Methods and pharmaceutical compositions for reliable...

A - Human Necessities – 61 – K

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A61K 31/56 (2006.01) A61K 31/565 (2006.01) A61K 31/568 (2006.01) A61K 47/14 (2006.01)

Patent

CA 2518910

The present invention relates to pharmaceutical compositions, formulated for injectable administration, which comprises a testosterone ester, in particularly testosterone undecanoate, in a vehicle comprising castor oil and a co-solvent. Upon injecting the compositions according to a particular administration scheme, reliable levels of testosterone in serum in the normal physiological range is achieved for a long period. This allows for the use of the compositions in hormone replacement therapy and male contraception without concomitant monitoring of testosterone levels in serum by a physician.

L'invention concerne des compositions pharmaceutiques injectables qui contiennent un ester de testostérone, notamment la testostérone undécanoate dans un excipient qui comprend l'huile de ricin et un co-solvant. Lorsque les compositions sont injectées selon un programme particulier d'administration, on obtient des niveaux fiables de testostérone dans le sérum dans la plage physiologique normale pendant une longue période. Cela permet d'utiliser ces compositions dans des thérapies de remplacement hormonal et en contraception masculine sans la surveillance associée des niveaux de testostérone dans le sérum par un médecin.

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