US Patent:
20130129700, May 23, 2013
Inventors:
Rebecca L. Wedel - Lawrence KS, US
Karen T. Johnson - Lawrence KS, US
Stephen G. Machatha - Overland Park KS, US
Jane A. Cowee - Kansas City MO, US
Daniel J. Cushing - Phoenixville PA, US
Assignee:
Cydex Pharmaceuticals, Inc. - Lenexa KS
International Classification:
A61K 47/48
US Classification:
424 943, 514301, 514 58, 424 9464, 424 9463, 514161, 514 56, 514 213
Abstract:
The present invention provides compositions containing clopidogrel, present as a free base or a pharmaceutically acceptable salt thereof, and sulfoalkyl ether cyclodextrin (SAE-CD). The compositions can be liquid, suspension or solid compositions. They can be adapted for oral, peroral or parenteral administration. The SAE-CD serves to aid in dissolution and stabilization of the clopidogrel in aqueous media. The stability of clopidogrel against hydrolytic degradation, thermal degradation, and photolytic degradation are improved. SAE-CD provides improved results over other cyclodextrin derivatives. The SAE-CD-containing composition of clopidogrel can be provided in liquid form, solid form or as a reconstitutable powder. Both ready-to-use and concentrated liquid compositions can be prepared. The liquid composition is optionally available as a clear solution. The compositions herein can be administered perorally or parenterally and provide substantial pharmacokinetic, pharmacodynamic and/or therapeutic advantages over a tablet composition administered perorally and excluding SAE-CD.