefits of non-irritating smell and easy application. With proper adjustment of pH, polymers can be dissolved in such film-forming compositions without adding additional solvents such as ethyl acetate or acetone. After application of a film-forming composition provided herein to a surface such as a nail plate, the composition forms a film quickly (e.g., in 2 minutes) and cannot be removed by water or hand soap. In some embodiments, provided herein are compositions comprising an active pharmaceutical ingredient (API) , a film forming polymer, a plasticizer for promoting the film formation, a volatile solvent comprising ethanol, and a non-volatile solvent. In some embodiments, the API is present in an amount of 0.01% (w / v) to 15% (w / v) . In some embodiments, the film forming polymer is present in an amount of 5% (w / v) to 15% (w / v) . In some embodiments, the ethanol is present in an amount of 60%to 100% (v / v) . In some embodiments, the plasticizer is present in an amount of 0.5% (w / v) to 5% (w / v) . In some embodiments, additional excipients are included in the compositions, such as plasticizers, solubilizers, and / or permeation enhancers. Also provided herein are methods of making film-forming compositions comprising providing an aqueous solution comprising a volatile solvent, adjusting the pH of the solution to pH 8 to pH 11, dissolving a polymer and an active ingredient in the aqueous solution, and adding a plasticizer, thereby forming the film-forming solution.The following description and examples illustrate embodiments of the present disclosure in detail. It is to be understood that this disclosure is not limited to the particular embodiments described herein and as such can vary. Those of skill in the art will recognize that there are numerous variations and modifications of this disclosure, which are encompassed within its scope.All terms are intended to be understood as they would be understood by a person skilled in the art. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure pertains.The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.Although various features of the present disclosure may be described in the context of a single embodiment, the features can also be provided separately or in any suitable combination. Conversely, although the present disclosure may be described herein in the context of separate embodiments for clarity, the present disclosure can also be implemented in a single embodiment.DefinitionsThe following definitions supplement those in the art and are directed to the current application and are not to be imputed to any related or unrelated case, e.g., to any commonly owned patent or application. Although any methods and materials similar or equivalent to those described herein can be used in the practice for testing of the present disclosure, the preferred materials and methods are described herein. Accordingly, the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.In this application, the use of the singular includes the plural unless specifically stated otherwise. It must be noted that, as used in the specification, the singular forms “a, ” “an” and “the” include plural referents unless the context clearly dictates otherwise. In this application, the use of “or” means “and / or” unless stated otherwise. Furthermore, use of the term “including” as well as other forms, such as “include” , “includes, ” and “included, ” is not limiting.Reference in the specification to “some embodiments, ” “an embodiment, ” “one embodiment” or “other embodiments” means that a particular feature, structure, or characteristic described in connection with the embodiments is included in at least some embodiments, but not necessarily all embodiments, of the present disclosure.As used in this specification and claim (s) , the words “comprising” (and any form of comprising, such as “comprise” and “comprises” ) , “having” (and any form of having, such as “have” and “has” ) , “including” (and any form of including, such as “includes” and “include” ) or “containing” (and any form of containing, such as “contains” and “contain” ) are inclusive or open-ended and do not exclude additional, un-recited elements or method steps. It is contemplated that any embodiment discussed in this specification can be implemented with respect to any method or composition of the present disclosure, and vice versa. Furthermore, compositions of the present disclosure can be used to achieve methods of the present disclosure.Unless specifically stated or obvious from context, as used herein, the term “about” in reference to a number or range of numbers is understood to mean the stated number and numbers + / -10 %thereof.The term “pharmaceutically acceptable salt” used herein means any salt that is pharmaceutically acceptable and has the desired pharmacological properties. Such salts include salts that may be derived from an inorganic or organic acid, or an inorganic or organic base, including amino acids, which is not toxic or undesirable in anyway. Suitable inorganic salts include those formed with the alkali metals, e.g., sodium and potassium, magnesium, calcium, and aluminum. Suitable organic salts include those formed with organic bases such as the amine bases, e.g., ethanolamine, diethanolamine, triethanolamine, tromethamine, N-methylglucamine, and the like. Such salts also include acid addition salts formed with inorganic acids (e.g., hydrochloric and hydrobromic acids) and organic acids (e.g., acetic acid, citric acid, maleic acid, and the alkane and arene-sulfonic acids such as methanesulfonic acid, benzenesulfonic acid, sulfonic acid, and phosphatic acid) . When there are two acidic groups present, a pharmaceutically acceptable salt may be a mono-acid-mono-salt or a di-salt; and similarly, where there are more than two acidic groups present, some or all of such groups can be salified.CompositionsProvided herein provided herein are compositions comprising an active pharmaceutical ingredient, a film-forming polymer, a plasticizer, a volatile solvent, and a non-volatile solvent.a. Active Pharmaceutical Ingredient (API)Provided herein are compositions comprising an active pharmaceutical ingredient (API) , wherein the API is selected from an anti-bacterial, anti-fungal, anti-tumor, or anti-inflammation substance in an amount of 0.01-20%by weight. Various embodiments described herein are directed to compositions comprising an effective amount of an active pharmaceutical ingredient (API) . “Active pharmaceutical agent, ” “API, ” “APIs, ” “drug, ” “pharmaceutically active agent, ” “bioactive agent, ” “therapeutic agent, ” and “active agent” and the like may be used interchangeably and refer to a substance, such as a chemical compound or complex, that has a measurable beneficial physiological effect on the body, such as a therapeutic effect in treatment of a disease or disorder when administered in an effective amount. Further, when these terms are used, or when a particular active ingredient is specifically identified by name or category, it is understood that such recitation is intended to include the active agent per se, as well as pharmaceutically acceptable, pharmacologically active derivatives thereof, or compounds significantly related thereto, including without limitation, salts, pharmaceutically acceptable salts, N-oxides, prodrugs, active metabolites, isomers, fragments, analogs, solvates hydrates, radioisotopes, etc.In some embodiments, an API described herein is an anti-bacterial substance. In some embodiments, an anti-bacterial substance described herein comprises penicillin, penicillin G, hetacillin potassium, cloxacillin benzathine, ampicillin and amoxicillin trihydrate, aminocoumarins such as novobiocin, cephalosporins such as cephalexin, ceftiofur sodium, ceftiofur hydrochloride, ceftiofur crystalline free acid. In some embodiments, an anti-bacterial substance described herein comprises a macrolide. The macrolides described herein include, but are not limited to, tildipirosin, tylosin, tulathromycin, erythromycin, clarithromycin, and azithromycin. In some embodiments, an anti-bacterial substance described herein comprises a quinolone or a fluoroquinolone. Exemplary quinolones and fluoroquinolones include, but are not limited to, enrofloxacin, ciprofloxacin, levofloxacin, and ofloxacin. In some embodiments, an anti-bacterial substance described herein comprises sulfonamides. Exemplary sulfonamides include, but are not limited to, sulfadimethoxine, co-trimoxazole and trimethoprim. In some embodiments, an anti-bacterial substance described herein comprises a retinoid. Exemplary retinoids include, but are not limited to, retinol, retinal, tretinoin (retinoic acid) , isotretinoin, alitretinoin, etretinate, adapalene, bexarotene, and tazarotene. In some embodiments, an anti-bacterial substance described herein comprises a trifarotene. In some embodiments, an anti-bacterial substance described herein comprises a tetracycline. Exemplary tetracyclines include, but are not limited to, tetracycline, oxytetracycline and doxycycline. In some embodiments, an anti-bacterial substance described herein comprises an aminoglycoside. Exemplary aminoglycosides include, but are not limited to, dihydrostreptomycin sulfate, neomycin, gentamicin and tobramycin. In some embodiments, an anti-bacterial substance described herein comprises a lincosamide. Exemplary lincosamides include, but are not limited to, pirlimycin hydrochloride, lincomycin, clindamycin, and pirlimycin. In some embodiments, an anti-bacterial substance described herein comprises an amphenicol. Exemplary amphenicols include, but are not limited to, florfenicol, or any combinations thereof. In some embodiments, an anti-bacterial substance described herein is selected from a group consisting of penicillin, sulfonamides, Streptogramins, polypeptides, tetracycline, doxycycline, amoxicillin, carbapenems, cephalosporins, fluoroquinolones, glycopeptides and lipoglycopeptides, macrolides, monobactams, and any combinations thereof.In some embodiments, an API described herein is an anti-fungal substance. In some embodiments, an anti-fungal substance described herein is an antimycotic substance. In some embodiments, an antimycotic substance described herein comprises polyenes such as amphotericin b, candicidin, filipin, hamycin, natamycin, nystatin, and rimocidin; azoles such as imidazole, triazole, thiazole, bifonazole, butoconazole, clotrimazole, econazole, fenticonazole, isoconazole, ketoconazole, luliconazole, miconazole, omoconazole, oxiconazole, sertaconazole, sulconazole, tioconazole, albaconazole, efinaconazole, epoxiconazole, fluconazole, isavuconazole, itraconazole, posaconazole, propiconazole, ravuconazole, terconazole, voriconazole, and abafungin; allylamines such as amorolfin, butenafine, naftifine, and terbinafine; echinocandins such as anidulafungin, caspofungin and micafungin; aurones, benzoic acid, ciclopirox olamine, flucytosine or 5-fluorocytosine, griseofulvin, haloprogin, tolnaftate, undecylenic acid, triacetin, crystal violet, castellani's paint, orotomide (f901318) , miltefosine, potassium iodide, coal tar, copper (ii) sulfate, selenium disulfide, sodium thiosulfate, piroctone olamine, iodoquinol, clioquinol, acrisorcin, zinc pyrithione, and sulfur, antiprotozoals such as melarsoprol, eflornithine, metronidazole, tinidazole, miltefosine, antihelminthics such as mebendazole, pyrantel pamoate, thiabendazole, diethylcarbamazine, ivermectin, aticestodes such as niclosamide, praziquantel, albendazole, antitrematodes such as praziquantel, antiamoebics such as rifampin and amphotericin B, and broad-spectrum drugs such as nitazoxanide, or any combinations thereof. In some embodiments, an anti-fungal substance described herein is efinaconazole, tavaborole, ciclopirox, amorolfine, luliconazole, terbinafine, miconazole, ketoconazole, intraconazole, fluconazole, econazole, oxiconazole, clotrimazole, naftifine, voriconazole, isavuconazole, fenticonazole, tavaborole, or amorolfine. In some embodiments, an anti-fungal substance described herein is terbinafine. In some embodiments, an anti-fungal substance described herein are imidazoles or triazoles. In some embodiments, an anti-fungal substance described herein is anidulafungin, caspofungin, micafungin, or rezafungin. In some embodiments, an anti-fungal substance is Flucytosine. In some embodiments, an anti-fungal substance described herein is Amphotericin B. In some embodiments, an anti-fungal substance described herein is amorolfine hydrochloride. In some embodiments, an anti-fungal substance is terbinafine.In some embodiments, an API described herein is an anti-viral substance. In some embodiments, an anti-viral substance described herein comprises peramivir, zanamivir, oseltamivir phosphate, baloxavir marboxil, acyclovir, valacyclovir, valganciclovir, brivudin, cidofovir, famciclovir, fomivirsen, foscarnet, ganciclovir, penciclovir, amantadine, rimantadine, ribavirin, telbivudine, adefovir, entecavir, emtricita bine, lamivudine, tenofovir, boceprevir, telaprevir, interferons, or any combinations thereof.In some embodiments, an API described herein is an anti-inflammation substance. In some embodiments, an anti-inflammation substance described herein is a substance targeting psoriasis and eczema. In some embodiments, anti-inflammation substances described herein include, but are not limited to gluococorticoid, JAK inhibitors and phosphodiesterase-4 (PDE4) inhibitors. In some embodiment, a JAK inhibitor is baricitinib, tofacitinib, filgotinib, or upadacitinib. In some embodiment, a PDE4 inhibitor is apremilast, crisaborole, or roflumilast. In some embodiments, a gluococorticoid is triamcinolone acetonide, prednisone, or dexamethasone.In some embodiments, the API is present in the form of a free base. In some embodiments, the API is present in the form of a pharmaceutically acceptable salt. As used herein, a pharmaceutically acceptable salt includes but is not limited to, metal salts, such as sodium salts, potassium salts, and lithium salts; alkaline earth metals, such as calcium salts, magnesium salts, and the like; organic amine salts, such as triethylamine salts, pyridine salts, picoline salts, ethanolamine salts, triethanolamine salts, dicyclohexylamine salts, N, N’ -dibenzylethylenediamine salts, and the like; inorganic acid salts such as hydrochloride salts, hydrobromide salts, sulfate salts, phosphate salts, and the like; organic acid salts such as formate salts, acetate salts, trifluoroacetate salts, maleate salts, tartrate salts, and the like; sulfonate salts such as methanesulfonate salts, benzenesulfonate salts, p-toluenesulfonate salts, and the like; and amino acid salts, such as arginate salts, asparginate salts, glutamate salts, and the like. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, vilazodone or a pharmaceutically acceptable salt or ester thereof. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone. In some embodiments, the API is a pharmaceutically acceptable salt of abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, vilazodone. In some embodiments, the API is lipophilic. In some embodiments, the lipophilic API is one listed in Table 1, or a pharmaceutically acceptable salt thereof. In some embodiments, the API has a log P 2.0 or higher. In some embodiments, the API has a log P 3.0 or higher. In some embodiments, the API has a log P 3.5 or higher. In some embodiments, the API has a log P 4.0 or higher. In some embodiments, the API has a log P 4.5 or higher. In some embodiments, the lipophilic API, hydrophilic polymer, and the surfactant is formulated as an amorphous solid dispersion. In some embodiments, an amorphous solid dispersion includes a lipophilic API, a hydrophilic polymer, and a surfactant. In some embodiments, the amorphous solid dispersions described herein additionally comprise one or more adsorbents. In some embodiments, the amorphous solid dispersions described herein additionally comprise one or more other additives. In some embodiments, other additives comprise organic and inorganic acids. In some embodiments, other additives comprise antioxidants.Pharmaceutically acceptable salts include bitartrate, bitartrate hydrate, hydrochloride, p-toluenesulfonate, phosphate, sulfate, trifluoroacetate, bitartrate hemipentahydrate, pentafluoropropionate, hydrobromide, mucate, oleate, phosphate dibasic, phosphate monobasic, acetate trihydrate, bis (heptafuorobutyrate) , bis (pentaflu oropropionate) , bis (pyridine carboxylate) , bis (trifluoroacetate) , chlorhydrate, and sulfate pentahydrate. Other representative pharmaceutically acceptable salts include, e.g., water-soluble and water-insoluble salts, such as the acetate, amsonate (4, 4-diaminostilbene-2, 2-disulfonate) , benzenesulfonate, benzonate, bicarbonate, bisulfate, bitartrate, borate, butyrate, calcium edetate, camphorsulfonate, camsylate, carbonate, citrate, clavulariate, dihydrochloride, edetate, edisylate, estolate, esylate, fiunarate, fumarate, gluceptate, gluconate, glutamate, glycollylarsanilate, hexafluorophosphate, hexylresorcinate, hydrabamine, hydrobromide, hydrochloride, hydroxynaphthoate, iodide, 19ydroxyapat, lactate, lactobionate, laurate, malate, maleate, mandelate, mesylate, methylbromide, methylnitrate, methylsulfate, mucate, napsylate, nitrate, N-methylglucamine ammonium salt, 3-hydroxy-2-naphthoate, oleate, oxalate, palmitate, pamoate (1, 1-methene-bis-2-hydroxy-3-naphthoate, einbonate) , pantothenate, phosphate / diphosphate, picrate, polygalacturonate, propionate, p-toluenesulfonate, salicylate, stearate, subacetate, succinate, sulfate, sulfosalicylate, suramate, tannate, tartrate, teoclate, tosylate, triethiodide, and valerate salts. Ahydrate is another example of a pharmaceutically acceptable salt. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, vilazodone or a pharmaceutically acceptable salt thereof. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone. In some embodiments, the API is a pharmaceutically acceptable salt of abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone.In the presence of negatively charged radicals, such as carboxy or sulfonium, salts may also be formed with bases. In some embodiments, the bases described herein comprise metal or ammonium salts. In some embodiments, the bases described herein comprise alkali metal salts or alkaline earth metal salts. Exemplary alkali metal salts and alkaline earth metal salts include, but are not limited to example sodium, potassium, magnesium, or calcium salts. In some embodiments, the ammonium salts described herein comprise ammonia or suitable organic amines, such as tertiary monoamines, for example, triethylamine or tri (2-hydroxyethyl) amine, or heterocyclic bases, for example, N-ethyl-piperidine or N, N′-dimethylpiperazine.When a basic group and an acid group are present in the same molecule, a compound disclosed herein may also form internal salts. For isolation or purification purposes it is also possible to use pharmaceutically unacceptable salts, for example, picrates or perchlorates. For therapeutic use, only pharmaceutically acceptable salts or free compounds are employed (where applicable in the form of pharmaceutical preparations) .In some embodiments, an API or a salt thereof described herein is present in an amount of about 0.1 % (w / v) to about 20 % (w / v) . In some embodiments, an API or a salt thereof described herein is present in an amount of about 0.1 % (w / v) to about 1.0 % (w / v) , about 0.2 % (w / v) to about 1.2 % (w / v) , about 0.3 % (w / v) to about 1.3 % (w / v) , about 0.4 % (w / v) to about 1.4% (w / v) , about 0.5 % (w / v) to about 1.5 % (w / v) , about 0.6 % (w / v) to about 1.6% (w / v) , about 0.7 % (w / v) to about 1.7% (w / v) , about 0.8% (w / v) to about 1.8 % (w / v) , about 0.9 % (w / v) to about 2.9 % (w / v) , about 1.0% (w / v) to about 2.0 % (w / v) , about 1.5 % (w / v) to about 2.5 % (w / v) , about 2% (w / v) to about 3% (w / v) , about 2.5% (w / v) to about 3.5 % (w / v) , about 3% (w / v) to about 4% (w / v) , about 3.5 % (w / v) to about 4.5 % (w / v) , about 4 % (w / v) to about 5 % (w / v) , about 4.5 % (w / v) to about 5.5 % (w / v) , about 5 % (w / v) to about 6 % (w / v) , about 5.5 % (w / v) to about 6.5 % (w / v) , about 6 % (w / v) to about 7 % (w / v) , about 6.5 % (w / v) to about 7.5 % (w / v) , about 7% (w / v) to about 8% (w / v) , about 7.5 % (w / v) to about 8.5 % (w / v) , about 8% (w / v) to about 9% (w / v) , about 8.5 % (w / v) to about 9.5 % (w / v) , about 9% (w / v) to about 10 % (w / v) , about 9.5 % (w / v) to about 10.5 % (w / v) , about 10% (w / v) to about 11 % (w / v) , about 10.5 % (w / v) to about 11.5 % (w / v) , about 11 % (w / v) to about 12 % (w / v) , about 11.5% (w / v) to about 12.5 % (w / v) , about 12 % (w / v) to about 13 % (w / v) , about 12.5% (w / v) to about 13.5 % (w / v) , about 13 % (w / v) to about 14% (w / v) , about 13.5 % (w / v) to about 14.5 % (w / v) , about 14% (w / v) to about 15% (w / v) , about 14.5 % (w / v) to about 15.5 % (w / v) , about 15% (w / v) to about 16% (w / v) , about 15.5 % (w / v) to about 16.5 % (w / v) , about 16% (w / v) to about 17% (w / v) , about 16.5 % (w / v) to about 17.5 % (w / v) , about 17% (w / v) to about 18% (w / v) , about 17.5 % (w / v) to about 18.5 % (w / v) , about 18% (w / v) to about 19% (w / v) , about 18.5 % (w / v) to about 19.5 % (w / v) , or about 19% (w / v) to about 20% (w / v) . In some embodiments, an API or a salt thereof described herein is present in an amount of about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 2 % (w / v) , about 2.5 % (w / v) , about 3 % (w / v) , about 3.5 % (w / v) , about 4 % (w / v) , about 4.5 % (w / v) , about 5 % (w / v) , about 5.5 % (w / v) , about 6 % (w / v) , about 6.5 % (w / v) , about 7 % (w / v) , about 7.5 % (w / v) , about 8 % (w / v) , about 8.5 % (w / v) , about 9 % (w / v) , about 9.5 % (w / v) , about 10 % (w / v) , about 11 % (w / v) , about 12 % (w / v) , about 13 % (w / v) , about 14 % (w / v) , about 15 % (w / v) , about 16 % (w / v) , about 17 % (w / v) , about 18 % (w / v) , about 19 % (w / v) , or about 20 % (w / v) .b.Film Forming PolymerIn some embodiments, a composition described herein comprises a film-forming polymer. In some embodiments, a film-forming polymer described herein is water-soluble. In some embodiments, a film-forming polymer described herein comprises a hydrophilic high-molecular weight material. In some embodiments, the high-molecular weight material comprises at least one of polyvinylpyrrolidone (povidone) (e.g., PVP-K30) , vinylpyrrolidone-vinyl acetate copolymer (copovidone or PVP-VA64, e.g., sold under the trade name VA 64) , polyvinyl alcohol (PVA) , polysaccharide, hydroxypropyl methylcellulose (HPMC or Hypromellose; e.g., HPMC-E5) , hydroxyethyl cellulose (HEC) , hydroxypropyl cellulose (HPC) , polyethylene oxide, hydroxypropyl-β-cyclodextrin (HP-β-CD) , sulfobutylether-β-cyclodextrin, hydroxypropyl methylcellulose acetate succinate (HPMC-AS) , Hypromellose phthalate (HPMCP) , polyethylene glycol (PEG) , polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (PVAc-PVCap-PEG, e.g., sold under the trade name Soluplus) , polysaccharide, polymethacrylates, or any combinations thereof. In some embodiments, the hydrophilic high-molecular weight material is polyvinylpyrrolidone (PVP) , copovidone, crospovidone, HPMC, or any combinations thereof. In some embodiments, the high-molecular weight material comprises HPMC and crospovidone. In some embodiments, the high-molecular weight material comprises HPMC and PVP. In some embodiments, the high-molecular weight material comprises HPMC and copovidone. In some embodiments, the high-molecular weight material comprises Hypromellose phthalate (HPMCP) . In some embodiments, a film-forming polymer described herein is selected from Hypromellose derivatives, polymethacrylates, or any combinations thereof. In some embodiments, the high-weight material comprises polymethacrylates (e.g., sold under the trade name ) . An “Eudragit” described herein refers to a copolymer derived from methacrylic acid and methacrylic or acrylic esters. Depending on the specific grade, they may also include other monomers such as methyl methacrylate, ethyl acrylate, butyl methacrylate, dimethylaminoethyl methacrylate, or trimethylammonioethyl methacrylate chloride. An Eudragit E grade polymer comprises Poly (butyl methacrylate-co- (2-dimethylamino) ethyl methacrylate-co-methyl methacrylate) . An Eudragit S or L grade polymer comprises Poly (methacrylic acid-co-methyl methacrylate) . An Eudragit RS or RL grade polymer comprises Poly (ethyl acrylate-co-methyl methacrylate-co-trimethylammonioethyl methacrylate chloride) . Eudragit L100 is a methacrylic acid–methyl methacrylate copolymer with a ratio of 1: 1. In some embodiments, a film-forming polymer described herein is Eudragit L100. In some embodiments, the high-molecular weight material comprises HPMC-AS. In some embodiments, the high-molecular weight material comprises polyurethane.In some embodiments, a film-forming polymer described herein is present in an amount of about 0.1 % (w / v) to about 15 % (w / v) . In some embodiments, a film forming polymer described herein is present in an amount of about 0.1 % (w / v) to about 1.0 % (w / v) , about 0.2 % (w / v) to about 1.2 % (w / v) , about 0.3 % (w / v) to about 1.3 % (w / v) , about 0.4 % (w / v) to about 1.4% (w / v) , about 0.5 % (w / v) to about 1.5 % (w / v) , about 0.6 % (w / v) to about 1.6% (w / v) , about 0.7 % (w / v) to about 1.7% (w / v) , about 0.8% (w / v) to about 1.8 % (w / v) , about 0.9 % (w / v) to about 2.9 % (w / v) , about 1.0% (w / v) to about 2.0 % (w / v) , about 1.5 % (w / v) to about 2.5 % (w / v) , about 2% (w / v) to about 3% (w / v) , about 2.5% (w / v) to about 3.5 % (w / v) , about 3% (w / v) to about 4% (w / v) , about 3.5 % (w / v) to about 4.5 % (w / v) , about 4 % (w / v) to about 5 % (w / v) , about 4.5 % (w / v) to about 5.5 % (w / v) , about 5 % (w / v) to about 6 % (w / v) , about 5.5 % (w / v) to about 6.5 % (w / v) , about 6 % (w / v) to about 7 % (w / v) , about 6.5 % (w / v) to about 7.5 % (w / v) , about 7% (w / v) to about 8% (w / v) , about 7.5 % (w / v) to about 8.5 % (w / v) , about 8% (w / v) to about 9% (w / v) , about 8.5 % (w / v) to about 9.5 % (w / v) , about 9% (w / v) to about 10 % (w / v) , about 9.5 % (w / v) to about 10.5 % (w / v) , about 10% (w / v) to about 11 % (w / v) , about 10.5 % (w / v) to about 11.5 % (w / v) , about 11 % (w / v) to about 12 % (w / v) , about 11.5% (w / v) to about 12.5 % (w / v) , about 12 % (w / v) to about 13 % (w / v) , about 12.5% (w / v) to about 13.5 % (w / v) , about 13 % (w / v) to about 14% (w / v) , about 13.5 % (w / v) to about 14.5 % (w / v) , or about 14% (w / v) to about 15% (w / v) . In some embodiments, a film forming polymer described herein is present in an amount of about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 2 % (w / v) , about 2.5 % (w / v) , about 3 % (w / v) , about 3.5 % (w / v) , about 4 % (w / v) , about 4.5 % (w / v) , about 5 % (w / v) , about 5.5 % (w / v) , about 6 % (w / v) , about 6.5 % (w / v) , about 7 % (w / v) , about 7.5 % (w / v) , about 8 % (w / v) , about 8.5 % (w / v) , about 9 % (w / v) , about 9.5 % (w / v) , about 10 % (w / v) , about 11 % (w / v) , about 12 % (w / v) , about 13 % (w / v) , about 14 % (w / v) , or about 15 % (w / v) .In some embodiments, the Eudragit L100, when used as a film-forming polymer described herein, is present in an amount of about 5% (w / v) to about 15% (w / v) . In some embodiments, the Eudragit L100, when used as a film-forming polymer described herein, is present in an amount of about 5 % (w / v) , about 5.5 % (w / v) , about 6 % (w / v) , about 6.5 % (w / v) , about 7 % (w / v) , about 7.5 % (w / v) , about 8 % (w / v) , about 8.5 % (w / v) , about 9 % (w / v) , about 9.5 % (w / v) , about 10 % (w / v) , about 11 % (w / v) , about 12 % (w / v) , about 13 % (w / v) , about 14 % (w / v) , or about 15 % (w / v) . In some embodiments, the Eudragit L100, when used as a film-forming polymer described herein, is present in an amount of about 10 % (w / v) .In some embodiments, the HPMC-AS LF, when used as a film-forming polymer described herein, is present in an amount of about 0.5% (w / v) to about 4 % (w / v) . In some embodiments, the HPMC-AS LF, when used as a film-forming polymer described herein, is present in an amount of about 0.5% (w / v) to about 1 % (w / v) . In some embodiments, the HPMC-AS, when used as a film-forming polymer described herein, is present in an amount of about 0.1 % (w / v) to about 1.0 % (w / v) , about 0.2 % (w / v) to about 1.2 % (w / v) , about 0.3 % (w / v) to about 1.3 % (w / v) , about 0.4 % (w / v) to about 1.4% (w / v) , about 0.5 % (w / v) to about 1.5 % (w / v) , about 0.6 % (w / v) to about 1.6% (w / v) , about 0.7 % (w / v) to about 1.7% (w / v) , about 0.8% (w / v) to about 1.8 % (w / v) , about 0.9 % (w / v) to about 2.9 % (w / v) , about 1.0% (w / v) to about 2.0 % (w / v) , about 1.5 % (w / v) to about 2.5 % (w / v) , about 2% (w / v) to about 3% (w / v) , about 2.5% (w / v) to about 3.5 % (w / v) , or about 3% (w / v) to about 4% (w / v) . In some embodiments, the HPMC-AS, when used as a film-forming polymer described herein, is present in an amount of about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 1.6 % (w / v) , about 1.7 % (w / v) , about 1.8 % (w / v) , about 1.9 % (w / v) , about 2 % (w / v) , about 2.1 % (w / v) , about 2.2 % (w / v) , about 2.3 % (w / v) , about 2.4 % (w / v) , about 2.5 % (w / v) , about 2.6 % (w / v) , about 2.7 % (w / v) , about 2.8 % (w / v) , about 2.9 % (w / v) , about 3 % (w / v) , about 3.1 % (w / v) , about 3.2 % (w / v) , about 3.3 % (w / v) , about 3.4 % (w / v) , about 3.5 % (w / v) , about 3.6 % (w / v) , about 3.7 % (w / v) , about 3.8 % (w / v) , about 3.9 % (w / v) , or about 4 % (w / v) .In some embodiments, a composition described herein comprises a Hypromellose derivative and a polymethacrylate. In some embodiments, a composition described herein comprises both Eudragit L100 and HPMC-AS LF. In some embodiments, in a composition described herein comprising both Eudragit L100 and HPMC-AS LF, Eudragit L100 is present in an amount of about 5% (w / v) to about 15% (w / v) and HPMC-AS LF is present in an amount of about 0.5% (w / v) to about 4 % (w / v) . In some embodiments, in a composition described herein comprising both Eudragit L100 and HPMC-AS LF, Eudragit L100 is present in an amount of about 5% (w / v) , about 6% (w / v) , about 7% (w / v) , about 8% (w / v) , about 9% (w / v) , about 10% (w / v) , about 11% (w / v) , about 12% (w / v) , about 13% (w / v) , about 14% (w / v) , or about 15% (w / v) and HPMC-AS LF is present in an amount of about 0.5% (w / v) , about 1% (w / v) , about 1.5% (w / v) , about 2% (w / v) , about 2.5% (w / v) , about 3% (w / v) , about 3.5% (w / v) , or about 4 % (w / v) . In some embodiments, in a composition described herein comprising both Eudragit L100 and HPMC-AS LF, Eudragit L100 is present in an amount of about 10% (w / v) and HPMC-AS LF is present in an amount of about 0.5% (w / v) to about 1% (w / v) .c. PlasticizerIn some embodiments, a composition described herein comprises at least one plasticizer. Plasticizers can confer flexibility on the films formed from the compositions described herein. In some embodiments, a plasticizer described herein comprises polyethylene glycol, glyceryl trioctanoate, dibutyl sebacate, triethyl citrate, triacetin, (acetylated monoglycerides) , diethyl phthalate, butyl stearate, lauric acid, dioctyl glutarate, triglyceride, dioctyl oxalate, triethyl phosphate, acetyl tributyl citrate, or any combinations thereof. In some embodiments, a plasticizer described herein is polyethylene glycol (PEG) . In some embodiment, a plasticizer described herein is PEG 6000.In some embodiments, a plasticizer described herein is present in an amount of about 0.1 % (w / v) to about 5 % (w / v) . In some embodiments, a plasticizer described herein is present in an amount of about 0.1 % (w / v) to about 1.0 % (w / v) , about 0.2 % (w / v) to about 1.2 % (w / v) , about 0.3 % (w / v) to about 1.3 % (w / v) , about 0.4 % (w / v) to about 1.4% (w / v) , about 0.5 % (w / v) to about 1.5 % (w / v) , about 0.6 % (w / v) to about 1.6% (w / v) , about 0.7 % (w / v) to about 1.7% (w / v) , about 0.8% (w / v) to about 1.8 % (w / v) , about 0.9 % (w / v) to about 2.9 % (w / v) , about 1.0% (w / v) to about 2.0 % (w / v) , about 1.5 % (w / v) to about 2.5 % (w / v) , about 2% (w / v) to about 3% (w / v) , about 2.5% (w / v) to about 3.5 % (w / v) , about 3% (w / v) to about 4% (w / v) , about 3.5 % (w / v) to about 4.5 % (w / v) , or about 4 % (w / v) to about 5 % (w / v) . In some embodiments, a film-forming polymer described herein is present in an amount of about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 2 % (w / v) , about 2.5 % (w / v) , about 3 % (w / v) , about 3.5 % (w / v) , about 4 % (w / v) , about 4.5 % (w / v) , or about 5 % (w / v) . In some embodiments, a plasticizer described herein is present in an amount of about 2% (w / v) to about 4% (w / v) . In some embodiments, when PEG 6000 is present as a plasticizer in a composition described herein, the PEG 6000 is present in an amount of about 2% (w / v) to about 4% (w / v) .d. SolventIn some embodiments, a composition described herein comprises a volatile solvent and a non-volatile solvent. The term “volatile solvent” means the portion of the composition that evaporates after application of the composition. That is, “volatile solvent” refers to one or more solvents including a co-solvent, if used, that leave a carrier, such as the delivery vehicle, within less than 24 hours at a specified chosen temperature, typically at room temperature of approximately 23℃., so that the presence of the solvent in the composition is fleeting. Moreover, the “volatile solvent” is capable of dissolving the API. The volatile solvent is generally cosmetically-acceptable and is a liquid at room temperature. Furthermore, the volatile solvent is, in certain embodiments, miscible with water. By “miscible with water” it means that the volatile solvent is fully soluble in water in all proportions. Suitable examples of volatile solvents that are miscible with water include ethanol, propanol, and isopropanol. The volatile solvent, if not miscible with water, may, in certain embodiments, be soluble to at least some extent in isopropanol. In some embodiments, a volatile solvent described herein comprises ethanol, propanol, isopropanol, ethyl acetate, or a mixture thereof. In some embodiment, a volatile solvent described herein is ethanol. The term “non-volatile solvent” refers to a solvent that is unlikely to evaporate easily. In some embodiments, the non-volatile solvent described herein is water.In some embodiments, the ratio of the volatile solvent to the non-volatile solvent is from about 9: 1 (v / v) to about 5: 5 (v / v) . In some embodiments, the ratio of the volatile solvent to the non-volatile solvent is about 9 to 1 (v / v) , about 8.5 to 1.5 (v / v) , about 8 to 2 (v / v) , about 7.5 to 3.5 (v / v) , about 7 to 3 (v / v) , about 6.5 to 5.5 (v / v) , about 6 to 4 (v / v) , about 5.5 to 4.5 (v / v) , or about 5 to 5 (v / v) .In some embodiments, the volatile solvent is ethanol, and the non-volatile solvent is water. In some embodiments, the ratio of ethanol to water is from 10: 0 (v / v) to about 5: 5 (v / v) . In some embodiments, the ratio of ethanol to water is 10: 0 (v / v) , about 9 to 1 (v / v) , about 8.5 to 1.5 (v / v) , about 8 to 2 (v / v) , about 7.5 to 3.5 (v / v) , about 7 to 3 (v / v) , about 6.5 to 5.5 (v / v) , about 6 to 4 (v / v) , about 5.5 to 4.5 (v / v) , or about 5 to 5 (v / v) . In some embodiments, the ratio of ethanol to water is about 9 to 1 (v / v) . In some embodiments, the ratio of ethanol to water is about 8 to 2 (v / v)e. SolubilizerIn some embodiments, a composition described herein comprises a solubilizer. In some embodiments, a solubilizer described herein is transcutol, propylene glycol, labrosol, PEG400, isopropyl palmitate, or triethyl citrate. In some embodiments, a solubilizer described herein is transcutol or propylene glycol. In some embodiments, a solubilizer described herein is propylene glycol. In some embodiments, a solubilizer described herein is propylene glycol.In some embodiments, a solubilizer described herein is present in an amount of about 0.1 % (w / v) to about 5 % (w / v) . In some embodiments, a solubilizer described herein is present in an amount of about 0.1 % (w / v) to about 1.0 % (w / v) , about 0.2 % (w / v) to about 1.2 % (w / v) , about 0.3 % (w / v) to about 1.3 % (w / v) , about 0.4 % (w / v) to about 1.4% (w / v) , about 0.5 % (w / v) to about 1.5 % (w / v) , about 0.6 % (w / v) to about 1.6% (w / v) , about 0.7 % (w / v) to about 1.7% (w / v) , about 0.8% (w / v) to about 1.8 % (w / v) , about 0.9 % (w / v) to about 2.9 % (w / v) , about 1.0% (w / v) to about 2.0 % (w / v) , about 1.5 % (w / v) to about 2.5 % (w / v) , about 2% (w / v) to about 3% (w / v) , about 2.5% (w / v) to about 3.5 % (w / v) , about 3% (w / v) to about 4% (w / v) , about 3.5 % (w / v) to about 4.5 % (w / v) , or about 4 % (w / v) to about 5 % (w / v) . In some embodiments, a solubilizer described herein is present in an amount of about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 2 % (w / v) , about 2.5 % (w / v) , about 3 % (w / v) , about 3.5 % (w / v) , about 4 % (w / v) , about 4.5 % (w / v) , or about 5 % (w / v) . In some embodiments, the propylene glycol or transcutol, when used as a solubilizer as described herein, is present in an about from about 3% (w / v) to about 5% (w / v) .f. Other componentsIn some embodiments, a composition described herein comprises additional excipients. In some embodiments, additional excipients include, but are not limited to, a permeability enhancer, a thicker, a color substance, or any combinations thereof.In some embodiments, a composition disclosed herein comprises a permeation enhancer. A “permeation enhancer” is a natural or synthetic compound which increases the flux of the API or combination of APIs across a barrier. In some embodiments, a composition disclosed herein comprises an API, a polymer described herein, a plasticizer described herein, a volatile solvent described herein, a non-volatile solvent described herein, and a permeation enhancer. In some embodiments, a composition disclosed herein comprises an API, a polymer described herein, a plasticizer described herein, a volatile solvent described herein, a non-volatile solvent described herein, a solubilizer described herein, and a permeation enhancer. In some embodiments, a permeation enhancer described herein is selected from a group consisting of a hydrating agent, a keratolytic agent, an acid, a disulfide bond break agent, a chelating agent, and any combinations thereof. In some embodiments, a hydrating agent described herein is cyclodextrin or one of its derivatives. In some embodiments, an acid described herein is phosphoric acid, lactic acid, or ethyl lactate. In some embodiments, a keratolytic agent described herein is urea or one of its derivatives. In some embodiments, a disulfide bond break agent is acetylcysteine. In some embodiments, a chelating agent is EDTA or one of its derivatives. In some embodiments, a permeation enhancer described herein is the permeation enhancer is selected from the group consisting of cyclodextrin and its derivatives, urea and its derivatives, lactic acid and its derivatives, sodium sulfite and its derivatives, EDTA, and cysteine and its derivatives, and any combinations thereof. In some embodiments, a permeation enhancer described herein is Hydroxypropyl β –cyclodextrin. In some embodiments, a permeation enhancer described herein is lactic acid.In some embodiments, a permeation enhancer described herein is present in an amount in an amount of about 0.1 % (w / v) to about 15 % (w / v) . In some embodiments, a permeation enhancer described herein is present in an amount of about 0.1 % (w / v) to about 1.0 % (w / v) , about 0.2 % (w / v) to about 1.2 % (w / v) , about 0.3 % (w / v) to about 1.3 % (w / v) , about 0.4 % (w / v) to about 1.4% (w / v) , about 0.5 % (w / v) to about 1.5 % (w / v) , about 0.6 % (w / v) to about 1.6% (w / v) , about 0.7 % (w / v) to about 1.7% (w / v) , about 0.8% (w / v) to about 1.8 % (w / v) , about 0.9 % (w / v) to about 2.9 % (w / v) , about 1.0% (w / v) to about 2.0 % (w / v) , about 1.5 % (w / v) to about 2.5 % (w / v) , about 2% (w / v) to about 3% (w / v) , about 2.5% (w / v) to about 3.5 % (w / v) , about 3% (w / v) to about 4% (w / v) , about 3.5 % (w / v) to about 4.5 % (w / v) , about 4 % (w / v) to about 5 % (w / v) , about 4.5 % (w / v) to about 5.5 % (w / v) , about 5 % (w / v) to about 6 % (w / v) , about 5.5 % (w / v) to about 6.5 % (w / v) , about 6 % (w / v) to about 7 % (w / v) , about 6.5 % (w / v) to about 7.5 % (w / v) , about 7% (w / v) to about 8% (w / v) , about 7.5 % (w / v) to about 8.5 % (w / v) , about 8% (w / v) to about 9% (w / v) , about 8.5 % (w / v) to about 9.5 % (w / v) , about 9% (w / v) to about 10 % (w / v) , about 9.5 % (w / v) to about 10.5 % (w / v) , about 10% (w / v) to about 11 % (w / v) , about 10.5 % (w / v) to about 11.5 % (w / v) , about 11 % (w / v) to about 12 % (w / v) , about 11.5% (w / v) to about 12.5 % (w / v) , about 12 % (w / v) to about 13 % (w / v) , about 12.5% (w / v) to about 13.5 % (w / v) , about 13 % (w / v) to about 14% (w / v) , about 13.5 % (w / v) to about 14.5 % (w / v) , or about 14% (w / v) to about 15% (w / v) . In some embodiments, a permeation enhancer described herein is present in an amount of about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 2 % (w / v) , about 2.5 % (w / v) , about 3 % (w / v) , about 3.5 % (w / v) , about 4 % (w / v) , about 4.5 % (w / v) , about 5 % (w / v) , about 5.5 % (w / v) , about 6 % (w / v) , about 6.5 % (w / v) , about 7 % (w / v) , about 7.5 % (w / v) , about 8 % (w / v) , about 8.5 % (w / v) , about 9 % (w / v) , about 9.5 % (w / v) , about 10 % (w / v) , about 11 % (w / v) , about 12 % (w / v) , about 13 % (w / v) , about 14 % (w / v) , or about 15 % (w / v) .In some embodiments, Hydroxypropyl β –cyclodextrin, when used as a permeation enhancer in a composition described herein, is present in an amount in an amount of about 0.1 % (w / v) to about 10 % (w / v) . In some embodiments, Hydroxypropyl β –cyclodextrin, when used as a permeation enhancer in a composition described herein, is present in an amount in an amount of about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 2 % (w / v) , about 2.5 % (w / v) , about 3 % (w / v) , about 3.5 % (w / v) , about 4 % (w / v) , about 4.5 % (w / v) , about 5 % (w / v) , about 5.5 % (w / v) , about 6 % (w / v) , about 6.5 % (w / v) , about 7 % (w / v) , about 7.5 % (w / v) , about 8 % (w / v) , about 8.5 % (w / v) , about 9 % (w / v) , about 9.5 % (w / v) , about 10 % (w / v) .In some embodiments, lactic acid, when used as a permeation enhancer in a composition described herein, is present in an amount in an amount of about 0.1 % (w / v) to about 10 % (w / v) . In some embodiments, lactic acid, when used as a permeation enhancer in a composition described herein, is present in an amount in an amount of about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 2 % (w / v) , about 2.5 % (w / v) , about 3 % (w / v) , about 3.5 % (w / v) , about 4 % (w / v) , about 4.5 % (w / v) , about 5 % (w / v) , about 5.5 % (w / v) , about 6 % (w / v) , about 6.5 % (w / v) , about 7 % (w / v) , about 7.5 % (w / v) , about 8 % (w / v) , about 8.5 % (w / v) , about 9 % (w / v) , about 9.5 % (w / v) , about 10 % (w / v) .In some embodiments, a composition disclosed herein comprises a thickening agent or a thickener. Thickening agents are added to solutions to provide various degrees of viscosity to the compositions and to stabilize the films formed from the compositions described herein. In some embodiments, a thickener described herein is selected from pharmaceutically acceptable hydrophilic polymers. Hydrophilic polymers include, but are not limited to, partially etherified cellulose derivatives, completely synthetic hydrophilic polymers, and natural gums. Partially etherified cellulose derivatives include, but are not limited to, carboxymethyl-, hydroxyethyl-, hydroxypropyl-, hydroxypropylmethyl-and methyl-cellulose. Completely synthetic hydrophilic polymers include, but are not limited to, polyacrylates, polymethacrylates, poly (hydroxyethyl) -, poly (hydroxypropyl) -, poly (hydroxypropylmethyl) methacrylate, polyacrylonitrile, methallyl-sulphonate, polyethylenes, polyoxiethylenes, polyethylene glycols, polyethylene glycol-lactide, polyethylene glycol-diacrylate, polyvinylpyrrolidone, polyvinyl alcohols, poly (propylmethacrylamide) , polypropylene fumarate-co-ethylene glycol) , poloxamers, polyaspartamide, (hydrazine cross-linked) hyaluronic acid, and silicone. Natural gums include, but are not limited to, alginates, carrageenan, guar-gum, gelatine, tragacanth, (amidated) pectin, xanthan, chitosan collagen, agarose; mixtures and further derivatives or co-polymers thereof and / or other pharmaceutically, or at least biologically, acceptable polymers. In some embodiments, a thickener described herein comprises PEG 400. In some embodiments, a thickener described herein is Propylene glycol. In some embodiments, a thickener described herein is selected from Polyvinylpyrrolidone and its derivatives. In some embodiments, a thickener described herein is selected from polyurethane and its derivatives.In some embodiments, a composition described herein comprises a color substance. In some embodiments, a color substance described herein color substance comprises a pigment, a dye, a colorant, or any combinations thereof. In some embodiments, a color substance described herein is a pigment. Non-limiting examples of pigments in the compositions described herein include Titanium Dioxide, Black Iron Oxide, D&C Black #2, FD&C Red #4, D&C Red #6, D&C Red #7, D&C Red #17, D&C Red #21, D&C Red #22, D&C Red #27, D&C Red #28, D&C Red #30, D&C Red #31, D&C Red #33, D&C Red #34, D&C Red #36, D&C Red #40, FD&C Blue #1, D&C Orange #4, D&C Orange #5, D&C Orange #10, D&C Orange #11, D&C Blue #4, D&C Brown #1, FD&C Green #3, D&C Green #5, D&C Green #6, D&C Green #8, FD&C Yellow #5, FD&C Yellow #6, D&C Yellow #7, D&C Yellow #8, D&C Yellow #10, and D&C Yellow #11 and combinations thereof.In some embodiments, a color substance described herein is present in an amount of about 0.05% (w / v) to about 0.2% (w / v) . In some embodiments, a color substance described herein is present in an amount of about 0.05% (w / v) , about 0.06% (w / v) , about 0.07% (w / v) , about 0.08% (w / v) , about 0.09% (w / v) , about 0.1% (w / v) , about 0.15% (w / v) , to about 0.2%. In some embodiments, a color substance described herein is present in an amount of about 0.1%.Provided herein provided herein are nail film-forming compositions comprising an active pharmaceutical ingredient (API) described herein in an amount of 0.01-15% (w / v) , a film forming polymer described herein present in an amount of 5-15% (w / v) , a plasticizer described herein in an amount of 0.5-5 % (w / v) , ethanol, and a non-volatile solvent described herein. Also provided herein are nail film-forming compositions comprising an active pharmaceutical ingredient (API) in an amount of 0.01-15% (w / v) , a film forming polymer described herein present in an amount of 5-15% (w / v) , a permeation enhancer described herein present in an amount of 3%-15% (w / v) , a plasticizer described herein in an amount of 0.5-5 % (w / v) , ethanol, and a non-volatile solvent described herein. In some embodiments, the API is selected from an anti-bacterial substance, an anti-viral substance, an anti-fungal substance, an anti-inflammation substance and an ant-tumor substance. In some embodiments, the API comprises an anti-bacterial substance selected from penicillin, sulfonamides, Streptogramins, polypeptides, tetracycline, doxycycline, amoxicillin, carbapenems, cephalosporins, fluoroquinolones, glycopeptides and lipoglycopeptides, macrolides, monobactams, and any combinations thereof. In some embodiments, the API comprises an anti-viral substance described herein. In some embodiments, the API comprises an anti-fungal substance described herein selected from efinaconazole, tavaborole, ciclopirox, amorolfine, luliconazole, terbinafine, miconazole, ketoconazole, intraconazole, fluconazole, econazole, oxiconazole, clotrimazole, naftifine, voriconazole, isavuconazole, fenticonazole, tavaborole, amorolfine, anidulafungin, caspofungin, micafungin, rezafungin, Amphotericin B, terbinafine, and any combinations thereof. In some embodiments, the API comprises an anti-inflammation substance described herein comprising a JAK inhibitor, a PDE4 inhibitor, a corticosteroid, vitamin A, vitamin D3, an anti-IL-17 agent, an anti-IL-23 agent, an anti-TNFα agent, an anti-IL-4 agent, an S1PR inhibitor, a PI3Kδ inhibitor, or a TYK2 inhibitor. In some embodiments, the API comprises an anti-tumor substance described herein selected from JAK inhibitor, a PDE4 inhibitor, a corticosteroid, a checkpoint inhibitor, an anti-TNFα agent, an anti-IL-7 agent, 5-fluorouracil (F-FU) , and any combinations thereof. In some embodiments, the film forming polymer is Polymethacrylates or cellulose derivative. In some embodiments, the film forming polymer comprises Eudragit L100 and HPMC-AS-LF. In some embodiments, the permeation enhancer is an acid. In some embodiments, the permeation enhancer is lactic acid. In some embodiments, the plasticizer is PEG. In some embodiments, the PEG is PEG 6000. In some embodiments, the non-volatile solvent is water. In some embodiments, the compositions further comprise a solubilizer. In some embodiments, the solubilizer is Transcutol, PEG400, or benzyl alcohol.In some embodiments, a pharmaceutical composition provided herein comprises an API at an amount of from about an amount from about 1.0 mg to about 1000 mg, including but not limited to about 1.0 mg, 1.5 mg, 2.5 mg, 3.0 mg, 4.0 mg, 5.0 mg, 6.0 mg, 6.5 mg, 7.0 mg, 7.5 mg, 8.0 mg, 8.5 mg, 9.0 mg, 9.5 mg, 10.0, 10.5 mg, 11.0 mg, 12.0 mg, 12.5 mg, 13.0 mg, 13.5 mg, 14.0 mg, 14.5 mg, 15.0 mg, 15.5 mg, 16 mg, 16.5 mg, 17 mg, 17.5 mg, 18 mg, 18.5 mg, 19 mg, 19.5 mg, 20 mg, 20.5 mg, 21 mg, 21.5 mg, 22 mg, 22.5 mg, 23 mg, 23.5 mg, 24 mg, 24.5 mg, 25 mg, 25.5 mg, 26 mg, 26.5 mg, 27 mg, 27.5 mg, 28 mg, 28.5 mg, 29 mg, 29.5 mg, 30 mg, 30.5 mg, 31 mg, 31.5 mg, 32 mg, 32.5 mg, 33 mg, 33.5 mg, 36 mg, 36.5 mg, 37 mg, 37.5 mg, 38 mg, 38.5 mg, 39 mg, 39.5 mg, 40 mg, 40.5 mg, 41 mg, 41.5 mg, 42 mg, 42.5 mg, 43 mg, 43.5 mg, 44 mg, 44.5 mg, 45 mg, 45.5 mg, 46 mg, 46.5 mg, 47 mg, 47.5 mg, 48 mg, 48.5 mg, 49 mg, 49.5 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 135 mg, 140 mg, 145 mg, 150 mg, 155 mg, 160 mg, 165 mg, 170 mg, 175 mg, 180 mg, 185 mg, 190 mg, 200 mg, 205 mg, 210 mg, 215 mg, 220 mg, 225 mg, 230 mg, 235 mg, 240 mg, 245 mg, 250 mg, 255 mg, 260 mg, 265 mg, 270 mg, 275 mg, 280 mg, 285 mg, 290 mg, 295 mg, 300 mg, 305 mg, 310 mg, 315 mg, 320 mg, 325 mg, 326 mg, 326.5 mg, 327 mg, 327.5 mg, 328 mg, 328.5 mg, 329 mg, 329.5 mg, 330 mg, 330.5 mg, 331 mg, 331.5 mg, 332 mg, 332.5 mg, 333 mg, 333.5 mg, 334 mg, 334.5 mg, 335 mg, 335.5 mg, 336 mg, 336.5 mg, 337 mg, 337.5 mg, 338 mg, 338.5 mg, 339 mg, 339.5 mg, 340 mg, 340.5 mg, 341 mg, 341.5 mg, 342 mg, 342.5 mg, 343 mg, 343.5 mg, 344 mg, 344.5 mg, 345 mg, 345.5 mg, 346 mg, 346.5 mg, 347 mg, 347.5 mg, 348 mg, 348.5 mg, 349 mg, 349.5 mg, 350 mg, 350.5 mg, 351 mg, 351.5 mg, 352 mg, 352.5 mg, 353 mg, 353.5 mg, 354 mg, 354.5 mg, 355 mg, 355.5 mg, 356 mg, 356.5 mg, 357 mg, 357.5 mg, 358 mg, 358.5 mg, 359 mg, 359.5 mg, 360 mg, 360.5 mg, 361 mg, 361.5 mg, 362 mg, 362.5 mg, 363 mg, 363.5 mg, 364 mg, 364.5 mg, 365 mg, 365.5 mg, 366 mg, 366.5 mg, 367 mg, 367.5 mg, 368 mg, 369.5 mg, 370 mg, 370.5 mg, 371 mg, 371.5 mg, 372 mg, 372.5 mg, 373 mg, 373.5 mg, 374 mg, 374.5 mg, 375 mg, 375.5 mg, 376 mg, 376.5 mg, 377 mg, 377.5 mg, 378 mg, 378.5 mg, 379 mg, 379.5 mg, 380 mg, 380.5 mg, 381 mg, 381.5 mg, 382 mg, 382.5 mg, 383 mg, 383.5 mg, 384 mg, 384.5 mg, 385 mg, 385.5 mg, 386 mg, 386.5 mg, 387 mg, 387.5 mg, 388 mg, 388.5 mg, 389 mg, 389.5 mg, 390 mg, 390.5 mg, 391 mg, 391.5 mg, 392 mg, 392.5 mg, 393 mg, 393.5 mg, 394 mg, 394.5 mg, 395 mg, 395.5 mg, 396 mg, 396.5 mg, 397 mg, 397.5 mg, 398 mg, 398.5 mg, 399 mg, 399.5 mg, 400 mg, 405 mg, 410 mg, 415 mg, 420 mg, 425 mg, 430 mg, 435 mg, 440 mg, 445 mg, 450 mg, 455 mg, 460 mg, 465 mg, 470 mg, 475 mg, 480 mg, 485 mg, 490 mg, 495 mg, 500 mg, 505 mg, 510 mg, 515 mg, 520 mg, 525 mg, 530 mg, 535 mg, 540 mg, 545 mg, 550 mg, 555 mg, 560 mg, 565 mg, 570 mg, 575 mg, 580 mg, 585 mg, 590 mg, 595 mg, 600 mg, 605 mg, 610 mg, 615 mg, 620 mg, 625 mg, 630 mg, 635 mg, 640 mg, 645 mg, 650 mg, 655 mg, 660 mg, 665 mg, 675 mg, 680 mg, 685 mg, 690 mg, 695 mg, 700 mg, 705 mg, 710 mg, 715 mg, 720 mg, 725 mg, 730 mg, 735 mg, 740 mg, 745 mg, 750 mg, 755 mg, 760 mg, 765 mg, 770 mg, 775 mg, 780 mg, 785 mg, 790 mg, 795 mg, 800 mg, 805 mg, 810 mg, 815 mg, 820 mg, 825 mg, 830 mg, 835 mg, 840 mg, 845 mg, 850 mg, 855 mg, 860 mg, 865 mg, 870 mg, 875 mg, 880 mg, 885 mg, 890 mg, 895 mg, 900 mg, 905 mg, 910 mg, 915 mg, 920 mg, 925 mg, 930 mg, 935 mg, 940 mg, 945 mg, 950 mg, 955 mg, 960 mg, 965 mg, 970 mg, 975 mg, 980 mg, 985 mg, 990 mg, 995 mg, or 1000 mg.In some embodiments, a composition provided herein comprises an API in an amount of about 0.01% (w / v) to about 20% (w / v) . In some embodiments, a pharmaceutical composition provided herein comprises an API in an amount of about 0.01 % (w / v) , about 0.02 % (w / v) , about 0.03 % (w / v) , about 0.04 % (w / v) , about 0.05 % (w / v) , about 0.06 % (w / v) , about 0.07 % (w / v) , about 0.08 % (w / v) , about 0.09 % (w / v) , about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 2 % (w / v) , about 2.5 % (w / v) , about 3 % (w / v) , about 3.5 % (w / v) , about 4 % (w / v) , about 4.5 % (w / v) , about 5 % (w / v) , about 5.5 % (w / v) , about 6 % (w / v) , about 6.5 % (w / v) , about 7 % (w / v) , about 7.5 % (w / v) , about 8 % (w / v) , about 8.5 % (w / v) , about 9 % (w / v) , about 9.5 % (w / v) , about 10 % (w / v) , about 11 % (w / v) , about 12 % (w / v) , about 13 % (w / v) , about 14 % (w / v) , about 15 % (w / v) , about 16 % (w / v) , about 17 % (w / v) , about 18 % (w / v) , about 19 % (w / v) , or about 20 % (w / v) . In some embodiments, a composition provided herein comprises an API comprising terbinafine in an amount of 0.01 % (w / v) , about 0.02 % (w / v) , about 0.03 % (w / v) , about 0.04 % (w / v) , about 0.05 % (w / v) , about 0.06 % (w / v) , about 0.07 % (w / v) , about 0.08 % (w / v) , about 0.09 % (w / v) , about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 2 % (w / v) , about 2.5 % (w / v) , about 3 % (w / v) , about 3.5 % (w / v) , about 4 % (w / v) , about 4.5 % (w / v) , about 5 % (w / v) , about 5.5 % (w / v) , about 6 % (w / v) , about 6.5 % (w / v) , about 7 % (w / v) , about 7.5 % (w / v) , about 8 % (w / v) , about 8.5 % (w / v) , about 9 % (w / v) , about 9.5 % (w / v) , about 10 % (w / v) , about 11 % (w / v) , about 12 % (w / v) , about 13 % (w / v) , about 14 % (w / v) , or about 15 % (w / v) . In some embodiments, a composition provided herein comprises an API comprising efinaconazole in an amount of 0.01 % (w / v) , about 0.02 % (w / v) , about 0.03 % (w / v) , about 0.04 % (w / v) , about 0.05 % (w / v) , about 0.06 % (w / v) , about 0.07 % (w / v) , about 0.08 % (w / v) , about 0.09 % (w / v) , about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 2 % (w / v) , about 2.5 % (w / v) , about 3 % (w / v) , about 3.5 % (w / v) , about 4 % (w / v) , about 4.5 % (w / v) , about 5 % (w / v) , about 5.5 % (w / v) , about 6 % (w / v) , about 6.5 % (w / v) , about 7 % (w / v) , about 7.5 % (w / v) , about 8 % (w / v) , about 8.5 % (w / v) , about 9 % (w / v) , about 9.5 % (w / v) , about 10 % (w / v) , about 11 % (w / v) , about 12 % (w / v) , about 13 % (w / v) , about 14 % (w / v) , or about 15 % (w / v) .In some embodiments, a film-forming polymer described herein comprises Eudragit L100 and HPMC-AS. In some embodiment, a composition described herein comprises Eudragit L100 at an amount of about 1.0 mg to about 1000 mg and HPMC-AS at an amount of about 1.0 mg to about 1000 mg. In some embodiments, a pharmaceutical composition described herein comprises Eudragit L100 at an amount of at an amount of from about an amount from about 1.0 mg to about 1000 mg, including but not limited to about 1.0 mg, 1.5 mg, 2.5 mg, 3.0 mg, 4.0 mg, 5.0 mg, 6.0 mg, 6.5 mg, 7.0 mg, 7.5 mg, 8.0 mg, 8.5 mg, 9.0 mg, 9.5 mg, 10.0, 10.5 mg, 11.0 mg, 12.0 mg, 12.5 mg, 13.0 mg, 13.5 mg, 14.0 mg, 14.5 mg, 15.0 mg, 15.5 mg, 16 mg, 16.5 mg, 17 mg, 17.5 mg, 18 mg, 18.5 mg, 19 mg, 19.5 mg, 20 mg, 20.5 mg, 21 mg, 21.5 mg, 22 mg, 22.5 mg, 23 mg, 23.5 mg, 24 mg, 24.5 mg, 25 mg, 25.5 mg, 26 mg, 26.5 mg, 27 mg, 27.5 mg, 28 mg, 28.5 mg, 29 mg, 29.5 mg, 30 mg, 30.5 mg, 31 mg, 31.5 mg, 32 mg, 32.5 mg, 33 mg, 33.5 mg, 36 mg, 36.5 mg, 37 mg, 37.5 mg, 38 mg, 38.5 mg, 39 mg, 39.5 mg, 40 mg, 40.5 mg, 41 mg, 41.5 mg, 42 mg, 42.5 mg, 43 mg, 43.5 mg, 44 mg, 44.5 mg, 45 mg, 45.5 mg, 46 mg, 46.5 mg, 47 mg, 47.5 mg, 48 mg, 48.5 mg, 49 mg, 49.5 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 135 mg, 140 mg, 145 mg, 150 mg, 155 mg, 160 mg, 165 mg, 170 mg, 175 mg, 180 mg, 185 mg, 190 mg, 200 mg, 205 mg, 210 mg, 215 mg, 220 mg, 225 mg, 230 mg, 235 mg, 240 mg, 245 mg, 250 mg, 255 mg, 260 mg, 265 mg, 270 mg, 275 mg, 280 mg, 285 mg, 290 mg, 295 mg, 300 mg, 305 mg, 310 mg, 315 mg, 320 mg, 325 mg, 326 mg, 326.5 mg, 327 mg, 327.5 mg, 328 mg, 328.5 mg, 329 mg, 329.5 mg, 330 mg, 330.5 mg, 331 mg, 331.5 mg, 332 mg, 332.5 mg, 333 mg, 333.5 mg, 334 mg, 334.5 mg, 335 mg, 335.5 mg, 336 mg, 336.5 mg, 337 mg, 337.5 mg, 338 mg, 338.5 mg, 339 mg, 339.5 mg, 340 mg, 340.5 mg, 341 mg, 341.5 mg, 342 mg, 342.5 mg, 343 mg, 343.5 mg, 344 mg, 344.5 mg, 345 mg, 345.5 mg, 346 mg, 346.5 mg, 347 mg, 347.5 mg, 348 mg, 348.5 mg, 349 mg, 349.5 mg, 350 mg, 350.5 mg, 351 mg, 351.5 mg, 352 mg, 352.5 mg, 353 mg, 353.5 mg, 354 mg, 354.5 mg, 355 mg, 355.5 mg, 356 mg, 356.5 mg, 357 mg, 357.5 mg, 358 mg, 358.5 mg, 359 mg, 359.5 mg, 360 mg, 360.5 mg, 361 mg, 361.5 mg, 362 mg, 362.5 mg, 363 mg, 363.5 mg, 364 mg, 364.5 mg, 365 mg, 365.5 mg, 366 mg, 366.5 mg, 367 mg, 367.5 mg, 368 mg, 369.5 mg, 370 mg, 370.5 mg, 371 mg, 371.5 mg, 372 mg, 372.5 mg, 373 mg, 373.5 mg, 374 mg, 374.5 mg, 375 mg, 375.5 mg, 376 mg, 376.5 mg, 377 mg, 377.5 mg, 378 mg, 378.5 mg, 379 mg, 379.5 mg, 380 mg, 380.5 mg, 381 mg, 381.5 mg, 382 mg, 382.5 mg, 383 mg, 383.5 mg, 384 mg, 384.5 mg, 385 mg, 385.5 mg, 386 mg, 386.5 mg, 387 mg, 387.5 mg, 388 mg, 388.5 mg, 389 mg, 389.5 mg, 390 mg, 390.5 mg, 391 mg, 391.5 mg, 392 mg, 392.5 mg, 393 mg, 393.5 mg, 394 mg, 394.5 mg, 395 mg, 395.5 mg, 396 mg, 396.5 mg, 397 mg, 397.5 mg, 398 mg, 398.5 mg, 399 mg, 399.5 mg, 400 mg, 405 mg, 410 mg, 415 mg, 420 mg, 425 mg, 430 mg, 435 mg, 440 mg, 445 mg, 450 mg, 455 mg, 460 mg, 465 mg, 470 mg, 475 mg, 480 mg, 485 mg, 490 mg, 495 mg, 500 mg, 505 mg, 510 mg, 515 mg, 520 mg, 525 mg, 530 mg, 535 mg, 540 mg, 545 mg, 550 mg, 555 mg, 560 mg, 565 mg, 570 mg, 575 mg, 580 mg, 585 mg, 590 mg, 595 mg, 600 mg, 605 mg, 610 mg, 615 mg, 620 mg, 625 mg, 630 mg, 635 mg, 640 mg, 645 mg, 650 mg, 655 mg, 660 mg, 665 mg, 675 mg, 680 mg, 685 mg, 690 mg, 695 mg, 700 mg, 705 mg, 710 mg, 715 mg, 720 mg, 725 mg, 730 mg, 735 mg, 740 mg, 745 mg, 750 mg, 755 mg, 760 mg, 765 mg, 770 mg, 775 mg, 780 mg, 785 mg, 790 mg, 795 mg, 800 mg, 805 mg, 810 mg, 815 mg, 820 mg, 825 mg, 830 mg, 835 mg, 840 mg, 845 mg, 850 mg, 855 mg, 860 mg, 865 mg, 870 mg, 875 mg, 880 mg, 885 mg, 890 mg, 895 mg, 900 mg, 905 mg, 910 mg, 915 mg, 920 mg, 925 mg, 930 mg, 935 mg, 940 mg, 945 mg, 950 mg, 955 mg, 960 mg, 965 mg, 970 mg, 975 mg, 980 mg, 985 mg, 990 mg, 995 mg, or 1000 mg.In some embodiments, a composition described herein comprises HPMC-AS at an amount of at an amount of from about an amount from about 1.0 mg to about 1000 mg, including but not limited to about 1.0 mg, 1.5 mg, 2.5 mg, 3.0 mg, 4.0 mg, 5.0 mg, 6.0 mg, 6.5 mg, 7.0 mg, 7.5 mg, 8.0 mg, 8.5 mg, 9.0 mg, 9.5 mg, 10.0, 10.5 mg, 11.0 mg, 12.0 mg, 12.5 mg, 13.0 mg, 13.5 mg, 14.0 mg, 14.5 mg, 15.0 mg, 15.5 mg, 16 mg, 16.5 mg, 17 mg, 17.5 mg, 18 mg, 18.5 mg, 19 mg, 19.5 mg, 20 mg, 20.5 mg, 21 mg, 21.5 mg, 22 mg, 22.5 mg, 23 mg, 23.5 mg, 24 mg, 24.5 mg, 25 mg, 25.5 mg, 26 mg, 26.5 mg, 27 mg, 27.5 mg, 28 mg, 28.5 mg, 29 mg, 29.5 mg, 30 mg, 30.5 mg, 31 mg, 31.5 mg, 32 mg, 32.5 mg, 33 mg, 33.5 mg, 36 mg, 36.5 mg, 37 mg, 37.5 mg, 38 mg, 38.5 mg, 39 mg, 39.5 mg, 40 mg, 40.5 mg, 41 mg, 41.5 mg, 42 mg, 42.5 mg, 43 mg, 43.5 mg, 44 mg, 44.5 mg, 45 mg, 45.5 mg, 46 mg, 46.5 mg, 47 mg, 47.5 mg, 48 mg, 48.5 mg, 49 mg, 49.5 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 135 mg, 140 mg, 145 mg, 150 mg, 155 mg, 160 mg, 165 mg, 170 mg, 175 mg, 180 mg, 185 mg, 190 mg, 200 mg, 205 mg, 210 mg, 215 mg, 220 mg, 225 mg, 230 mg, 235 mg, 240 mg, 245 mg, 250 mg, 255 mg, 260 mg, 265 mg, 270 mg, 275 mg, 280 mg, 285 mg, 290 mg, 295 mg, 300 mg, 305 mg, 310 mg, 315 mg, 320 mg, 325 mg, 326 mg, 326.5 mg, 327 mg, 327.5 mg, 328 mg, 328.5 mg, 329 mg, 329.5 mg, 330 mg, 330.5 mg, 331 mg, 331.5 mg, 332 mg, 332.5 mg, 333 mg, 333.5 mg, 334 mg, 334.5 mg, 335 mg, 335.5 mg, 336 mg, 336.5 mg, 337 mg, 337.5 mg, 338 mg, 338.5 mg, 339 mg, 339.5 mg, 340 mg, 340.5 mg, 341 mg, 341.5 mg, 342 mg, 342.5 mg, 343 mg, 343.5 mg, 344 mg, 344.5 mg, 345 mg, 345.5 mg, 346 mg, 346.5 mg, 347 mg, 347.5 mg, 348 mg, 348.5 mg, 349 mg, 349.5 mg, 350 mg, 350.5 mg, 351 mg, 351.5 mg, 352 mg, 352.5 mg, 353 mg, 353.5 mg, 354 mg, 354.5 mg, 355 mg, 355.5 mg, 356 mg, 356.5 mg, 357 mg, 357.5 mg, 358 mg, 358.5 mg, 359 mg, 359.5 mg, 360 mg, 360.5 mg, 361 mg, 361.5 mg, 362 mg, 362.5 mg, 363 mg, 363.5 mg, 364 mg, 364.5 mg, 365 mg, 365.5 mg, 366 mg, 366.5 mg, 367 mg, 367.5 mg, 368 mg, 369.5 mg, 370 mg, 370.5 mg, 371 mg, 371.5 mg, 372 mg, 372.5 mg, 373 mg, 373.5 mg, 374 mg, 374.5 mg, 375 mg, 375.5 mg, 376 mg, 376.5 mg, 377 mg, 377.5 mg, 378 mg, 378.5 mg, 379 mg, 379.5 mg, 380 mg, 380.5 mg, 381 mg, 381.5 mg, 382 mg, 382.5 mg, 383 mg, 383.5 mg, 384 mg, 384.5 mg, 385 mg, 385.5 mg, 386 mg, 386.5 mg, 387 mg, 387.5 mg, 388 mg, 388.5 mg, 389 mg, 389.5 mg, 390 mg, 390.5 mg, 391 mg, 391.5 mg, 392 mg, 392.5 mg, 393 mg, 393.5 mg, 394 mg, 394.5 mg, 395 mg, 395.5 mg, 396 mg, 396.5 mg, 397 mg, 397.5 mg, 398 mg, 398.5 mg, 399 mg, 399.5 mg, 400 mg, 405 mg, 410 mg, 415 mg, 420 mg, 425 mg, 430 mg, 435 mg, 440 mg, 445 mg, 450 mg, 455 mg, 460 mg, 465 mg, 470 mg, 475 mg, 480 mg, 485 mg, 490 mg, 495 mg, 500 mg, 505 mg, 510 mg, 515 mg, 520 mg, 525 mg, 530 mg, 535 mg, 540 mg, 545 mg, 550 mg, 555 mg, 560 mg, 565 mg, 570 mg, 575 mg, 580 mg, 585 mg, 590 mg, 595 mg, 600 mg, 605 mg, 610 mg, 615 mg, 620 mg, 625 mg, 630 mg, 635 mg, 640 mg, 645 mg, 650 mg, 655 mg, 660 mg, 665 mg, 675 mg, 680 mg, 685 mg, 690 mg, 695 mg, 700 mg, 705 mg, 710 mg, 715 mg, 720 mg, 725 mg, 730 mg, 735 mg, 740 mg, 745 mg, 750 mg, 755 mg, 760 mg, 765 mg, 770 mg, 775 mg, 780 mg, 785 mg, 790 mg, 795 mg, 800 mg, 805 mg, 810 mg, 815 mg, 820 mg, 825 mg, 830 mg, 835 mg, 840 mg, 845 mg, 850 mg, 855 mg, 860 mg, 865 mg, 870 mg, 875 mg, 880 mg, 885 mg, 890 mg, 895 mg, 900 mg, 905 mg, 910 mg, 915 mg, 920 mg, 925 mg, 930 mg, 935 mg, 940 mg, 945 mg, 950 mg, 955 mg, 960 mg, 965 mg, 970 mg, 975 mg, 980 mg, 985 mg, 990 mg, 995 mg, or 1000 mg. In some embodiments, a composition described herein comprises Eudragit L100 in an amount of about 5 % (w / v) to about 15 % (w / v) and HPMC-AS in an amount of about 0.5 % (w / v) to about to about 4 % (w / v) . In some embodiments, a composition described herein comprises Eudragit L100 in an amount of about 5 % (w / v) , about 5.1 % (w / v) , about 5.2 % (w / v) , about 5.3 % (w / v) , about 5.4 % (w / v) , about 5.5 % (w / v) , about 5.6 % (w / v) , about 5.7 % (w / v) , about 5.8 % (w / v) , about 5.9 % (w / v) , about 6 % (w / v) , about 6.1 % (w / v) , about 6.2 % (w / v) , about 6.3 % (w / v) , about 6.4 % (w / v) , about 6.5 % (w / v) , about 6.6 % (w / v) , about 6.7 % (w / v) , about 6.8 % (w / v) , about 6.9 % (w / v) , about 7 % (w / v) , about 7.1 % (w / v) , about 7.2 % (w / v) , about 7.3 % (w / v) , about 7.4 % (w / v) , about 7.5 % (w / v) , about 7.6 % (w / v) , about 7.7 % (w / v) , about 7.8 % (w / v) , about 7.9 % (w / v) , about 8 % (w / v) , about 8.1 % (w / v) , about 8.2 % (w / v) , about 8.3 % (w / v) , about 8.4 % (w / v) , about 8.5 % (w / v) , about 8.6 % (w / v) , about 8.7 % (w / v) , about 8.8 % (w / v) , about 8.9 % (w / v) , about 9 % (w / v) , about 9.1 % (w / v) , about 9.2 % (w / v) , about 9.3 % (w / v) , about 9.4 % (w / v) , about 9.5 % (w / v) , about 9.6 % (w / v) , about 9.7 % (w / v) , about 9.8 % (w / v) , about 9.9 % (w / v) , about 10 % (w / v) , about 10.1 % (w / v) , about 10.2 % (w / v) , about 10.3 % (w / v) , about 10.4 % (w / v) , about 10.5 % (w / v) , about 10.6 % (w / v) , about 10.7 % (w / v) , about 10.8 % (w / v) , about 10.9 % (w / v) , about 11 % (w / v) , about 11.1 % (w / v) , about 11.2 % (w / v) , about 11.3 % (w / v) , about 11.4 % (w / v) , about 11.5 % (w / v) , about 11.6 % (w / v) , about 11.7 % (w / v) , about 11.8 % (w / v) , about 11.9 % (w / v) , about 12 % (w / v) , about 12.1 % (w / v) , about 12.2 % (w / v) , about 12.3 % (w / v) , about 12.4 % (w / v) , about 12.5 % (w / v) , about 12.6 % (w / v) , about 12.7 % (w / v) , about 12.8 % (w / v) , about 12.9 % (w / v) , about 13 % (w / v) , 13.1 % (w / v) , 13.2 % (w / v) , 13.3 % (w / v) , 13.4 % (w / v) , 13.5 % (w / v) , 13.6 % (w / v) , 13.7 % (w / v) , 13.8 % (w / v) , 13.9 % (w / v) , about 14 % (w / v) , 14.1 % (w / v) , 14.2 % (w / v) , 14.3 % (w / v) , 14.4 % (w / v) , 14.5 % (w / v) , 14.6 % (w / v) , 14.7 % (w / v) , 14.8 % (w / v) , 14.9 % (w / v) , or about 15 % (w / v) . In some embodiments, a composition described herein comprises HPMC-AS in an amount of about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 1.6 % (w / v) , about 1.7 % (w / v) , about 1.8 % (w / v) , about 1.9 % (w / v) , about 2 % (w / v) , about 2.1 % (w / v) , about 2.2 % (w / v) , about 2.3 % (w / v) , about 2.4 % (w / v) , about 2.5 % (w / v) , about 2.6 % (w / v) , about 2.7 % (w / v) , about 2.8 % (w / v) , about 2.9 % (w / v) , about 3 % (w / v) , about 3.1 % (w / v) , about 3.2 % (w / v) , about 3.3 % (w / v) , about 3.4 % (w / v) , about 3.5 % (w / v) , about 3.6 % (w / v) , about 3.7 % (w / v) , about 3.8 % (w / v) , about 3.9 % (w / v) , or about 4 % (w / v) .In some embodiments, a composition described herein comprises Eudragit L100 in an amount of about 10 % (w / v) and HPMC-AS in an amount of about 0.1 % (w / v) to about 1.0 % (w / v) , about 0.2 % (w / v) to about 1.2 % (w / v) , about 0.3 % (w / v) to about 1.3 % (w / v) , about 0.4 % (w / v) to about 1.4% (w / v) , about 0.5 % (w / v) to about 1.5 % (w / v) , about 0.6 % (w / v) to about 1.6% (w / v) , about 0.7 % (w / v) to about 1.7% (w / v) , about 0.8% (w / v) to about 1.8 % (w / v) , about 0.9 % (w / v) to about 2.9 % (w / v) , about 1.0% (w / v) to about 2.0 % (w / v) , about 1.5 % (w / v) to about 2.5 % (w / v) , about 2% (w / v) to about 3% (w / v) , about 2.5% (w / v) to about 3.5 % (w / v) , or about 3% (w / v) to about 4% (w / v) .In some embodiments, a composition described herein comprises Eudragit L100 in an amount of about 5 % (w / v) and HPMC-AS in an amount of about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 1.6 % (w / v) , about 1.7 % (w / v) , about 1.8 % (w / v) , about 1.9 % (w / v) , about 2 % (w / v) , about 2.1 % (w / v) , about 2.2 % (w / v) , about 2.3 % (w / v) , about 2.4 % (w / v) , about 2.5 % (w / v) , about 2.6 % (w / v) , about 2.7 % (w / v) , about 2.8 % (w / v) , about 2.9 % (w / v) , about 3 % (w / v) , about 3.1 % (w / v) , about 3.2 % (w / v) , about 3.3 % (w / v) , about 3.4 % (w / v) , about 3.5 % (w / v) , about 3.6 % (w / v) , about 3.7 % (w / v) , about 3.8 % (w / v) , about 3.9 % (w / v) , or about 4 % (w / v) . In some embodiments, a composition described herein comprises Eudragit L100 in an amount of about 10 % (w / v) and HPMC-AS in an amount of about 0.5 % (w / v) to about 1.0 % (w / v) .In some embodiments, a composition provided herein comprises a plasticizer at an amount of from about an amount from about 1.0 mg to about 1000 mg, including but not limited to about 1.0 mg, 1.5 mg, 2.5 mg, 3.0 mg, 4.0 mg, 5.0 mg, 6.0 mg, 6.5 mg, 7.0 mg, 7.5 mg, 8.0 mg, 8.5 mg, 9.0 mg, 9.5 mg, 10.0, 10.5 mg, 11.0 mg, 12.0 mg, 12.5 mg, 13.0 mg, 13.5 mg, 14.0 mg, 14.5 mg, 15.0 mg, 15.5 mg, 16 mg, 16.5 mg, 17 mg, 17.5 mg, 18 mg, 18.5 mg, 19 mg, 19.5 mg, 20 mg, 20.5 mg, 21 mg, 21.5 mg, 22 mg, 22.5 mg, 23 mg, 23.5 mg, 24 mg, 24.5 mg, 25 mg, 25.5 mg, 26 mg, 26.5 mg, 27 mg, 27.5 mg, 28 mg, 28.5 mg, 29 mg, 29.5 mg, 30 mg, 30.5 mg, 31 mg, 31.5 mg, 32 mg, 32.5 mg, 33 mg, 33.5 mg, 36 mg, 36.5 mg, 37 mg, 37.5 mg, 38 mg, 38.5 mg, 39 mg, 39.5 mg, 40 mg, 40.5 mg, 41 mg, 41.5 mg, 42 mg, 42.5 mg, 43 mg, 43.5 mg, 44 mg, 44.5 mg, 45 mg, 45.5 mg, 46 mg, 46.5 mg, 47 mg, 47.5 mg, 48 mg, 48.5 mg, 49 mg, 49.5 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 135 mg, 140 mg, 145 mg, 150 mg, 155 mg, 160 mg, 165 mg, 170 mg, 175 mg, 180 mg, 185 mg, 190 mg, 200 mg, 205 mg, 210 mg, 215 mg, 220 mg, 225 mg, 230 mg, 235 mg, 240 mg, 245 mg, 250 mg, 255 mg, 260 mg, 265 mg, 270 mg, 275 mg, 280 mg, 285 mg, 290 mg, 295 mg, 300 mg, 305 mg, 310 mg, 315 mg, 320 mg, 325 mg, 326 mg, 326.5 mg, 327 mg, 327.5 mg, 328 mg, 328.5 mg, 329 mg, 329.5 mg, 330 mg, 330.5 mg, 331 mg, 331.5 mg, 332 mg, 332.5 mg, 333 mg, 333.5 mg, 334 mg, 334.5 mg, 335 mg, 335.5 mg, 336 mg, 336.5 mg, 337 mg, 337.5 mg, 338 mg, 338.5 mg, 339 mg, 339.5 mg, 340 mg, 340.5 mg, 341 mg, 341.5 mg, 342 mg, 342.5 mg, 343 mg, 343.5 mg, 344 mg, 344.5 mg, 345 mg, 345.5 mg, 346 mg, 346.5 mg, 347 mg, 347.5 mg, 348 mg, 348.5 mg, 349 mg, 349.5 mg, 350 mg, 350.5 mg, 351 mg, 351.5 mg, 352 mg, 352.5 mg, 353 mg, 353.5 mg, 354 mg, 354.5 mg, 355 mg, 355.5 mg, 356 mg, 356.5 mg, 357 mg, 357.5 mg, 358 mg, 358.5 mg, 359 mg, 359.5 mg, 360 mg, 360.5 mg, 361 mg, 361.5 mg, 362 mg, 362.5 mg, 363 mg, 363.5 mg, 364 mg, 364.5 mg, 365 mg, 365.5 mg, 366 mg, 366.5 mg, 367 mg, 367.5 mg, 368 mg, 369.5 mg, 370 mg, 370.5 mg, 371 mg, 371.5 mg, 372 mg, 372.5 mg, 373 mg, 373.5 mg, 374 mg, 374.5 mg, 375 mg, 375.5 mg, 376 mg, 376.5 mg, 377 mg, 377.5 mg, 378 mg, 378.5 mg, 379 mg, 379.5 mg, 380 mg, 380.5 mg, 381 mg, 381.5 mg, 382 mg, 382.5 mg, 383 mg, 383.5 mg, 384 mg, 384.5 mg, 385 mg, 385.5 mg, 386 mg, 386.5 mg, 387 mg, 387.5 mg, 388 mg, 388.5 mg, 389 mg, 389.5 mg, 390 mg, 390.5 mg, 391 mg, 391.5 mg, 392 mg, 392.5 mg, 393 mg, 393.5 mg, 394 mg, 394.5 mg, 395 mg, 395.5 mg, 396 mg, 396.5 mg, 397 mg, 397.5 mg, 398 mg, 398.5 mg, 399 mg, 399.5 mg, 400 mg, 405 mg, 410 mg, 415 mg, 420 mg, 425 mg, 430 mg, 435 mg, 440 mg, 445 mg, 450 mg, 455 mg, 460 mg, 465 mg, 470 mg, 475 mg, 480 mg, 485 mg, 490 mg, 495 mg, 500 mg, 505 mg, 510 mg, 515 mg, 520 mg, 525 mg, 530 mg, 535 mg, 540 mg, 545 mg, 550 mg, 555 mg, 560 mg, 565 mg, 570 mg, 575 mg, 580 mg, 585 mg, 590 mg, 595 mg, 600 mg, 605 mg, 610 mg, 615 mg, 620 mg, 625 mg, 630 mg, 635 mg, 640 mg, 645 mg, 650 mg, 655 mg, 660 mg, 665 mg, 675 mg, 680 mg, 685 mg, 690 mg, 695 mg, 700 mg, 705 mg, 710 mg, 715 mg, 720 mg, 725 mg, 730 mg, 735 mg, 740 mg, 745 mg, 750 mg, 755 mg, 760 mg, 765 mg, 770 mg, 775 mg, 780 mg, 785 mg, 790 mg, 795 mg, 800 mg, 805 mg, 810 mg, 815 mg, 820 mg, 825 mg, 830 mg, 835 mg, 840 mg, 845 mg, 850 mg, 855 mg, 860 mg, 865 mg, 870 mg, 875 mg, 880 mg, 885 mg, 890 mg, 895 mg, 900 mg, 905 mg, 910 mg, 915 mg, 920 mg, 925 mg, 930 mg, 935 mg, 940 mg, 945 mg, 950 mg, 955 mg, 960 mg, 965 mg, 970 mg, 975 mg, 980 mg, 985 mg, 990 mg, 995 mg, or 1000 mg.In some embodiments, a composition provided herein comprises a plasticizer in an amount of about 0.1 % (w / v) to about 5 % (w / v) . In some embodiments, a composition provided herein comprises a plasticizer in an amount of about 0.1 % (w / v) to about 1.0 % (w / v) , about 0.2 % (w / v) to about 1.2 % (w / v) , about 0.3 % (w / v) to about 1.3 % (w / v) , about 0.4 % (w / v) to about 1.4 % (w / v) , about 0.5 % (w / v) to about 1.5 % (w / v) , about 0.6 % (w / v) to about 1.6% (w / v) , about 0.7 % (w / v) to about 1.7% (w / v) , about 0.8% (w / v) to about 1.8 % (w / v) , about 0.9 % (w / v) to about 2.9 % (w / v) , about 1.0% (w / v) to about 2.0 % (w / v) , about 1.5 % (w / v) to about 2.5 % (w / v) , about 2 % (w / v) to about 3% (w / v) , about 2.5% (w / v) to about 3.5 % (w / v) , about 3 % (w / v) to about 4 % (w / v) , about 3.5% (w / v) to about 4.5 % (w / v) , about 4 % (w / v) to about 5 % (w / v) . In some embodiments, a composition provided herein comprises a plasticizer in an amount of about 2 % (w / v) to about 4 % (w / v) . In some embodiments, a plasticizer is PEG 6000. In some embodiments, a composition provided herein comprises PEG 6000 in an amount of about 2 % (w / v) to about 4 % (w / v) .In some embodiments, a composition provided herein further comprises a solubilizer described herein. In some embodiments, a solubilizer described herein is transcutol or propylene glycol. In some embodiments, a solubilizer described herein is propylene glycol. In some embodiments, a solubilizer described herein is transcutol.In some embodiments, a composition described herein comprises a solubilizer at an amount of at an amount of from about an amount from about 1.0 mg to about 1000 mg, including but not limited to about 1.0 mg, 1.5 mg, 2.5 mg, 3.0 mg, 4.0 mg, 5.0 mg, 6.0 mg, 6.5 mg, 7.0 mg, 7.5 mg, 8.0 mg, 8.5 mg, 9.0 mg, 9.5 mg, 10.0, 10.5 mg, 11.0 mg, 12.0 mg, 12.5 mg, 13.0 mg, 13.5 mg, 14.0 mg, 14.5 mg, 15.0 mg, 15.5 mg, 16 mg, 16.5 mg, 17 mg, 17.5 mg, 18 mg, 18.5 mg, 19 mg, 19.5 mg, 20 mg, 20.5 mg, 21 mg, 21.5 mg, 22 mg, 22.5 mg, 23 mg, 23.5 mg, 24 mg, 24.5 mg, 25 mg, 25.5 mg, 26 mg, 26.5 mg, 27 mg, 27.5 mg, 28 mg, 28.5 mg, 29 mg, 29.5 mg, 30 mg, 30.5 mg, 31 mg, 31.5 mg, 32 mg, 32.5 mg, 33 mg, 33.5 mg, 36 mg, 36.5 mg, 37 mg, 37.5 mg, 38 mg, 38.5 mg, 39 mg, 39.5 mg, 40 mg, 40.5 mg, 41 mg, 41.5 mg, 42 mg, 42.5 mg, 43 mg, 43.5 mg, 44 mg, 44.5 mg, 45 mg, 45.5 mg, 46 mg, 46.5 mg, 47 mg, 47.5 mg, 48 mg, 48.5 mg, 49 mg, 49.5 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 135 mg, 140 mg, 145 mg, 150 mg, 155 mg, 160 mg, 165 mg, 170 mg, 175 mg, 180 mg, 185 mg, 190 mg, 200 mg, 205 mg, 210 mg, 215 mg, 220 mg, 225 mg, 230 mg, 235 mg, 240 mg, 245 mg, 250 mg, 255 mg, 260 mg, 265 mg, 270 mg, 275 mg, 280 mg, 285 mg, 290 mg, 295 mg, 300 mg, 305 mg, 310 mg, 315 mg, 320 mg, 325 mg, 326 mg, 326.5 mg, 327 mg, 327.5 mg, 328 mg, 328.5 mg, 329 mg, 329.5 mg, 330 mg, 330.5 mg, 331 mg, 331.5 mg, 332 mg, 332.5 mg, 333 mg, 333.5 mg, 334 mg, 334.5 mg, 335 mg, 335.5 mg, 336 mg, 336.5 mg, 337 mg, 337.5 mg, 338 mg, 338.5 mg, 339 mg, 339.5 mg, 340 mg, 340.5 mg, 341 mg, 341.5 mg, 342 mg, 342.5 mg, 343 mg, 343.5 mg, 344 mg, 344.5 mg, 345 mg, 345.5 mg, 346 mg, 346.5 mg, 347 mg, 347.5 mg, 348 mg, 348.5 mg, 349 mg, 349.5 mg, 350 mg, 350.5 mg, 351 mg, 351.5 mg, 352 mg, 352.5 mg, 353 mg, 353.5 mg, 354 mg, 354.5 mg, 355 mg, 355.5 mg, 356 mg, 356.5 mg, 357 mg, 357.5 mg, 358 mg, 358.5 mg, 359 mg, 359.5 mg, 360 mg, 360.5 mg, 361 mg, 361.5 mg, 362 mg, 362.5 mg, 363 mg, 363.5 mg, 364 mg, 364.5 mg, 365 mg, 365.5 mg, 366 mg, 366.5 mg, 367 mg, 367.5 mg, 368 mg, 369.5 mg, 370 mg, 370.5 mg, 371 mg, 371.5 mg, 372 mg, 372.5 mg, 373 mg, 373.5 mg, 374 mg, 374.5 mg, 375 mg, 375.5 mg, 376 mg, 376.5 mg, 377 mg, 377.5 mg, 378 mg, 378.5 mg, 379 mg, 379.5 mg, 380 mg, 380.5 mg, 381 mg, 381.5 mg, 382 mg, 382.5 mg, 383 mg, 383.5 mg, 384 mg, 384.5 mg, 385 mg, 385.5 mg, 386 mg, 386.5 mg, 387 mg, 387.5 mg, 388 mg, 388.5 mg, 389 mg, 389.5 mg, 390 mg, 390.5 mg, 391 mg, 391.5 mg, 392 mg, 392.5 mg, 393 mg, 393.5 mg, 394 mg, 394.5 mg, 395 mg, 395.5 mg, 396 mg, 396.5 mg, 397 mg, 397.5 mg, 398 mg, 398.5 mg, 399 mg, 399.5 mg, 400 mg, 405 mg, 410 mg, 415 mg, 420 mg, 425 mg, 430 mg, 435 mg, 440 mg, 445 mg, 450 mg, 455 mg, 460 mg, 465 mg, 470 mg, 475 mg, 480 mg, 485 mg, 490 mg, 495 mg, 500 mg, 505 mg, 510 mg, 515 mg, 520 mg, 525 mg, 530 mg, 535 mg, 540 mg, 545 mg, 550 mg, 555 mg, 560 mg, 565 mg, 570 mg, 575 mg, 580 mg, 585 mg, 590 mg, 595 mg, 600 mg, 605 mg, 610 mg, 615 mg, 620 mg, 625 mg, 630 mg, 635 mg, 640 mg, 645 mg, 650 mg, 655 mg, 660 mg, 665 mg, 675 mg, 680 mg, 685 mg, 690 mg, 695 mg, 700 mg, 705 mg, 710 mg, 715 mg, 720 mg, 725 mg, 730 mg, 735 mg, 740 mg, 745 mg, 750 mg, 755 mg, 760 mg, 765 mg, 770 mg, 775 mg, 780 mg, 785 mg, 790 mg, 795 mg, 800 mg, 805 mg, 810 mg, 815 mg, 820 mg, 825 mg, 830 mg, 835 mg, 840 mg, 845 mg, 850 mg, 855 mg, 860 mg, 865 mg, 870 mg, 875 mg, 880 mg, 885 mg, 890 mg, 895 mg, 900 mg, 905 mg, 910 mg, 915 mg, 920 mg, 925 mg, 930 mg, 935 mg, 940 mg, 945 mg, 950 mg, 955 mg, 960 mg, 965 mg, 970 mg, 975 mg, 980 mg, 985 mg, 990 mg, 995 mg, or 1000 mg.In some embodiments, a composition described herein comprises a solubilizer present in an amount of about 0.1 % (w / v) to about 5 % (w / v) . In some embodiments, a composition described herein comprises a solubilizer present in an amount of about 0.1 % (w / v) to about 1.0 % (w / v) , about 0.2 % (w / v) to about 1.2 % (w / v) , about 0.3 % (w / v) to about 1.3 % (w / v) , about 0.4 % (w / v) to about 1.4% (w / v) , about 0.5 % (w / v) to about 1.5 % (w / v) , about 0.6 % (w / v) to about 1.6% (w / v) , about 0.7 % (w / v) to about 1.7% (w / v) , about 0.8% (w / v) to about 1.8 % (w / v) , about 0.9 % (w / v) to about 2.9 % (w / v) , about 1.0% (w / v) to about 2.0 % (w / v) , about 1.5 % (w / v) to about 2.5 % (w / v) , about 2% (w / v) to about 3% (w / v) , about 2.5% (w / v) to about 3.5 % (w / v) , about 3% (w / v) to about 4% (w / v) , about 3.5 % (w / v) to about 4.5 % (w / v) , or about 4 % (w / v) to about 5 % (w / v) . In some embodiments, a composition described herein comprises a solubilizer present in an amount of about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 2 % (w / v) , about 2.5 % (w / v) , about 3 % (w / v) , about 3.5 % (w / v) , about 4 % (w / v) , about 4.5 % (w / v) , or about 5 % (w / v) . In some embodiments, a composition described herein comprises propylene glycol or transcutol, when used as a solubilizer as described herein, is present in an about from about 3% (w / v) to about 5% (w / v) . In some embodiments, a composition described herein comprises propylene glycol in an about from about 3% (w / v) to about 5% (w / v) . In some embodiments, a composition described herein comprises transcutol in an about from about 3% (w / v) to about 5% (w / v) .In some embodiments, a composition provided herein further comprises a permeation enhancer described herein. In some embodiments, a composition described herein comprises a permeation enhancer at an amount of at an amount of from about an amount from about 1.0 mg to about 1000 mg, including but not limited to about 1.0 mg, 1.5 mg, 2.5 mg, 3.0 mg, 4.0 mg, 5.0 mg, 6.0 mg, 6.5 mg, 7.0 mg, 7.5 mg, 8.0 mg, 8.5 mg, 9.0 mg, 9.5 mg, 10.0, 10.5 mg, 11.0 mg, 12.0 mg, 12.5 mg, 13.0 mg, 13.5 mg, 14.0 mg, 14.5 mg, 15.0 mg, 15.5 mg, 16 mg, 16.5 mg, 17 mg, 17.5 mg, 18 mg, 18.5 mg, 19 mg, 19.5 mg, 20 mg, 20.5 mg, 21 mg, 21.5 mg, 22 mg, 22.5 mg, 23 mg, 23.5 mg, 24 mg, 24.5 mg, 25 mg, 25.5 mg, 26 mg, 26.5 mg, 27 mg, 27.5 mg, 28 mg, 28.5 mg, 29 mg, 29.5 mg, 30 mg, 30.5 mg, 31 mg, 31.5 mg, 32 mg, 32.5 mg, 33 mg, 33.5 mg, 36 mg, 36.5 mg, 37 mg, 37.5 mg, 38 mg, 38.5 mg, 39 mg, 39.5 mg, 40 mg, 40.5 mg, 41 mg, 41.5 mg, 42 mg, 42.5 mg, 43 mg, 43.5 mg, 44 mg, 44.5 mg, 45 mg, 45.5 mg, 46 mg, 46.5 mg, 47 mg, 47.5 mg, 48 mg, 48.5 mg, 49 mg, 49.5 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 135 mg, 140 mg, 145 mg, 150 mg, 155 mg, 160 mg, 165 mg, 170 mg, 175 mg, 180 mg, 185 mg, 190 mg, 200 mg, 205 mg, 210 mg, 215 mg, 220 mg, 225 mg, 230 mg, 235 mg, 240 mg, 245 mg, 250 mg, 255 mg, 260 mg, 265 mg, 270 mg, 275 mg, 280 mg, 285 mg, 290 mg, 295 mg, 300 mg, 305 mg, 310 mg, 315 mg, 320 mg, 325 mg, 326 mg, 326.5 mg, 327 mg, 327.5 mg, 328 mg, 328.5 mg, 329 mg, 329.5 mg, 330 mg, 330.5 mg, 331 mg, 331.5 mg, 332 mg, 332.5 mg, 333 mg, 333.5 mg, 334 mg, 334.5 mg, 335 mg, 335.5 mg, 336 mg, 336.5 mg, 337 mg, 337.5 mg, 338 mg, 338.5 mg, 339 mg, 339.5 mg, 340 mg, 340.5 mg, 341 mg, 341.5 mg, 342 mg, 342.5 mg, 343 mg, 343.5 mg, 344 mg, 344.5 mg, 345 mg, 345.5 mg, 346 mg, 346.5 mg, 347 mg, 347.5 mg, 348 mg, 348.5 mg, 349 mg, 349.5 mg, 350 mg, 350.5 mg, 351 mg, 351.5 mg, 352 mg, 352.5 mg, 353 mg, 353.5 mg, 354 mg, 354.5 mg, 355 mg, 355.5 mg, 356 mg, 356.5 mg, 357 mg, 357.5 mg, 358 mg, 358.5 mg, 359 mg, 359.5 mg, 360 mg, 360.5 mg, 361 mg, 361.5 mg, 362 mg, 362.5 mg, 363 mg, 363.5 mg, 364 mg, 364.5 mg, 365 mg, 365.5 mg, 366 mg, 366.5 mg, 367 mg, 367.5 mg, 368 mg, 369.5 mg, 370 mg, 370.5 mg, 371 mg, 371.5 mg, 372 mg, 372.5 mg, 373 mg, 373.5 mg, 374 mg, 374.5 mg, 375 mg, 375.5 mg, 376 mg, 376.5 mg, 377 mg, 377.5 mg, 378 mg, 378.5 mg, 379 mg, 379.5 mg, 380 mg, 380.5 mg, 381 mg, 381.5 mg, 382 mg, 382.5 mg, 383 mg, 383.5 mg, 384 mg, 384.5 mg, 385 mg, 385.5 mg, 386 mg, 386.5 mg, 387 mg, 387.5 mg, 388 mg, 388.5 mg, 389 mg, 389.5 mg, 390 mg, 390.5 mg, 391 mg, 391.5 mg, 392 mg, 392.5 mg, 393 mg, 393.5 mg, 394 mg, 394.5 mg, 395 mg, 395.5 mg, 396 mg, 396.5 mg, 397 mg, 397.5 mg, 398 mg, 398.5 mg, 399 mg, 399.5 mg, 400 mg, 405 mg, 410 mg, 415 mg, 420 mg, 425 mg, 430 mg, 435 mg, 440 mg, 445 mg, 450 mg, 455 mg, 460 mg, 465 mg, 470 mg, 475 mg, 480 mg, 485 mg, 490 mg, 495 mg, 500 mg, 505 mg, 510 mg, 515 mg, 520 mg, 525 mg, 530 mg, 535 mg, 540 mg, 545 mg, 550 mg, 555 mg, 560 mg, 565 mg, 570 mg, 575 mg, 580 mg, 585 mg, 590 mg, 595 mg, 600 mg, 605 mg, 610 mg, 615 mg, 620 mg, 625 mg, 630 mg, 635 mg, 640 mg, 645 mg, 650 mg, 655 mg, 660 mg, 665 mg, 675 mg, 680 mg, 685 mg, 690 mg, 695 mg, 700 mg, 705 mg, 710 mg, 715 mg, 720 mg, 725 mg, 730 mg, 735 mg, 740 mg, 745 mg, 750 mg, 755 mg, 760 mg, 765 mg, 770 mg, 775 mg, 780 mg, 785 mg, 790 mg, 795 mg, 800 mg, 805 mg, 810 mg, 815 mg, 820 mg, 825 mg, 830 mg, 835 mg, 840 mg, 845 mg, 850 mg, 855 mg, 860 mg, 865 mg, 870 mg, 875 mg, 880 mg, 885 mg, 890 mg, 895 mg, 900 mg, 905 mg, 910 mg, 915 mg, 920 mg, 925 mg, 930 mg, 935 mg, 940 mg, 945 mg, 950 mg, 955 mg, 960 mg, 965 mg, 970 mg, 975 mg, 980 mg, 985 mg, 990 mg, 995 mg, or 1000 mg. In some embodiments, a permeation enhancer described herein is Hydroxypropyl β –cyclodextrin. In some embodiments, Hydroxypropyl β –cyclodextrin, when used as a permeation enhancer in a composition described herein, is present in an amount in an amount of about 0.1 % (w / v) to about 10 % (w / v) . In some embodiments, Hydroxypropyl β –cyclodextrin, when used as a permeation enhancer in a composition described herein, is present in an amount in an amount of about 0.1 % (w / v) , about 0.2 % (w / v) , about 0.3 % (w / v) , about 0.4 % (w / v) , about 0.5 % (w / v) , about 0.6 % (w / v) , about 0.7 % (w / v) , about 0.8 % (w / v) , about 0.9 % (w / v) , about 1.0 % (w / v) , about 1.5 % (w / v) , about 2 % (w / v) , about 2.5 % (w / v) , about 3 % (w / v) , about 3.5 % (w / v) , about 4 % (w / v) , about 4.5 % (w / v) , about 5 % (w / v) , about 5.5 % (w / v) , about 6 % (w / v) , about 6.5 % (w / v) , about 7 % (w / v) , about 7.5 % (w / v) , about 8 % (w / v) , about 8.5 % (w / v) , about 9 % (w / v) , about 9.5 % (w / v) , about 10 % (w / v) . In some embodiments, Hydroxypropyl β –cyclodextrin, when used as a permeation enhancer in a composition described herein, is present in an amount in an amount of about 10 % (w / v) . In some embodiments, a composition provided herein further comprises a color substance. In some embodiments, a composition described herein comprises a solubilizer at an amount of at an amount of from about an amount from about 1.0 mg to about 100 mg, including but not limited to about 1.0 mg, 1.5 mg, 2.5 mg, 3.0 mg, 4.0 mg, 5.0 mg, 6.0 mg, 6.5 mg, 7.0 mg, 7.5 mg, 8.0 mg, 8.5 mg, 9.0 mg, 9.5 mg, 10.0, 10.5 mg, 11.0 mg, 12.0 mg, 12.5 mg, 13.0 mg, 13.5 mg, 14.0 mg, 14.5 mg, 15.0 mg, 15.5 mg, 16 mg, 16.5 mg, 17 mg, 17.5 mg, 18 mg, 18.5 mg, 19 mg, 19.5 mg, 20 mg, 20.5 mg, 21 mg, 21.5 mg, 22 mg, 22.5 mg, 23 mg, 23.5 mg, 24 mg, 24.5 mg, 25 mg, 25.5 mg, 26 mg, 26.5 mg, 27 mg, 27.5 mg, 28 mg, 28.5 mg, 29 mg, 29.5 mg, 30 mg, 30.5 mg, 31 mg, 31.5 mg, 32 mg, 32.5 mg, 33 mg, 33.5 mg, 36 mg, 36.5 mg, 37 mg, 37.5 mg, 38 mg, 38.5 mg, 39 mg, 39.5 mg, 40 mg, 40.5 mg, 41 mg, 41.5 mg, 42 mg, 42.5 mg, 43 mg, 43.5 mg, 44 mg, 44.5 mg, 45 mg, 45.5 mg, 46 mg, 46.5 mg, 47 mg, 47.5 mg, 48 mg, 48.5 mg, 49 mg, 49.5 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, or 100 mg.In some embodiments, a composition described herein comprises a color substance described herein in an amount of about 0.1%. color substance described herein is a pigment. In some embodiments, a pigment is D&C Red #27, D&C Red #17, or Yellow #7 present in an amount of about 0.1%.In some embodiments, a film forming composition described herein comprises: terbinafine or terbinafine HCl in an amount of 0.5-20%by weight; a film forming polymer, wherein the film forming polymer present in an amount of 5-15%by weight; a plasticizer, wherein the plasticizer is in an amount of 0.5-5 %by weight; a permeation enhancer, wherein the permeation enhancer is lactic acid present in an amount of 2%to 30%by weight, a volatile solvent, wherein the volatile solvent comprises ethanol; and a non-volatile solvent.In some embodiments, a film forming composition described herein comprises: terbinafine or terbinafine HCl; a film forming polymer, wherein the film forming polymer present in an amount of 5-15%by weight; a plasticizer, wherein the plasticizer is in an amount of 0.5-5 %by weight; lactic acid, wherein the ratio of terbinafine and the lactic acid is from 1: 10 (w: w) to 1: 2 (w: w) , and wherein the lactic acid is present in an amount sufficient for permeation enhancement of the terbinafine; a volatile solvent, wherein the volatile solvent comprises ethanol; and a non-volatile solvent. In some embodiments, the ratio of terbinafine and the lactic acid is 1: 10 (w: w) , 1: 9 (w: w) , 1: 8 (w: w) , 1: 17 (w: w) , 1: 6 (w: w) , 1: 5 (w: w) , 1: 4 (w: w) , 1: 3 (w: w) , or 1: 2 (w: w) .In some embodiments, a film forming composition described herein comprises: efinaconazole in an amount of 0.5-20%by weight; a film forming polymer, wherein the film forming polymer present in an amount of 5-15%by weight; a plasticizer, wherein the plasticizer is in an amount of 0.5-5 %by weight; a permeation enhancer, wherein the permeation enhancer is lactic acid present in an amount of 2%to 30%by weight, a volatile solvent, wherein the volatile solvent comprises ethanol; and a non-volatile solvent.In some embodiments, a film forming composition described herein comprises: efinaconazole; a film forming polymer, wherein the film forming polymer present in an amount of 5-15%by weight; a plasticizer, wherein the plasticizer is in an amount of 0.5-5 %by weight; lactic acid, wherein the ratio of efinaconazole and the lactic acid is from 1: 10 (w: w) to 1: 2 (w: w) , and wherein the lactic acid is present in an amount sufficient for permeation enhancement of the terbinafine; a volatile solvent, wherein the volatile solvent comprises ethanol; and a non-volatile solvent. In some embodiments, the ratio of terbinafine and the lactic acid is 1: 10 (w: w) , 1: 9 (w: w) , 1: 8 (w: w) , 1: 17 (w: w) , 1: 6 (w: w) , 1: 5 (w: w) , 1: 4 (w: w) , 1: 3 (w: w) , or 1: 2 (w: w) .Methods of PreparationProvided herein are methods of making a film-forming solutions comprising providing a solution comprising a volatile solvent described herein and a non-volatile solvent described herein, wherein the volatile solvent is present in an amount of 60%to 100%by volume in the solvent; adjusting the solvent pH to pH 7 to pH 11; adding an active pharmaceutical ingredient (API) described herein and a polymer described herein in the aqueous solvent; and adding a plasticizer or other excipients described herein, thereby forming the film-forming composition.In some embodiments, the step of adjusting the pH comprises raising the pH of the solvent. In some embodiments, the step of adjusting the pH comprises adding a strong base to the solution. Strong bases for adjusting the pH include but are not limited to, sodium hydroxide (NaOH) , potassium hydroxide (KOH) , and sodium bicarbonate.In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 7 to pH 9. In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 8 to pH 10. In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 9 to pH 11.In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 9.0. In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 9.1. In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 9.2. In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 9.3. In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 9.4. In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 9.5. In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 9.6. In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 9.7. In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 9.8. In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 9.9. In some embodiments, the step of adjusting the pH comprises adjusting the pH to pH 10.In some embodiments, the API is added to the solution before the addition of the polymers. In some embodiments, the polymers are added before the API is added to the solution. In some embodiments, the API and the polymers are added simultaneously to the solution. In some embodiments, an API, one or more polymers, and a plasticizer are added simultaneously to the solution.Methods of TreatmentProvided herein are methods of treating a nail disorder comprising contacting the nail with a composition described herein. Exemplary nail disorders that may be treated and / or prevented using a system and / or method described herein include, but are not limited to, nail psoriasis, psoriatic nail dystrophy, onychia, onychiagryposis, onychia trophia, onychocryptosis, onychodystrophy, onychomycosis, onychogryposis, onycholysis, onychomadesis, onychauxis, onychorrhexis, onychoschizia, tines unguium, onychophosis, onychoptosis, paronychia, pseudomonas, pterygium and pterygium inversum unguis, koilonychia, subungual hematoma or other trauma to the nail, folic acid deficiency, sublingual hyperkeratosis, leukonychia, nail patella syndrome, melanonychia, protein deficiency, brittle and peeling nails, methyl methacrylate damaged nails, vitamin C deficiency, vitamin deficiency, tinea unguis, thinning nails associated with lichen planus, Raynaud's disease, nail dystrophy associated with rheumatoid arthritis, beau's lines, Mee's lines associated with certain kinds of poisoning, discoloration, lamellar splitting, longitudinal grooves and / or ridges, transverse grooves, pitting, soft nails, brittle nail syndrome, eczema, atopic dermatitis, and any combination thereof. In some embodiments, the nail disorder is not onychomycosis, and / or the nail disorder is not induced and / or caused by onychomycosis. In some embodiments, a nail disorder is eczema, atopic dermatitis, onycholysis, subungual hyperkeratosis, discoloration, onychauxis, psoriatic nail, onychorrhexis, onychoschizia, lamellar splitting, onychomadesis, brittle nail syndrome, transverse grooves, nail pitting, soft nails, nail dystrophy, nail fragility of intact or damaged nails, or any combination thereof.In some embodiments, a composition and / or method disclosed herein is used to treat and / or prevent nail dystrophy (i.e., onychodystrophy) in a nail of a subject. “Nail dystrophy” and “onychodystrophy” as used herein refer to a nail that is poorly formed, misshapen, damaged, and / or discolored. Nail dystrophy may be caused by an endogenous and / or exogenous factor and / or may be a secondary presentation from complete or partial disruption of the nail matrix, proximal nail fold, nail bed, hyponichium, and / or underlying bony phalanx. In some embodiments, nail dystrophy is induced and / or caused by onychomycosis. In some embodiments, nail dystrophy is not induced and / or caused by onychomycosis. In some embodiments, one or more signs and / or symptoms of nail dystrophy is treated and / or prevented by a composition and / or method described herein. In some embodiments, nail splitting and / or nail fragility is treated and / or prevented by a system and / or method described herein.In some embodiments, a nail disorder described herein is selected from the group consisting of onycholysis (e.g., distal separation of the nail plate) , psoriatic onychorrhexis (e.g., longitudinal grooves and / or ridging of the nail plate) , subungual hyperkeratosis (e.g., excessive skin cell growth under nail plate) , discoloration, onychoschizia (e.g., peeling of the nail plate surface) , lamellar splitting, onychomadesis (e.g., proximal separation of nail plate) , brittle nail syndrome, transverse grooves, onychauxis (e.g., nail plate thickening) , nail pitting, soft nails, nail dystrophy, nail fragility of intact or damaged nails, nail tumor, and any combination thereof. In some embodiments, a composition and / or method described herein is used for treating and / or preventing nail splitting and / or nail fragility. In some embodiments, a composition and / or method described herein is used for treating and / or preventing direct abrasion and / or friction on a nail surface and / or provides protection against moisture and / or the effects of moisture. a composition and / or method described herein is used for protecting a nail from a subsequent infection (i.e., reinfection) by a fungal disease.In some embodiments, the nail disorder, such as, but not limited to, nail dystrophy, may or may not be induced and / or caused by an infectious pathogen, such as bacteria, fungi, viruses, parasites, and / or protozoa. In some embodiments, the nail disorder, such as, but not limited to, nail dystrophy, may or may not be induced and / or caused by a fungus. According to some embodiments, a composition and / or method provided herein is used for preventing a nail disorder induced and / or caused by an infectious pathogen.In some embodiments, the methods of treatment described herein comprise cleaning the nail prior to and / or after the step of applying the composition described herein to the nail. The nail may be cleaned by washing, soaking, wiping, and / or the like the nail with water, soap and water, and / or a nail polish remover such as, but not limited to, a solution comprising an organic solvent such as acetone. In some embodiments, the nail is cleaned one, two, three, or more times per day or one, two, three, four, five, six, seven, or more times per week. In some embodiments, the nail is cleaned once per week or as needed. In some embodiments, the nail is optionally dried after it is cleaned. In certain embodiments, the nail may be cleaned and optionally dried prior to application with a composition described herein.In some embodiments, the methods of treatment described herein further comprise cleaning a nail prior to application of a composition of the present invention, optionally drying the nail, topically applying a composition of the present invention, and drying the composition to for a coating and / or film. After the coating or film has been formed and is dry, the coating and / or film may be cleaned as needed to remove debris build-up on the nail. The cleaning, however, may not remove the coating and / or film, which may allow for the nail to be protected for a longer duration of time.In some embodiments, a composition and / or method of the present invention further comprises part of a multi-treatment regime. In some embodiments, a medicament is used concurrently with a composition and / or method provided herein to treat an underlying disease, and a composition of the present invention is used to improve the appearance of a nail and / or protect the nail.In some embodiments, a method of treatment described herein further comprises topically applying a composition of the present invention in an amount of about 1 μL to about 15 μL, or any range and / or individual value therein, to a nail and / or the surrounding skin of the nail. In some embodiments, about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 μL of the composition may be topically applied to a nail and / or the surrounding skin of the nail. The composition may be topically applied to the nail and / or the surrounding skin of the nail at least once daily. The composition may be topically applied as a thin layer and / or may cover at least a portion of the nail and / or surrounding skin of the nail. In some embodiments, the composition covers the entire nail. The composition may be applied as a thin layer that substantially evenly covers a nail. The composition may be allowed to dry, such as, for example, the composition may be allowed to dry for about 2 to about 3 minutes.In some embodiments, the composition may be topically applied to a nail and / or the surrounding skin of the nail in an amount having a weight of about 1 mg to about 10 mg, or any range and / or individual value therein, in some embodiments, about 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mg of the composition may be topically applied to a nail and / or the surrounding skin of the nail. Once dry, this may provide a coating and / or film on the nail and / or the surrounding skin of the nail having a weight of about 0.1 rug to about 2 mg, or any range and / or individual value therein, such as, but not limited to, about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 mg.In some embodiments, the composition is topically applied to a nail and / or the surrounding skin of the nail at least once daily for at least five consecutive days. In some embodiments, a treatment regime comprises topically applying the composition described herein once daily for five consecutive days; on the sixth day cleaning the nail and / or the surrounding skin of the nail, such as, but not limited to, cleaning with a nail polish remover (e.g., an acetone solution) ; and on the sixth and seventh days, the composition is not applied. In some embodiments, a treatment regime comprises topically applying the composition once daily to the nail and / or the surrounding skin of the nail and cleaning the nail and / or the surrounding skin of the nail at least once a week. Either exemplary treatment regime may be repeated for a defined time period (e.g., 2 weeks, a month, etc. ) or until improvement and / or alleviation of at least one sign and / or symptom is observed.In some embodiments, prior to topically applying the composition, loose debris and / or nail material is removed from the nail and / or the surrounding skin of the nail. In some embodiments, nail clippers and / or a nail file are used to remove the loose debris and / or nail material.Also disclosed herein are methods of improving the appearance of a nail. Infected nails show symptoms such as thickened nails, discoloration of nails, brittle or crumbly texture, misshapen nails, separation from nail bed, foul odor, white spots or streaks, pain or discomfort. Improvement in the appearance of a nail can be determined by a visual assessment of the nail, such as by visually assessing the color, surface smoothness, shape, and / or thickness. In some embodiments, a method provided herein reduces discoloration of nails. In some embodiments, a method provided herein reduces the thickness of nails. In some embodiments, a method provided herein clears fungal debris. In some embodiments, a system and / or method of the present invention may improve nail strength compared to the strength of a nail in the absence of a system and / or method of the present invention.EXAMPLESExample 1. Ethanol as Solvent for PolymersTo optimize the polymers and concentrations for nail film formulations, film-forming solutions having different polymers (HPMC-AS-LF, HPMC E5, HPMC K100, HPC EF, PVP K30) at various concentrations were prepared according to Table 1 are evaluated based on their ease of film-forming, quality of film (smoothness of the film, persistence on nails, etc. ) , and ease of removal by water. The solutions were vortexed to clear. The solution is applied to nails, and the appearance of the film, waterproof, drying time, formulation viscosity, and solubility of polymers were evaluated.Table 1. FormulationsAs shown in Table 2, the polymers in most of the formulations did not dissolve in ethanol or ethanol-water mixture well, which can be observed from the formation of white plaques during film drying. In particular, film-forming formulations with higher contents (≥5%) of Eudragit were difficult to dissolve and white plaques formed in the films after drying and contacting with water.Table 2.Formulation A1 showed a good film after drying and could be stayed on the nail even after washing hand not vigorously. However, it took a long time to dry, and kept sticky during the drying process. If reducing the content of PEG400 to 5% (such as A2) , the film viscosity decreased, while the drying time became shorter, and the sticky feeling disappeared. If reducing the content of Eudragit L100 to 2% (A3) , the drying film could be removed easily by washing hands.
[0001] Formulation B1 showed a thin film after drying but could be easily removed from the nail by washing hand. When the content of HPMC E5 was increased to 4%as in B2, the film took more time to dry and still cracked easily. When 5%Eudragit L100 was added (B3) , the drying film became good waterproof again.
[0002] Formulations C1 and C2 resulted in stronger film formations after drying, suggesting inclusion of HPC EF in the formulation promoted film-forming.
[0003] Formulations D1-D5 showed that Carfil 9235NP, also known as polyurethane, helped strengthen the film adhesive to the nail, improve the smoothness of the film. But when its content exceeded 5%, the drying speed was reduced. Additionally, inclusion of 10%Eudragit L100 made the film thicker than 5%and showed better waterproof features.Formulation E3 showed a better drying film which could stay on the nail surface for more than 2 days when adding HPMC-AS-LF, but PVP K30 and HPMC K100 could not be dissolved in ethanol-water solution (Formulation E1-2) .While the addition of Carfil 9235NP and HPMC-AS-LF caused solution turbidity, at the same time they also promoted film formation.When the polymer content was less than 5%, the viscosity of the solution was low making it difficult to stay on the nail. But with the addition of PEG400 and Carfil 9235NP, as well as high polymer content (10%) , the viscosity of the solution increased, and the solution stopped from flowing out.Example 2. Solubility of Polymers in Ethanol / Water SolventTo confirm the advantages of ethanol / water solvent with pH higher than pH 7 in dissolving polymer, formulations according to Table 3 were prepared by the following method: different ratios of ethanol and water were mixed, followed by adjusting the pH of the solvent to pH 8 to pH 11 with 10 M sodium hydroxide or triethanolamine. The pH of the solvent is determined using pH test strips. Formulations prepared by solvent that without pH adjustment were included as control groups. Then the corresponding amount of HPMC-AS-LF and Eudragit L100 were weighed and added to the solvents. After the ingredients were stirred in solution until they changed from wrapped state to dispersed state, the solution was vortexed with a vortex mixer (VORTEX-GENIE 2) . The solution conditions and dissolution times were recorded.Table 3. Formulation TableTable 4. Dissolution Profile of Polymers in Solvent (without pH adjustment)Table 5. Dissolution Profile of Polymers in Solvent (pH = 8)Table 6. Dissolution Profile of Polymers in Solvent (pH = 9)Table 7. Dissolution Profile of Polymers in Solvent (pH = 10)Table 8. Dissolution Profile of Polymers in Solvent (pH = 11)Table 9. Dissolved Time Record of Polymers in Ethanol / Water Solution (without pH adjustment)Table 10. Dissolved Time Record of Polymers in Ethanol / Water Solution (pH = 8)Table 11. Dissolved Time Record of Polymers in Ethanol / Water Solution (pH = 9)Table 12. Dissolved Time Record of Polymers in Ethanol / Water Solution (pH = 10)Table 13. Dissolved Time Record of Polymers in Ethanol / Water Solution (pH = 11)It was confirmed that enteric-polymers under certain proportions could not be dissolved completely in ethanol or ethanol-water mixture. They were either insoluble or needed a very long time to dissolve. Enteric polymers dissolved more easily in an alkaline ethanol-water mixture. However, they showed little solubility in solvents when pH > 11 (Table 7) . The solubility of the polymers in ethanol-water mixture increased when the pH of the ethanol solution was adjusted to above pH 8. According to the results from Tables 4-13 Adjusting pH to pH 8 to pH 11, preferably pH 9 to pH 10, improved dissolution of enteric polymers in ethanol / water solvent.Once the enteric polymers were dissolved in high pH ethanol / water solvent, the pH value of the solution decreased. For example, the ethanol / water solvent was adjusted pH to 9-10, after dissolving the polymers completely, the final pH became 7-8.The amount of Eudragit L100 also affected the solubility of enteric polymers. The content of Eudragit L100 was about 5%-15%, while the preferred concentration was 5%-10% (w / v) . When the Eudragit L100 content exceeded 15%, the dissolution became difficult.The ethanol % (v / v) used in the assay was between 60%and 100%, While the preferred concentration was 80%-90%. When it’s below 80%, not only does the solubility decrease, but it also significantly increases the viscosity of the formulation, resulting in a prolong drying time significantly.Compared to the solution with only Eudragit L100, adding HPMC-AS LF resulted in a better film and waterproofing and an increase in the solubility of polymers. The dissolution time was shortened when HPMC-AS LF was less than 2%.When the ratio of Eudragit L100 to HPMC-AS LF was between 10 and 20, the solubility of the polymer reached its maximum. Outside of this range, the solubility decreased. When HPMC-AS LF was less than 2%, increasing its concentration was beneficial for dissolution.Example 3. Effects of Plasticizer on Film FormulationsTo confirm the advantages of a plasticizer for film forming, formulations with the varying percentages (w / v) of Eudragit L100, HPMC-AS-LF, and PEG 6000 (plasticizer) according to Table 14 were prepared by the following steps: Ethanol and water at different ratios were mixed, and adjusted ethanol / water solvents PH to about pH 10 with 10 M sodium hydroxide. The final volume of each solvent after adjusting the pH was 5 mL. Then the corresponding amount HPMC-AS-LF Eudragit L100, and PEG6000 were weighed and added to the solvents. The ingredients were stirred in solution until they changed from wrapped state to dispersed state, the solution was vortexed with a vortex mixer (VORTEX-GENIE 2) and the dissolution times were recorded. For each formulation, the same volume was taken out and wiped on a glass slide at room temperature, and the drying time was recorded. After drying, the glass slides were sunk in water for 20 min. After 20 min, the glass slides were taken out to be wiped with tissue. The films formed on each slide were taken off with a tweezer after the slide surface was dry. Images of the films were taken as shown in FIG. 1. The properties of each formulation are recorded in Table 15.Table 14. Formulation TableTable 15. Properties of Formulations in Presence of PEG6000As shown in FIG. 1, the addition of 2%or 4%PEG6000 made the drying film more flexible and complete. Without PEG6000 or when the content of PEG6000 was less than 2%, the drying process after soaking in water for 20 min, either non-transparent, white plaques were formed, or the film cracked, regardless of the ratio of Eudragit L100 / HPMC-AS LF. Additionally, PEG6000 also strengthened film waterproofing.The ratio of ethanol-water also affected film formation. Formulations resulted in poor drying film with an ethanol-water ratio of 6: 4 or 7: 3 and PEG6000 less than 2%.Example 4. Effects of Solubilizer on Film FormulationsBefore determining the effects of a solubilizer on film formulations, film-forming solutions were optimized by varying the Terbinafine HCl content in an Ethanol / water (8 / 2) solution containing Eudragit L100, HPMC-AS LF, PEG 600 according to Table 16. The solutions were prepared with the same methods as Example 3.1 mL of the above solutions were wiped on glass slides to form drying films. The drying films were taken contact with or without water for XRPD measurement and the results are shown in FIG. 2. Terbinafine HCl was used as a model active pharmaceutical ingredient ( “API” ) and presented in three different concentrations, 5% (w / v) , 10 % (w / v) , and 15% (w / v) , respectively.Table 16. Formulation TableAs shown in FIG. 2, solutions with lower content API (5%) did not undergo crystallization during the film forming process (no peak detected) . When the percentage of API increased to 10%or 15%, API crystallization occurred during the film-forming, especially with the film contacting water. During the film forming process, API crystallization is undesirable and should be avoided. Therefore, the low API content is preferred for the film formulation.Then to confirm the advantage of the presence of a solubilizer, such as propylene glycol and transcutol, film-forming solutions were prepared according to Table 17. Specifically, to prepare a film-forming solution, ethanol and water were mixed to make a 5 mL ethanol / water solution with pH adjusted to about 10. Solubilizers and API were then added to the solution. After API was dissolved completely, HPMC-AS-LF, Eudragit L100, and PEG6000 were added to the solution to be dissolved. 1 mL from each of the solutions was wiped on glass slides until films were formed and dried. For groups tested with water contacting, 1 mL of water was dropped on the slide. The films were then taken off from the slide for XRPD measurement and observations under a polarizing microscope.Table 17. Formulation TableThe XRPD analyses for dry films from the above formulations are shown in FIG. 3. polymers in ethanol / water solution containing propylene glycol or transcutol did not show any peaks (B-E) , suggesting higher solubilities than polymers in ethanol / water solution without solubilizer (A) .The XRPD analyses for films from the above formulations after contacting water are shown in in FIG. 4. The dry film contacting the water resulted in API precipitant at high API concentrations. However, API crystallization decreased significantly when solubilizers were added to the formulation, and when the content of solubilizers increased, the crystallization inhibition effect was more significant. Higher content of solubilizers (5%) showed higher crystallization inhibition. From the perspective of reducing the intensity of crystal peaks, 5%Transcutal showed better results than 5%propylene glycol.Polarizing microscope differentiates between crystal and non-crystal. crystals show high light while non-crystals are relatively dark. As shown in FIGS. 5A-5E, images from the polarizing microscope suggest that the dry-film formulation without solubilizer showed a lot of crystal under the microscope (FIG. 5A) . Fewer crystals were observed in 3%transcutol or propylene glycol (FIG. 5B and FIG. 5D) near no crystal could be observed with 5%solubilizer (FIG. 5C and FIG. 5E) .To further confirm the advantages of the inclusion of a solubilizer in the film forming-formulations described herein, solubilizers were selected from Transcutol, Propylene glycol, Labrosol, PEG400, Isopropyl palmitate, and Triethyl citrate. 1.0%HPMC-AS-LF, 10%Eudragit L100 were added to a tube, followed by adding 2 mL of a solubilizer to the tube and. The tube was then vortexed with a vortex mixer to dissolve the polymers. The dissolution condition with the addition of each solubilizer was recorded.Based on observations from the solution status, polymers had a higher solubility in propylene glycol and transcutol, lower solubility in Labrosal and PEG400, and insoluble in isopropyl palmitate and triethyl citrate. Transcutol and propylene glycol were selected for preparing the film-forming solutions according to Table 18 using the same methods as above.Table 18. Formulation TableBecause the film-forming solutions also have a good condition when propylene glycol and transcutol act as solubilizers, propylene glycol and transcutol can be chosen as solubilizers when terbinafine HCl was used as the API.To confirm the advantages of solubilizers in solutions with varying concentration of polymers and ethanol, film-forming solutions were prepared according to Table 19 with the same method as above. The solutions were vortexed, and the dissolution times were recorded. The same volume of liquid was taken from each solution and wiped on glass slide at room temperature and the drying time was recorded. The glass slides were then sunk in water for 20 min. After 20 min, the glass slides were taken out and the films on the glass slides were scrapped with tweezers for observations. The dissolving conditions and qualities of films are recorded in Table 20.Table 19. Formulation TableTable 20. Properties of Film Formulations in Presence of SolubilizersResults from Table 20 suggest solubilizers, such as transcutol and propylene glycol, enhanced the film adhesion to glass slide, prevented water, optimized formulation physical properties. Additionally, the solubilizers decreased the drying time of formulations containing 10%Eudragit L100 compared to 5%Eudragit L100.To confirm the advantages of transcutol as a solubilizer in API dissolution from drying film, formulations were prepared according to Table 21 using the same methods as described above. For each formulation solution, 500 μL was dropped on the dialysis membrane (Cut-off molecular weight: 7000) to form a dry film. The membranes for each group were then fixed on the Franz cell, whereas the receiving cell was filled with PBS buffer. Franz cell was then placed in a water bath at 32 degrees Celsius. The samples were taken for API assay at 1 h, 2 h, 3 h, 4 h, 5 h, and 6 h respectively for measuring the API concentrations. The results are shown in FIG. 6.Table 21. Formulation TableThe results in FIG. 6 show that the formulation with higher solubilizer had good dissolution form the drying film, which could help nail permeation. As mentioned above, 15%API film formulation did not show much higher content than that of 10%API formulation, and the 15%API formulation showed obvious API precipitation, solubilizers should be considered to be included to reduce API concentration to achieve the same penetration.To confirm the advantages of solubilizer in speeding up API dissolution from drying film, formulations were prepared according to Table 22 using the same methods as described above. The dialysis membranes (Cut-off molecular weight: 7000) were soaked in water for 1 h before being fixed on the Franz cell. 500 μL from each formulation was injected into the supply cell for drying. Then inject PBS solution into the receiving cell, and place Franz cell in 32 degrees Celsius water bath. The solution from receiving cell was taken at 1 h, 2 h, 3 h, 4 h, 5 h, and 6 h, respectively, and the concentration of API was detected.Table 22. Formulations.As indicated by the dissolution of API at different times in FIG. 7, API dissolved from the dry film when the solutions were formulated with solubilizers. Specifically, Transcutol is better than propylene glycol as a solubilizer to speed up dissolution.Example 5. Effects of Penetration Enhancer on Film FormulationsTo assay the penetration of film formulation on human nails, different formulations, and cow nails were used for nail penetration experiment and the effects of penetration enhancers on API penetration were investigated. Formulations were prepared according to Table 23 below. Briefly, PEG 400 and API were added to ethanol to be dissolved completely. Eudragit L100 and Hydroxypropyl β –cyclodextrin were then added to the ethanol solution. The final volume was brought up to 5 ml.Table 23. Formulation TableThe cow nails were soaked in physiological saline and hydrated for 3 h, then the surface of each nail was positioned to face the supply cell so that the back was facing receiving cell and fixed in the specific nail Franz cell. 20%ethanol-physiological saline was injected into the receiving cell and 50 μL formulation was injected into the supply cell to allow for film forming. Then the Franz cell was incubated in 32 degrees Celsius water bath for 48 h. When the penetration experiment was completed, the solution was collected from the receiving cell. The remaining formulation on each cow nail was cleaned with ethanol, grind the nails and API was extracted from the nail with ethanol. Finally, ethanol was used to extract API adsorbed on the rotor. The API content in each nail, the receiving solution, and the rotor was detected separately and the results were summarized in Table 24.Table 24. Film Formulations with Penetration EnhancerThe amount of API entered and penetrated through the nails was relatively higher in the formulation containing a penetration enhancer (hydroxypropyl beta-cyclodextrin) than that without penetration enhancer. The results suggest that adding penetration enhancers such as hydroxypropyl β –cyclodextrin is beneficial for API penetration.Example 6. Effects of Permeation EnhancersAccording to results from Examples 2 to 5 with regards to the type of polymer coating agents, plasticizer and solubilizers, solvent pH, their content range, and ratio, exemplary suitable formulations are listed in Table 25. To prepare the formulations listed in Table 15, the corresponding amounts of ethanol and purified water are taken separately and mixed into different ratios of ethanol-water solvent. 10 M sodium hydroxide is added to adjust pH. API is added to the ethanol / water solution.Table 25. Exemplary FormulationsExample 7. Nail Film Formulations with Different APIsTo confirm the advantages of the film formulations are applicable to various APIs, different anti-fungal formulations were prepared according to Table 25. In addition, different Jak, PED4 and glucocorticoid molecules formulation were prepared according to Table 26. All formulations could be dissolved to form clear solutions and could be easily dissolved.Table 25. Formulation TableTable 26. Formulation TableExample 7. Effects of Permeation EnhancersThe effect of etching agent, solid agents and liquid agents, on nail permeability were assayed. Liquid acid and solid acid were used as penetrating agents, and the API permeation was compared. The solid agents were selected from tartaric acid, citric acid, malic acid, fumaric acid, and succinic acid. The liquid agents were selected from lactic acid, phosphoric acid. Fumaric acid and succinic acid dissolve slowly or cannot dissolve in solvents. Therefore, tartaric acid and citric acid were selected as solid acids.Table 27. FormulationsAs briefly demonstrated in FIG. 8, the nail penetration testing was performed with the following procedures:1. Bovine nails or human nails act as membrane. Bovine nail membranes were prepared from healthy cattle hooves via precision cutting and processing. Bovine nails with thickness range from 0.3 to 0.4 mm, and a diameter of 25 mm. Inter-batch variability in bovine nail membrane (the source of bovine nail or nail membrane processing) may affect outcomes. To standardize the formulations evaluations, the same batch of bovine nail membranes was used in each example. Human nails were from healthy volunteers.2. Prior to experimentation, nail specimens were hydrated by soaking in physiological saline for 24 hours.3. The nail membrane was fixed on a custom-designed nail diffusion cell, with the receptor compartment filled with physiological saline and 5%Transcutol that make sure the receiving liquid has sufficient solubility for the permeated API, ensuring complete bubble removal.4. 100 μL of test solution was loaded uniformly on the nail membrane surface. And then place the diffusion cell in temperature-controlled water bath (32±0.5℃) . Five to six replicate samples were prepared for each test solution.5. The determination of nail permeation was performed by collecting samples from the receptor compartment at specified time intervals, followed by HPLC analysis.6. The determination of drug content in nails was performed by cleaning and pulverizing the nails post-experiment, followed by extracting the nail powders with ethanol sonicated for 30min, and subsequently measure the contents via HPLC analysis.After 48 hours, the permeation and deposition of drug in receive pool and nail showed that, both liquid acid and solid acid have effect on promoting drug penetration (FIGS. 9A-9B) . Among them, promoting effect of liquid acid was greater than solid acid. The reason could be that liquid acid still had free hydrogen ions after nail lacquer was dried and could be volatilized. Phosphoric acid was most effective in promoting drug penetration, however, when the phosphoric acid exceeded 5%, the polymer precipitated, making the formulation unstable. Accordingly, lactic acid was the most suitable permeation enhancer.Example 8. Effects of Different Penetrating Agents on Nail PermeabilityEffects of different penetrating agents on nail permeability were assayed. The penetration enhancers were selected from: Hydrating agent (cyclodextrin HP-β-CD) , Keratolytic agents (urea or its derivatives) , Disulfide bond break agent (acetylcysteine) , Chelating agent (EDTA or its derivative) , Acids (lactic acid) . The formulations with different penetration enhancers are shown in Table 28. The nail penetration tests were performed according to the procedure described in Example 7.Table 28. FormulationsThe permeation and deposition of drug in receive pool and nail showed that urea and acetylcysteine had moderate effect on promoting permeation (FIGS. 10A-10B) . In addition, compared with the formulation without permeation enhancer, urea and EDTA promoted drug deposit on nail. Compared with cyclodextrin HP-β-CD, urea, acetylcysteine, and EDTA, lactic acid still showed the best effect.Example 9. Effects of Solvent on PermeationAssays were performed to confirm whether the esterification of acid can also promote drug permeation and whether the solvent in the formulation will affect the drug permeation. The formulations were prepared according to Table 29. The nail penetration tests were performed according to the procedure described in Example 7.Table 29. FormulationsAs shown in FIGS. 11A and 11B, the solvent in the formulation significantly affected permeation. The solution showed the best permeation effect (301.84 μg) when ethanol was used as the solvent (first bar) . Because esterified acids could provide free protons, the permeation effect deteriorated.Example 10. Effects of waterThe formulations were prepared according to Table 30 to test the effect of water on permeation. The nail penetration tests were performed according to the procedure described in Example 7.Table 30. FormulationsAs shown in FIGS. 12A and 12B, after removing water from solvent, drug permeation was relatively reduced as compared to the results in Example 10 , suggesting that water in the formulations helps improve permeation.Example 11. Effects of SolubilizersPhosphoric acid, lactic acid, acetylcysteine, and EDTA were also assayed in the same settings to compare their effects. The formulations in the presence of Transcutol or PEG 400 were prepared according to Tables 31 and 32. The nail penetration tests were performed according to the procedure described in Example 7.Table 31. FormulationsTable 32. FormulationsAfter 48 hrs, the results showed that there was no difference between formulation with or without the solubilizer –transcutol, PEG400 (FIGS. 13A-13B) . But the drug deposition in nail was higher with transcutol, seems that the formulation with transcutol maybe like to enter and stay in the nail (FIGS. 13C-13D) . Because nail penetration is the critical factor in antifungal efficacy, the assays suggest Transcutol and PEG400 provides minimal therapeutic advantage in lower drug content formulations (5%) .All results from Examples 7-11 were compiled and plotted in FIGS. 14A-14B. To conclude, film formulation with ethanol and water as solvents, and lactic acid as the permeation enhancer have the best permeation effect and thus are used as nail lacquers.Example 12. Comparison of Exemplary Formulations with Conventional FormulationsTo compare the efficacy of the terbinafine formulation of the present disclosure with conventional terbinafine formulations, exemplary terbinafine HCl formulations were prepared according to Table 33. The conventional terbinafine formulations in the assays contain the ingredients listed in Table 34. The nail penetration tests were performed according to the procedure described in Example 7.Table 33. Terbinafine HCl FormulationsTable 34. Conventional FormulationsAs shown in FIGS. 15A and 15B, at the same concentration of lactic acid and a lower concentration of terbinafine HCl (5%as compared to 10%) , the exemplary ethanol-based nail lacquers with 5%Terbinafine HCl showed more permeation over time as compared to the known non-ethanol based formulations with 10%Terbinafine HCl. Therefore, the ethanol-based nail lacquers at lower Terbinafine HCl concentration (5%) outperformed the known formulations with higher Terbinafine HCl concentrations (10%) .To compare the permeation of the exemplary ethanol-based nail lacquers at different concentrations of API with that of a commercial Terbinafine product, Samples were prepared according to Table 35. Four different treatments after loading samples were performed according to the method in Table 36. Briefly, after treatment, the exemplary ethanol-based nail lacquers dried and formed a film that cannot be removed by touching or washing. On the contrary, after being applied to the nail surface, the commercial product could not dry and could be removed easily by touching or washing. The nail penetration tests were performed according to the procedure described in Example 7.Table 35. FormulationsTable 36. Treatment MethodsAs shown in FIGS. 16A-16B, after removal and washing of the conventional formulation, the API cannot permeate continuously, while Pharmacin nail lacquer can permeate continuously. When API concentration of the exemplary ethanol-based nail lacquer was more than 10%, the permeability difference is not significant. Overall, at the same concentration of the API, the exemplary ethanol-based nail lacquer outperformed the commercial nail formulation in terms of permeation.To make further comparisons in human nails, an exemplary ethanol-based nail lacquer was prepared according to Table 37 and loaded to human nails following the procedures in Table 38.Table 37. Nail Lacquer FormulationTable 38. TreatmentAs shown in FIGS. 17A-17B, the exemplary ethanol-based nail lacquer outperformed the commercial formulation in terms of both permeation and deposition in human nails.Example 13. Additional exemplary ethanol-based nail lacquersTo confirm that the ethanol-based nail lacquers developed in the present disclosure with other APIs also outperformed the corresponding commercial nail lacquers, film-forming formulations with various APIs (amorolfine hydrochloride, efinaconazole, ciclopirox, triamcinolone acetonide, tofacitinib, ruxolitinib, roflumilast) were prepared according to Tables 39 and 40. The nail penetration tests were performed according to the procedure described in Example 7.Table 39. FormulationsTable 40. FormulationsAs shown in FIGS. 18A-18F and FIG. 19A-19B, in each assay comparing the test film formulation with a commercial product containing the same API, the test film formulation outperformed the commercial product in terms of both 67-hour permeation in bovine nail and API deposit in bovine nail plate.For formulations containing tofacitinib (JAK inhibitor) , ruxolitinib (JAK inhibitor, or roflumilast (PDE4) as API, currently, there are no commercially available nail topical formulations for comparison. As shown in FIG. 19C-19D, both the tofacitinib and ruxolitinib formulations had effective permeation and API deposit in bovine nail.Example 14. Therapeutic Efficacy of a Nail Film FormulationTo confirm the therapeutic efficacy of an exemplary formulation in patients with onychomycosis, a nail film forming solution was prepared according to Table 41. The nail penetration tests were performed according to the procedure described in Example 7. The formulation was applied to patients following the following protocol: (1) wipe the hands dry before using; (2) apply once a day at night, use a brush to spread on nails, and wait for 2 minutes for drying to form a film; (3) do not touch other objects during drying period, do not contact with water within 1 hour after administration, do not scrape the film deliberately after administration. Before treatment, all patients had symptoms associated with onychomycosis, including thickened nails, discoloration of nails (yellow or brown color) , and / or brittle textures. After 3 months treatment, patients’ nail conditions were significantly improved. Reduced coloration was observed, as the nail began to retain their natural colors, with yellow, brown, or white patched almost completely faded. All of the patients’ thickened nails started to normalize, suggesting the clearance of fungal debris.Table 41. Terbinafine HCl FormulationExample 15. Nail Permeation TestThe formulations of the present disclosure are also compared with conventional formulations containing lactic acid, benzyl alcohol and ethanol. Exemplary formulations and the conventional formulations are prepared according to Table 42.Table 42. FormulationsAs shown in FIGS-20A-20B, for the exemplary formulations, when lactic acid contents decreased from 10%to 4%, the nail permeations decreased significantly, which was consistent with other results. In conventional formulations, the lactic acid concentration did not seem to correlate with nail permeation. When PVP was added to those formulations, the nail permeation increased, whereas the API contents decreased. However, when the PVP increased from 0.5 to 10%, the solution could not form a dry film easily, but could only be present as thicken gel, and the permeation decreased significantly. Therefore, the exemplary formulations of the present disclosure outperformed the conventional formulations.Example 16. Lactic Acid ConcentrationsTo confirm the lactic acid concentrations for the nail film formulations, different formulations with varying concentration of lactic acid were prepared according to Table 43 (in the absence of API) and Table 44 (in the presence of API) . It was noted that, for the formulations without API, the maximum lactic acid content could be as high as 40%. If the content was further increased, the solution could not dry to form a film after being applied to a surface. In the presence of API, when the maximum lactic acid content was above 20%, the drying time significantly prolonged and the solution could not form a dry film after being applied to a surface.Table 43 FormulationsTable 44 FormulationsExample 17. Nail film-forming FormulationsDescribed herein are different combinations of ingredients used in generation of formulations, including nail film-forming formulations for treatment of infections, inflammations, and tumors. The combinations are listed in Table 45. The top row in the table has a list of F1-F12, which represents the formulation having components indicated in the column below by an “X” for the component added. For each formulation, pH of the solution is adjusted to be from pH 9 to pH 10.Table 45Provided are additional formulations with anti-fungal APIs in F1, F2, and F3, where the anti-fungal APIs are: efinaconazole, tavaborole, ciclopirox, amorolfine, luliconazole, miconazole, ketoconazole, intraconazole, fluconazole, econazole, oxiconazole, clotrimazole, naftifine, voriconazole, isavuconazole, fenticonazole, tavaborole, amorolfine, anidulafungin, caspofungin, micafungin, rezafungin, Amphotericin B, and terbinafine. These are numbered as formulations F1.1-F1.24, F2.1-F2.24, and F3.1-F3.24. For these additional formulations, the last number corresponds to the specific API number in this paragraph.Provided are additional Formulations with anti-bacterial APIs in F4, F5, and F6, where the anti-bacterial APIs are: penicillin, sulfonamides, Streptogramins, polypeptides, tetracycline, doxycycline, amoxicillin, carbapenems, cephalosporins, fluoroquinolones, glycopeptides and lipoglycopeptides, macrolides, and monobactams. These are numbered as formulations F4.1-F4.13, F5.1-F5.13, and F6.1-F6.13. For these additional formulations, the last number corresponds to the specific API number in this paragraph.Provided are additional formulations with anti-inflammation APIs in F7, F8, and F9, where the anti-inflammation APIs are a JAK inhibitor, a PDE4 inhibitor, a corticosteroid, vitamin A, vitamin D3, an anti-IL-17 agent, an anti-IL-23 agent, an anti-TNFα agent, an anti-IL-4 agent, an S1PR inhibitor, a PI3Kδ inhibitor, and a TYK2 inhibitor. These are numbered as formulations F7.1-F7.12, F8.1-F8.12, and F9.1-F9.12. For these additional formulations, the last number corresponds to the specific API number in this paragraph.Provided are additional formulations with anti-tumor APIs in F10, F11, and F12, wherein the anti-tumor APIs are a checkpoint inhibitor, an anti-IL-7 agent, and 5-fluorouracil (F-FU) . These are numbered as formulations F10.1-F10.3, F11.1-F11.3, and F12.1-F12.3. For these additional formulations, the last number corresponds to the specific API number in this paragraph.The foregoing description and accompanying drawings set forth a number of representative embodiments at the present time. Various modifications, additions, and alternative designs will, of course, become apparent to those skilled in the art in light of the foregoing teachings without departing from the scope hereof, which is indicated by the following claims rather than by the foregoing description. All changes and variations that fall within the meaning and range of equivalency of the claims are to be embraced within their scope.
Claims
1.A composition, comprising:an active pharmaceutical ingredient (API) in an amount of no more than 20% (w / v) ;a film forming polymer, wherein the film-forming polymer is present in an amount of 5-15% (w / v) ;a plasticizer, wherein the plasticizer is in an amount of no more than 5 % (w / v) ;a volatile solvent, wherein the volatile solvent is ethanol; anda non-volatile solvent.2.The composition of claim 1, wherein the film-forming polymer comprises Hypromellose derivatives, polymethacrylates, polyurethane, or any combinations thereof.3.The composition of claim 1, wherein the film-forming polymer comprises a Hypromellose derivative, a polymethacrylate, or any combinations thereof.4.The composition of claim 3, wherein the Hypromellose derivative is hydroxypropyl methylcellulose acetate succinate (HPMC-AS) .5.The composition of claim 4, wherein the HPMC-AS is present in an amount of about 0.5%(w / v) to about 1% (w / v) .6.The composition of claim 3, wherein the polymethacrylate is an Eudragit.7.The composition of claim 6, wherein the Eudragit is present in an amount of about 5-15%(w / v) .8.The composition of claim 6, wherein the Eudragit is present in an amount of about 10%(w / v) .9.The composition of claim 1, further comprising at least one solubilizer.10.The composition of claim 9, wherein the at least one solubilizer comprises propylene, glycol, transcutol, polyethylene glycol, or any combinations thereof.11.The composition of claim 9, wherein the at least one solubilizer comprises transcutol.12.The composition of claim 1, further comprising a plasticizer.13.The composition of claim 12, wherein the plasticizer is polyethylene glycol 6000.14.The composition of claim 1, further comprising a permeation enhancer.15.The composition of claim 14, wherein the permeation enhancer is selected from the group consisting of a hydrating agent, a keratolytic agent, an acid, a disulfide bond break agent, a chelating agent, and any combinations thereof.16.The composition of claim 14, wherein the permeation enhancer is acid.17.The composition of claim 16, wherein the acid is lactic acid.18.The composition of claim 17, wherein the lactic acid is present in an amount of about 3%(w / v) to about 30% (w / v) .19.The composition of claim 17, wherein the lactic acid is present in an amount of about 10%(w / v) .20.The composition of claim 1, further comprising at least one thickener.21.The composition of claim 20, wherein the at least one thickener comprises PEG400.22.The composition of claim 1, further comprising a color substance.23.The composition of claim 22, wherein the color substance comprises a pigment, a dye, a colorant, or any combinations thereof.24.A method of treating a nail disorder comprising topically applying the composition of any one of claims 1 to 23 to the nail.25.The method of claim 24, wherein the nail disorder is selected from the group consisting of eczema, atopic dermatitis, onycholysis, subungual hyperkeratosis, discoloration, onychauxis, psoriatic nail, onychorrhexis, onychoschizia, lamellar splitting, onychomadesis, brittle nail syndrome, transverse grooves, nail pitting, soft nails, nail dystrophy, nail fragility of intact or damaged nails, nail tumor, and any combinations thereof.26.The method of claim 24, wherein the nail disorder is onychomycosis.27.The method of claim 24, wherein the nail disorder is nail psoriasis.28.A method of improving an appearance of a nail of a subject comprising topically applying a composition of any one of claims 1 to 23 to the nail.29.The method of claim 28, wherein the method improves a color, a surface smoothness, a shape, and / or a thickness of the nail.30.The method of claim 28, wherein topically applying the composition is carried out at least once per week.31.The method of claim 28, wherein topically applying the composition is carried out at least once per day.32.A method for making a film-forming formulation comprising:providing a solvent comprising a volatile solvent, wherein the volatile solvent is present in an amount of 60%to 100%by volume in the solvent;adjusting a pH of the solvent from pH 8 to pH 11;dissolving an active ingredient and at least one polymer in the solvent after adjusting the pH; andadding a plasticizer, thereby forming the film-forming formulation.33.The method of claim 32, wherein the volatile solvent comprises ethanol, propanol, isopropanol, ethyl acetate, or any mixtures thereof.34.The method of claim 32, wherein the volatile solvent is ethanol.35.The method of claim 32, wherein the polymer is selected from Hypromellose derivatives, polymethacrylates, and any combinations thereof.36.The method of claim 32, wherein the active ingredient is selected from an anti-bacterial substance, an anti-viral substance, an anti-fungal substance, an anti-inflammation substance, and an anti-tumor substance, in an amount of 0.01-20%by weight.37.The method of claim 36, wherein the anti-bacterial substance comprises at least one selected from penicillin, sulfonamides, Streptogramins, polypeptides, tetracycline, doxycycline, amoxicillin, carbapenems, cephalosporins, fluoroquinolones, glycopeptides and lipoglycopeptides, macrolides, monobactams, and any combinations thereof.38.The method of claim 36, wherein the anti-fungal substance comprises efinaconazole, tavaborole, ciclopirox, amorolfine, luliconazole, terbinafine, miconazole, ketoconazole, intraconazole, fluconazole, econazole, oxiconazole, clotrimazole, naftifine, voriconazole, isavuconazole, fenticonazole, tavaborole, amorolfine, anidulafungin, caspofungin, micafungin, rezafungin, Amphotericin B, terbinafine, or any combinations thereof.39.The method of claim 36, wherein the anti-inflammation substance comprises a JAK inhibitor, a PDE4 inhibitor, a corticosteroid, vitamin A, vitamin D3, an anti-IL-17 agent, an anti-IL-23 agent, an anti-TNFα agent, an anti-IL-4 agent, an S1PR inhibitor, a PI3Kδinhibitor, or a TYK2 inhibitor.40.The method of claim 36, wherein the anti-tumor substance comprises a checkpoint inhibitor, an anti-IL-7 agent, 5-fluorouracil (F-FU) , or any combinations thereof.41.The method of claim 32, further comprising adding at least one solubilizer.42.The method of claim 41, wherein the at least one solubilizer is propylene glycol, transcutol, or polyethylene glycol (PEG) .43.The method of claim 32, further comprising adding a permeation enhancer.44.The method of claim 43, wherein the permeation enhancer comprises at least one selected from cyclodextrin and its derivatives, urea and its derivatives, lactic acid and its derivatives, sodium sulfite and its derivatives, EDTA, cysteine and its derivatives, and any combinations thereof.45.The method of claim 43, wherein the permeation enhancer is an acid.46.The method of claim 45, wherein the acid is lactic acid.47.The method of claim 32, further comprising adding at least one thickener.48.The method of claim 47, wherein the at least one thickener comprises PEG400.49.The method of claim 32, further comprising adding a color substance.50.The method of claim 49, wherein the color substance comprises a pigment, a dye, a colorant, or any combinations thereof.51.A composition comprising:an active pharmaceutical ingredient (API) , wherein the active pharmaceutical ingredient is selected from an anti-bacterial substance, an anti-viral substance, an anti-fungal substance, an anti-inflammation substance, and an anti-tumor substance, in an amount of 0.01% (w / v) to 20% (w / v) ;film-forming polymers comprising HPMC-AS and Eudragit L100, wherein the HPMC-AS is present in an amount of 0.5% (w / v) to 4% (w / v) and the Eudragit L100 is present in an amount of 5% (w / v) to 15% (w / v) ;a plasticizer, wherein the plasticizer is PEG 6000 present in an amount of 0.5 % (w / v) to 4 % (w / v) ;a solubilizer, wherein the solubilizer is propylene glycol or transcutol; anda volatile solvent, wherein the volatile solvent is ethanol.52.The composition of claim 51, wherein the anti-bacterial substance comprises at least one selected from a group consisting of penicillin, sulfonamides, Streptogramins, polypeptides, tetracycline, doxycycline, amoxicillin, carbapenems, cephalosporins, fluoroquinolones, glycopeptides and lipoglycopeptides, macrolides, monobactams, and any combinations thereof.53.The composition of claim 51, wherein the anti-fungal substance comprises efinaconazole, tavaborole, ciclopirox, amorolfine, luliconazole, terbinafine, miconazole, ketoconazole, intraconazole, fluconazole, econazole, oxiconazole, clotrimazole, naftifine, voriconazole, isavuconazole, fenticonazole, tavaborole, amorolfine, anidulafungin, caspofungin, micafungin, rezafungin, Amphotericin B, terbinafine, or any combinations thereof.54.The composition of claim 51, wherein the anti-inflammation substance comprises a JAK inhibitor, a PDE4 inhibitor, a corticosteroid, vitamin A, vitamin D3, an anti-IL-17 agent, an anti-IL-23 agent, an anti-TNFα agent, an anti-IL-4 agent, an S1PR inhibitor, a PI3Kδinhibitor, or a TYK2 inhibitor.55.The composition of claim 51, wherein the anti-tumor substance comprises a checkpoint inhibitor, an anti-IL-7 agent, 5-fluorouracil (F-FU) , or any combinations thereof.56.The composition of claim 51, wherein the API is terbinafine HCl.57.The composition of claim 51, wherein the HPMC-AS is present in an amount of 0.5% (w / v) to 4% (w / v) .58.The composition of claim 51, wherein the HPMC-AS is present in an amount of 0.5%(w / v) .59.The composition of claim 51, wherein the Eudragit L100 is present in an amount of 5-15%(w / v) .60.The composition of claim 51, wherein the Eudragit L100 is present in an amount of 10%(w / v) .61.The composition of claim 51, wherein the PEG 6000 is present in an amount of 2 % (w / v) to 4 % (w / v) .62.The composition of claim 51, wherein solubilizer is present in an amount of 3% (w / v) to 5%(w / v) .63.The composition of any one of claims 51 to 62, further comprising water.64.The composition of claim 63, wherein the volume ratio of ethanol to water is from 9: 1 to 6:4.65.The composition of claim 63, wherein the volume ratio of ethanol to water is from 9: 1 to 8:2.66.The composition of claim 51, further comprising a permeation enhancer, wherein the permeation enhancer is selected from the group consisting of a hydrating agent, a keratolytic agent, an acid, a disulfide bond break agent, a chelating agent, and any combinations thereof.67.The composition of claim 66, wherein the permeation enhancer is an acid.68.The composition of claim 67, wherein the acid is lactic acid.69.The composition of claim 68, wherein the lactic acid is present in an amount of about 3%to about 30%.70.The composition of claim 68, wherein the lactic acid is present in an amount of 10%.71.The composition of claim 66, further comprising a pigment.72.The composition of claim 71, wherein the pigment is present in an amount of about 0.1%.73.A composition, comprising:terbinafine or terbinafine HCl in an amount of 0.5-20%by weight;a film forming polymer, wherein the film forming polymer present in an amount of 5-15%by weight;a plasticizer, wherein the plasticizer is present in an amount of 0.5-5 %by weight;a permeation enhancer, wherein the permeation enhancer is lactic acid present in an amount of 2%to 30%by weight,a volatile solvent, wherein the volatile solvent comprises ethanol; anda non-volatile solvent.74.The composition of claim 73, wherein the composition is in a topical form.75.The composition of claim 73, wherein film forming polymer is selected from Hypromellose derivatives, polymethacrylates, or any combinations thereof.76.The composition of claim 75, wherein the film forming polymer comprises Eudragit L100 and HPMC-AS-LF.77.The composition of claim 76, wherein the HPMC-AS-LF is present in an amount of 0.5%(w / v) to 4% (w / v) and the Eudragit L100 is present in an amount of 5% (w / v) to 15% (w / v) .78.The composition of claim 76, wherein the HPMC-AS-LF is present in an amount of 0.5%(w / v) and the Eudragit L100 is present in an amount of 10% (w / v) .79.The composition of claim 73, wherein the plasticizer is PEG 6000.80.The composition of claim 79, wherein PEG 6000 is present in an amount of equal to or less than 4%.81.The composition of claim 79, wherein PEG 6000 is present in an amount of 4%.82.The composition of claim 73, wherein the volatile solvent is ethanol, and the non-volatile solvent is an aqueous solution.83.The composition of claim 73, further comprising a solubilizer.84.The composition of claim 83, wherein the solubilizer is Transcutol or PEG 400.85.The composition of claim 84, wherein the solubilizer is Transcutol.86.The composition of claim 85, wherein the Transcutol is present in an amount of equal to or less than 5%.87.The composition of claim 73, wherein the lactic acid is present in an amount of about 3%to about 10%.88.The composition of claim 87, wherein the lactic acid is present in an amount of about 10%.89.The composition of claim 73, wherein the volume ratio of the ethanol to the non-volatile solvent is from 9: 1 to 6: 4.90.The composition of claim 73, wherein the non-volatile solvent is water.91.The composition of claim 90, wherein the volume ratio of the ethanol to water is 4: 1.92.A composition, comprising:terbinafine or terbinafine HCl;a film forming polymer, wherein the film forming polymer present in an amount of 5-15%by weight;a plasticizer, wherein the plasticizer is in an amount of 0.5-5 %by weight;lactic acid, wherein the ratio of terbinafine or terbinafine HCl and the lactic acid is from 1:10 (w: w) to 1: 2 (w: w) , and wherein the lactic acid is present in an amount sufficient for permeation enhancement of the terbinafine or terbinafine HCl;a volatile solvent, wherein the volatile solvent comprises ethanol; anda non-volatile solvent.93.The composition of claim 92, wherein the terbinafine or terbinafine HCl is present in an amount of 0.5-15%by weight.94.The composition of claim 92, wherein the composition is in a topical form.95.The composition of claim 92, wherein the film forming polymer is selected from Hypromellose derivatives, polymethacrylates, or any combinations thereof.96.The composition of claim 95, wherein the film forming polymer comprises Eudragit L100 and HPMC-AS-LF.97.The composition of claim 96, wherein the HPMC-AS-LF is present in an amount of 0.5%(w / v) to 4% (w / v) and the Eudragit L100 is present in an amount of 5% (w / v) to 15% (w / v) .98.The composition of claim 97, wherein the HPMC-AS-LF is present in an amount of 0.5%(w / v) and the Eudragit L100 is present in an amount of 10% (w / v) .99.The composition of claim 92, wherein the plasticizer is PEG 6000.100.The composition of claim 99, wherein PEG 6000 is present in an amount of equal to or less than 4%.101.The composition of claim 100, wherein PEG 6000 is present in an amount of 4%.102.The composition of claim 92, wherein the volatile solvent is ethanol, and the non-volatile solvent is an aqueous solution.103.The composition of claim 92, further comprising a solubilizer.104.The composition of claim 103, wherein the solubilizer is Transcutol or PEG 400.105.The composition of claim 103, wherein the solubilizer is Transcutol.106.The composition of claim 105, wherein the Transcutol is present in an amount of equal to or less than 5%.107.The composition of claim 92, wherein the lactic acid is present in an amount of about 3%to about 10%.108.The composition of claim 107, wherein the lactic acid is present in an amount of about 10%.109.The composition of claim 92, wherein the volume ratio of the ethanol to the non-volatile solvent is from 9: 1 to 6: 4.110.The composition of claim 92, wherein the non-volatile solvent is water.111.The composition of claim 110, wherein the volume ratio of the ethanol to water is 4: 1.112.A method for treating a nail disorder comprising contacting the nail with an effective amount of the composition of any one of claims 1 to 23, or 51 to 111.113.The method of claim 112, wherein after contacting the nail, the composition forms a film on a surface of the nail in less than 2 minutes.114.The method of claim 112, wherein the film is resistant to hand washing.
Citation Information
Patent Citations
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WO2001060325A1