Solid dosage form of olmesartan medoxomil and amlodipine with reduced amounts of impurities and reducing sugars

摘要

Disclosed is a solid dosage form comprising olmesartan, medoxomil and amlodipine or a pharmacologically acceptable salt thereof, wherein said solid dosage form is substantially free of reducing sugars. In particular the composistions have small amounts of the impurities 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-imidazol-5-carboxylic acid and 3-ethyl-5-methyl-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate. Also disclosed is the method of treating hypertension in a warm-blooded non-human animal and the use of a solid dosage form in the manufacture of a medicament for the treatment or prophylaxis of hypertension.