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AssigneesSankyo Company, Limited, Ube Industries, Ltd.
InventorsNaoki Wakiyama, Fusao Usui, Kenji Nishimura
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The present invention provides a pharmaceutical composition containing a calcium channel blocker of the following formula or a pharmacologically acceptable salt thereof and a pharmacologically acceptable alkaline material which is added to an extent such that an aqueous solution or dispersion solution of said pharmaceutical composition containing a calcium channel blocker has a pH of at least 8: [wherein R1 represents an optionally substituted C1-C4 alkyl group, an amino group or a cyano group; R2 represents an optionally substituted C1-C4 alkyl group, a substituted C3-C4 alkenyl group, or a substituted 4- to 6-membered cyclic amino group; R3 represents a substituted phenyl group; R4 represents an optionally substituted C1-C4 alkoxycarbonyl group, a 1,3,2-phosphorinan-2-yl group, or a 5,5-dimethyl-1,3,2-phosphorinan-2-yl group, R5 represents a C1-C4 alkyl group].
A method for stabilizing a pharmaceutical composition containing azelnidipine or a pharmacologically acceptable salt thereof by adding to the pharmaceutical composition a pharmacologically acceptable alkaline material to an extent such that an aqueous solution or dispersion solution of the pharmaceutical composition has a pH of at least 8.
A method according to claim I wherein the alkaline material is an alkali metal hydroxide, an alkaline earth metal hydroxide, an aluminum hydroxide, an alkali metal carbonate, an alkaline earth metal carbonate, an alkali metal hydrogencarbonate, a di-alkali metal phosphate, a di-alkaline earth metal phosphate, a tri-alkali metal phosphate, an alkaline earth metal oxide, aluminum oxide, an alkali metal silicate, an alkaline earth metal silicate, a silicic acid-aluminum complex compound, an aluminum-magnesium complex compound, or a mixture thereof.
A method according to claim I wherein the alkaline material is an alkali metal carbonate, an alkaline earth metal carbonate, an alkali metal hydrogencarbonate, an alkaline earth metal oxide, an alkali metal silicate, an alkaline earth metal silicate, an aluminum-magnesium complex compound, or a mixture thereof.
A method according to claim. 1 wherein the alkaline material is sodium carbonate, sodium bicarbonate, calcium silicate, magnesium aluminosilicate, magnesium aluminometasilicate, or a mixture thereof.
A method according to any one of claims I to 5 wherein the pharmaceutical composition is a tablet.
Dependencies are inferred from the claim text.