Formulation comprising testosteron undecanoate and castor oil

A - Human Necessities – 61 – K

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Details

A61K 31/568 (2006.01) A61K 9/48 (2006.01) A61K 47/44 (2006.01)

Patent

CA 2366856

Disclosed is a pharmaceutical formulation in the form of a capsule for oral administration comprising testosterone undecanoate as an active ingredient dissolved in a pharmaceutically acceptable liquid carrier, characterised in that the liquid carrier comprises at least 50 % by weight of castor oil. The choice of castor oil as the liquid carrier, in conjunction with the choice of testosterone undecanoate as the androgen, makes for a solution which can comprise about 200-250 mg/ml of TU. This is a novel achievement for any orally administerable solution of testosterone. The solution may also contain a lipophilic surfactant such as lauroglycol.

L'invention concerne une préparation pharmaceutique sous forme de capsule destinée à l'administration par voie orale, contenant une matière active, la testostérone undécanoate, dissoute dans un excipient liquide acceptable d'un point de vue pharmaceutique, caractérisée en ce que ledit excipient liquide comprend au moins 50 % en poids d'huile de ricin. L'huile de ricin, l'excipient liquide, associée à la testostérone undécanoate, l'androgène, donnent une solution pouvant comporter environ 200-250mg/ml de testostérone undécanoate (TU). Cette préparation est un nouvel avancement pour toutes les solutions de testostérone administrables par voie orale. Ladite solution peut en outre contenir un surfactant lipophile tel que le lauroglycol.

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