Pharmaceutical formulation comprising glycine as a stabilizer

Details Pharmaceutical formulation comprising glycine as a stabilizer Pharmaceutical formulation comprising glycine as a stabilizer

A - Human Necessities

61

K

A61K 31/44 (2006.01) A61K 31/4439 (2006.01) A61K 47/18 (2006.01) A61K 47/02 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2308143

The present invention provides pharmaceutical formulations suitable for intravenous injection comprising a lyophilized anti-ulcerative agent reconstituted in isotonic solutions suitable for intravenous administration, such as 5 % dextrose or 0.9 % sodium chloride. The solutions are brought to a pH of between about 9 and about 12, preferably between about pH 10 and 11, by a glycine-sodium hydroxide buffer. Such formulations are chemically and physically stable, and do not significantly change color, for at least between about 6 and about 12 hours at room temperature, and are stable to color change for from between about 24 and 48 hours if kept at 5 ~C.

Cette invention se rapporte à des formulations pharmaceutiques pour injection intraveineuse, qui comprennent un agent anti-ulcéreux lyophilisé, reconstitué dans des solutions isotoniques propres à une administration intraveineuse, par exemple 5 % de dextrose ou 0,9 % de chlorure de sodium. Ces solutions sont amenées à un pH compris entre environ 9 et environ 12, de préférence entre environ 10 et 11, par un tampon glycine-hydroxide de sodium. Ces formulations sont chimiquement et physiquement stables et elles ne changent pour ainsi dire pas de couleur, au moins pendant une période comprise entre environ 6 et environ 12 heures à température ambiante, et elles sont stables à tout changement de couleur pendant une période comprise entre environ 24 et 48 heures, si elles sont maintenues à 5 ·C.

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