Vasopressin antagonist formulation and process

Details Vasopressin antagonist formulation and process Vasopressin antagonist formulation and process

A - Human Necessities

61

K

A61K 9/48 (2006.01) A61K 31/5513 (2006.01) A61K 31/5517 (2006.01)

Patent

CA 2388474

This invention provides novel formulations for N-[4-(5H-pyrrolo[2,1- c][1,4]benzodiazepin-10(11H)ylcarbonyl)-3-chlorophenyl]-5-fluoro-2-methyl- benzamide, or a pharmaceutically acceptable salt thereof, and processes for making them, the formulations comprising from about 1 % to about 20 % of active ingredient, from about 1 % to about 18 % of a surfactant component, from about 50 % to about 80 % of a component of one or more polyethylene glycols, from about 1 % to about 20 % of a component of one or more sucrose fatty acid esters and/or polyvinylpyrrolidone and, optionnaly, one or more pharmaceutically acceptable preservatives or antioxidants.

L'invention concerne de nouvelles formulations de N-[4-(5H-pyrrolo[2,1-c][1,4]benzodiazépin-10(11H)ylcarbonyl)-3-chlorophényl]-5-fluoro-2-méthyl-benzamide, ou leurs sels pharmaceutiquement acceptables, et leurs procédés de fabrication. Lesdites formulations comprennent environ 1 % à environ 20 % d'un ingrédient actif, environ 1 % à environ 18 % d'un composant tensio-actif, environ 50 % à environ 80 % d'un composant renfermant un ou plusieurs polyéthylèneglycols, environ 1 % à environ 20 % d'un composant renfermant un ou plusieurs esters d'acides gras de sucrose et/ou de polyvinylpyrrolidone et, éventuellement, un ou plusieurs conservateurs ou antioxydants pharmaceutiquement acceptables.

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