Discloses novel crystalline forms of 2-[4-(2-Oxo-cyclopentylmethyl)-phenyl]-propionic acid (Formula II) and its sodium derivatives (Formula I) and the process for preparation thereof.
C07C 51/43 - SéparationPurificationStabilisationEmploi d'additifs par changement de l'état physique, p. ex. par cristallisation
C07C 59/86 - Composés non saturés contenant des groupes cétone contenant des cycles aromatiques à six chaînons et d'autres cycles
A61K 31/192 - Acides carboxyliques, p. ex. acide valproïque ayant des groupes aromatiques, p. ex. sulindac, acides 2-aryl-propioniques, acide éthacrynique
An improved process for the preparation of Tenofovir disoproxil Fumarate using Wittig reagents as phase transfer catalyst. Another object of the invention is to provide a simple, cost effective process for the preparation of Tenofovir Disoproxil Fumarate with high purity and without the formation of undesired impurities. Yet another object of the present invention is to provide an efficient process which avoids the use of large quantities of catalysts. Further object of the invention is to provide a process for preparation of Tenofovir Disoproxil Fumarate in high yield and purity in short span of time, thereby substantially minimize the product degradation.
Disclosed is the process suitable for industrial synthesis of Pregabalin from (R)-(-)-3-(carbamoylmethyl)-5-methylhexanoic using sodium hypochlorite with low ash content by means of reverse addition. The invention relates to process for the preparation of Pregabalin with low ash content and the process is a reverse addition process. More specifically, the invention relates to process for the preparation of Pregabalin which is viable for large scale preparation.
Disclosed are synthetic processes to produce phosphate salt of Cinacalcet unsaturated free base with a high degree of purity, and thereby producing Cinacalcet hydrochloride of very high purity by employing the above said intermediate along with an improved solvent system. A preferred process for preparing phosphate salt of cinacalcet unsaturated free base, comprising: dissolving cinacalcet unsaturated free base in organic solvent; cooling the reaction mixture; providing a source of phosphate; maintaining reaction mass obtained for sufficient time; cooling the reaction mixture; and isolating phosphate salt of cinacalcet unsaturated free base.
The present invention relates to a novel salt of (3aR,4S,7R,7aS)-2-[((1R,2R)-2-{[4-(1,2-benzisothiazol-3-yl)-piperazin-1-yl]methyl} cyclohexyl)methyl]hexahydro-1 H-4,7-methanisoindol-1,3-dione and hydrates thereof, to methods for preparing the novel salt and its hydrates. In one aspect, the present invention provides a compound which is lurasidone dihydrochloride. In another aspect, the present invention provides a process for preparation of lurasidone dihydrochloride comprising: (i) mixing lurasidone free base in an organic solvent system; (ii) subjecting step (i) mixture to acid proton source; and (iii) isolating compound of lurasidone dihydrochloride.
The instant invention discloses a process for the preparation of lurasidone hydrochloride with lesser impurity profile comprising of isolating Lurasidone base as a solid whereby subjecting the base with isopropyl alcohol-hydrochloric acid. The instant invention is also directed to a composition of matter comprising lurasidone hydrochloride of more than 99.95% purity or less than 0.05% impurity.
Preparing a dexibuprofen pharmaceutical formulation in the form of granules that can be directly compressed into tablets. The process consists of two steps: (i) preparation of base granules, and (ii) blending base granules with a compression aid. The process of preparing base granules involves use of liquid bed granulator with top spray method, or slugging by roll compaction. The granules prepared by using both the methods showed improved compressibility and flowability compared to granules prepared by conventional granulation process using rapid mixer granulator. The ready-to-compress granules prepared by the process show no signs of sticking when compressed on a high-speed commercial scale tablet compression machine.
A61K 31/192 - Acides carboxyliques, p. ex. acide valproïque ayant des groupes aromatiques, p. ex. sulindac, acides 2-aryl-propioniques, acide éthacrynique
A61K 31/185 - AcidesLeurs anhydrides, halogénures ou sels, p. ex. acides du soufre, acides imidiques, hydrazoniques ou hydroximiques
8.
NOVEL TABLET COMPOSITION OF POLYALLYLAMINE POLYMERS
The present invention relates to pharmaceutical compositions comprising polyallylamine polymer, binder, disintegrant, diluents and pharmaceutically acceptable inert excipients, substantially free of cellulose or cellulose derivatives and stearic acid. The polyallylamine polymer includes such as sevelamer hydrochloride, sevelamer carbonate and colesevelam hydrochloride. Particularly, the present invention provides pharmaceutical composition comprising a tablet core substantially free of cellulose. Moreover, the present invention relates to a process of preparing the pharmaceutical composition in tablet form by direct compression method.
Stable non-alcoholic transdermal hydrogel of dexibuprofen was prepared by using a simple manufacturing process, and the experimental trials showed that the pH modifying agent, antioxidant and water miscible solvent are the essential excipients to obtain stable non-alcoholic transdermal hydrogel of dexibuprofen. The dexibuprofen hydrogel prepared using carbopol as a gelling polymer produced an opaque gel, whereas hydrogel prepared using hyroxypropyl methylcellulose (HPMC) as a gelling polymer produced a transparent gel. There was no significant changes observed with respect to physical description, pH, assay and particularly to the related substance values when the hydrogels were subjected to the stability study at accelerated condition (40°C / 75% RH) for 3 months in laminated tubes.
A61K 31/192 - Acides carboxyliques, p. ex. acide valproïque ayant des groupes aromatiques, p. ex. sulindac, acides 2-aryl-propioniques, acide éthacrynique
A61K 47/36 - PolysaccharidesLeurs dérivés, p. ex. gommes, amidon, alginate, dextrine, acide hyaluronique, chitosane, inuline, agar-agar ou pectine
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