The present invention relates to, in part, methods for the treatment of methanogen-associated disorders such as, for example, Irritable Bowel Syndrome (IBS) using at least one anti-methanogenic lovastatin analog or derivative. In addition, modified-release formulations comprising at least one anti-methanogenic lovastatin analog or derivative are provided which release the anti-methanogenic lovastatin analog or derivative in the gastrointestinal tract.

The invention relates to solid medicinal forms containing at least one active ingredient and at least one pharmaceutically compatible, water soluble drying agent which is selected from the group consisting of trimagnesium dicitrate and/or calcium chloride, the solid medicinal form having a drying loss of at most 6% and a relative equilibrium moisture content of 25% or less. The invention also relates to solid medicinal forms containing a moisture-sensitive active ingredient and trimagnesium dicitrate.

A particulate, modified release barrier coated drug-cation exchange resin complex comprising a core composed of a drug complexed with a pharmaceutically acceptable ion-exchange resin is provided. Methods of making and products containing this coated complex are described.

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 invention provides a sterile lyophilizate composition having improved stability and shelf-life, the lyophilizate having from 30 to 100% of Mesna and 0 to 70% of an excipient. The invention further provides a process for the preparation of the sterile lyophilizate composition and a dosage unit formulation with the lyophilizate composition.

Disclosed herein a pharmaceutical composition comprising aprepitant a pharmaceutically acceptable salt thereof; at least one hydrocarbon derivative selected from among a fatty acid of 14 to 18 carbon atoms, and a fatty alcohol of 14 to 18 carbon atoms; and at least one selected from among polyoxyethyelene-type nonionic surfactant, sucrose fatty acid ester, and Macrogol 15 hydroxystearate. The pharmaceutical composition of the present disclosure can release aprepitant or a pharmaceutically acceptable salt thereof to effectively exert the pharmaceutical efficacy, and can be dissolved in a fasted state simulated gastrointestinal fluid so that it can be useful for study on the in vivo pharmacokinetic behavior of aprepitant.

A multi-particle dosage form that can deliver phenylephrine in controlled pulsed doses. The dosage form can contain an immediate release form that can contain phenylephrine or a salt thereof and a plurality of delayed release particles with a coating that can contain phenylephrine or salt thereof and a pH sensitive coating.

Methods for making particulate material include providing a first solution comprising one or more solvents and an active agent, providing a second solution comprising an antisolvent, mixing the first solution with the second solution to form a mixture, atomizing the mixture with a gas to produce droplets, and drying the droplets by directing the droplets into a chamber for removal of the solvent and the antisolvent to produce solid particles. Various apparatuses for producing particulate material in this manner are also provided.

The invention includes a granular composition comprising the active ingredient (S)-N-(3-(6-isopropoxypyridin-3-yl)-1H-indazol-5-yl)-1-(2-(4-(4-(1-methyl-1H-1,2,4-triazol-3-yl)phenyl)-3,6-dihydropyridin-1(2H)-yl)-2-oxoethyl)-3-(methylthio)pyrrolidine-3- carboxamide, wherein a total amount of active ingredient comprises by weight % about 60-90% (5)-N-(3-(6-isopro-poxypyridin-3-yl)-1H-indazol-5-yl)-1-(2-(4-(4-(1-methyl-1H-1,2,4-triazol-3-yl)phenyl)-3,6-di-hydropyridin-1(2H)-yl)-2-oxoethyl)-3-(methylthio)pyrrolidine-3-carboxamide Form 1 HCl, about 10-30% (5)-N-(3-(6-isopropoxypyridin-3-yl)-1H-indazol-5-yl)-1-(2-(4-(4-(1-methyl-1H-1,2,4-triazol-3-yl)phenyl)-3,6-dihydropyridin-1(2H)-yl)-2-oxoethyl)-3-(methylthio)pyrrolidine-3-carboxamide amorphous HCl, and about 0-5% (S)-N-(3-(6-isopropoxypyridin-3-yl)-1H-indazol-5-yl)-1-(2-(4-(4-(1-methyl-1H-1,2,4-triazol-3-yl)phenyl)-3,6-dihydropyridin-1(2H)-yl)-2-oxoethyl)-3-(methylthio)pyrrolidine-3-carboxamide amorphous free base.

A silybin injection contains silybin, sulfobutyl ether-β-cyclodextrin, an organic solvent for injection and may further contain a co-solvent, a lyophilization proppant, a pH regulator, water for injection and the like.