Abstract: An improved process for the preparation of Pralatrexate which is less hazardous. The invention further relates to novel intermediates and process thereof useful for the preparation of Pralatrexate. The present invention also relates to a substantially pure Pralatrexate and a process for obtaining the same in high yield.

Abstract: The present invention discloses a process for the preparation of 4-acetoxy-2?-benzoyloxy-5?,20-epoxy-1-hydroxy-7?,10?-dimethoxy-9-oxotax-11-en-13?-yl(2R,3S)-3-tert-butoxycarbonylamino-2-hydroxy-3-phenyl-propionate Cabazitaxel (I).

Abstract: The invention relates to a biocompatible, non-biodegradable, and non-toxic polymer of formula (I), comprising of three monomeric units, selected from 1-Vinylpyrrolidne (VP), N-Isopropylactylamide (NIPAM), and ester of Maleic anhydride and Polyethylene glycol (MPEG), cross-linked with a bi-functional vinyl derivative, of high purity and substantially free of respective toxic monomeric contaminants, and a process for preparation thereof. The invention further relates to nanoparticulate pharmaceutical compositions of poorly water-soluble drugs or compounds comprising the polymer of the invention, which are safe, less-toxic and convenient for bedside administration to patients in need thereof. Furthermore, the invention relates to a highly selective method for preparation of nanoparticulate pharmaceutical compositions of poorly water-soluble drugs or compounds.

Abstract: The present invention relates to a process of preparing a stable pharmaceutical composition of compounds which are susceptible to hydrolysis comprising a. Addition of required quantity of pharmaceutically acceptable lyophilization excipients optionally in Water for Injection in a formulation vessel; b. Addition of organic solvent to form a appropriate proportion of aqueous and organic solvent; c. Maintaining the temperature of the formulation vessel from the range ?5±1° C. to ?5±3° C.; d. Addition of required quantity of compound susceptible to hydrolysis to form a solution and lyophilizing the solution.

Abstract: The present invention provides Crystalline Forms of 4-acetoxy-2?-benzoyloxy-5?-20-epoxy-1-hydroxy-7?,10?-dimethoxy-9-oxotax-11-en-13?-yl(2R,3S)-3-tert-butoxycarbonylamino-2-hydroxy-3-phenylpropionate, i.e Cabazitaxel. The present invention also discloses methods for the preparation of Crystalline Forms of Cabazitaxel and pharmaceutical compositions thereof.

Abstract: The present invention discloses a process for the preparation of 4-acetoxy-2?-benzoyloxy-5?,20-epoxy-1-hydroxy-7?,10?-dimethoxy-9-oxotax-11-en-13?-yl(2R,3S)-3-tert-butoxycarbonylamino-2-hydroxy-3-phenyl-propionate Cabazitaxel (I).

Abstract: The present invention relates to an improved process for the synthesis of bendamustine, in particular, bendamustine hydrochloride of the formula (VI) and its intermediate 1-Methyl-5-[bis(2-chloroethyl)amino]-1H-benzimidazol-2-yl]lithium butanoate of formula (V), both having a purity of ?99%, which is simple, convenient, economical, does not use hazardous chemicals and industrially viable.

Abstract: The present invention discloses a process for the preparation of 4-acetoxy-2?-benzoyloxy-5?,20-epoxy-1-hydroxy-7?,10?-dimethoxy-9-oxotax-11-en-13?-yl(2R,3S)-3-tert-butoxycarbonylamino-2-hydroxy-3-phenyl-propionate Cabazitaxel (I).

Abstract: The invention relates to a biocompatible, non-biodegradable, and non-toxic polymer of formula (I), comprising of three monomeric units, selected from 1-Vinylpyrrolidne (VP), N-Isopropylactylamide (NIPAM), and ester of Maleic anhydride and Polyethylene glycol (MPEG), cross-linked with a bi-functional vinyl derivative, of high purity and substantially free of respective toxic monomeric contaminants, and a process for preparation thereof. The invention further relates to nanoparticulate pharmaceutical compositions of poorly water-soluble drugs or compounds comprising the polymer of the invention, which are safe, less-toxic and convenient for bedside administration to patients in need thereof. Furthermore, the invention relates to a highly selective method for preparation of nanoparticulate pharmaceutical compositions of poorly water-soluble drugs or compounds.

Abstract: Novel intermediates, process for their preparation and their use in the preparation of therapeutically effective antineoplastic agents, in particular Temsirolimus of formula (I).

Abstract: The present invention provides Crystalline Forms of 4-acetoxy-2?-benzoyloxy-5?-20-epoxy-1-hydroxy-7?,10?-dimethoxy-9-oxotax-11-en-13?-yl(2R,3S)-3-tert-butoxycarbonylamino-2-hydroxy-3-phenylpropionate, i.e Cabazitaxel. The present invention also discloses methods for the preparation of Crystalline Forms of Cabazitaxel and pharmaceutical compositions thereof.

Abstract: An Amorphous Form of Cabazitaxel is disclosed. It is preferably characterized by an X-ray powder diffraction (XRD) pattern as depicted in FIG.-1. It is prepared by (a) preparing a solution of Cabazitaxel in a suitable solvent and mixture thereof; and (b) recovering the Amorphous Forms of Cabazitaxel from the solution thereof by removal of the solvent.

Abstract: The invention relates to a biocompatible, non-biodegradable, and non-toxic polymer of formula (I), comprising of three monomeric units, selected from 1-Vinylpyrrolidone (VP), N-Isopropylacrylamide (NIPAM), and ester of Maleic anhydride and Polyethylene glycol (MPEG), cross-linked with a bi-functional vinyl derivative, of high purity and substantially free of respective toxic monomeric contaminants, and a process for preparation thereof. The invention further relates to nanoparticulate pharmaceutical compositions of poorly water-soluble drugs or compounds comprising the polymer of the invention, which are safe, less-toxic and convenient for bedside administration to patients in need thereof. Furthermore, the invention relates to a highly selective method for preparation of nanoparticulate pharmaceutical compositions of poorly water-soluble drugs or compounds.

Abstract: Novel intermediates, process for their preparation and their use in the preparation of therapeutically effective antineoplastic agents, in particular Temsirolimus of formula (I).

Abstract: The invention provides two crystalline forms A and B of the skeletal muscle relaxant and anxiolytic agent, Metaxalone of formula (I), and a process for preparation thereof. The two crystalline forms A and B are bioavailable. The invention further provides pharmaceutical compositions comprising the two bioavailable crystalline forms, useful for the relief of discomforts associated with acute, painful musculoskeletal conditions.

Abstract: A storage stable pharmaceutical composition comprising a solution of Oxaliplatin in water and a catalytic amount of a carbohydrate. A process for forming such pharmaceutical composition comprising dissolving a known amount of Oxaliplatin in water; adding an amount of carbohydrate in the range of 0.0010% to 0.05% w/v with respect to such solution; agitating the mixture to get clear solution; filtering it through a filter membrane under aseptic conditions; and filling the solution resulting into glass vials sealed with elastomeric stoppers and aluminium flip-off seals.

Abstract: We disclose here processes for making Platinum complex of general formula (I) where in, the conformation of 1,2-diaminocyclohexane is cis, trans-l or trans-d isomer and R1 and R2 combinedly make dicarboxylic acid having formulae (II), (III) and (IV), here in, the two carboxylic acid groups are on the same or on vicinal carbon atoms, n is zero or an integer ranging from 1 to 5 and R3 is either hydrogen or a substituent with electron withdrawing or electron releasing effects exemplified by alkoxy, halo, and nitro groups by reacting a compound of formula M2PtX4 wherein X represents halogen atom such as Cl or Br or thiocyanate with (i) 1,2-diaminocyclohexane (ii) source of silver ion selected from a silver compound containing divalent anion in presence of a corresponding carboxylic acid of formula (II) or (III) or (IV) to get the compound of formula (I), purifying the said compound by treating with alkali metal iodide and isolating the title compound by any conventional methods.