An oral amphetamine extended release solid dose is described. The compositions contain a combination of an uncoated amphetamine-cation exchange resin complex, a barrier coated amphetamine—cation exchange resin complex—matrix, and an uncomplexed amphetamine, wherein one or more of these components contains blends of different forms of amphetamines. Either the modified release coated and/or the uncoated amphetamine—cation exchange resin complex may have two forms of amphetamine in a complex with a single cation exchange resin. Following administration of a single dose of the composition, a therapeutically effective amount of amphetamine is reached by about one hour and the composition provides at least a thirteen hour effect post-dose.

Modified release pharmaceutical compositions of epalrestat are provided. Methods of manufacturing the tablets and treating various diseases and conditions, including diabetes and diabetic complications, by administering the modified release compositions to patients in need thereof are also provided.

The present invention relates to pharmaceutical tablet compositions comprising the compound gefitinib as the active pharmaceutical ingredient and a PVA-based coating, suitable for oral administration as well as to processes for their preparation. The compositions exhibit good long-term stability and dissolution properties.

Disclosed are pharmaceutical compositions comprising Compound I, having the formula: ##STR00001##
and an effective amount of sofosbuvir wherein the sofosbuvir is substantially crystalline. Also disclosed are methods of use for the pharmaceutical composition.

An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate - ion exchange resin complex, a barrier coated methylphenidate - ion exchange resin complex -matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.

In a delayed release formulation comprising a core containing a drug and a delayed release coating for providing intestinal release, release of the drug in the colon is accelerated by including an isolation layer between the core and the delayed release coating. The delayed release coating comprises an inner layer and an outer layer. The outer layer comprises a pH dependently soluble polymeric material which has a pH threshold at about pH 5 or above. The inner layer comprises a soluble polymeric material which is soluble in intestinal fluid or gastrointestinal fluid, said soluble polymeric material being selected from the group consisting of a polycarboxylic acid polymer that is at least partially neutralised, and a non-ionic polymer, provided that, where said soluble polymeric material is a non-ionic polymer, said inner layer comprises at least one additive selected from a buffer agent and a base.

Provided herein are solid dispersions comprising rifaximin and pharmaceutical compositions and uses thereof.

The present disclosure relates to a process for preparing a pharmaceutical formulation, said process comprises: i) blending chlorpromazine hydrochloride and microcrystalline cellulose under a first set of pre-determined conditions to obtain a first mixture; ii) blending lactose monohydrate with first mixture under a second set of pre-determined conditions to obtain a second mixture; iii) blending pre-gelatinized starch, colloidal silicon dioxide and magnesium stearate with second mixture under a third set of pre-determined conditions to obtain a third mixture; iv) screening the third mixture through #40 Mesh and dry blending under a fourth set of pre-determined conditions to obtain a fourth mixture; and v) directly compressing the fourth mixture to obtain the pharmaceutical formulation.

The present disclosure is directed to a method of treating overactive bladder comprising orally administering to a subject in need thereof an amount of from about 50 mg to about 100 mg (e.g., about 75 mg) of vibegron per day. The present disclosure also provides a method of treating overactive bladder comprising orally administering to a subject in need thereof a first dosage of vibegron per day for a first period and a second dosage of vibegron per day thereafter.