Stabilized pharmaceutical compositions of safingol and...

A - Human Necessities – 61 – K

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A61K 31/133 (2006.01)

Patent

CA 2516399

The present invention provides stable aqueous solutions consisting essentially of: (a) a sphingolipid; (b) lactic acid; and (c) optionally a stabilizing agent; wherein the solution has a molar ratio of lactic acid to sphingolipid of 1:1 to 10:1. The present invention further provides an emulsion formulation consisting essentially of: (a) lactic acid; (b) a sphingolipid, wherein the sphingolipid is present in an amount of about .1 to about 30 mg/ml of emulsion; (b) optionally an isotonic agent; and (c) a phospholipid present in an amount of about 0.2 to about 200 mg/ml of emulsion. Methods of making and using the compositions are also provided.

La présente invention porte sur des solutions aqueuses stables comprenant principalement: <i>(a)</i> un sphingolipide; <i>(b)</i> l'acide lactique et <i>(c)</i> éventuellement un agent stabilisateur. Cette solution a un rapport molaire de l'acide lactique à sphingolipide de 1:1 à 10:1. La présente invention porte également sur une formulation en émulsion comprenant principalement: <i>(a)</i> l'acide lactique; <i>(b)</i> un sphingolipide, le sphingolipide étant présent dans une quantité comprise entre environ 0,1 et environ 30 mg/ml de l'émulsion; <i>(b)</i> éventuellement, un agent isotonique et <i>(c)</i> un phospholipide présent dans une quantité comprise entre environ 0,2 et environ 200 mg/ml de l'émulsion. L'invention porte également sur des procédés de fabrication et d'utilisation de ces compositions.

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