Abstract: A ready to use or ready to dilute for use, stable liquid Bendamustine solution formed of 90 to about 200 mg/mL Bendamustine Hydrochloride or a hydrate form thereof, and a co-solvent consisting of 1% v/v to 12% v/v water and 88% v/v to 99% v/v N,N-Dimethylacetamide (DMA). The liquid Bendamustine solution is room-temperature stable for at least 90 days. Optionally, 0.01 to about 0.5 mg/mL antioxidant, preferably, butylated hydroxytoluene is included in the solution.

Abstract: An improved process for the preparation of high purity Levosimendan includes treatment of Levosimendan crude with an organic acid, adding an organic acid to precipitate Levosimendan and isolating pure Levosimendan from the precipitate. Levosimendan obtained by the improved process is pharmaceutically acceptable with no impurity higher than 0.2 percent.

Abstract: Liquid pharmaceutical formulation of Bendamustine that include bendamustine active pharmaceutical ingredient, N,N-Dimethylacetamide, and water in an amount of about 0.3% to 40%. The active pharmaceutical ingredient is Bendamustine, a pharmaceutically acceptable salt, and/or a hydrate form thereof, preferably Bendamustine HCl monohydrate. The formulations contain 20-200 mg/mL Bendamustine. The formulations are stable upon long term storage at refrigerated conditions. They can be administered to treat neoplastic conditions without reconstituting prior to administration.

Abstract: Dicyclohexylamine salt of fosaprepitant (fosaprepitant DCHA), a process for preparing fosaprepitant DCHA, and a use of fosaprepitant DCHA in the preparation of pharmaceutically acceptable fosaprepitant dimeglumine with high purity is provided. Fosaprepitant dimeglumine is prepared by treating fosaprepitant DCHA with an acid to form fosaprepitant, followed by adding N-methyl-D-glucamine to fosaprepitant.

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 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 provides dicyclohexylamine salt of fosaprepitant (fosaprepitant DCHA), a process for preparing fosaprepitant DCHA, and a use of fosaprepitant DCHA in the preparation of pharmaceutically acceptable fosaprepitant dimeglumine with high purity. Fosaprepitant dimeglumine is prepared by treating fosaprepitant DCHA with an acid to form fosaprepitant, followed by adding N-methyl-D-glucamine to fosaprepitant.

Abstract: A process for the preparation and isolation of crystalline miglustat without the use of a column chromatography or ion exchange purification. The crystalline miglustat has a high purity and a melting point of 128° C. and an endothermic peak is 133° C.

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: This invention provides a process of making optically pure melphalan of the formula by hydroxyethylation, in a regioselective manner, of the aromatic amino group rather than the glycinic amino group.

Abstract: A novel process of manufacturing sevelamer carbonate from a polyallylamine carbonate or bicarbonate chloride salt. Process for manufacture of carbonate and/or bicarbonate salts of water insoluble polymers containing amino groups that are useful as anion binders in the gastrointestinal (GI) system. The process arranges the polyallylamine chain in a solution in such a way that the cross-linking reaction with epichlorohydrin can be controlled at a desired reaction rate.

Abstract: A synthesis and purification of felbamate, an anticonvulsant, are provided. The product of the synthesis and purification is with high untapped and tapped bulk densities, which increase ease of handling and suitability for use in pharmaceutical formulations. The felbamate may be incorporated into pharmaceutical compositions that can be administered orally for treatment of epilepsy.

Abstract: The present invention provides an improved process of preparing hydralazine hydrochloride, which involves the preparation of 1-chlorophthalazine salt and further reacting with hydrazine followed by purification of hydralazine hydrochloride, which is free of phosphate, does not contain any individual impurities more than 0.05%, total impurities less than 0.5%, and a hydrazine content of not more than 0.001%, and preferably less than 0.0003%. One benefit of improved purity is enhanced storage stability.

Abstract: The present invention describes a novel process of preparation of optically pure L-Pipecolic acid and an improved process for the conversion of L-pipecolic acid to L-N-(2,6-dimethylphenyl)-1-propyl-2-piperidinocarboxamide, its hydrochloride salt and hydrochloride monohydrate.

Abstract: A process is provided for preparing an iron sucrose complex, substantially free of excipients, for providing an iron sucrose complex co-precipitated with sucrose, and for providing iron sucrose complexes in aqueous solution.

Abstract: A process of preparing a stable parenteral solution of a 1,4-dihydropyridine salt, such as nicardipine hydrochloride, in an acidic aqueous medium. The presence of L-arginine in the solution enhances the solubility of the salt, which is poorly soluble in water. An aqueous, injectable isotonic solution at pH about 3.5-3.6 consists essentially of nicardipine hydrochloride, L-arginine, and a sugar alcohol. An improved single pot manufacturing process for obtaining unsymmetrical 1,4-dihydropyridines by using more than one mole equivalent of aldehyde with respect to the other reactants (amino crotonate and acetoacetate ester). The reaction can be conducted in a solvent present at 20 times the amount of any one component. A process for changing one polymorph of nicardipine hydrochloride (Form A) into another (Form B), and a separate process for the reverse (Form B into Form A).

Abstract: The present invention provides an improved process of preparing hydralazine hydrochloride, which involves the preparation of 1-chlorophthalazine salt and further reacting with hydrazine followed by purification of hydralazine hydrochloride, which is free of phosphate, does not contain any individual impurities more than 0.05%, total impurities less than 0.5%, and a hydrazine content of not more than 0.001 %, and preferably less than 0.0003%. One benefit of improved purity is enhanced storage stability.

Abstract: The present invention provides an improved process of preparing hydralazine hydrochloride, which involves the preparation of 1-chlorophthalazine salt and further reacting with hydrazine followed by purification of hydralazine hydrochloride, which is free of phosphate, does not contain any individual impurities more than 0.05%, total impurities less than 0.5%, and a hydrazine content of not more than 0.001%, and preferably less than 0.0003%. One benefit of improved purity is enhanced storage stability.

Abstract: A synthesis and purification of felbamate, an anticonvulsant, are provided. The product of the synthesis and purification is with high untapped and tapped bulk densities, which increase ease of handling and suitability for use in pharmaceutical formulations. The felbamate may be incorporated into pharmaceutical compositions that can be administered orally for treatment of epilepsy.