Formulations containing clopidogrel and sulfoalkyl ether cyclodextrin and methods of use
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.
Mosher; Gerold L. (Kansas City, MO), Wedel; Rebecca L. (Lawrence, KS), Johnson; Karen T. (Lawrence, KS), Machatha; Stephen G. (Overland Park, KS), Cowee; Jane A. (Kansas City, MO), Cushing; Daniel J. (Phoenixville, PA)
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