Compositions of estrogen-cyclodextrin complexes

Details Compositions of estrogen-cyclodextrin complexes Compositions of estrogen-cyclodextrin complexes

A - Human Necessities

61

K

A61K 47/40 (2006.01) A61K 31/565 (2006.01) A61K 31/58 (2006.01) C08K 5/13 (2006.01) C08L 5/16 (2006.01)

Patent

CA 2432151

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 -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.

L'invention concerne des compositions pharmaceutiques comprenant de faibles doses de complexes sensibles form~s d'un oestrog­ne et d'une cyclodextrine, lesquelles compositions pr~sentent une stabilit~ am~lior~e. Dans des modes de r~alisation sp~cifiques, la composition comprend un complexe d'~thinyloestradiol et de .beta.-cyclodextrine dans une pr~paration granuleuse. Dans un autre mode de r~alisation, la composition comprend une quantit~ limit~e de polyvinylpyrrolidone, ~tant donn~ que l'on a d~couvert que cet excipient d~grade l'~thinyloestradiol. En outre, l'invention concerne un proc~d~ permettant d'am~liorer la stabilit~ d'un oestrog­ne dans une composition et de fabriquer une telle composition stable. Il est essentiel que la pr~paration granul~e soit fabriqu~e avec un contrÙle consciencieux de l'humidit~ relative.

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