Novel epoprostenol formulation and method of making thereof

Details Novel epoprostenol formulation and method of making thereof Novel epoprostenol formulation and method of making thereof

A - Human Necessities

61

K

A61K 31/557 (2006.01) A61K 31/5585 (2006.01)

Patent

CA 2641393

This invention relates to a stable epoprostenol composition that can be combined with commercially available IV fluids and can be administered in its reconstituted and/or diluted form under ambient conditions of about 15-30oC for greater than 24 hours. The composition preferably contains (a) epoprostenol or a salt thereof; (b) a alkalinization agent; and (c) a base, such that when reconstituted or in solution, the solution has a pH > 11. Methods for making the lyophilized composition are also disclosed.

La présente invention concerne une composition stable d'époprosténol qui peut être combinée à des fluides disponibles dans le commerce IV et peut être administrée sous sa forme reconstituée et/ou diluée dans des conditions de température ambiante d'environ 15 à 30 °C sur une période supérieure à 24 heures. La composition contient de préférence (a) l'époprosténol ou un sel de celui-ci ; (b) un agent d'alcalinisation ; et (c) une base, de sorte que lorsqu'elle est sous forme reconstituée ou en solution, la solution ait un pH > 11. La présente invention concerne également les procédés de fabrication de la composition lyophilisée.

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