Dispersible concentrate for the delivery of cyclosporin

Details Dispersible concentrate for the delivery of cyclosporin Dispersible concentrate for the delivery of cyclosporin

A - Human Necessities

61

K

A61K 38/13 (2006.01) A61K 9/14 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 47/14 (2006.01) A61K 47/22 (2006.01) A61K 47/24 (2006.01) A61K 47/44 (2006.01) A61P 29/00 (2006.01) A61P 37/00 (2006.01) A61P 37/06 (2006.01)

Patent

CA 2358448

A formulation for the administration of a cyclosporin. This formulation features a hydrophilic solvent which is characterized by being a lower alkyl ester of hydroxyalkanoic acid; and a surfactant, preferably a combination of a surfactant with a high HLB (hydrophilic/lipophilic balance) of at least about 8 and a surfactant with a low HLB of less than about 5. Other ingredients are optional, such as a fatty acid ester such as tricaprin, a phospholipid, and an ethoxylated fat such as Cremophor or another similar substance. Optionally, the ethoxylated fat is substituted for the surfactant. The preferred particle size of the resultant formulation is less than about 100 nm, more preferably less than about 60 nm, and most preferably from about 5 nm to about 50 nm. The formulation of the present invention is characterized by having high bioavailability.

L'invention concerne une préparation destinée à l'administration d'une cyclosporine. Cette préparation contient un solvant hydrophile caractéristique en tant qu'ester d'alkyle inférieur d'acide hydroxyalcanoïque, et un tensioactif constitué de préférence d'un tensioactif ayant un HLB (rapport hydrophile-lipophile) élevé d'au moins environ 8 combiné à un tensioactif ayant un HLB faible inférieur à environ 5. D'autres ingrédients facultatifs peuvent être un ester d'acide gras (tricaprine, par exemple), un phospholipide, ou un corps gras éthoxylé (Cremophor ou autre substance similaire). Le corps gras éthoxylé est éventuellement substituée au tensioactif. La taille des particules préférée de la préparation résultante est inférieure à environ 100 nm. De préférence, cette taille est inférieure à environ 60 nm ou, mieux encore, à environ 5 à 50 nm. La préparation de l'invention est caractérisée par une biodisponibilité élevée.

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