Unitary vaginal dosage form useful as a local contraceptive...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/48 (2006.01) A61K 9/00 (2006.01) A61K 9/02 (2006.01) A61K 9/14 (2006.01) A61P 15/18 (2006.01) A61P 31/00 (2006.01) A61P 31/18 (2006.01)

Patent

CA 2208436

Dosage form comprising, firstly, an outer envelope comprising gelatine and, secondly, an inner non-aqueous liquid or semi-liquid phase containing an active ingredient in a solution. The invention is characterized in that the active ingredient consists of a spermicide and the inner phase includes, in addition to the active ingredient: a major proportion of a lipophilic agent compatible with the rubber latex forming a condom; a minor proportion of at least one hydrodispersible agent; at least one bioadhesion agent; and at least one gelling agent for the lipophilic agent. Said vaginal dosage form combines the advantages associated with a soft capsule with spermicidal, antiseptic and lubricating properties. It can be used safely in conjunction with condoms without altering their rubber latex composition.

Cette forme galénique, qui comprend, d'une part, une enveloppe externe comportant de la gélatine et, d'autre part, une phase interne liquide ou semi-liquide non aqueuse contenant un principe actif en solution, est caractérisée en que le principe actif est constitué d'un spermicide et en ce que la phase interne comporte, outre le principe actif: en proportion majoritaire, un agent lipophile compatible avec le latex de caoutchouc d'un préservatif; en proportion minoritaire, au moins un agent hydrodispersible; au moins un agent de bioadhésion; et au moins un agent gélifiant de l'agent lipophile. Cette forme galénique destinée à la voie vaginale, qui procure les avantages connus de la capsule molle, présente des propriétés à la fois spermicides, antiseptiques et lubrifiantes et, de plus, est compatible de façon sûre avec les préservatifs, sans risque de détérioration du latex de caoutchouc de ces derniers.

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