Crystalline polymorphs of clopidogrel

US7897613B2 · kind B2 · utility

Assignee

• Generics [UK] Limited · GB

Inventors

• Ramakrishnan Arul · Jamkhed, IN
• Ajay Singh Rawat · Jamkhed, IN
• Maheshkumar Gadakar · Jamkhed, IN
• Rajesh Rao · Norwood, US
• Abhinay Pise · Thane, IN
• Jason Gray · North Hinksey, GB

Key dates

• Filing date: Sep 9, 2004
• Grant date: Mar 1, 2011
• Expiry date: Oct 25, 2025

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61P7/02
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

The present invention relates to novel crystalline forms of the platelet aggregation inhibitor (+)-(S)-methyl-2-(2-chlorophenyl)-(6,7-dihydro-4H-thieno[3,2-c]pyrid-5-yl)acetate, clopidogrel (1), in the form of hydrogen bromide salts, identified as polymorph forms 1, 2 and 3. The present invention further relates to processes for preparing such forms, pharmaceutical compositions comprising such forms, and uses for such forms and compositions. The pharmaceutical compositions may be used, in particular, for inhibiting platelet aggregation or for treating, preventing or managing thrombosis, atherothrombosis, an atherothrombotic event, ischaemic stroke, myocardial infarction, non-Q-wave myocardial infarction, atherosclerosis, peripheral arterial disease, or unstable angina. The present invention also relates to methods of treating said disorders. Formula (1).