Excipient granulations

TWI935440BActive Publication Date: 2026-08-11XW LABORATORIES (TAIWAN) INC
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Patent Information

Application Number
TW113128573
Authority / Receiving Office
TW · TW
Patent Type
Patents
Current Assignee / Owner
Priority Date
2023-07-31
Filing Date
2024-07-31
Publication Date
2026-08-11
Estimated Expiration
2044-07-30

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Abstract

This invention discloses excipient granules containing a thickener, a disintegrant, and one or more additional excipients. The excipient granules can be combined with pharmaceutical granules to provide pharmaceutical compositions. These excipient granules can be used to increase the viscosity of aqueous compositions such as oral pharmaceutical compositions. When added to an aqueous solution, the excipient granules dissolve to provide a suspension of pharmaceutical particles in a viscous solution. The excipient granules can be used to improve the palatability of oral pharmaceutical compositions containing pharmaceutical granules.
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Description

Excipient Granules This disclosure relates to excipient granules, compositions comprising such excipient granules, and uses of such excipient granules. The excipient granules can be used to improve the palatability of oral pharmaceutical compositions. Active pharmaceutical ingredients can be administered in the form of pharmaceutical granules. To improve the palatability of the pharmaceutical granules administered to a patient, the pharmaceutical granules can be dispersed and / or suspended in a viscous solution. A thickening agent and additional excipients can be conveniently provided together with the pharmaceutical granules such that the thickening agent, additional excipients, and pharmaceutical granules can be combined with water to provide a palatable oral pharmaceutical composition. According to the present invention, an excipient granule comprises a plurality of excipient particles, wherein the excipient particles comprise: a thickening agent; a disintegrant; and one or more additional excipients. According to the present invention, a method for preparing the excipient particles comprises: dry mixing the thickening agent, the disintegrant, and the one or more excipients to provide a dry mixture; forming the dry mixture into particles with a buffer solution to provide a first granulate; wet agglomerating the first granulate to form a first wet agglomerate; forming the first wet agglomerate into particles with water to provide a second granulate; wet agglomerating the second granulate to form a second wet agglomerate; and drying the second wet agglomerate to provide the excipient particles. According to the present invention, an excipient granule comprises excipient particles prepared according to the present invention. According to the present invention, a composition comprises an excipient granule according to the present invention. According to the present invention, a pharmaceutical composition comprises: an excipient granule according to the present invention; and an active pharmaceutical ingredient. According to the present invention, a product comprises an excipient granule according to the present invention or a composition according to the present invention. According to the present invention, a pharmaceutical product comprises a pharmaceutical composition according to the present invention. According to the present invention, a composition for oral administration is prepared using an excipient granule according to the present invention. According to the present invention, an oral pharmaceutical composition for oral administration is prepared using an excipient granule according to the present invention. This application claims the benefit of U.S. Provisional Application No. 63 / 529,880, filed Jul. 31, 2023, under 35 U.S.C. § 119(e), which is incorporated herein by reference in its entirety. For the purposes of the following embodiments, it is to be understood that, unless explicitly stated to the contrary therein, the embodiments provided by this disclosure may adopt various alternative variations and step sequences. Additionally, except where any operating examples or otherwise indicated, all numbers used in the specification and claims to express, for example, quantities of ingredients, are to be understood as being modified in all instances by the term "about". Accordingly, unless stated to the contrary, the numerical parameters set forth in the following specification and the appended claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and without attempting to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. While the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. However, any numerical value inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. In addition, it is to be understood that any numerical range recited herein is intended to include all sub-ranges subsumed therein. For example, a range of "1 to 10" is intended to include all sub-ranges between the recited minimum value of 1 and the recited maximum value of 10 (and including the minimum value of 1 and the maximum value of 10), that is, all sub-ranges having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10. "Immediate release" means that when tested in a dissolution apparatus 2 according to USP 38 in a 0.1 N HCl dissolution medium at a temperature of 37°C and a paddle speed of 75 rpm, the composition releases at least 80% of the component within 1 hour. An immediate release type composition or formulation can release substantially all of the pharmaceutically active ingredient into the gastrointestinal tract of a patient in less than 1 hour after oral administration, such as in less than 50 minutes, less than 40 minutes, less than 30 minutes, less than 20 minutes or less than 10 minutes after oral administration. For example, an immediate release dosage form can release more than 90%, more than 95% or more than 98% of the components of the pharmaceutical composition into the gastrointestinal tract in less than 1 hour after oral administration, such as less than 50 minutes, less than 40 minutes, less than 30 minutes, less than 20 minutes or less than 10 minutes after oral administration. An immediate release type pharmaceutical composition can be suitable for administering a pharmaceutically active ingredient that is absorbed from the upper gastrointestinal tract into the systemic circulation. "Modified release" pharmaceutical compositions and formulations may include controlled release formulations, delayed release formulations, extended release formulations, sustained release formulations, timed release formulations, pulsed release formulations, and pH-dependent release formulations. These formulations are designed to release the pharmaceutically active ingredient from the pharmaceutical composition at a desired rate and / or at a desired time and / or at one or more locations within the gastrointestinal tract and / or at a certain pH within the gastrointestinal tract after oral administration to a patient. The United States Pharmacopeia (USP) defines a modified release system as a system in which the time course or location or both of drug release are selected to achieve therapeutic effectiveness or convenience goals that cannot be achieved by immediate release dosage forms. Modified release oral dosage forms may include extended release and delayed release components. A delayed release dosage form is a dosage form that does not release the drug immediately upon administration, but rather releases all of the drug at one time at a certain time after administration. Modified release formulations may include delayed release using enteric coatings; site or timed release, such as for colonic delivery; extended release, including formulations capable of providing zero-order, first-order, or biphasic release profiles; and programmed release, such as pulsed and delayed extended release. "Patient" refers to a mammal, such as a human. "Pharmaceutically acceptable" means approved or approvable by a regulatory agency of the Federal or a State government or listed in the United States Pharmacopeia (USP) or other generally recognized pharmacopeia as being acceptable for use in animals and more particularly in humans. "Curing" a disease means eliminating the disease or disorder or eliminating the symptoms of the disease or disorder. "Treating" or "treatment" of a disease or disorder means reducing the severity of one or more clinical symptoms of the disease or disorder, delaying the onset of one or more clinical symptoms of the disease or disorder, and / or alleviating one or more clinical symptoms of the disease or disorder. "Treating" or "treatment" of a disease or disorder means inhibiting the disease or disorder or one or more clinical symptoms of the disease or disorder, arresting the development of the disease or disorder or one or more clinical symptoms of the disease or disorder, alleviating the disease or disorder or one or more clinical symptoms of the disease or disorder, causing the disease or disorder or one or more clinical symptoms of the disease or disorder to regress, and / or stabilizing the disease or disorder or one or more clinical symptoms of the disease or disorder. "Treating" or "treatment" of a disease or disorder means producing a clinically beneficial effect without curing the underlying disease or disorder. The recombinant viscosity or viscosity of an aqueous solution prepared using excipient granules can be determined using a Brookfield digital viscometer, model LVDV-1+, equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm and a temperature of 23°C. The excipient granules, such as 1.2 g of excipient granules, can be added to water, such as 40 mL of water, in a 50 mL beaker and mixed for a specified time, such as 30, 60, 90, 120, 150, or 180 seconds. Mixing can be stopped and the viscosity measured. The bulk density can be determined according to USP <616> method 1. The tapped bulk density can be determined according to USP <616>. The Hausner Ratio can be determined according to USP <1174>. The Hausner Ratio is the ratio of the tapped density to the bulk density. The compression index is 100 × [(tapped density - bulk density) / tapped density]. The particle size distribution or average particle size of the granulate can be determined by laser diffraction or by sieve analysis. The Flodex value can be determined according to USP <1174>. The luminosity can be determined using a Datacolor 650™ instrument from Technical Color Solutions. The friability can be measured using a sonic sifter. Friability is defined as the number of particles with a diameter less than 75 µm produced by subjecting the granulate to a sonic sifter operating at an amplitude corresponding to 3,600 sonic energy pulses per minute for at least 2 minutes. A "pharmaceutical granulate" refers to a plurality of pharmaceutical granules, wherein the pharmaceutical granules contain an active pharmaceutical ingredient. An "excipient granulate" refers to a plurality of excipient granules, wherein the excipient granules do not contain an active pharmaceutical ingredient. A "pharmaceutical composition" refers to a composition comprising an excipient granulate and an active pharmaceutical ingredient. An "oral pharmaceutical composition" refers to a pharmaceutical composition intended to be orally ingested by a patient. Reference is now made to the excipient granulate, excipient granules, pharmaceutical compositions comprising excipient granules, and uses of excipient granules. The disclosed excipient granulate, excipient granules, pharmaceutical compositions, and uses are not intended to limit the scope of the patent application. On the contrary, the scope of the patent application is intended to cover all alternatives, modifications, and equivalents. The excipient granulate provided by the present disclosure can improve the palatability of orally administered pharmaceutical granulates. Palatability can be defined as the overall evaluation of an oral medicine with respect to odor, taste, aftertaste, and mouthfeel or the sensation in the mouth. Palatability includes the overall acceptance of the taste, flavor, odor, dose volume or size, and mouthfeel of the medicine administered into the mouth and / or swallowed. The excipient granulate provided by the present disclosure can increase the viscosity of an orally administered solution containing a pharmaceutical granulate, and thereby reduce the harshness or roughness in the mouth. For improving convenience during use, the excipient granulate can provide a viscous solution capable of suspending the pharmaceutical granulate within 30 seconds after being combined with water. The viscosity of a solution suitable for oral administration can be determined by various factors, such as the density of the pharmaceutical granulate, the average size of the granules, the size distribution of the granules, and the average volume of the granules. The excipient granules provided by the present disclosure can be particularly useful for high-dose drugs. High-dose drugs may require the administration of a larger tablet or multiple tablets. By using a pharmaceutical granulate, the inconvenience and / or discomfort of administering a high-dose drug in tablet form can be avoided. However, high-dose granulates can produce a harsh or rough feeling in the mouth. For convenience, it is desirable that the viscous solution prepared using the excipient granulate provided by the present disclosure is drinkable. The viscosity of the drinkable solution at a temperature of 20°C to 25°C (such as 23°C) can be, for example, 50 cP to 600 cP, which is measured using a Brookfield digital viscometer of model LVDV-I+ equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm. However, the excipient granules can also be used to provide a pharmaceutical composition with a higher viscosity that is more suitable for consumption. For example, the viscosity of the pharmaceutical composition at a temperature of 20°C to 25°C (such as 23°C) can be greater than 1,000 cP, which is measured using a Brookfield digital viscometer of model LVDV-I+ equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm. In the oral pharmaceutical composition provided by the present disclosure, 30 seconds after being mixed with 40 mL of water at 23°C, the viscosity of the oral pharmaceutical composition can be, for example, 60 cP to 600 cP, such as 200 cP to 600 cP, 300 cP to 600 cP, which is measured using a Brookfield digital viscometer of model LVDV-I+ equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm. In the oral pharmaceutical composition provided by the present disclosure, 60 seconds after mixing with 40 mL of water at 23°C, the viscosity of the oral pharmaceutical composition can be, for example, 200 cP to 1,100 cP, such as 400 cP to 1,000 cP or 600 cP to 1,000 cP. The viscosity is measured using a Brookfield digital viscometer of model LVDV-I+ equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm. The viscosity of the oral pharmaceutical composition can be similar to that of a drinkable yogurt product. The intended objectives of the excipient granulate provided by the present disclosure include, for example: (1) providing an oral pharmaceutical composition having a viscosity of 50 cP to 1,000 cP, such as 50 cP to 600 cP or 50 cP to 500 cP within less than 90 seconds after mixing with an aqueous solution at 23°C; (2) providing an average excipient particle size similar to that of a pharmaceutical granulate; (3) providing physically stable excipient particles for storage and transportation; and / or (4) providing a homogeneous particle composition such that the excipient particles and other particles (such as pharmaceutical particles) in the pharmaceutical composition do not separate. It is desired that the excipient particles and other particles in the composition remain homogeneously dispersed to facilitate the ability of the reconstituted solution and / or suspension to be homogeneous. Other intended objectives may include: (1) improving taste; (2) maintaining pH value; (3) rapid dissolution; and (4) low wt% or low volume. The excipient granulate provided by the present disclosure comprises a plurality of excipient particles. The excipient granulate provided by the present disclosure may comprise a pharmaceutically acceptable excipient. When combined with water, the excipient granulate provides a viscous aqueous solution. The viscosity of the viscous aqueous solution can be selected to improve the palatability of a pharmaceutical composition comprising pharmaceutical granulates dispersed and suspended in the viscous solution. A suitable viscosity that effectively improves the palatability of the pharmaceutical granulates can depend on, for example, the average size of the pharmaceutical particles, the size distribution of the pharmaceutical particles, the density of the pharmaceutical particles, the volume percentage of the pharmaceutical particles in the viscous aqueous solution, or a combination of any of the foregoing. The excipient granulate provided by the present disclosure can be configured to provide a viscosity of, for example, 20 cP to 100 cP when mixed with 40 mL of water at 23°C. The viscosity is measured using a Brookfield digital viscometer of model LVDV-I+ equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm. The excipient particles provided by the present disclosure may comprise a thickening agent, a disintegrant, and one or more additional excipients. The excipient granules provided by the present disclosure may include an amount of each excipient suitable for achieving the intended purpose of the excipient granulate, such as an amount suitable for improving the palatability of a pharmaceutical granulate. When combined with an aqueous solution, the excipient granulate may provide a viscous solution that contains pharmaceutical granules dispersed and suspended therein that are palatable for oral ingestion. Additional excipients of the excipient granulate provided by the present disclosure may be selected, for example, to reduce the graininess of a pharmaceutical granulate and to improve the taste of a pharmaceutical composition. Additional excipients may be selected to adjust the pH value of a pharmaceutical composition and to enhance the storage stability of the excipient granules and / or the pharmaceutical granules. The excipient granules provided by the present disclosure may include, for example, a thickening agent, a disintegrant, and one or more additional excipients. The one or more additional excipients are excipients other than the thickening agent and the disintegrant. The excipient granules provided by the present disclosure may include a thickening agent or a combination of thickening agents. The thickening agent may be a pharmaceutically acceptable thickening agent. The thickening agent may be used to increase the viscosity of a liquid composition, such as an aqueous composition including an oral pharmaceutical composition. Suitable thickening agents include, for example, plant extracts such as starch, pectin, alginate, carrageenan, acacia gum, tragacanth, and cellulose; modified polysaccharides such as modified starch, amidated pectin, and propylene glycol alginate; cellulose ethers such as microcrystalline cellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, and carboxymethyl cellulose; animal extracts such as gelatin, chitosan, and caseinate; fermentation products such as xanthan gum, gellan gum, polydextrose, and polyglucose; seed polysaccharides such as guar gum and locust bean extract; and combinations of any of the foregoing. The thickening agent may include, for example, hydrocolloid gums, including hydrocolloids of plant origin such as pectin, agar, alginate, acacia gum, tragacanth, Karaya gum, guar gum, starch, cellulose, and locust bean; fermentation hydrocolloid products such as xanthan gum, polyglucose, gellan gum, and polydextrose; semi-synthetic hydrocolloids including modified starch, cellulose ethers (such as methyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, hydroxypropyl cellulose, and hydroxyethyl cellulose), amidated pectin, and propylene glycol alginate; hydrocolloids of animal origin such as gelatin, chitosan, and caseinate; and combinations of any of the foregoing. The thickening agent may include aluminosilicates such as bentonite, lithium soapstone, and magnesium aluminum silicate. The thickening agent may include carbomer. The thickening agent may include polyols, sugars, oligosaccharides such as sorbitol, liquid maltitol, sucrose, fructose, dextrose, maltodextrin, and polydextrose. Other suitable tackifiers include polyethylene glycol, polyethylene oxide, colloidal silica, polysiloxane, glycerin, fatty acids, and stearin. The tackifier may include vinyl polymers such as water-soluble polyvinylpyrrolidone with an average molecular weight of 2,500 g / mol to 1,250,000 g / mol, such as povidone and crospovidone; ethylene-vinyl acetate; and polyvinyl alcohol such as with a degree of hydrolysis greater than 88% and a molecular weight of 20,000 g / mol to 100,000 g / mol. Suitable tackifiers include, for example, guar gum, xanthan gum, sodium carboxymethyl cellulose, and combinations of any of the foregoing. The tackifier may be in the form of granules, where the average particle diameter of the granules is less than 75 µm, less than 50 µm, less than 35 µm, or less than 25 µm. The average particle diameter of the tackifier granules may be, for example, 10 µm to 75 µm, 20 µm to 70 µm, 25 µm to 65 µm, or 25 µm to 45 µm, where the particle diameter is determined by sieve analysis or by laser diffraction. The average particle diameter of a tackifier such as xanthan gum may be less than 35 µm. The tackifier may include xanthan gum, such as Xnatural® 75 purchased from CP Kelco. The particle diameter of a tackifier such as xanthan gum may be, for example, no less than 100% of the particles passing through a 80-mesh (180 µm) sieve, such as no less than 92% of the particles passing through a 200-mesh (75 µm) sieve, as determined by sieve screening. The loss on drying (LOD) of a tackifier such as xanthan gum may be, for example, no more than 15%. A tackifier such as xanthan gum may provide, for example, a viscosity of 1,200 mPa×s to 1,600 mPa×s at 1 wt% tackifier in a 1% KCL solution at 60 rpm, as determined using transmittance. A tackifier such as xanthan gum may provide, for example, a viscosity ratio of 1.02 to 1.45. A tackifier such as xanthan gum may provide, for example, a solution pH value of 6.0 to 8.0 at 1 wt% tackifier in distilled water, as determined using transmittance. The excipient granules may contain, for example, 1 wt% to 40 wt%, 1 wt% to 35 wt%, 1 wt% to 30 wt%, 1 wt% to 20 wt%, 5 wt% to 15 wt%, or 8 wt% to 12 wt% of the tackifier, where wt% is based on the total weight of the excipient granules. The excipient granules provided by the present disclosure may contain a disintegrant or a combination of disintegrants. The disintegrant may be a pharmaceutically acceptable disintegrant. Disintegrants help the excipient granules to quickly disintegrate or decompose and dissolve after being mixed with an aqueous solution at a temperature of 20°C to 25°C (such as 23°C). It may be required that the excipient granules completely dissolve in water within less than 30 seconds, within less than 60 seconds, within less than 90 seconds, or within less than 120 seconds after being mixed with an aqueous solution at a temperature of 20°C to 25°C (such as 23°C). Disintegrants can include, for example, crospovidone, sodium carboxymethylcellulose cross-linked, low-substituted hydroxypropyl cellulose, sodium starch glycolate, chitosan hydrochloride, corn starch and pregelatinized starch, calcium alginate and calcium sodium alginate, docusate sodium, microcrystalline cellulose, hydroxypropyl starch, magnesium aluminum silicate, methyl cellulose, sodium alginate, starch, pregelatinized starch, calcium carboxymethylcellulose, calcium cellulose glycolate, calcium carboxymethylcellulose, powdered cellulose, or a combination of any of the foregoing. Examples of suitable disintegrants include crospovidone, sodium carboxymethylcellulose cross-linked, sodium starch glycolate, soy polysaccharide, cross-linked alginic acid, gellan gum, xanthan gum, calcium silicate, and cross-linked polyacrylate. The excipient can include crospovidone, such as crospovidone CL-M purchased from BASF. Suitable crospovidone disintegrants can have a pH value of 5 to 8 when in the form of a 1 wt% solution in water at a temperature of 20°C to 25°C (such as 23°C); a bulk density of 0.25 g / cm 3 to 0.45 g / cm 3 ; and / or an average particle size of 20 µm to 40 µm. The excipient granules can include, for example, 1 wt% to 40 wt% of a disintegrant, 1 wt% to 30 wt%, 1 wt% to 25 wt%, 1 wt% to 20 wt%, 5 wt% to 20 wt%, 7 wt% to 17 wt%, or 10 wt% to 14 wt% of a disintegrant, where wt% is based on the total weight of the excipient granules. The excipient granules provided by the present disclosure can include one or more additional excipients. The additional excipients can be pharmaceutically acceptable excipients. Examples of suitable excipients include preservatives, antioxidants, adsorbents, acidifying agents, alkalizing agents, buffers, chelating agents, coloring agents, clarifying agents, emulsifiers, flavoring agents, water-soluble polymers, diluents, binders, lubricants, wetting agents, surfactants, glidants, and fillers. One or more additional excipients can include diluents, binders, flavoring agents, buffers, acids, sweeteners, fillers, or a combination of any of the foregoing. The excipient granules provided by the present disclosure may contain, for example, 40 wt% to 98 wt% of additional excipients or a combination of additional excipients, which do not include thickeners and dispersants. The excipient granules provided by the present disclosure may contain, for example, 40 wt% to 98 wt% of one or more additional excipients, 50 wt% to 95 wt%, 60 wt% to 90 wt%, 70 wt% to 85 wt%, or 75 wt% to 85 wt% of one or more additional excipients, where wt% is based on the total weight of the excipient granules. The excipient granules provided by the present disclosure may contain, for example, less than 95 wt% of additional excipients, less than 90 wt%, less than 80 wt%, less than 70 wt%, or less than 60 wt% of one or more additional excipients, where wt% is based on the total weight of the excipient granules. The excipient granules provided by the present disclosure may contain, for example, more than 40 wt% of one or more additional excipients, more than 50 wt%, more than 60 wt%, more than 70 wt%, more than 80 wt%, or more than 90 wt% of one or more additional excipients, where wt% is based on the total weight of the excipient granules. The excipient granules may contain a diluent or a combination of diluents. The diluent may be a pharmaceutically acceptable diluent. The diluent may provide volume to the excipient granules, enhance flow characteristics, and facilitate processing. Examples of suitable diluents include microcrystalline cellulose, powdered cellulose, anhydrous lactose, lactose monohydrate, spray-dried lactose, mannitol, starch, pregelatinized starch, corn starch, maize starch, sorbitol, sucrose, compressible sugar, powdered sugar, sugar spheres, glucose binder, dextrin, dextrose, calcium hydrogen phosphate, anhydrous calcium phosphate, calcium carbonate, maltose, maltodextrin, kaolin, calcium hydrogen phosphate, calcium phosphate dihydrate, tricalcium phosphate, calcium sulfate, cellulose acetate butyrate, calcium lactate, cellulose acetate, siliconized microcrystalline cellulose, cellulose acetate, corn syrup, pregelatinized starch and corn starch, corn syrup solids, erythritol, ethyl cellulose, ethyl acrylate and methyl methacrylate copolymer dispersion, fructose, isomalt, α-lactalbumin, lactitol, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer, polydextrose, sodium chloride, polydimethylsiloxane, pregelatinized modified starch, pea starch, hydroxypropyl pea starch, pregelatinized hydroxypropyl pea starch, potato starch, hydroxypropyl potato starch, pregelatinized hydroxypropyl potato starch, tapioca starch, wheat starch, hydrogenated starch hydrolysate, polyglycitol, talc, amino methacrylate copolymer, trehalose, xylitol, and combinations of any of the foregoing. Examples of suitable diluents include lactose, microcrystalline cellulose, starch, calcium phosphate (such as anhydrous calcium hydrogen phosphate, hydrated calcium hydrogen phosphate, and tricalcium phosphate), calcium carbonate, maltodextrin, mannitol, sorbitol, and sodium chloride. The diluent may comprise anhydrous calcium hydrogen phosphate. The anhydrous calcium hydrogen phosphate may be A-Comprez® purchased from Markan Global Enterprises. The excipient granules may comprise, for example, 1 wt% to 40 wt%, 10 wt% to 30 wt%, 15 wt% to 25 wt%, or 17 wt% to 23 wt% of a diluent, such as anhydrous calcium hydrogen phosphate, where wt% is based on the total weight of the excipient granules. The excipient granules provided by the present disclosure may comprise a binder or a combination of binders. The binder may be a pharmaceutically acceptable binder. The binder promotes the cohesion of the components of the excipient granules. Examples of suitable binders include natural binders such as starch, pregelatinized starch, sodium alginate, and gelatin; synthetic and semi-synthetic binders such as polyvinylpyrrolidone, methylcellulose, hydroxypropylmethylcellulose, polymethacrylate, sodium carboxymethylcellulose, polyethylene glycol, and methylcellulose; sugars such as lactose, sucrose, starch, cellulose, and modified celluloses such as microcrystalline cellulose and cellulose ethers such as hydroxypropyl cellulose, and sugar derivatives such as sorbitol, xylitol, and mannitol. Other examples of suitable binders include gum arabic, copovidone, carbomer, corn starch and pregelatinized starch, calcium carboxymethylcellulose, calcium hydroxyacetate cellulose, calcium carboxymethyl cellulose, sodium carboxymethylcellulose, sodium carboxymethyl cellulose, Ceratonia, chitosan hydrochloride, glucose binder, dextrin, ethyl cellulose, liquid glucose, guar gum, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl starch, hydroxypropylmethyl cellulose, inulin, magnesium aluminum silicate, maltodextrin, methyl cellulose, polyethylene glycol, polyethylene oxide, povidone, sodium alginate, starch, pregelatinized starch, sucrose, compressible sugar, zein, gelatin, polymethyl methacrylate, sorbitol, glucose, and sodium alginate. Examples of suitable binders include hydroxypropyl cellulose, polyvinyl alcohol, hydroxypropylmethyl cellulose, hydroxypropylethyl cellulose, polyvinylpyrrolidone, or polyethylene glycol. The binder may comprise polyvinylpyrrolidone. Suitable polyvinylpyrrolidone may be characterized in that its average molecular weight is, for example, 58,000 daltons, where the average molecular weight is determined by column chromatography. The viscosity of a suitable polyvinylpyrrolidone in the form of a 5% aqueous solution at 25 °C can be, for example, 2.5 cP. The average particle size of a suitable polyvinylpyrrolidone can be, for example, 80 µm. The bulk density of a suitable polyvinylpyrrolidone can be, for example, 0.36 g / cm 3 and / or the tapped density can be 0.47 g / cm 3 . The excipient granules can contain, for example, 1 wt% to 30 wt%, 2 wt% to 25 wt%, 5 wt% to 20 wt%, or 7 wt% to 13 wt% of a binder such as polyvinylpyrrolidone, where wt% is based on the total weight of the excipient granules. The excipient granules provided by the present disclosure can contain a flavoring agent or a combination of flavoring agents. The flavoring agent can be a pharmaceutically acceptable flavoring agent. The flavoring agent can make the pharmaceutical composition more palatable and can mask the unpleasant taste of the active pharmaceutical ingredient. The nature of the unpleasant taste to be masked can determine the choice of a suitable flavoring agent. Examples of suitable flavoring agents include vanilla extract, mint flavor powder, berry flavor powder, strawberry flavor powder, orange flavor powder, lemon flavor powder, orange essence, ethyl maltol, eucalyptus oil, isobutanol, sodium succinate, adipic acid, almond oil, anethole, benzaldehyde, denatonium benzoate, ethyl acetate, ethyl vanillin, ethyl cellulose, fructose, fumaric acid, L-glutamate hydrochloride, lactitol, leucine, malic acid, maltol, menthol / racemic menthol, methionine, methyl salicylate, monosodium glutamate, peppermint oil, strawberry flavor liquid, peppermint spirit, racemic methionine, rose oil, concentrated rose water, sodium acetate, sodium lactate solution, tartaric acid, thymol, fumaric acid, inulin, isomaltulose, and neohesperidin dihydrochalcone. The flavoring agent can include a citrus fruit flavoring agent, a berry flavoring agent, a punch flavoring agent, or a combination of any of the foregoing. The excipient granules provided by the present disclosure can contain, for example, 1 wt% to 40 wt% of a flavoring agent, 5 wt% to 35 wt%, 10 wt% to 35 wt%, 15 wt% to 35 wt%, 20 wt% to 30 wt%, or 22 wt% to 28 wt% of a flavoring agent, where wt% is based on the total weight of the excipient granules. The excipient granules provided by the present disclosure can contain a buffering agent or a combination of buffering agents. The buffering agent can be a pharmaceutically acceptable buffering agent. Examples of suitable buffers include sodium citrate dihydrate, citric acid anhydrous, disodium hydrogen phosphate, and sodium dihydrogen phosphate, potassium metaphosphate, potassium phosphate, sodium dihydrogen acetate, and sodium citrate anhydrous. The buffer may include sodium citrate dihydrate. The excipient granules may include, for example, 0.1 wt% to 10 wt% of a buffer, 0.5 wt% to 8 wt%, 0.5 wt% to 6.5 wt%, 1 wt% to 5 wt%, or 2 wt% to 4 wt% of a buffer, such as sodium citrate dihydrate, where wt% is based on the total weight of the excipient granules. The excipient granules provided by the present disclosure may include an acidifying agent or a combination of acidifying agents. The acidifying agent may be a pharmaceutically acceptable acidifying agent. Examples of suitable acidifying agents include sodium citrate anhydrous, fumaric acid, hydrochloric acid, and nitric acid. The excipient granules may include, for example, 0.1 wt% to 10 wt% of an acid, 0.5 wt% to 8 wt%, 1 wt% to 7 wt%, 2 wt% to 6 wt%, or 3 wt% to 5 wt% of an acidifying agent, such as sodium citrate anhydrous, where wt% is based on the total weight of the excipient granules. The excipient granules provided by the present disclosure may include a sweetening agent or a combination of sweetening agents. The sweetening agent may be a pharmaceutically acceptable sweetening agent. Examples of suitable sweetening agents include sucralose, sodium saccharin, neotame, sucrose, acesulfame potassium, aspartame, aspartame acesulfame, corn syrup, corn syrup solids, glucose binder, dextrose, dextrose excipient, erythritol, fructose, galactose, glucose, glycerin, inulin, invert sugar, isomalt, lactitol, maltitol, maltose, mannitol, saccharin, calcium saccharin, sorbitol, hydrogenated starch hydrolysate, compressible sugar, powdered sugar, tagatose, trehalose, and xylitol. Examples of suitable sweetening agents include mannitol, sucralose, aspartame, dextrose, glycerin, sodium saccharin, sorbitol, and sucrose. The sweetening agent may include sucralose. The excipient granules may include, for example, 0.1 to 10 wt% of a sweetening agent, 0.1 wt% to 7 wt%, 0.1 wt% to 6 wt%, 1 wt% to 5 wt%, or 2 wt% to 4 wt% of a sweetening agent, such as sucralose, where wt% is based on the total weight of the excipient granules. The excipient granules provided by the present disclosure may include a filler or a combination of fillers. The filler may be a pharmaceutically acceptable filler. Examples of suitable fillers include microcrystalline cellulose, powdered cellulose, anhydrous lactose, lactose monohydrate, spray-dried lactose, mannitol, starch, pregelatinized starch, corn starch, maize starch, sorbitol, sucrose, compressible sugar, powdered sugar, sugar spheres, glucose binder, dextrin, dextrose, anhydrous calcium hydrogen phosphate, calcium carbonate, maltose, maltodextrin, kaolin, dibasic calcium phosphate dihydrate, tricalcium phosphate, calcium sulfate, cellulose acetate butyrate, calcium lactate, cellulose acetate, siliconized microcrystalline cellulose, cellulose acetate, corn syrup, pregelatinized starch and corn starch, corn syrup solids, erythritol, ethyl cellulose, ethyl acrylate and methyl methacrylate copolymer dispersion, fructose, isomaltose, α-lactalbumin, lactitol, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer, polydextrose, sodium chloride, polydimethylsiloxane, pregelatinized modified starch, pea starch, hydroxypropyl pea starch, pregelatinized hydroxypropyl pea starch, potato starch, hydroxypropyl potato starch, pregelatinized hydroxypropyl potato starch, tapioca starch, wheat starch, hydrogenated starch hydrolysate, polytriose, talc, amino methacrylate copolymer, trehalose, xylitol, and combinations of any of the foregoing. Examples of suitable fillers include Starch 1500, Starch 1500 (gelatinized), microcrystalline cellulose, calcium phosphate powder, dibasic calcium phosphate dihydrate, mannitol, or calcium phosphate powder, lactose, calcium carbonate, calcium sulfate, compressible sugar, glucose binder, dextrin, dextrose, kaolin, magnesium carbonate, magnesium oxide, maltodextrin, powdered cellulose, sucrose, and combinations of any of the foregoing. The filler may comprise microcrystalline cellulose, such as Avicel® PH-101 or Celphere® CP-305, purchased from Asahi-Kasei. The excipient granules provided by the present disclosure may comprise, for example, 1 wt% to 20 wt% of a filler (such as microcrystalline cellulose), 5 wt% to 15 wt%, or 7 wt% to 13 wt% of a filler (such as microcrystalline cellulose), where wt% is based on the total weight of the excipient granules. The excipient granules provided by the present disclosure may include, for example, a thickening agent, a disintegrant, and one or more additional excipients, wherein the one or more additional excipients may include a filler or a combination of fillers. The excipient granules may include, for example, 40 wt% to 98 wt% of a filler, 50 wt% to 90 wt%, or 60 wt% to 80 wt% of a filler, where wt% is based on the total weight of the excipient granules. The excipient granules may include, for example, less than 90 wt% of a filler, less than 80 wt%, less than 70 wt%, less than 60 wt%, less than 50 wt% of a filler, where wt% is based on the total weight of the excipient granules. The excipient granules may include, for example, more than 40 wt% of a filler, more than 50 wt%, more than 60 wt%, more than 70 wt%, more than 80 wt%, or more than 90 wt% of a filler, where wt% is based on the total weight of the excipient granules. The excipient granules provided by the present disclosure may include a pharmaceutically acceptable glidant or a combination of pharmaceutically acceptable glidants. Examples of suitable pharmaceutically acceptable glidants include magnesium stearate, magnesium silicate, calcium stearate, sodium lauryl sulfate, sodium stearyl fumarate, magnesium lauryl sulfate, stearic acid, calcium stearate, glyceryl behenate, behenyl polyethyleneglycol glyceride, diglyceryl behenate, lauric acid, glycerol monostearate, tristearin, myristic acid, palmitic acid, poloxamer, polyethylene glycol, polyethylene glycol 3350, polysorbate 20, polyethylene glycol 10 oleyl ether, polyethylene glycol 15 hydroxystearate, polysorbate 40, polyethylene glycol 20 cetostearyl ether, polyethylene glycol 40 stearate, polysorbate 60, polysorbate 80, potassium benzoate, sodium benzoate, sorbitan monolaurate, sorbitan monooleate, sodium stearate, sorbitan monopalmitate, sorbitan monostearate, zinc stearate, sorbitan sesquioleate, sorbitan trioleate, and talc. The excipient granules provided by the present disclosure may include a pharmaceutically acceptable lubricant or a combination of pharmaceutically acceptable lubricants. Examples of suitable pharmaceutically acceptable lubricants include colloidal silicon dioxide, talc, tricalcium phosphate, calcium silicate, powdered cellulose, magnesium oxide, sodium stearate, magnesium silicate, dental silicon dioxide, magnesium trisilicate, and hydrophobic colloidal silicon dioxide. The excipient granules provided by the present disclosure may include a pharmaceutically acceptable alkalizing agent or a combination of pharmaceutically acceptable alkalizing agents. Examples of suitable pharmaceutically acceptable alkalizing agents include ammonium carbonate, diethanolamine, monoethanolamine, potassium hydroxide, sodium bicarbonate, sodium borate, sodium carbonate, sodium hydroxide, and triethanolamine. The excipient granules provided by the present disclosure may include a pharmaceutically acceptable surfactant or a combination of pharmaceutically acceptable surfactants. Examples of suitable pharmaceutically acceptable surfactants include behenoyl polyglyceryl polyethyleneglycol, polysorbate 20, polysorbate 40, sodium docusate, polysorbate 60, polysorbate 80, benzalkonium chloride, capryloyl hexanoyl polyglyceryl polyethyleneglycol, cetylpyridinium chloride, lauroyl polyglyceryl polyethyleneglycol, linoleoyl polyglyceryl polyethyleneglycol, octoxynol 9, oleoyl polyglyceryl polyethyleneglycol, poloxamer, polyethyleneglycol 10 oleyl ether, polyethyleneglycol 15 hydroxystearate, nonoxynol 9, polyethyleneglycol 20 cetostearyl ether, polyethyleneglycol 40 stearate, polydextrose, polyethyleneglycol lauryl ether, polyethyleneglycol stearyl ether, sodium lauryl sulfate, sorbitan monolaurate, sorbitan monooleate, polyethyleneglycol stearate, sorbitan monopalmitate, sorbitan monostearate, stearoyl polyglyceryl polyethyleneglycol, sorbitan sesquioleate, sorbitan trioleate, and tyloxapol. The excipient granules provided by the present disclosure may include a pharmaceutically acceptable colorant or a combination of pharmaceutically acceptable colorants. Examples of suitable pharmaceutically acceptable colorants include caramel, iron oxide, titanium dioxide, iron oxide black, aluminum oxide, FD & C Red No. 40 / Allura Red AC, amaranth, FD & C Blue No. 1 / Brilliant Blue FCF, canthaxanthin, carmine, Acid Red (Azorubine), curcumin (turmeric), FD & C Red No. 3 / Erythrosine, Fast Green FCF, Green S (Lissamine Green), D & C Red No. 30 / Helendon Pink, FD & C Blue No. 2 / Indigo Carmine, iron oxide black, iron oxide red, D & C Red No. 7 / Lithol Rubin BK, Patent Blue V, D & C Red No. 28 / Phloxine B, iron oxide yellow, D & C Red No. 27 / Phloxine O, Ponceau 4R (Cochineal Red A), Quinoline Yellow WS, D & C Yellow No. 10, riboflavin (lactoflavin), FD & C Yellow No. 5 / tartrazine, and FD & C Yellow No. 6 / sunset yellow FCF. The excipient granules and excipient agglomerates provided by the present disclosure may include, for example, 2 wt% to 22 wt% of a binder; 10 wt% to 30 wt% of a diluent; 1 wt% to 20 wt% of a filler; 15 wt% to 35 wt% of a flavoring agent; 0.5 wt% to 6.5 wt% of a buffering agent; 0.5 wt% to 8 wt% of an acidifying agent; and / or 0.1 wt% to 6 wt% of a sweetening agent, where wt% is based on the total weight of the excipient granules or excipient agglomerates. The excipient granules and excipient agglomerates provided by the present disclosure may include, for example, 1 wt% to 35 wt% of a thickening agent; and 1 wt% to 25 wt% of a disintegrant; where wt% is based on the total weight of the excipient granules or excipient agglomerates. The excipient granules and excipient agglomerates provided by the present disclosure may include, for example, 5 wt% to 15 wt% of a binder; 17 wt% to 27 wt% of a diluent; 6 wt% to 16 wt% of a filler; 20 wt% to 30 wt% of a flavoring agent; 1 wt% to 5 wt% of a buffering agent; 2 wt% to 6 wt% of an acidifying agent; and / or 1 wt% to 5 wt% of a sweetening agent, where wt% is based on the total weight of the excipient granules or excipient agglomerates. The excipient granules and excipient agglomerates provided by the present disclosure may include, for example, 5 wt% to 15 wt% of a thickening agent; and 7 wt% to 17 wt% of a disintegrant; wt% is based on the total weight of the excipient granules or excipient agglomerates. The excipient granules and excipient agglomerates provided by the present disclosure may include, for example: the thickening agent includes xanthan gum; the disintegrant includes crospovidone; the binder includes polyvinylpyrrolidone; the diluent includes dicalcium phosphate; the filler includes microcrystalline cellulose; the flavoring agent includes a berry / punch flavoring agent; the buffering agent includes sodium citrate dihydrate; the acidifying agent includes anhydrous citric acid; and / or the sweetening agent includes sucralose, where wt% is based on the total weight of the excipient granules or excipient agglomerates. The average particle diameter of the excipient agglomerates provided by the present disclosure may be, for example, 100 µm to 600 µm, 200 µm to 600 µm, 100 µm to 550 µm, 100 µm to 500 µm, 200 µm to 500 µm, or 250 µm to 450 µm, where the average particle diameter is measured by sieve analysis or by laser diffraction. The excipient agglomerates may have a particle size distribution characterized, for example, by: 8.5 wt% greater than 35 mesh (500 µm), 39 wt% between 35 - 60 mesh (500 - 250 µm), 52.2% is pan, less than 35 mesh (500 µm) 52.2 wt%; and the particle size is measured by sieve analysis or laser diffraction. The average bulk density of the excipient agglomerates (35 - 60 mesh portion) may be, for example, 0.5 g / mL to 0.9 g / mL, where the bulk density is measured using a bulk density cylinder. The bulk density of the excipient agglomerates provided by the present disclosure may be, for example, 0.5 g / mL to 0.7 g / mL, 0.6 g / mL to 0.9 g / mL, 0.65 g / L to 0.85 g / mL, or 0.7 g / mL to 0.8 g / mL, where the bulk density is measured according to USP <616> Method 1. The average tapped density of the excipient granule provided by the present disclosure can be, for example, 500 g / mL to 900 g / mL, 550 g / L to 850 g / mL, 600 g / mL to 800 g / mL, or 650 g / mL to 750 g / m, wherein the average tapped density is determined according to USP <616>. The Hausner ratio of the excipient granule provided by the present disclosure can be, for example, 1.0 to 1.5, 1.1 to 1.4, 1.1 to 1.35, or 1.1 to 1.25, wherein the average Hausner ratio is determined according to USP <1174>. The compression index of the excipient granule provided by the present disclosure can be, for example, 8 to 22, 10 to 20, or 12 to 18. The Flodex value of the excipient granule provided by the present disclosure can be, for example, less than 5 mm, less than 4 mm, less than 3 mm, or less than 2 mm, wherein the Flodex value is determined according to USP <1174>. The friability of the excipient granule provided by the present disclosure can be, for example, less than 2 or less than 1, wherein the friability is measured using a sonic sieve shaker. The loss on drying of the excipient granule provided by the present disclosure can be, for example, 1 wt% to 4 wt%, such as 1.5 wt% to 3.5 wt% or 2 wt% to 3 wt%, wherein the loss on drying is determined by thermogravimetric analysis. The excipient granule mixed with water at a concentration of 0.01 g / mL to 0.04 g / mL can provide a solution with a viscosity greater than 20 cP, greater than 30 cP, greater than 40 cP, greater than 50 cP, greater than 60 cP, greater than 70 cP, greater than 80 cP, greater than 90 cP, or greater than 100 cP in less than 2 minutes under stirring, agitation, and / or shaking at a temperature of 20°C to 25°C. For example, the excipient granule mixed with water at a concentration of 0.01 g / mL to 0.04 g / mL can provide a solution with a viscosity of 40 cP to 80 cP in less than 30 seconds, in less than 60 seconds, in less than 90 seconds, or in less than 120 seconds under stirring, agitation, and / or shaking at a temperature of 20°C to 25°C (such as 23°C). The viscosity can be measured using a Brookfield digital viscometer model LVDV-I+ equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm. The excipient granules provided by the present disclosure may be designed to provide a viscous solution within 90 seconds when combined and mixed with an aqueous solution at a temperature of 20°C to 25°C (such as 23°C). At a temperature of 20°C to 25°C (such as 23°C), the maximum viscosity of the aqueous solution may be, for example, 10 cP to 200 cP, 25 cP to 150 cP, 50 cP to 100 cP, 40 cP to 80 cP, or 50 cP to 70 cP. The excipient granulate provided by the present disclosure may completely dissolve, for example, within less than 120 seconds, within less than 90 seconds, within less than 60 seconds, or less than 30 seconds when mixed with an aqueous solution at a temperature of 20°C to 25°C (such as 23°C), where complete dissolution is defined as the time from the start of the combination of the excipient granulate and the aqueous solution until the viscosity of the viscous solution is greater than 90% of the maximum viscosity. A solution prepared by combining 1 wt% to 5 wt% of the excipient granulate with 95 wt% to 99 wt% of water at a temperature of 20°C to 25°C may reach its maximum viscosity within, for example, 15 seconds to 120 seconds (such as 15 seconds to 60 seconds) after mixing, where wt% is based on the total weight of the excipient granulate and water. For example, mixing can be accomplished by stirring, agitating, and / or vortexing the excipient granulate in water or a non-viscous aqueous solution. A solution prepared by combining 1 wt% to 5 wt% of the excipient granulate with 95 wt% to 99 wt% of water at a temperature of 20°C to 25°C (such as 23°C) may provide a solution having a viscosity of, for example, 25 cp to 200 cp. The excipient granulate provided by the present disclosure may completely dissolve within less than 60 seconds or within less than 30 seconds when reconstituted as a 1 w / v% solution in water at a temperature of 20°C to 25°C (such as 23°C). The excipient granulate provided by the present disclosure may provide a solution having a pH value of, for example, 4.0 to 8.0, such as 4.0 to 7.0 or 4.0 to 5.0 when reconstituted as a 1 w / v% solution in water at a temperature of 20°C to 25°C (such as 23°C). When 1.2 g of the excipient granulate provided by the present disclosure is reconstituted in 40 mL of water at a temperature of 20°C to 25°C (such as 23°C), the resulting solution exhibits a viscosity-time curve as shown in Figure 2. When 1.2 g of the excipient granulate provided by the present disclosure is reconstituted in 40 mL of water at a temperature of 20°C to 25°C (such as 23°C), the resulting solution exhibits a luminescence-time curve as shown in Figure 3. The excipient granulate may be configured to provide a viscosity of 20 cP to 100 cP when 1.2 gm of the excipient granulate is combined with 40 mL of water at a temperature of 20°C to 25°C. After mixing 1.2 g of the excipient granulate provided by the present disclosure with a solution of 40 mL of water at a temperature of 20°C to 25°C (such as 23°C) for 90 seconds, the viscosity of the solution can be in the range of 45 cP to 80 cP. After mixing 1.2 g of the excipient granulate provided by the present disclosure with a solution of 40 mL of water at a temperature of 20°C to 25°C (such as 23°C) for 60 seconds, the viscosity of the solution can be in the range of 35 cP to 60 cP. After mixing 1.2 g of the excipient granulate provided by the present disclosure with a solution of 40 mL of water at a temperature of 20°C to 25°C (such as 23°C) for 30 seconds, the viscosity of the solution can be in the range of 15 cP to 40 cP. The excipient granulate provided by the present disclosure can provide a composition with a recombinant pH value of 4 to 6. The composition provided by the present disclosure can include the excipient granulate provided by the present disclosure and one or more additional components. For example, the composition can include the excipient granulate and an antistatic agent in powder form to minimize the aggregation of excipient particles during storage and / or to promote the dispersion of excipient particles when combined with a solution. The composition provided by the present disclosure can include a pharmaceutical composition. The pharmaceutical composition provided by the present disclosure can include the excipient granulate provided by the present disclosure and an active pharmaceutical ingredient. The pharmaceutical composition can include an active pharmaceutical ingredient or a combination of active pharmaceutical ingredients. The active pharmaceutical ingredient can include any suitable active pharmaceutical ingredient, such as any active pharmaceutical ingredient that can be administered orally. The active pharmaceutical ingredient can be absorbed from the gastrointestinal tract into the systemic circulation. The active pharmaceutical ingredient includes, for example, an active pharmaceutical ingredient in free base form, a pharmaceutically acceptable salt of the active pharmaceutical ingredient, a prodrug of the active pharmaceutical ingredient, a hydrate of the active pharmaceutical ingredient, or a combination of any of the foregoing. The active pharmaceutical ingredient can be provided, for example, in the form of a solution, suspension, powder, granulate, or tablet. The active pharmaceutical ingredient can be combined with one or more pharmaceutically acceptable excipients. The active pharmaceutical ingredient can be dissolved in an aqueous solution at a temperature of 20°C to 25°C, or can be in the form of microparticles, granules, or powder, where these particles are insoluble or slightly soluble in the aqueous solution. The active pharmaceutical ingredient in dry powder form can include particles with an average size of less than 50 µm, less than 10 µm, or less than 1 µm. The granulate containing the active pharmaceutical ingredient is called a pharmaceutical granulate. The pharmaceutical composition provided by the present disclosure may include an excipient granulate and a pharmaceutical granulate. The physical properties of the excipient granulate can be selected to minimize or prevent sedimentation or separation of the pharmaceutical composition comprising the excipient granulate and the pharmaceutical granulate. To facilitate the ability of the pharmaceutical granulate to be homogeneously dispersed in the viscous solution prepared using the excipient granulate, it may be required that the pharmaceutical composition comprising the excipient granulate and the pharmaceutical granulate be homogeneously dispersed and remain homogeneously dispersed during storage and transportation. By making the physical properties of the excipient granulate and the pharmaceutical granulate similar, homogeneous dispersion of the excipient granulate and the pharmaceutical granulate in the pharmaceutical composition can be promoted. For example, certain physical properties of the excipient granulate and the pharmaceutical granulate, such as average particle size, bulk density, tapped density, Hausner ratio, compression index, Flodex value, and / or friability value, may be required to be similar. For example, it may be required that the value of the physical property of the excipient granulate be within ±20%, within ±15%, within ±10%, within ±5%, or less than ±2% of the value of the corresponding property of the pharmaceutical granulate. For a pharmaceutical granulate comprising more than one granulate population, such as an immediate-release pharmaceutical granulate and a modified-release pharmaceutical granulate, it may be required that the value of the physical property of the excipient granulate be within ±20%, within ±15%, within ±10%, within ±5%, or less than ±2% of the value of the corresponding property of each of the immediate-release pharmaceutical granulate and the modified-release granulate. In the pharmaceutical composition provided by the present disclosure, the average particle size of the excipient granulate provided by the present disclosure can be, for example, within ±20% of the average particle size of the pharmaceutical granulate combined with the excipient granulate, within ±15%, within ±10%, or within ±5% of the average particle size of the pharmaceutical granulate combined with the excipient granulate. In the pharmaceutical composition provided by the present disclosure, the average bulk density of the excipient granulate provided by the present disclosure can be, for example, within ±20% of the average bulk density of the pharmaceutical granulate combined with the excipient granulate, within ±15%, within ±10%, within ±5%, or less than ±2% of the average bulk density of the pharmaceutical granulate combined with the excipient granulate. In the pharmaceutical composition provided by the present disclosure, the average tapped density of the excipient granulate provided by the present disclosure can be, for example, within ±20% of the average tapped density of the pharmaceutical granulate combined with the excipient granulate, within ±15%, within ±10%, within ±5%, or less than ±2% of the average tapped density of the pharmaceutical granulate combined with the excipient granulate. In the pharmaceutical composition provided by the present disclosure, the Hausner ratio of the excipient granulate provided by the present disclosure can be, for example, within ±20% of the average Hausner ratio of the pharmaceutical granulate in combination with the excipient granulate, within ±15%, within ±10%, within ±5%, or less than ±2% of the Hausner ratio of the medicated granulate in combination with the excipient granulate. In the pharmaceutical composition provided by the present disclosure, the compression index of the excipient granulate provided by the present disclosure can be, for example, within ±20% of the compression index of the pharmaceutical granulate in combination with the excipient granulate, within ±15%, within ±10%, within ±5%, or less than ±2% of the compression index of the pharmaceutical granulate in combination with the excipient granulate. In the pharmaceutical composition provided by the present disclosure, the Flodex value of the excipient granulate provided by the present disclosure can be, for example, within ±20% of the Flodex value of the pharmaceutical granulate in combination with the excipient granulate, within ±15%, within ±10%, within ±5%, or less than ±2% of the Flodex value of the pharmaceutical granulate in combination with the excipient granulate. In the pharmaceutical composition provided by the present disclosure, the friability of the excipient granulate provided by the present disclosure can be, for example, within ±20% of the friability of the pharmaceutical granulate in combination with the excipient granulate, within ±15%, within ±10%, or within ±5%, or less than ±2% of the friability of the pharmaceutical granulate in combination with the excipient granulate. The pharmaceutical granulate provided by the present disclosure may comprise a plurality of pharmaceutical granules. The pharmaceutical granules may comprise an active pharmaceutical ingredient and one or more pharmaceutically acceptable excipients. The pharmaceutical granulate may comprise any suitable pharmaceutical active ingredient suitable for oral administration and absorbable from the gastrointestinal tract into the systemic circulation. The pharmaceutical granulate may comprise one or more pharmaceutically acceptable excipients. The one or more pharmaceutically acceptable excipients may comprise any suitable pharmaceutically acceptable excipients. Examples of suitable pharmaceutically acceptable excipients include, for example, binders, fillers, dispersants, pH regulators, and the like. The pharmaceutical granulate may comprise, for example, more than 10 wt% of the active pharmaceutical ingredient, more than 20 wt%, more than 30 wt%, more than 40 wt%, more than 50 wt%, more than 60 wt%, more than 70 wt%, more than 80 wt%, or more than 90 wt% of the active pharmaceutical ingredient, where wt% is based on the total weight of the pharmaceutical granulate. The pharmaceutical granulate may contain, for example, 1 wt% to 99 wt% of an active pharmaceutical ingredient, 20 wt% to 99 wt%, 50 wt% to 99 wt%, 70 wt% to 99 wt%, 70 wt% to 95 wt%, or 70 wt% to 90 wt% of an active pharmaceutical ingredient, where wt% is based on the total weight of the pharmaceutical granulate. The pharmaceutical granulate may contain a pharmaceutically acceptable excipient or a combination of pharmaceutically acceptable excipients. The pharmaceutical granulate may contain, for example, less than 10 wt% of one or more pharmaceutically acceptable excipients, less than 20 wt%, less than 30 wt%, less than 40 wt%, less than 50 wt%, or less than 60 wt% of one or more pharmaceutically acceptable excipients, where wt% is based on the total weight of the pharmaceutical granulate. The granulate containing the drug may contain the same or different excipients or combinations of excipients as those used in the excipient granulate. The average particle size of the pharmaceutical granulate provided by the present disclosure may be, for example, 100 µm to 600 µm, 200 µm to 600 µm, 150 µm to 550 µm, 200 µm to 500 µm, or 250 µm to 450 µm, where the average particle size is determined by sieve analysis or laser diffraction. The pharmaceutical granulate contains a plurality of pharmaceutical granules containing an active pharmaceutical ingredient, where the average size of the pharmaceutical granules is, for example, greater than 50 µm, greater than 100 µm, greater than 200 µm, greater than 400 µm, or greater than 600 µm, where the particle size is determined by sieve analysis or by laser diffraction. The average particle size of the pharmaceutical granulate may be, for example, less than 600 µm, less than 500 µm, less than 400 µm, less than 300 µm, or less than 200 µm, where the particle size is determined by sieve analysis or by laser diffraction. The pharmaceutical granulate may contain a plurality of pharmaceutical granules having similar components and properties. For example, the pharmaceutical granulate may contain immediate-release granules or may contain modified-release granules. The pharmaceutical granulate may contain one or more pharmaceutical granulate populations. Each of the two or more pharmaceutical granulate populations may have different compositions and / or properties, such as average particle size, active pharmaceutical ingredient, release profile, and / or excipient composition. Each of the two or more pharmaceutical granulates may have a different release profile in the gastrointestinal tract. The average particle diameter of the pharmaceutical granule provided by the present disclosure can be, for example, 100 µm to 600 µm, 200 µm to 600 µm, 150 µm to 550 µm, 200 µm to 500 µm, or 250 µm to 450 µm, wherein the average particle diameter is measured by sieve analysis or laser diffraction. The average bulk density of the pharmaceutical granule provided by the present disclosure can be, for example, 500 g / mL to 700 g / mL. The average tapped density of the pharmaceutical granule provided by the present disclosure can be, for example, 600 g / mL to 800 g / mL. The average Hausner ratio of the pharmaceutical granule provided by the present disclosure can be, for example, 1.1 to 1.25. The friability of the pharmaceutical granule provided by the present disclosure can be, for example, less than 0.2, such as about 0.1, wherein the friability is measured using an ion sieve analyzer. The pharmaceutical granule can comprise an immediate-release pharmaceutical granule, a modified-release pharmaceutical granule, or a combination thereof. The pharmaceutical composition can comprise one or more immediate-release pharmaceutical granules and / or one or more modified-release pharmaceutical granules. The pharmaceutical granule can comprise an immediate-release pharmaceutical granule, a modified-release pharmaceutical granule, or a combination thereof. The pharmaceutical granule can comprise an immediate-release pharmaceutical granule and a modified-release pharmaceutical granule. The immediate-release pharmaceutical granule comprises a plurality of immediate-release particles. The immediate-release particle refers to a particle that completely disintegrates and / or dissolves within less than 90 seconds when mixed with an aqueous solution at 25°C. The modified-release pharmaceutical granule comprises a plurality of modified-release particles. In a pharmaceutical composition comprising an excipient granule and a pharmaceutical granule, it may be necessary for the physical properties of the excipient granule and the pharmaceutical granule to be similar. Having similar physical properties can minimize the sedimentation of the granule and / or maintain the integrity of the granule during transportation and storage. The relevant physical properties include, for example, average particle diameter, bulk density, tapped density, Hausner ratio, compression index, Flodex value, and friability. The average particle diameter of the pharmaceutical granule can be, for example, within ±20% of the average particle diameter of the excipient granule combined with the pharmaceutical granule, within ±15% of the average particle diameter of the excipient granule combined with the pharmaceutical granule, within ±10% of the average particle diameter of the excipient granule combined with the pharmaceutical granule, or within ±5% of the average particle diameter of the excipient granule combined with the pharmaceutical granule, wherein the average particle diameter is measured by sieve analysis or laser diffraction. The average bulk density of the pharmaceutical granulates provided by the present disclosure can be, for example, within ±20% of the average bulk density of the excipient granulates combined with the pharmaceutical granulates, within ±15%, ±10%, or ±5% of the average bulk density of the excipient granulates combined with the pharmaceutical granulates, wherein the average particle bulk density is measured using a bulk density cylinder. The average bulk density of the pharmaceutical granulates provided by the present disclosure can be, for example, 0.6 g / mL to 0.9 g / mL, 0.65 g / mL to 0.85 g / mL, or 0.7 g / mL to 0.8 g / mL, wherein the average particle bulk density is measured using a bulk density cylinder. The average tapped density of the pharmaceutical granulates provided by the present disclosure can be, for example, within ±20% of the average tapped density of the excipient granulates combined with the pharmaceutical granulates, within ±15%, ±10%, or ±5% of the average tapped density of the excipient granulates combined with the pharmaceutical granulates, wherein the average particle tapped density is determined according to USP <616>. The average tapped density of the pharmaceutical granulates provided by the present disclosure can be, for example, 500 g / mL to 900 g / mL, 550 g / L to 850 g / mL, 600 g / mL to 800 g / mL, or 650 g / mL to 750 g / mL, wherein the average particle tapped density is determined according to USP <616>. The Hausner ratio of the pharmaceutical granulates provided by the present disclosure can be, for example, within ±20% of the average Hausner ratio of the excipient granulates combined with the pharmaceutical granulates, within ±15%, ±10%, or ±5% of the Hausner ratio of the excipient combined with the pharmaceutical granulates, wherein the Hausner ratio is determined according to USP <1174>. The Hausner ratio of the pharmaceutical granulates provided by the present disclosure can be, for example, 1.0 to 1.5, 1.1 to 1.4, 1.1 to 1.35, or 1.1 to 1.25, wherein the Hausner ratio is determined according to USP <1174>. The compression index of the pharmaceutical granulates provided by the present disclosure can be, for example, within ±20% of the compression index of the excipient granulates combined with the pharmaceutical granulates, within ±15%, ±10%, or ±5% of the compression index of the excipient granulates combined with the pharmaceutical granulates. The compression index of the pharmaceutical granulates provided by the present disclosure can be, for example, 8 to 22, 10 to 20, or 12 to 18. The Flodex value of the pharmaceutical granulate provided by the present disclosure can be, for example, within ±20% of the Flodex value of the excipient granulate in combination with the pharmaceutical granulate, within ±15%, ±10%, or ±5% of the Flodex value of the excipient granulate in combination with the pharmaceutical granulate, wherein the Flodex value is determined according to USP <1174>. The Flodex value of the pharmaceutical granulate provided by the present disclosure can be, for example, less than 5 mm, less than 4 mm, less than 3 mm, or less than 2 mm, wherein the Flodex value is determined according to USP <1174>. The friability value of the pharmaceutical granulate provided by the present disclosure can be, for example, less than 0.2, such as about 0.1, wherein the friability is measured using an ion sieve analyzer. The pharmaceutical composition provided by the present disclosure can comprise an excipient granulate, one or more pharmaceutical granulates, and optionally one or more additional excipients. The pharmaceutical composition provided by the present disclosure can comprise, for example, 1 wt% to 15 wt% of the excipient granulate, 3 wt% to 12 wt%, 5 wt% to 10 wt%, or 6 wt% to 9 wt% of the excipient granulate, wherein wt% is calculated based on the total weight of the excipient granulate and the pharmaceutical granulate, or wherein wt% is calculated based on the total weight of the pharmaceutical composition. The pharmaceutical composition provided by the present disclosure can comprise, for example, 85 wt% to 99 wt% of the pharmaceutical granulate, 87 wt% to 97 wt%, or 89 wt% to 95 wt% of the pharmaceutical granulate, wherein wt% is calculated based on the total weight of the excipient granulate and the pharmaceutical granulate, or wherein wt% is calculated based on the total weight of the pharmaceutical composition. The pharmaceutical composition provided by the present disclosure can comprise, for example, 1 wt% to 15 wt% of the excipient granulate provided by the present disclosure; and 85 wt% to 99 wt% of the pharmaceutical granulate, wherein wt% is calculated based on the total weight of the excipient granulate and the pharmaceutical granulate, or wherein wt% is calculated based on the total weight of the pharmaceutical composition. The pharmaceutical composition provided by the present disclosure can comprise, for example, 5 wt% to 10 wt% of the excipient granulate provided by the present disclosure; and 90 wt% to 95 wt% of the pharmaceutical granulate, wherein wt% is calculated based on the total weight of the excipient granulate and the pharmaceutical granulate, or wt% is calculated based on the total weight of the pharmaceutical composition. The pharmaceutical composition can further comprise one or more excipients, and the one or more excipients can be, for example, in powder form and are unrelated to the excipient granulate. The one or more additional excipients can promote the dispersion of the excipient granulate and the pharmaceutical granulate and / or minimize or prevent the aggregation of the excipient granulate and the pharmaceutical granulate. The one or more additional excipients may include, for example, antistatic agents. Examples of suitable antistatic agents include talc (magnesium hydrosilicate), magnesium stearate, and silica. The pharmaceutical composition may include magnesium hydrosilicate (talc). The pharmaceutical composition may include, for example, 0.1 wt% to 1.0 wt%, 0.2 wt% to 0.9 wt%, 0.3 wt% to 0.8 wt%, or 0.4 wt% to 0.7 wt% of an antistatic agent such as magnesium hydrosilicate, where wt% is based on the total weight of the pharmaceutical composition. The oral pharmaceutical composition provided by the present disclosure may include a viscous aqueous solution and an active pharmaceutical ingredient. The oral pharmaceutical composition may be formed by combining the excipient granulate provided by the present disclosure and the active pharmaceutical ingredient with an aqueous solution (such as water). The active pharmaceutical ingredient may be dissolved in the viscous aqueous solution, may be a solid such as in the form of pharmaceutical granulates, or may be a combination thereof. The oral pharmaceutical composition provided by the present disclosure may include a pharmaceutical composition for oral ingestion, which is prepared by mixing the pharmaceutical composition provided by the present disclosure with water or an aqueous solution to provide a viscous solution that includes the active pharmaceutical ingredient dissolved in the viscous solution and / or includes pharmaceutical granulates containing the active pharmaceutical ingredient dispersed and suspended in the viscous solution. The viscous solution includes the components of the excipient granulate dissolved in water or an aqueous solution. The product provided by the present disclosure may include the excipient granulate provided by the present disclosure contained in a package. The package may be any suitable package, such as a container, sachet, vial, bottle, capsule, pouch, stick packaging, blister packaging, etc. The pharmaceutical product provided by the present disclosure may include the excipient granulate provided by the present disclosure and the active pharmaceutical ingredient contained in a primary package. The package may include any package suitable for use with pharmaceutical granulates. Examples of suitable primary packages include blister packaging, sachets, capsules, ampoules, pouches, stick packaging, vials, etc. In the pharmaceutical product, the active pharmaceutical ingredient may be in the form of a liquid, powder, granulate, or other solid dosage form. In the pharmaceutical product, the active pharmaceutical ingredient may be in the form of the pharmaceutical granulate provided by the present disclosure. In the pharmaceutical product, the active pharmaceutical ingredient may be in the form of the pharmaceutical granulate provided by the present disclosure, where the pharmaceutical granulate includes immediate-release pharmaceutical granulates and modified-release pharmaceutical granulates. In the pharmaceutical product, the excipient granulate and the pharmaceutical granulate may be contained in the same primary package. In pharmaceutical products, excipient granules and pharmaceutical granules can be accommodated in separate primary packages. In a pharmaceutical product comprising an immediate-release pharmaceutical granule and a modified-release pharmaceutical granule, the immediate-release pharmaceutical granule and the modified-release pharmaceutical granule can be accommodated in separate primary packages or in the same primary package. In a pharmaceutical product, the package can accommodate a unit dose of an active pharmaceutical ingredient or less than a unit dose of an active pharmaceutical ingredient. In a pharmaceutical product comprising a package (such as a sachet) containing less than a unit dose of an active pharmaceutical ingredient, the pharmaceutical product can contain two or more packages containing the active pharmaceutical ingredient such that the total amount of the active pharmaceutical ingredient in the two or more packages constitutes a unit dose of the active pharmaceutical ingredient. A pharmaceutical product can comprise one or more compartments accommodating excipient granules and pharmaceutical granules. The excipient granules and the pharmaceutical granules can be accommodated in the same compartment of the package. Each of the excipient granules and the pharmaceutical granules can be accommodated in separate, independent compartments of a common package. For example, the package can comprise a first compartment accommodating the excipient granules and a second compartment accommodating the pharmaceutical granules. A pharmaceutical product can comprise a compartment accommodating excipient granules and a second compartment accommodating pharmaceutical granules, wherein the compartments are configured to mix before or during combination with an aqueous solution. The pharmaceutical product provided by the present disclosure can include a first package containing the excipient granules provided by the present disclosure and a second package containing pharmaceutical granules. A pharmaceutical product can comprise a sachet accommodating both the excipient granules and the pharmaceutical granules provided by the present disclosure. A pharmaceutical product can comprise a combination of the excipient granules and the pharmaceutical granules provided by the present disclosure, for example, from 0.5 g to 20 g. The pharmaceutical product provided by the present disclosure can comprise a unit dose of an active pharmaceutical ingredient. The unit dose of the active pharmaceutical ingredient can be provided in one or more packages, such as in one or more sachets or one or more stick packages. The pharmaceutical product provided by the present disclosure can comprise more than a unit dose of an active pharmaceutical ingredient. Each of the one or more unit doses can be provided in separate packages, such as separate sachets or stick packages. The oral pharmaceutical composition provided by the present disclosure can comprise a viscous aqueous solution. The oral pharmaceutical composition is intended for oral administration. The viscous aqueous solution can be prepared by combining and mixing the excipient granules provided by the present disclosure with an aqueous solution. When the excipient granulate is mixed with water, the content of the excipient granulate provides, for example, 0.005 g / mL to 0.08 g / mL, 0.005 g / mL to 0.060 g / mL excipient granules, a concentration of the excipient granulate of 0.010 g / mL to 0.055 g / mL, 0.015 g / mL to 0.050 g / mL, 0.015 g / mL to 0.045 g / mL, 0.02 g / mL to 0.04 g / mL, or 0.025 g / mL to 0.035 g / mL, where g / mL is based on the number of grams of the excipient granulate mixed with that volume of water. For example, an oral pharmaceutical composition can be prepared, for example, by mixing 0.2 g to 2.2 g of excipient granules in 40 mL of water, mixing 0.4 g to 2.0 g, 0.6 g to 1.8 g, 0.8 g to 1.6 g, 1.0 g to 1.4 g of excipient granules in 40 mL of water. The oral pharmaceutical composition provided by the present disclosure can be prepared by combining an excipient granulate and a pharmaceutical granulate with water. The excipient granulate and the pharmaceutical granulate can be combined with water simultaneously or sequentially. For example, the excipient granulate can first be combined with water to form a viscous solution, and then the pharmaceutical granulate can be combined with and mixed into the viscous solution. Alternatively, the pharmaceutical granulate can first be combined with water, and then the excipient granulate can be added to the aqueous solution. The oral pharmaceutical composition can include a viscous solution and an active pharmaceutical ingredient dissolved in the viscous solution and / or a pharmaceutical granulate containing the active pharmaceutical ingredient suspended in the viscous solution. The oral pharmaceutical composition can include an immediate-release component and a modified-release component. The immediate-release component can include an active pharmaceutical ingredient dissolved in a viscous aqueous solution, an immediate-release pharmaceutical granulate, or a combination thereof. The modified-release component can include a modified-release pharmaceutical granulate. The immediate-release component and the modified-release component can include the same active pharmaceutical ingredient. The immediate-release component and the modified-release component can include different active pharmaceutical ingredients. The viscosity of the oral pharmaceutical composition at a temperature of 20°C to 25°C (such as 23°C) can be, for example, 10 cP to 1,000 cP or 20 cP to 800 cP. The viscosity of the oral pharmaceutical composition at a temperature of 20°C to 25°C (such as 23°C) can be, for example, greater than 10 cP, greater than 20 cP, greater than 50 cP, greater than 100 cP, greater than 200 cP, greater than 400 cP, greater than 600 cP, or greater than 800 cP. The viscosity of the oral pharmaceutical composition at a temperature of 20°C to 25°C (such as 23°C) can be, for example, less than 1,000 cP, less than 800 cP, less than 600 cP, less than 400 cP, or less than 200 cP. The viscosity is measured using a Brookfield digital viscometer, model LVDV-I+, equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm. The oral pharmaceutical composition can be prepared by combining and mixing, for example, 10 g to 20 g of the pharmaceutical composition with 30 mL to 50 mL of water. The oral pharmaceutical composition can be prepared by combining and mixing, for example, 12 g to 18 g of the pharmaceutical composition with 35 mL to 45 mL of water. The pharmaceutical composition concentration of the oral composition can be, for example, 0.20 g / mL to 0.70 g / mL, such as 0.30 g / mL to 0.42 g / mL, or 0.32 g / mL to 0.40 g / mL. The pharmaceutical composition can include an excipient granulate and a pharmaceutical granulate, the pharmaceutical granulate including an immediate-release pharmaceutical granulate and a modified-release pharmaceutical granulate. When combined with a suitable amount of water, the excipient granulate can disintegrate to increase the viscosity of the solution, the immediate-release pharmaceutical granulate can dissolve to provide an active pharmaceutical ingredient dissolved in the viscous solution, and the modified-release pharmaceutical granulate can be suspended and dispersed in the viscous solution. The pharmaceutical granulate can be configured to maintain its integrity in the gastrointestinal tract and dissolve and / or release the drug over time, the release profile being determined by the components and coating of the modified-release pharmaceutical granules. The method provided by the present disclosure can include combining the excipient granulate provided by the present disclosure with water to provide a viscous solution. The method provided by the present disclosure can include: a user opening a package containing the excipient granulate provided by the present disclosure; pouring the excipient granulate into an aqueous solution; and mixing the excipient granules in the aqueous solution to provide a viscous solution. The method provided by the present disclosure may include: a user opening a package containing an excipient granulate and an active pharmaceutical ingredient provided by the present disclosure; pouring the excipient granulate and the active pharmaceutical ingredient into an aqueous solution; and mixing the excipient granulate and the pharmaceutical granulate in the aqueous solution to provide a viscous aqueous solution containing the active pharmaceutical ingredient. The active pharmaceutical ingredient may be dissolved in the viscous aqueous solution or may be included in a pharmaceutical granulate or other solid dosage form suspended in the viscous aqueous solution. When combined with a suitable amount of water, the pharmaceutical composition provided by the present disclosure is configured to provide a solution having a viscosity capable of suspending pharmaceutical granulates. The suspension may include pharmaceutical particles suspended in the viscous solution. The aqueous solution may include, for example, 25 mL to 250 mL, 25 mL to 200 mL, 25 mL to 150 mL, 25 mL to 100 mL, or 25 mL to 75 mL. The aqueous solution may be water. The pharmaceutical composition provided by the present disclosure may be included in a kit that can be used to administer a compound to a patient for therapeutic purposes. The kit may include a pharmaceutical composition suitable for administering to a patient and instructions for administering the pharmaceutical composition to the patient. The kit may contain the pharmaceutical composition provided by the present disclosure, instructions for combining the contents of the kit with an aqueous solution to provide an oral pharmaceutical composition, and instructions for administering the oral pharmaceutical composition to the patient. The kit may include a primary package and a secondary package containing the pharmaceutical composition. The pharmaceutical composition provided by the present disclosure may be included in a container, package, or dispenser together with administration instructions. The instructions provided by the kit may be printed and / or provided, for example, in the form of an electronically readable medium, a video cassette, an audio tape, a flash memory device, or may be posted on an Internet website or sent to the patient and / or healthcare provider in an electronic communication. The pharmaceutical composition provided by the present disclosure can be used to treat a disease in a patient. A method of treating a disease in a patient includes orally administering to a patient in need of such treatment an oral pharmaceutical composition prepared from the pharmaceutical composition provided by the present disclosure, wherein the disease can be treated by the active pharmaceutical ingredient; and wherein the pharmaceutical composition contains a therapeutically effective amount of the active pharmaceutical ingredient for treating the disease. The pharmaceutical composition may include pharmaceutical granulates. The excipient granulate provided by the present disclosure can be combined with an active pharmaceutical ingredient for use in manufacturing a medicament. The pharmaceutical composition provided by the present disclosure can be used to manufacture a medicament. The medicament may include, for example, an active pharmaceutical ingredient dissolved in a viscous solution and / or a pharmaceutical granulate suspended in the viscous solution. The excipient granulate and the active pharmaceutical ingredient combination provided by the present disclosure can be used to prepare an oral pharmaceutical composition. The pharmaceutical composition provided by the present disclosure can be used to prepare an oral pharmaceutical composition. The method provided by the present disclosure includes combining the excipient granulate provided by the present disclosure with an aqueous solution to increase the viscosity of the aqueous solution. The method provided by the present disclosure includes combining the excipient granulate provided by the present disclosure to improve the palatability of an oral pharmaceutical composition, such as an oral pharmaceutical composition containing a pharmaceutical granulate. The scope of the present invention The present invention is further defined by one or more of the following scopes. Scope 1. An excipient granulate, wherein the excipient granulate comprises a plurality of excipient particles, and the excipient particles comprise: a thickening agent; a disintegrant; and one or more additional excipients. Scope 2. The excipient granulate according to Scope 1, wherein the excipient particles comprise: 1 wt% to 35 wt% of the thickening agent; 1 wt% to 25 wt% of the disintegrant; and 40 wt% to 98 wt% of the one or more additional excipients; wherein wt% is based on the total weight of the excipient particles. Scope 3. The excipient granulate according to Scope 1, wherein the excipient particles comprise: 5 wt% to 15 wt% of the thickening agent; 5 wt% to 20 wt% of the disintegrant; and 65 wt% to 90 wt% of the one or more additional excipients; wherein wt% is based on the total weight of the excipient particles. Scope 4. The excipient granulate according to any one of Scopes 1 to 3, wherein the excipient particles have a homogeneous composition. Scope 5. The excipient granulate according to any one of Scopes 1 to 4, wherein the average particle diameter of the excipient particles is 100 µm to 600 µm, and the particle diameter is measured by sieve analysis or laser diffraction. Scope 6. The excipient granulate according to any one of Scopes 1 to 5, wherein the average bulk density of the excipient particles is 0.5 g / mL to 0.7 g / mL, and the bulk density is measured according to USP <616> Method 1. Scope 7. The excipient granulate according to any one of Scopes 1 to 6, wherein the thickening agent comprises xanthan gum. Scope 8. The excipient granulate according to Scope 7, wherein the average particle diameter of the xanthan gum is 25 µm to 100 µm, and the particle diameter is measured using sieve analysis or laser diffraction. Scope 9. The excipient granulate according to Scope 7, wherein the average particle diameter of the xanthan gum is less than 75 µm, and the particle diameter is measured using sieve analysis or laser diffraction. Category 10. An excipient granule as in any one of Categories 7 to 9, wherein the viscosity ratio of the three xanthan gums is 1.0 to 1.5. Category 11. An excipient granule as in any one of Categories 7 to 10, wherein the three xanthan gums provide a viscosity of 1,200 mPa×s to 1600 mPa×s (cP), and the viscosity is measured using a Brookfield digital viscometer of model LVDV-1+ equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 RPM. Category 12. An excipient granule as in any one of Categories 1 to 11, wherein the disintegrant comprises crospovidone. Category 13. The excipient granule as in Category 12, wherein the crospovidone has a pH value of 5 to 8 when in the form of a 1% solution in water at 25°C; a bulk density of 0.25 g / cm 3 to 0.45 g / cm 3 ; and / or an average particle diameter of 20 µm to 40 µm. Category 14. An excipient granule as in any one of Categories 1 to 13, wherein the one or more additional excipients comprise a diluent, a binder, a flavoring agent, a buffering agent, an acid, a sweetening agent, a filler, or a combination of any of the foregoing. Category 15. An excipient granule as in any one of Categories 1 to 14, wherein the one or more additional excipients comprise a binder. Category 16. The excipient granule as in Category 15, wherein the binder comprises polyvinylpyrrolidone. Category 17. The excipient granule as in Category 16, wherein the polyvinylpyrrolidone has a K value of 29 to 32; a number average molecular weight of 58,000 daltons; a viscosity of 2.5 cP when in the form of a 5% aqueous solution at 25°C; an average particle diameter of 80 µm; a bulk density of 0.36 g / cm 3 ; and / or a tapped density of 0.47 g / cm 3 . Category 18. An excipient granule as in any one of Categories 14 to 17, wherein the excipient granules comprise 5 wt% to 20 wt% of the binder; and wt% is based on the total weight of the excipient granules. Category 19. An excipient granule as in any one of Categories 1 to 18, wherein the one or more additional excipients comprise a diluent. Category 20. The excipient granule as in Category 19, wherein the diluent comprises dicalcium phosphate anhydrous. Category 21. An excipient granulate as in any one of Categories 19 to 20, wherein the excipient granules comprise 10 wt% to 30 wt% of the diluent; and wt% is based on the total weight of the excipient granules. Category 22. An excipient granulate as in any one of Categories 1 to 21, wherein the one or more additional excipients comprise a filler. Category 23. The excipient granulate as in Category 22, wherein the filler comprises microcrystalline cellulose. Category 24. An excipient granulate as in any one of Categories 22 to 23, wherein the excipient granules comprise 1 wt% to 20 wt% of the binder; and wt% is based on the total weight of the excipient granules. Category 25. An excipient granulate as in any one of Categories 1 to 24, wherein the one or more additional excipients comprise a flavoring agent. Category 26. The excipient granulate as in Category 25, wherein the flavoring agent comprises a citrus fruit flavoring, a berry flavoring, a punch flavoring, or a combination of any of the foregoing. Category 27. An excipient granulate as in any one of Categories 25 to 26, wherein the excipient granules comprise 15 wt% to 35 wt% of the flavoring agent; and wt% is based on the total weight of the excipient granules. Category 28. An excipient granulate as in any one of Categories 1 to 27, wherein the one or more additional excipients comprise a buffering agent. Category 29. The excipient granulate as in Category 28, wherein the buffering agent comprises sodium citrate anhydrous. Category 30. An excipient granulate as in any one of Categories 28 to 29, wherein the excipient granules comprise 0.5 wt% to 6.5 wt% of the buffering agent; and wt% is based on the total weight of the excipient granules. Category 31. An excipient granulate as in any one of Categories 1 to 30, wherein the one or more additional excipients comprise an acid. Category 32. The excipient granulate as in Category 31, wherein the acid comprises citric acid anhydrous. Category 33. An excipient granulate as in any one of Categories 31 to 32, wherein the excipient granules comprise 0.5 wt% to 8 wt% of the acid; and wt% is based on the total weight of the excipient granules. Category 34. An excipient granulate as in any one of Categories 1 to 33, wherein the one or more additional excipients comprise a sweetening agent. Category 35. The excipient granulate as in Category 34, wherein the sweetening agent comprises sucralose. Category 36. An excipient granulate as in any one of Categories 34 to 35, wherein the excipient granules contain 0.1 wt% to 6 wt% of the sweetening agent; and wt% is based on the total weight of the excipient granules. Category 37. An excipient granulate as in Category 14, wherein the excipient granules contain: 2 wt% to 22 wt% of the binder; 10 wt% to 30 wt% of the diluent; 1 wt% to 20 wt% of the filler; 15 wt% to 35 wt% of the flavoring agent; 0.5 wt% to 6.5 wt% of the buffering agent; 0.5 wt% to 8 wt% of the acid; and / or 0.1 wt% to 6 wt% of the sweetening agent, where wt% is based on the total weight of the excipient granules. Category 38. An excipient granulate as in Category 37, wherein the excipient granules contain: 1 wt% to 35 wt% of the thickening agent; and 1 wt% to 25 wt% of the disintegrant; where wt% is based on the total weight of the excipient granules. Category 39. An excipient granulate as in Category 14, wherein the excipient granules contain: 5 wt% to 15 wt% of the binder; 17 wt% to 27 wt% of the diluent; 6 wt% to 16 wt% of the filler; 20 wt% to 30 wt% of the flavoring agent; 1 wt% to 5 wt% of the buffering agent; 2 wt% to 6 wt% of the acid; and / or 1 wt% to 5 wt% of the sweetening agent, where wt% is based on the total weight of the excipient granules. Category 40. An excipient granulate as in Category 39, wherein the excipient granules contain: 5 wt% to 15 wt% of the thickening agent; and 7 wt% to 17 wt% of the disintegrant; wt% is based on the total weight of the excipient granules. Category 41. An excipient granulate as in any one of Categories 14 to 40, wherein the thickening agent contains xanthan gum; the disintegrant contains crospovidone; the binder contains polyvinylpyrrolidone; the diluent contains dicalcium phosphate; the filler contains microcrystalline cellulose; the flavoring agent contains a berry / punch flavoring agent; the buffering agent contains sodium citrate dihydrate; the acid contains anhydrous citric acid; and the sweetening agent contains sucralose, where wt% is based on the total weight of the excipient granules. Category 42. An excipient granulate as in any one of Categories 1 to 41, wherein the average particle diameter of the excipient granules is 200 µm to 500 µm; and the particle diameter is determined by sieve analysis or laser diffraction. Category 43. An excipient granulate as in any one of Categories 1 to 39, wherein the average particle diameter of the excipient granules is 250 µm to 400 µm; and the particle diameter is determined by sieve analysis or laser diffraction. Category 44. An excipient granulate as in any one of Categories 1 to 39, wherein the excipient granules have a particle size distribution characterized by: 8.5 wt% greater than 35 mesh (500 µm), 39 wt% between 35 - 60 mesh (500 - 250 µm), 52.2% passing through, less than 35 mesh (500 µm) 52.2 wt%; and the particle diameter is determined by sieve analysis or laser diffraction. Category 45. An excipient granulate as in any one of Categories 1 to 44, wherein the average bulk density of the excipient granulate (35 - 60 mesh portion) is 0.5 g / mL to 0.9 g / mL; and the bulk density is determined using a bulk density cylinder. Category 46. An excipient granulate as in any one of Categories 1 to 44, wherein the average bulk density of the excipient granulate is 0.6 g / mL to 0.7 g / mL (35 - 60 mesh portion); and the bulk density is determined using a bulk density cylinder. Category 47. An excipient granulate as in any one of Categories 1 to 46, wherein the excipient granulate completely dissolves in less than 60 seconds when reconstituted in water at 25°C. Category 48. An excipient granulate as in any one of Categories 1 to 47, wherein the excipient granulate completely dissolves in less than 30 seconds when reconstituted in water at 25°C. Category 49. An excipient granulate as in any one of Categories 1 to 47, wherein the excipient granulate completely dissolves in less than 60 seconds when reconstituted as a 1 w / v% solution in water at 25°C. Category 50. An excipient granulate as in any one of Categories 1 to 47, wherein the excipient granulate completely dissolves in less than 30 seconds when reconstituted as a 1 w / v% solution in water at 25°C. Category 51. An excipient granulate as in any one of Categories 1 to 50, wherein the average Hausner ratio of the excipient granulate is 1.1 to 1.25, wherein the Hausner ratio is determined according to USP <1174>. Category 52. An excipient granulate as in any one of Categories 1 to 51, wherein the average compression index of the excipient granulate is 12 to 18. Category 53. An excipient granulate as in any one of Categories 1 to 52, wherein the average Flodex value of the excipient granulate is less than 5 mm. Category 54. An excipient granulate as in any one of Categories 1 to 53, wherein the average friability of the excipient granulate is less than 2 wt%; and the friability is measured using an ultrasonic sieve shaker. Category 55. An excipient granulate as in any one of Categories 1 to 54, wherein the excipient granulate provides a pH value of 4.0 to 8.0 when reconstituted as a 1 w / v% aqueous solution. Category 56. An excipient granulate as in any one of Categories 1 to 55, wherein when 1.2 g of the excipient granulate is reconstituted in 40 mL of water at 23°C, the resulting solution exhibits a viscosity-versus-time curve as shown in Figure 2. Category 57. An excipient granulate as in any one of Categories 1 to 52, wherein when 1.2 g of the excipient granulate is reconstituted in 40 mL of water at 23°C, the resulting solution exhibits a luminescence-versus-time curve as shown in Figure 3. Category 58. An excipient granulate as in any one of Categories 1 to 57, wherein after mixing a solution of 1.2 g of the excipient granulate with 40 mL of water at 23°C for 90 seconds, the viscosity of the solution is in the range of 45 cP to 80 cP, where the viscosity is measured using a Brookfield digital viscometer, model LVDV-I +, equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm. Category 59. An excipient granulate as in any one of Categories 1 to 57, wherein after mixing a solution of 1.2 g of the excipient granulate with 40 mL of water at 23°C for 30 seconds, the viscosity of the solution is in the range of 15 cP to 40 cP, where the viscosity is measured using a Brookfield digital viscometer, model LVDV-I +, equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm. Category 60. An excipient granulate as in any one of Categories 1 to 57, wherein after mixing a solution of 1.2 g of the excipient granulate with 40 mL of water at 23°C for 60 seconds, the viscosity of the solution is in the range of 35 cP to 60 cP, where the viscosity is measured using a Brookfield digital viscometer, model LVDV-I +, equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm. Category 61. An excipient granulate as in any one of Categories 1 to 60, wherein the excipient granules are prepared using wet granulation. Category 62. A method for preparing excipient granules as in any one of Categories 1 to 61, comprising: dry-mixing the tackifier, the disintegrant, and the one or more excipients to provide a dry mixture; forming the dry mixture into granules with a buffer solution to provide a first granulate; wet-agglomerating the first granulate to form a first wet mass; forming the first wet mass into granules with water to provide a second granulate; wet-agglomerating the second granulate to form a second wet mass; and drying the second wet mass to provide the excipient granules. Category 63. An excipient granulate comprising excipient granules prepared by the method as in Category 62. Category 64. A composition comprising an excipient granulate as in any one of Categories 1 to 61 and 63. Category 65. The composition as in Category 64, wherein the composition comprises: 1 wt% to 15 wt% of the excipient granulate; and wherein wt% is based on the total weight of the composition. Category 66. A pharmaceutical composition comprising: an excipient granulate as in any one of Categories 1 to 61 and 63; and an active pharmaceutical ingredient. Category 67. The pharmaceutical composition as in Category 65, wherein the active pharmaceutical ingredient is in the form of a solid dosage form. Category 68. The pharmaceutical composition as in Category 67, wherein the solid dosage form is in the form of a powder, granulate, or tablet. Category 69. The pharmaceutical composition as in any one of Categories 66 to 68, wherein the pharmaceutical composition comprises: 1 wt% to 15 wt% of the excipient granulate; and wherein wt% is based on the total weight of the pharmaceutical composition. Category 70. The pharmaceutical composition as in any one of Categories 66 to 69, wherein the pharmaceutical composition comprises a pharmaceutical granulate, and wherein the pharmaceutical granulate comprises the active pharmaceutical ingredient. Category 71. The pharmaceutical composition as in Category 70, wherein the pharmaceutical granulate comprises a plurality of immediate-release pharmaceutical granules, a plurality of modified-release pharmaceutical granules, or a combination thereof. Category 72. The pharmaceutical composition as in any one of Categories 70 to 71, wherein the pharmaceutical composition comprises: 1 wt% to 15 wt% of the excipient granulate; and 85 wt% to 99 wt% of the pharmaceutical granulate, wherein wt% is based on the total weight of the pharmaceutical composition. Category 73. The pharmaceutical composition as in any one of Categories 70 to 72, wherein the pharmaceutical composition comprises: 5 wt% to 11 wt% of the excipient granulate; and 89 wt% to 95 wt% of the pharmaceutical granulate, wherein wt% is based on the total weight of the pharmaceutical composition. Category 74. A pharmaceutical composition as in any one of Categories 64 to 73, wherein the pharmaceutical composition comprises an antistatic agent. Category 75. The pharmaceutical composition as in Category 74, wherein the antistatic agent comprises magnesium silicate hydrate. Category 76. The pharmaceutical composition as in any one of Categories 74 to 75, wherein the pharmaceutical composition comprises 0.1 wt% to 1.0 wt% of the antistatic agent, where wt% is based on the total weight of the pharmaceutical composition. Category 77. The pharmaceutical composition as in any one of Categories 70 to 76, wherein the excipient granulate has a first bulk density; the pharmaceutical granulate has a second bulk density; and the first bulk density is within ±20% of the second bulk density. Category 78. The pharmaceutical composition as in any one of Categories 70 to 77, wherein the excipient granulate has a first average particle diameter; the pharmaceutical granulate has a second average particle diameter; and the first average particle diameter is within ±20% of the second average particle diameter. Category 79. The pharmaceutical composition as in any one of Categories 70 to 78, wherein the excipient granulate has a first tapped density; the pharmaceutical granulate has a second tapped density; and the first average tapped density is within ±20% of the tapped density. Category 80. The pharmaceutical composition as in any one of Categories 70 to 79, wherein the excipient granulate has a first Hausner ratio; the pharmaceutical granulate has a second Hausner ratio; and the first Hausner ratio is within ±20% of the second Hausner ratio. Category 81. The pharmaceutical composition as in any one of Categories 70 to 80, wherein the excipient granulate has a first compression index; the pharmaceutical granulate has a second compression index; and the first compression index is within ±20% of the second compression index. Category 82. The pharmaceutical composition as in any one of Categories 70 to 81, wherein the excipient granulate has a first Flodex value; the pharmaceutical granulate has a second Flodex value; and the first Flodex value is within ±20% of the second Flodex value. Category 83. The pharmaceutical composition as in any one of Categories 70 to 82, wherein the excipient granulate has a first friability value; the pharmaceutical granulate has a second friability value; and the first friability value is within ±20% of the second friability value. Category 84. A product comprising an excipient granulate as in any one of Categories 1 to 61 and 63 or a composition as in any one of Categories 64 to 65. Category 85. A pharmaceutical product comprising a pharmaceutical composition as in any one of Categories 66 to 69. Category 86. A pharmaceutical product comprising a pharmaceutical composition as defined in any one of Categories 70 to 83. Category 87. A pharmaceutical product as defined in Category 86, wherein the product comprises the excipient granulate, the pharmaceutical granulate or a combination thereof contained within a package. Category 88. A pharmaceutical product as defined in Category 87, wherein the package comprises a sachet. Category 89. A pharmaceutical product as defined in any one of Categories 85 to 88, wherein the pharmaceutical product comprises the excipient granulate and the pharmaceutical granulate combined within the same package. Category 90. A pharmaceutical product as defined in any one of Categories 85 to 88, wherein the pharmaceutical product comprises a first package containing the excipient granulate and a second package containing the pharmaceutical granulate. Category 91. A pharmaceutical product as defined in any one of Categories 85 to 88, wherein the pharmaceutical product comprises a package, wherein the package comprises a first compartment containing the excipient granulate and a second compartment containing the pharmaceutical granulate. Category 92. A pharmaceutical product as defined in Category 91, wherein the package is configured to combine the contents of the first compartment with the contents of the second compartment during use to provide a pharmaceutical composition. Category 93. A pharmaceutical product as defined in any one of Categories 85 to 92, wherein the pharmaceutical product comprises 0.5 g to 20 g of the pharmaceutical composition. Category 94. A composition for oral administration prepared using an excipient granulate as defined in any one of Categories 1 to 61 and 63. Category 95. An oral pharmaceutical composition for oral administration prepared using an excipient granulate as defined in any one of Categories 66 to 83. Category 96. An oral pharmaceutical composition as defined in Category 95, wherein the oral pharmaceutical composition comprises water. Category 97. An oral pharmaceutical composition as defined in any one of Categories 95 to 96, wherein the viscosity of the oral pharmaceutical composition is from 50 cP to 1,000 cP, wherein the viscosity is measured using a Brookfield digital viscometer model LVDV-I+ equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm at a temperature of 23°C. Category 98. An oral pharmaceutical composition as defined in any one of Categories 95 to 97, wherein the oral pharmaceutical composition comprises an immediate release component, a modified release component or a combination thereof. Category 99. An oral pharmaceutical composition as defined in any one of Categories 95 to 98, wherein the oral pharmaceutical composition comprises an immediate release pharmaceutical granulate, a modified release pharmaceutical granulate or a combination thereof. Category 100. An oral composition as in Category 98, wherein the immediate-release component comprises an active pharmaceutical ingredient dissolved in a viscous aqueous solution. Category 101. An oral pharmaceutical composition as in any one of Categories 95 to 100, wherein the oral pharmaceutical composition comprises pharmaceutical granules suspended in a viscous aqueous solution. Category 102. An oral pharmaceutical composition as in any one of Categories 95 to 101, wherein the oral pharmaceutical composition comprises a modified-release component suspended in a viscous aqueous solution. Category 103. An oral pharmaceutical composition as in Category 98, wherein the immediate-release component comprises immediate-release pharmaceutical granules. Category 104. An oral pharmaceutical composition as in any one of Categories 98 to 103, wherein the modified-release component comprises modified-release pharmaceutical granules. Category 105. An oral pharmaceutical composition as in Category 94, wherein the modified-release granules are suspended in the viscous aqueous solution. Category 106. An oral pharmaceutical composition as in Category 95, wherein the viscosity of the viscous aqueous solution at a temperature of 20°C to 25°C (such as 23°C) is 50 cP to 600 cP, and the viscosity is measured using a Brookfield digital viscometer model LVDV-1+ equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 RPM. Category 107. A kit comprising an excipient granule as in any one of Categories 1 to 61 and 63, a composition as in any one of Categories 64 to 65, a pharmaceutical composition as in any one of Categories 66 to 83, a product as in Category 84, a pharmaceutical product as in any one of Categories 85 to 93, or an oral pharmaceutical composition as in any one of Categories 95 to 106, and instructions for using the contents of the kit. Category 108. A method of using a pharmaceutical product as in any one of Categories 85 to 93, comprising: opening the pharmaceutical package; pouring the pharmaceutical composition into water; and mixing the contents to provide an oral pharmaceutical composition. Category 109. The method as in Category 108, wherein the water comprises 10 mL to 60 mL of water. Category 110. The method as in any one of Categories 108 to 109, wherein the pharmaceutical composition comprises 1 g to 3 g of the excipient granules. Category 111. The method as in any one of Categories 108 to 110, wherein the method further comprises combining and mixing the excipient granule and the medicated granule to form a pharmaceutical composition before combining the contents with water. Category 112. A method as in any one of Categories 108 to 111, wherein the method comprises, after pouring the excipient granulate into water to form a viscous solution, combining the medicament-containing granulate with the viscous solution to provide a pharmaceutical composition. Category 113. A method of treating a disease in a patient, comprising orally administering to a patient in need of such treatment an oral pharmaceutical composition prepared from a pharmaceutical composition as in any one of Categories 66 to 83, wherein the disease is treatable by the medicament; and wherein the pharmaceutical composition comprises a therapeutically effective amount of the medicament for treating the disease. Category 114. A method of treating a disease in a patient, comprising orally administering to a patient in need of such treatment an oral pharmaceutical composition as in any one of Categories 95 to 106, wherein the disease is treatable by the active pharmaceutical ingredient; and wherein the pharmaceutical composition comprises a therapeutically effective amount of the active pharmaceutical ingredient for treating the disease. Category 115. A method as in any one of Categories 113 to 114, wherein the pharmaceutical composition comprises pharmaceutical granulates. Category 116. Use of an excipient granulate as in any one of Categories 1 to 61 for the manufacture of a medicament. Category 117. Use of a pharmaceutical composition as in any one of Categories 66 to 83 for the manufacture of a medicament. Category 118. Use as in any one of Categories 116 to 117, wherein the medicament comprises an oral pharmaceutical composition. Category 119. Use as in any one of Categories 116 to 118, wherein the medicament comprises pharmaceutical granulates suspended in a viscous aqueous solution. Category 120. A method of increasing the viscosity of an aqueous solution using an excipient granule as in any one of Categories 1 to 61. Category 121. A method of improving the palatability of an oral pharmaceutical composition using an excipient granule as in any one of Categories 1 to 61. Examples The embodiments provided by the present disclosure are further illustrated with reference to the following examples, which describe excipient granulates, characteristics of excipient granulates, and compositions comprising excipient granulates. It will be apparent to those of ordinary skill in the art to which the present invention pertains that many modifications can be made to the materials and methods without departing from the scope of the present disclosure. It should be noted that there are alternative ways of implementing the embodiments disclosed herein. Therefore, the embodiments of the present invention should be regarded as illustrative rather than restrictive. In addition, the scope of the claims should not be limited to the details given herein, and is entitled to the full scope thereof and its equivalents. Example 1 Excipient Granulates Excipient granulates were prepared using high-shear dry granulation and high-shear wet granulation methods. Formulation development work was carried out with various excipients to identify an excipient granule formulation that rapidly forms a viscous solution after reconstitution with 40 mL of water and is suitable for oral administration. The method for manufacturing excipient granules is as follows: (1) dry granulation by rolling and / or tableting on a tableting machine; and (2) for small-scale experiments, high-shear wet granulation using a small coffee grinder, or for larger batches, high-shear wet granulation using a 4 L pan high-shear granulator. Examples of excipient granule compositions are provided in Table 1. Table 1. Examples of excipient granule components. The excipient granules are prepared by dry mixing the components and then forming granules of the dry mixture with a buffer containing sodium citrate dihydrate and anhydrous citric acid dissolved in water to provide a first granulation. The first granulation is wet agglomerated to provide a first wet mass, and then the first wet mass is granulated with water to provide a second granulation. The second granulation is wet agglomerated to provide a second wet mass and dried to provide excipient granules. Granulation was carried out using a Collette (GEA) GRAL 25 high-shear granulator equipped with a 25 L jacketed pan. The jacketed pan was coupled to an Advantage Engineering air-cooled water chiller set at 46°F (8°C). A two-fluid nozzle with a nozzle aperture of 1 mm was used to spray the buffer or water into the mixture at an atomization pressure of 45 bar. The excipient granules were dried at 60°C using a Freund-Vector FLM-3 fluidized bed dryer. The dried excipient granules were milled using a Quadro Comil® 197 equipped with a 50G or 32G screen and sieved using a bench-top vibratory screening base equipped with #35 and #70 mesh screens. The fines (< 210 µm) passing through the #70 mesh screen were removed. Example 2 Characteristics of excipient granulations Figure 1 shows the particle size distribution of the excipient granules prepared in Example 1 at different stages during the sieving process. The size distribution includes the distribution of the overall granules before sieving (overall), the 35G - 75G sieved fraction (35 - 70), after passing through the 50G screen (50G), and after passing through the 32G screen (30G). The particle size distribution was determined using sieve analysis or laser diffraction. The excipient granules (1.2 g) were combined with 40 mL of water and mixed to provide a reconstituted viscous solution. The pH value of the reconstituted viscous solution was 4.3. Figure 2 shows the reconstitution viscosity curves of various excipient granulations containing different components and prepared using different granulation and wet agglomeration conditions. The reconstructed viscosity curve of the excipient granules of Example 1 is shown as a thick line (O) in Figure 2. Other examples are shown as lines A to N. The reconstructed viscosity was measured using a Brookfield digital viscometer, model LVDV-I+, equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm by combining and mixing 1.2 g of the excipient granules with 40 mL of water at a temperature of 23°C. The reconstructed luminescence curves of the excipient granulates of Example 1 and other excipient granules are shown as a thick line (O) in Figure 3. Other examples are shown as lines A to N. The luminescence was measured by combining and mixing the excipient granules of Example 1 with 40 mL of water at a temperature of 23°C and measuring the viscosity using a Technical Color Solutions Datacolor™ 650 spectrophotometer. The bulk density of the excipient granules of Example 1 is 0.58 g / mL to 0.62 g / mL, the tapped density is 0.69 g / mL to 0.74 g / mL, the Hausner ratio is 0.18 to 1.20, the compression index is 15.5 to 16.8, and the Flodex value is 4. It should be noted that there are alternative ways of implementing the embodiments disclosed herein. Therefore, the embodiments of the present invention should be considered illustrative rather than restrictive. In addition, the scope of the patent claims should not be limited to the details given herein, and is entitled to the full scope thereof and equivalents. Those of ordinary skill in the art to which the present invention pertains should understand that the drawings described herein are for illustrative purposes only. These drawings are not intended to limit the scope of the present disclosure. Figure 1 shows an example of the particle size distribution of the excipient granulates provided by the present disclosure. Figure 2 shows an example of the reconstructed viscosity of a solution prepared using the excipient granulates. Figure 3 shows an example of the reconstructed luminescence of a solution prepared using the excipient.

Claims

1. An excipient granule comprising a plurality of excipient particles, wherein the excipient particles comprise: 5 wt% to 15 wt% xanthan gum; 5 wt% to 15 wt% dicalcium phosphate; 6 wt% to 16 wt% microcrystalline cellulose; 20 wt% to 30 wt% flavoring agent; 7 wt% to 17 wt% crospovidone; and 5 wt% to 20 wt% polyvinylpyrrolidone, wherein the wt% is based on the total weight of the excipient particles.

2. The excipient granules of claim 1, wherein the average particle size of the excipient particles is 100 µm to 600 µm, wherein the particle size is determined by sieve analysis or laser diffraction.

3. The excipient granules of claim 1, wherein the excipient granules further comprise a buffer, an acid, a sweetener, or a combination of any of the foregoing.

4. The excipient granules as claimed in claim 1, wherein after mixing 1.2 g of the excipient granules with a solution of 40 mL of water at a temperature of 23°C for 90 seconds, the viscosity of the solution is in the range of 40 cP to 100 cP, wherein the viscosity is measured using a Brookfield digital viscometer, model LVDV-1+, equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 RPM.

5. A pharmaceutical composition comprising: an excipient granule as claimed in claim 1; and an active pharmaceutical ingredient.

6. The pharmaceutical composition of claim 5, wherein the pharmaceutical composition comprises: 1 wt% to 15 wt% of the excipient granules; and wherein the wt% is based on the total weight of the pharmaceutical composition.

7. The pharmaceutical composition of claim 5, wherein the pharmaceutical composition comprises a pharmaceutical granule, wherein the pharmaceutical granule comprises the active pharmaceutical ingredient.

8. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition comprises: 1 wt% to 15 wt% of the excipient granules; and 85 wt% to 99 wt% of the pharmaceutical granules, wherein wt% is based on the total weight of the pharmaceutical composition.

9. The pharmaceutical composition as claimed in claim 7, wherein, The excipient granules have a first volume density; the pharmaceutical granules have a second volume density; and the first volume density is within ±20% of the second volume density, wherein the volume density is determined according to Method 1 of USP <616>.

10. A pharmaceutical product comprising a pharmaceutical composition as claimed in any one of claims 5 to 9.

11. The pharmaceutical product of claim 10, wherein the pharmaceutical product comprises the excipient granules, the pharmaceutical granules, or a combination thereof contained in a package.

12. The pharmaceutical product as claimed in claim 11, wherein the packaging includes a pouch.

13. The pharmaceutical product of claim 11, wherein the pharmaceutical product comprises the excipient granules and the pharmaceutical granules combined in the same package.

14. The pharmaceutical product of claim 12, wherein the pharmaceutical product comprises a first package containing the excipient granules and a second package containing the pharmaceutical granules.

15. An oral pharmaceutical composition for oral administration, prepared using excipient granules of any one of claims 1 to 4, a pharmaceutical composition of any one of claims 5 to 9, or a pharmaceutical product of any one of claims 10 to 14, wherein the oral pharmaceutical composition comprises a viscous aqueous solution with a viscosity of 50 cP to 1,000 cP, wherein the viscosity is measured using a Brookfield digital viscometer of model LVDV-I+ equipped with a Brookfield SC4-18 spindle at a spindle speed of 30 rpm and a temperature of 23°C.

16. The oral pharmaceutical composition of claim 15, wherein the oral pharmaceutical composition comprises pharmaceutical granules suspended in the viscous aqueous solution.

17. The oral pharmaceutical composition of claim 15, wherein the oral pharmaceutical composition comprises an active pharmaceutical ingredient suspended in the viscous aqueous solution.

Citation Information

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