Abstract: This present invention relates to a method of stabilizing an aqueous pharmaceutical preparation susceptible to de-gradation by formulating in a dual buffer system wherein the individual buffers are selected from phosphate, aspartate, glutamate, and succinate buffer.

Abstract: Aspects of the present application relate to solid forms of Venetoclax and preparative processes thereof. Specific aspects relate to an amorphous form of Venetoclax, its solid dispersion and crystalline forms of Venetoclax or salts thereof. Further aspects of the present application relate to processes for the preparation of Venetoclax.

Abstract: Aspects of the present application relates to co-crystal of carfilzomib with maleic acid, process for the preparation of co-crystal of carfilzomib with maleic acid, process for the preparation of pure carfilzomib from co-crystal of carfilzomib with maleic acid and process for the preparation of amorphous carfilzomib.

Abstract: A pharmaceutical composition and preparing processes thereof. The composition comprises bortezomib or pharmaceutically acceptable salt or solvate thereof, tromethamine and an organic carboxylic acid, and the pH of the composition is from about 3.0 to 6.0.

Abstract: Provided is a method for producing glycoprotein composition with an increased percentage of Man5 and/or afucosylated glycans. Use of manganese for increasing the percentage of Man5 and afucosylated glycans in glycoprotein composition is further provided.

Abstract: The present application relates to crystalline and amorphous Vilazodone hydrochloride. The present application further relates to amorphous solid dispersions of vilazodone hydrochloride with pharmaceutically acceptable carriers. The present application also relates to a process for the preparation of form I of vilazodone free base.

Abstract: Crystalline Forms R5, R5a, R5b and R6 of nilotinib hydrochloride and processes for their preparation.

Abstract: Provided is a method of refolding of recombinant GCSF that minimizes the generation of oxidized forms of GCSF by optimizing the refolding of inclusion bodies containing recombinant GCSF.

Abstract: A process for preparing Nilotinib hydrochloride Form R5 and Form R6 comprises: step a) providing a solution of Nilotinib free base in acetic acid and optionally an organic solvent, step b) adding hydrochloric acid taken in an organic solvent to the solution of step a), then separating Nilotinib hydrochloride Form R5 (step c), and finally drying at about 100° C. to 150° C. to obtain Nilotinib hydrochloride Form R6.

Abstract: The present application relates to a regioselective and stereoselective processes for the preparation of dehydroepi-androsterone (DHEA) and processes for its intermediates.

Abstract: The present application relates to crystalline and amorphous forms of Enzalutamide. The present application further relates to amorphous solid dispersions of Enzalutamide with pharmaceutically acceptable carriers. The present application also relates to a process for the preparation of Form R1 of Enzalutamide.

Abstract: The present invention is directed to novel crystalline forms of pemetrexed tromethamine salts and processes for preparation thereof.

Abstract: The invention provides a pharmaceutical composition for intranasal administration comprising a salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester and optionally at least one pharmaceutically acceptable excipient, wherein the said composition provides Tmax value of less than 30 minutes upon said administration. Other aspects and embodiments are contemplated and described. The invention also provides a pharmaceutical composition for intranasal administration comprising a triptan, a pharmaceutically acceptable vehicle and a mucosal permeation enhancer, wherein upon said administration said composition provides a Tmax substantially equivalent to subcutaneous administration of said triptan. Other aspects and embodiments are contemplated and described.

Abstract: Crystalline Forms R5, R5a, R5b and R6 of nilotinib hydrochloride and processes for their preparation.

Abstract: Provided are processes for preparing Ticagrelor and its intermediates that are useful in the processes. Also provided are salts of Ticagrelor, their processes and solid dispersion of Ticagrelor having Ticagrelor in amorphous form.

Abstract: Aspects of the present disclosure include crystalline bazedoxifene free base, crystalline bazedoxifene acetate Form D, and processes for their preparation. The drug compound having the adopted name “bazedoxifene acetate” has a chemical name 1-[4-(2-azepan-1-yl-ethoxy)benzyl]-2-(4-hydroxyphenyl)-3-methyl-1H-indol-5-ol acetic acid, and has the chemical structure shown below as Formula I.

Abstract: The present application provides a process for preparation of Linagliptin reacting (R)-piperidine-3-amine of Formula II or an acid addition salt thereof with 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-bromoxanthine of Formula III in the presence of a suitable base in an inert organic solvent.

Abstract: The present application relates to an improved process for the preparation of (S)-equol (1). The present application also relates to novel intermediates of formula (7), (7A), (8) and (9) and their use for the synthesis of (S)-equol.

Abstract: Single step method of enriching highly sialylated variant/s of a protein by use of a strong ion exchange chromatography support and a pH gradient in absence of any salt gradient.

Abstract: There is provided a process for preparation of sitagliptin of Formula II or a pharmaceutically acceptable salt thereof by deprotection of Formula IX.