Aqueous pharmaceutical formulation

Details Aqueous pharmaceutical formulation Aqueous pharmaceutical formulation

A - Human Necessities

61

K

A61K 9/08 (2006.01) A61K 31/505 (2006.01) A61K 47/10 (2006.01)

Patent

CA 2721014

The invention concerns a stable aqueous pharmaceutical composition comprising 5-[(2RS)-2-cyclopropyl-7,8--dimethoxy-2H-1-benzopyran-5-ylmethyl]-pyrimidine- 2,4- diamine in form of the water soluble methanesulfonic acid salt, a physi-ological sodium chloride solution, ethanol and Povidone 12 PF, the liquid having a pH of over and above 4.8, but not higher than 5.2, and wherein the oxygen amount is controlled to be 0.8 ppm or less; which can be sterilized by filtration and/or by heated treatment, stored for longer time periods and which can be use for bolus injection or diluted for i.v. infusion.

La présente invention concerne une composition pharmaceutique aqueuse stable comprenant de la 5-[(2RS)-2-cyclopropyle-7,8-diméthoxy-2H-1-benzopyrane-5-ylméthyle]-pyrimidine-2,4- diamine sous forme de sel dacide méthanésulfonique soluble dans leau, une solution de chlorure de sodium physiologique, déthanol et de Povidone 12 PF, le liquide ayant un pH supérieur à 4,8, mais inférieur à 5,2, et la quantité doxygène devant être inférieure ou égale à 0,8 ppm ; cette composition peut être stérilisée par filtration et/ou traitement thermique, conservée à long terme et utilisée pour l'injection de bolus ou diluée pour injection par i.v.

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