Fluvastatin sodium pharmaceutical compositions

Details Fluvastatin sodium pharmaceutical compositions Fluvastatin sodium pharmaceutical compositions

A - Human Necessities

61

K

A61K 9/20 (2006.01) A61K 31/405 (2006.01) A61P 3/06 (2006.01)

Patent

CA 2642195

Various fluvastatin compositions and methods for preparing them are described. One example is a controlled release pharmaceutical composition comprising fluvastatin and at least one non-ionic hydrophilic polymer, wherein the composition is substantially free of hydroxypropyl methylcellulose. Another example is a stable pharmaceutical composition comprising fluvastatin, preferably, fluvastatin sodium wherein the composition is substantially free of an alkalizing stabilizing agent. Another example is a stable controlled release pharmaceutical formulation, comprising fluvastatin, preferably, fluvastatin sodium, that is stable with a water content greater than 3.5 percent by weight.

L'invention concerne différentes compositions de fluvastatine et des procédés servant à préparer celles-ci. Un mode de réalisation concerne une composition pharmaceutique à libération contrôlée comprenant de la fluvastatine et au moins un polymère hydrophile non ionique, ladite composition étant pratiquement exempte d'hydroxypropylméthylcellulose. Un autre mode de réalisation concerne une composition pharmaceutique stable comprenant de la fluvastatine, de préférence de la fluvastatine sodique, ladite composition étant pratiquement exempte d'un agent stabilisant alcalinisant. Un autre mode de réalisation concerne une formulation pharmaceutique à libération contrôlée stable, comprenant de la fluvastatine, de préférence de la fluvastatine sodique, qui est stable avec une teneur en eau supérieure à 3,5 pour cent en poids.

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