Novel stable pharmaceutical compositions of clopidogrel...

Details Novel stable pharmaceutical compositions of clopidogrel... Novel stable pharmaceutical compositions of clopidogrel...

A - Human Necessities

61

K

A61K 9/20 (2006.01) A61K 9/28 (2006.01) A61K 31/4365 (2006.01)

Patent

CA 2683611

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.

L'invention concerne de nouvelles compositions pharmaceutiques orales stables contenant l'ingrédient actif bisulfate de Clopidogrel et des polymères hydrophiles, ainsi que des excipients acceptables sur le plan pharmaceutique. En particulier, ledit bisulfate de Clopidogrel se présente sous sa forme cristalline 1 et la composition contient, de plus, un ou plusieurs agents chélatants et antioxydants. L'invention concerne également un nouveau procédé de préparation de compositions pharmaceutiques stables dans lesquelles la forme I du bisulfate de Clopidogrel est revêtue d'un polymère hydrophile, ce qui permet d'augmenter la stabilité physique et chimique de la composition.

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