Cyclodextrin-drospirenone inclusion complexes

US6958326B2 · kind B2 · utility

Assignee

• SCHERING CORPORATION · US

Inventors

• Thomas Backensfeld · Berlin, DE
• Wolfgang Heil · Berlin, DE
• Ralph Lipp · Berlin, DE

Key dates

• Filing date: Dec 20, 2001
• Grant date: Oct 25, 2005
• Expiry date: Dec 20, 2021

Classification

• Technology area (CPC C): Chemistry; Metallurgy
• CPC primary: C08B37/0015
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

Pharmaceutical compositions comprising low doses of sensitive complexes between an estrogen and a cyclodextrin are provided with improved stability. In specific embodiments the composition comprises a complex between ethinyl estradiol and β-cyclodextrin in a granulate preparation and in yet another embodiment the composition comprises a limited amount of polyvinylpyrrolidone since this excipient was found to degrade ethinyl estradiol. Furthermore, a method for improving the stability of an estrogen in a composition and for manufacturing such a stable composition is provided. Essentially, the granulate preparation are manufactured under careful control of the relative humidity.