Method for preparing and using polyoxyethylated castor oil...

A - Human Necessities – 61 – K

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A61K 31/337 (2006.01) A61K 47/44 (2006.01)

Patent

CA 2466851

A method is provided for preparing a pharmaceutical composition comprising: taking polyoxyethylated castor oil which if diluted 1:10 in water has a pH greater than 5 and aging the polyoxyethylated castor oil by exposing the polyoxyethylated castor oil to a gas comprising oxygen for a period of time, the exposure to the gas over the period of time causing an acidity of the polyoxyethylated castor oil to increase; and forming a pharmaceutical composition comprising the aged polyoxyethylated castor oil and a pharmaceutically active agent such as paclitaxel; wherein at least 80% of the potency of the pharmaceutically active agent is retained by the pharmaceutical composition after the pharmaceutical composition is stored for at least 7 days at 40~C.

L'invention concerne un procédé permettant de préparer une composition pharmaceutique consistant à utiliser de l'huile de ricin polyoxyéthylée qui, lorsqu'elle est diluée 1:10 dans de l'eau, présente un pH supérieur à 5; à porter l'huile de ricin à maturation par exposition de celle-ci à un gaz contenant de l'oxygène pendant un certain laps de temps, cette exposition au gaz entraînant l'augmentation de l'acidité de l'huile de ricin; puis, à former une composition pharmaceutique comprenant l'huile de ricin polyoxyéthylée portée à maturation et un agent à activité pharmaceutique, tel que le paclitaxel; au moins 80% de l'activité dudit agent étant retenus par la composition pharmaceutique après stockage de cette dernière durant sept jours à 40·C.

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