Oral pharmaceutical compositions containing long-chain...

A - Human Necessities – 61 – K

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Details

A61K 31/568 (2006.01) A61K 9/48 (2006.01) A61K 47/10 (2006.01) A61K 47/14 (2006.01) A61K 47/24 (2006.01) A61K 47/44 (2006.01)

Patent

CA 2366754

The invention disclosed herein relates to liquid pharmaceutical compositions for oral administration which contain a drug or active ingredient dissolved in a liquid vehicle or carrier in which the liquid vehicle comprises a glyceride of a long chain fatty acid having from 14 to 22 carbon atoms and a lipophilic surfactant having an HLB of less than 10. Compositions of the invention provide increased drug or active ingredient stability and contain a liquid vehicle which is less reactive with the drug or active ingredient than free fatty acids. In one embodiment, the liquid pharmaceutical compositions contain testosterone undecanoate, a long chain triglyceride, and lauroglycol. The compositions can be orally administered and formulated in soft gel or hard shell capsule form.

L'invention concerne des compositions pharmaceutiques liquides destinées à être administrées par voie orale, ces compositions renfermant un médicament ou un principe actif dissous dans un excipient ou un support liquide qui comprend un glycéride d'un acide gras à longue chaîne avec 14 à 22 atomes de carbone, ainsi qu'un tensioactif lipophile présentant un rapport HLB inférieur à 10. Les compositions de la présente invention, qui assurent une stabilité améliorée du médicament ou du principe actif, renferment également un excipient liquide moins réactif avec le médicament ou le principe actif que les acides gras libres. Dans un mode de réalisation, ces compositions pharmaceutiques liquides renferment du testostérone undécanoate, un triglycéride à longue chaîne, et du lauroglycol. Enfin, les compositions de cette invention peuvent être administrées par voie orale et se présenter sous la forme de capsules molles ou de gélules.

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