Liquid and semi-solid pharmaceutical formulations for oral...

Details Liquid and semi-solid pharmaceutical formulations for oral... Liquid and semi-solid pharmaceutical formulations for oral...

A - Human Necessities

61

K

A61K 31/4035 (2006.01) A61K 9/48 (2006.01) A61P 13/10 (2006.01)

Patent

CA 2662435

3-[(3aR,4R,5S,7aS)-5-{(lR)-l-[3,5-bis(Trifluoromethyl)phenyl]ethoxy}-4-(4-fluorophenyl)-octahydro-2H-isoindol-2-yl]cyclopent-2-en-1-one (Compound I) has surprisingly improved solubility, bioavailability and stability in an ampiphilic vehicle that can include propylene glycol, a propylene glycol sparing agent, an antioxidant, or a mixture thereof. In one embodiment of the present invention is a solution comprising the active or a pharmaceutically acceptable salt or solvate thereof, and an amphiphilic agent, said amphiphilic agent being a fatty acid ester of glycerol, propylene glycol or sorbitol.

La présente invention concerne un 3-[(3aR,4R,5S,7aS)-5-{(1R)-1-[3,5-bis(trifluorométhyl)phényl]éthoxy}-4-(4-fluorophényl)-octahydro-2H-isoindol-2-yl]cyclopent-2-en-1-one (composé I), dont la solubilité, la biodisponibilité et la stabilité sont étonnamment améliorées, dans un véhicule amphiphile qui peut inclure du propylène glycol, un agent économisant le propylène glycol, un antioxydant ou un mélange de ceux-ci. Un mode de réalisation de la présente invention est une solution qui comprend la matière active, ou un de ses sels ou solvates pharmaceutiquement acceptable, et un agent amphiphile, ledit agent amphiphile étant un ester d'acide gras du glycérol, du propylène glycol ou du sorbitol.

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