Cyclodextrin-drospirenone inclusion complexes

Details Cyclodextrin-drospirenone inclusion complexes Cyclodextrin-drospirenone inclusion complexes

2005-10-25

2005-10-25

Wilson, James O. (Department: 1623)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Carbohydrate doai

C514S023000, C514S025000, C514S054000, C514S060000, C536S103000, C536S123100, C536S124000

Reexamination Certificate

active

06958326

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.

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