Abstract: A kit for treating psychosis by administering a pharmaceutically acceptable liquid composition of Asenapine to oral mucosa includes a formulation having Asenapine, or a pharmaceutically acceptable salt or hydrate thereof, ethanol, and water and a multidose pump filled with the formulation. The Asenapine compositions are stable for an extended period of time at normal storage conditions.

Abstract: The present invention provides a method for designing a ferric pyrophosphate citrate complex composition containing pyrophosphate, citrate, ferric, sodium, and sulfate ions and calculating and adjusting each salt needed based on a choice of salts that contain the above ions and a desired concentration of each ion in the final product. The present invention also provides a process for preparing a pharmaceutical dosage form of ferric pyrophosphate citrate complex composition in liquid form which is ready to be administrated to patients in need and which maintains the mass balance of ion sources throughout the process.

Abstract: The present invention provides stable bendamustine-containing pharmaceutical compositions suitable for long term storage. The compositions include bendamustine, a pharmaceutically acceptable salt, and/or a hydrate form thereof, a solvent mixture of N,N-dimethylacetamide and glycerin, and an antioxidant. The bendamustine-containing compositions have less than about 2% of total impurities after two month storage at 25° C./60% RH. The pharmaceutical compositions may be used for treating neoplastic diseases.

Abstract: A novel process of manufacturing colesevelam hydrochloride including the steps of alkylating polyallylamine with n-decylbromide and 6-bromohexyl trimethyl ammonium bromide, followed by cross-linking the alkylated polyallylamine with epichlorohydrin in an aqueous medium, and adding a suitable chloride ion source to obtain colesevelam hydrochloride.

Abstract: The present invention provides stable bendamustine-containing pharmaceutical compositions suitable for long term storage. The compositions include bendamustine, a pharmaceutically acceptable salt, and/or a hydrate form thereof, a solvent mixture of N,N-dimethylacetamide and glycerin, and an antioxidant. The bendamustine-containing compositions have less than about 2% of total impurities after two month storage at 25° C./60% RH. The pharmaceutical compositions may be used for treating neoplastic diseases.

Abstract: The present invention provides pharmaceutical formulations of lyophilized carmustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized carmustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with carmustine, such as neoplastic diseases.

Abstract: The present invention provides a lyophilized bendamustine hydrochloride (HCL) pharmaceutical composition. The present invention further provides methods of producing the lyophilized bendamustine HCL composition from a composition including bendamustine HCL, mannitol, formic acid, and water. The pharmaceutical formulation can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.

Abstract: A novel process of manufacturing colesevelam hydrochloride including the steps of alkylating polyallylamine with n-decylbromide and 6-bromohexyl trimethyl ammonium bromide, followed by cross-linking the alkylated polyallylamine with epichlorohydrin in an aqueous medium, and adding a suitable chloride ion source to obtain colesevelam hydrochloride.

Abstract: The invention provides a process for preparing stable, high API content, solid pharmaceutical dosage forms by direct compression or dry granulation, characterized in that the pharmaceutical tablets rapidly disintegrate in water or other aqueous solutions to produce a clear or almost clear solution. Also provided is a pharmaceutical carglumic acid tablet, which has improved manufacturing, dissolution, and stability properties, and is less expensive to produce, compared to the equivalent commercial product.

Abstract: The present invention relates to processes for preparing a polypeptide or pharmaceutically acceptable salt thereof comprising L-tyrosine, L-alanine, L-glutamate, and L-lysine. The polypeptide or pharmaceutically acceptable salt thereof is preferably glatiramer acetate.

Abstract: The present invention relates to an improved process for preparing a polypeptide or pharmaceutically acceptable salt thereof comprising L-tyrosine, L-alanine, L-glutamate, and L-lysine. The polypeptide or pharmaceutically acceptable salt thereof is preferably glatiramer acetate.

Abstract: A stabilized pharmaceutical composition comprises a drug-resin complex wherein the resin has been treated with an alkaline material prior to the formation of the drug-resin complex. The drug-resin complex may further be impregnated with an alkalizing agent, L-methionine, an antioxidant agent, or a combination thereof, or be coated with a diffusion barrier. A method of preparation of the pharmaceutical composition is provided.

Abstract: An extended-release antibiotic composition comprising at least one antibiotic, and greater than 50 weight percent, based on the total weight of the composition, of a polymer component, wherein said polymer component comprises at least one pharmaceutically acceptable hydrophilic polymer, and said polymer component has a viscosity of less than about 50 cps.

Abstract: A pharmaceutical composition having improved solubility comprising a hydrophobic drug or pharmaceutically acceptable salt thereof and a compound having at least one carboxylic acid moiety, wherein the molar ratio of the compound having at least one carboxylic acid moiety to the hydrophobic drug or pharmaceutically acceptable salt thereof is from about 0.1:1 to about 25:1. The pharmaceutical composition exhibits rapid dissolution upon contact with physiological solvents, such as water, saliva or gastrointestinal fluids.

Abstract: The invention provides an Olanzapine pseudopolymoph Form E. The invention provides methods of preparing polymorphic Olanzapine Form E employing rapid crystallization and seeding. The invention provides methods of preparing anhydrous Olanzapine Form I from the Olanzapine Form E by step-wise drying.

Abstract: The present invention relates to an improved process for preparing a polypeptide or pharmaceutically acceptable salt thereof comprising L-tyrosine, L-alanine, L-glutamate, and L-lysine. The polypeptide or pharmaceutically acceptable salt thereof is preferably glatiramer acetate.

Abstract: The present invention relates to an improved process for preparing a polypeptide or pharmaceutically acceptable salt thereof comprising L-tyrosine, L-alanine, L-glutamate, and L-lysine. The polypeptide or pharmaceutically acceptable salt thereof is preferably glatiramer acetate.

Abstract: The present invention relates to an improved process for preparing a polypeptide or pharmaceutically acceptable salt thereof comprising L-tyrosine, L-alanine, L-glutamate, and L-lysine. The polypeptide or pharmaceutically acceptable salt thereof is preferably glatiramer acetate.

Abstract: A pharmaceutical composition having improved solubility comprising a hydrophobic drug or pharmaceutically acceptable salt thereof and a compound having at least one carboxylic acid moiety, wherein the molar ratio of the compound having at least one carboxylic acid moiety to the hydrophobic drug or pharmaceutically acceptable salt thereof is from about 0.1:1 to about 25:1. The pharmaceutical composition exhibits rapid dissolution upon contact with physiological solvents, such as water, saliva or gastrointestinal fluids.

Abstract: A process for the preparation of polymorph Form I of 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2.3-b][1,5]benzodiazepine, or olanzapine.