Pharmaceutical composition containing a tetrahydrofolic acid

A - Human Necessities – 61 – K

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Details

A61K 9/20 (2006.01) A61K 31/525 (2006.01) A61K 31/567 (2006.01) A61K 31/585 (2006.01) A61P 15/18 (2006.01)

Patent

CA 2656131

The present invention relates to solid pharmaceutical compositions, in particular to oral contraceptives, comprising a progestogen, such as drospirenone; an estrogen, such as ethinylestradiol; a tetrahydrofolic acid or a pharmaceutically acceptable salt thereof, such as calcium 5-methyl-(6S)-tetrahydrofolate; and at least one pharmaceutical acceptable excipient or carrier. The compositions of the invention provide good stability of the tetrahydrofolic acid upon storage while still ensuring a fast and reliable release of the estrogen and the progestogen present in the composition.

La présente invention concerne des compositions pharmaceutiques solides, en particulier des contraceptifs oraux, qui comprennent un progestogène tel que la drospirénone; un AEstrogène tel que l'éthinylestradiol; un acide tétrahydrofolique ou un sel de qualité pharmaceutique dudit acide, tel que le 5-méthyl-(6S)-tétrahydrofolate de calcium; et au moins un excipient ou vecteur de qualité pharmaceutique. Les compositions selon l'invention présentent une bonne stabilité au stockage de l'acide tétrahydrofolique, tout en assurant une libération rapide et fiable de l'AEstrogène et du progestogène présents dans la composition.

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