Abstract: The present invention relates to analytical methods such as molecular weight determination of polypeptide, in particular Glatiramer acetate. The present invention further relates to an improved process for preparation of polypeptides or pharmaceutically acceptable salts thereof, particularly Glatiramer acetate also known as Copolymer-1. The present invention further relates to characterization of Glatiramer acetate by peptide mapping.

Abstract: Disclosed herein are multiparticulate modified release pharmaceutical compositions comprising: (a) a first portion comprising an active ingredient, at least one surfactant and at least one release modifying agent and (b) a second portion comprising an active ingredient and optionally a release modifying agent. Particularly, the active ingredient in the first portion is a calcium channel blocker and the modified release composition is in the form of a multiparticulate tablet.

Abstract: A process for the production of pramlintide, a 37-mer peptide, is provided. The synthesis provides a high yield synthesis of the peptide in relatively pure form. Further purification can be achieved by preparative HPLC.

Abstract: The present invention relates to an improved process for the preparation of Rasagiline or pharmaceutically acceptable salts thereof. The present invention also relates to Rasagiline salts, polymorphs thereof and process for preparation thereof.

Abstract: The present invention relates to analytical methods such as molecular weight determination of polypeptide, in particular Glatiramer acetate. The present invention further relates to an improved process for preparation of polypeptides or pharmaceutically acceptable salts thereof, particularly Glatiramer acetate also known as Copolymer-1. The present invention further relates to characterization of Glatiramer acetate by peptide mapping.

Abstract: A process for the production of pramlintide, a 37-mer peptide, is provided. The synthesis provides a high yield synthesis of the peptide in relatively pure form. Further purification can be achieved by preparative HPLC.

Abstract: The present invention discloses a process for the preparation of rhPTH (1-34) also known as teriparatide by construction of a novel nucleotide, as an NcoI.IXhoI fragment as set forth in SEQ. ID. No.:1 encoding a chimeric fusion protein as set forth in SEQ.ID. No.:2 comprising of a fusion partner consisting of 41 amino acids belonging to Escherichia coli ?-galactosidase (LacZ) gene, an endopeptidase cleavage site, rhPTH (1-34) gene fragment, cloning the said nucleotide in an expression vector under the control of T7 promoter, transforming Escherichia coli with the said vector and expressing the chimeric fusion protein in fed batch fermentation. The present invention further discloses a low feed rate lactose induction for optimized expression of rhPTH (1-34) in Escherichia coli.

Abstract: The present invention relates to an improved process for the preparation of Chlorothiazide and pharmaceutically acceptable salts thereof. The present invention relates to novel polymorphs of Chlorothiazide and Chlorothiazide salts, in particular Chlorothiazide sodium. The present invention further relates to pharmaceutical compositions comprising Chlorothiazide and Chlorothiazide salts, in particular Chlorothiazide sodium and process for preparation thereof.

Abstract: The present invention relates to a process for improving pegylation reaction yield of r-metHuG-CSF comprising conjugating r-metHuG-CSF to a PEG aldehyde at a free amine moiety at the N terminal end on the G-CSF in presence of a reducing agent in a pegylation buffer solution comprising a polyol having the formula CnH2n+2On where n is from 3 to 6, or a carbohydrate, or a derivative thereof wherein the concentration of said polyol or carbohydrate or derivative thereof is in the range of 0.1% to 10% w/w.

Abstract: A low cell density fermentation process for the production of heterologous proteins in microorganisms. The cell culture obtained by cultivating host microorganisms transformed with a vector carrying genetic material for the said proteins and an inducible promoter under batch fermentation conditions is fed with a feed medium after an OD600 of 0.16 to 8 has been achieved or after 0 to 4 hrs from the start of the fermentation process. The feed medium comprises 5 to 30% of carbon source and 1 to 30% of nitrogen source and 0 mg to 400 mg antibiotics and 2.5 to 4.25% inorganic phosphates and trace elements. The concentration of the carbon source in the feed medium is 10 to 30 and the amino acid content in nitrogen source is 45 to 95%. The initial feed rate is in the range of 0 ml/hr to 12 ml/hr and is raised exponentially by an exponent in the range of 0.1 to 0.4 and/or linearly with the slope of the curve in the range of 0.5 to 3. The production of the heterologous proteins is induced with 0.

Abstract: Disclosed herein are multiparticulate modified release pharmaceutical compositions comprising: (a) a first portion comprising an active ingredient, at least one surfactant and at least one release modifying agent and (b) a second portion comprising an active ingredient and optionally a release modifying agent. Particularly, the active ingredient in the first portion is a calcium channel blocker and the modified release composition is in the form of a multiparticulate tablet.

Abstract: The present invention relates to an improved process for the preparation of Rasagiline or pharmaceutically acceptable salts thereof. The present invention also relates to Rasagiline salts, polymorphs thereof and process for preparation thereof.

Abstract: The present invention discloses a process for the preparation of rhPTH (1-34) also known as teriparatide by con-struction of a novel nucleotide, as an NcoI.IXhoI fragemt as set forth in SEQ. ID. No.:1 encoding a chimeric fusion protein as set forth in SEQ.ID. No.:2 comprising of a fusion partner consisting of 41 amino acids belonging to Escherichia coli ?-galactosidase (LacZ) gene, an endopeptidase cleavage site, rhPTH (1-34) gene fragment, cloning the said nucleotide in an expression vector under the control of T7 promoter, transforming Escherichia coli with the said vector and expressing the chimeric fusion protein in fed batch fermentation. The present invention further discloses a low feed rate lactose induction for optimized expression of rhPTH (1-34) in Escherichia coli.

Abstract: The present invention discloses novel stable oral pharmaceutical compositions comprising the active ingredient Clopidogrel bisulfate and hydrophilic polymers along with pharmaceutically acceptable excipients. Particularly, the said Clopidogrel bisulfate is crystalline Form 1 and the composition additionally comprises of one or more chelating agents and antioxidants. Further the invention relates to a novel process for preparation of stable pharmaceutical compositions wherein the Clopidogrel bisulfate Form I is coated with a hydrophilic polymer thereby providing an increased physical and chemical stability to the composition.

Abstract: A low cell density fermentation process for the production of heterologous proteins in microorganisms. The cell culture obtained by cultivating host microorganisms transformed with a vector carrying genetic material for the said proteins and an inducible promoter under batch fermentation conditions is fed with a feed medium after an OD600 of 0.16 to 8 has been achieved or after 0 to 4 hrs from the start of the fermentation process. The feed medium comprises 5 to 30% of carbon source and 1 to 30% of nitrogen source and 0 mg to 400 mg antibiotics and 2.5 to 4.25% inorganic phosphates and trace elements. The concentration of the carbon source in the feed medium is 10 to 30 and the amino acid content in nitrogen source is 45 to 95%. The initial feed rate is in the range of 0 ml/hr to 12 ml/hr and is raised exponentially by an exponent in the range of 0.1 to 0.4 and/or linearly with the slope of the curve in the range of 0.5 to 3. The production of the heterologous proteins is induced with 0.

Abstract: A process for the preparation of highly pure (E)-N,N-diethyl-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)acrylamide (Entacapone). It comprises condensing 3,4-dihydroxy-5-nitro benzaldehyde with N,N-diethyl cyano acetamide in an organic solvent in the presence of an organic base and an acid under reflux conditions followed by distilling off the solvent under vacuum and treating the residue with a lower aliphatic carboxylic acid at 40-8O0 C. The resulting residue is extracted with a chlorinated solvent and the solvent is distilled off under vacuum. The resulting residue is extracted with an organic solvent to obtain crude N,N-diethyl-2-cyano-3-3,4-dihydroxy-5-nitrophenyl)acrylamide. The crude product N,N-diethyl-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl) acrylamide formed is treated with a mixture of organic alcohol and organic acid in the molar ratio of the crude product to organic alcohol 1:5 to 15 and crude product to organic acid 1:1 to 3 under reflux conditions.

Abstract: The present invention discloses a process for the synthesis of N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulphonyl]-2-hydroxy-2-methyl propanamide (Form I). The invention discloses a reagent for oxidation of N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)thio]-2-hydroxy-2-methyl propanamide to N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulphonyl]-2-hydroxy-2-methyl propanamide. More particularly, the invention discloses a method of purification of N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulphonyl]-2-hydroxy-2-methyl propanamide in a mixture of methylethyl ketone and hexane giving form (I). This form (I) is useful as an active pharmaceutical and has antiandrogenic activity.

Abstract: The present invention relates to pharmaceutical compositions containing fenofibrate in the form of an inclusion complex with cyclodextrin, having high dissolution profile and in vivo enhanced bioavailability as compared with plain micronized fenofibrate compositions. An inclusion complex has a molar ratio of fenofibrate (preferably in micronized form) to cyclodextrin of from about 1:0.5 to about 1:4, preferably from about 1:1 to about 1:2. The immediate release fenofibrate composition is preferably in the form of a tablet or in the form of granules inside a capsule.

Abstract: A process for preparing racemic mixtures containing nearly equal amounts of stereo isomers of compounds of formula (I), or their salts, by heating an enantiomerically enriched material with thionyl chloride. A required useful enantiomer may thereby be recovered from unwanted mother liquors that would otherwise be otherwise be discarded.

Abstract: Inclusion complexes of glipizide and a nonionic surfactant with cyclodextrin and cyclodextrin derivatives. A method of preparing the inclusion complexes of glipizide and a nonionic surfactant with cyclodextrin and cyclodextrin derivatives, by wetting cyclodextrin or a derivative thereof with a nonionic surfactant, and mixing the resulting mixture with glipizide. A pharmaceutical composition containing an inclusion complex of glipizide and a nonionic surfactant with cyclodextrin and cyclodextrin derivatives, in combination with pharmaceutically acceptable excipients.