The invention provides a solid composition of the peripheral mu opioid antagonist axelopran and a combination dosage form of the mu opioid antagonist axelopran sulfate in an immediate release form and an opioid analgesic agent which may be in an extended release, sustained release, modified release, or controlled release form and methods of preparing such a combination dosage form.

Sodium ibuprofen compositions and methods of manufacturing tablets and caplets comprising sodium ibuprofen are described. The formulation is advantageous because it allows for the formation of tablets having low sodium content and further provides tablets exhibiting improved physical stability, high tablet hardness and high strength, coupled with excellent dissolution and bioavailability characteristics. The formulations and processes are further advantageous because they can be produced in large quantities without an unacceptable number of defective tablets,

A rapidly dispersible, fine-particle film-coating composition which is in powder form and is not prone to segregation for coating pharmaceutical dosage forms, consisting of a) 40-90% by weight of a polyvinyl alcohol-polyether graft copolymer (component A), b) 1-20% by weight of a polyvinylpyrrolidone or of a vinylpyrrolidone-vinyl acetate-copolymer with a K value of from 10 to 100 (component B) c) 10-60% by weight of organic or inorganic pigments having an average particle size of less than 8 μm (component C) d) 0.5-15% by weight of a surfactant having an HLB of greater than 10 (component D) and e) 0-30% by weight of further customary coating ingredients (components E),
in which the particles of component C are embedded in a coherent polymer matrix,
where the total amount of components A to E is 100% by weight.

A sustained-release formulation for an acetylcholinesterase inhibitor, comprising an acetylcholinesterase inhibitor and at least two gel-forming polymers, and methods of manufacture thereof. The acetylcholinesterase inhibitor preferably comprises donepezil.

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

Compositions and procedures for applying pharmaceutical tablet coatings, recognized as film coating wherein it is possible to obtain a final product coated with brightness superior to that achievable with typical compositions. The main difference in the composition is in the inclusion of the product derived from isomaltulose, which is a mixture of 6-O-α-D-glucopyranosyl-D-mannitol dihydrate with 6-O-α-D-glucopyranosyl-D-sorbitol, known as Isomalt, combined with a variety of film-forming polymers such as ethylene glycol and polyvinyl alcohol copolymer, copovidone, polyvinyl alcohol, and cellulosic derivatives, wherein the process conditions are advantageous as it is possible to handle high concentrations of solids in their preparation and wider applying temperature ranges than normally recommended for film coatings.

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

Controlled release dosage forms are described herein. The controlled release formulations described herein provide prolonged delivery of high dose drugs that are highly water soluble and highly hygroscopic. In specific embodiments, controlled release dosage forms for delivery of a drug selected from GHB and pharmaceutically acceptable salts, hydrates, tautomers, solvates and complexes of GHB. The controlled release dosage forms described herein may incorporate both controlled release and immediate release formulations in a single unit dosage form.

The present invention provides a film coating composition for a solid preparation that is easy to take. The present invention also provides a solid preparation that is easy to take. A film coating composition according to an embodiment of the present invention contains a polyvinyl alcohol-polyethylene glycol graft copolymer and a thickening agent. The thickening agent may be composed of one or more substances that are selected from the group consisting of xanthan gum, locust bean gum, pectin, carrageenan, guar gum, gellan gum, and carboxy vinyl polymer.

The present invention provides novel pharmaceutical compositions of dimethyl fumarate. The pharmaceutical compositions of the present invention are in the form of a bead and comprise (i) an inert core; (ii) a first layer surrounding the inert core, wherein the first layer comprises dimethyl fumarate; and (iii) an enteric coating surrounding the first layer. Also provided are pharmaceutical compositions in the form of a bead comprising a core and an enteric coating surrounding the core, wherein the core comprises dimethyl fumarate. Methods of using the pharmaceutical compositions of the present invention for treating multiple sclerosis are also included.