GB2471970A — Composition comprising olmesartan medoxomil, amlodipine and hydrochlorothiazide

USPTO Abstract

Composition comprising olmesartan medoxomil (angiotensin II receptor antagonist), amlodipine, preferably, amlodipine besylate (calcium channel blocker) and hydrochlorothiazide (diuretic). Preferably the composition is a solid dosage form, in particular a tablet and has less than 7.3% concentration (w/w) of total impurities. The composition preferably has less than 2.5% concentration (w/w) of 4- (1-hydroxy-1-methylethyl)-2-propyl -1-[[2'-(1H-tetrazol-5-y1)biphenyl-4-y1]methyl]-1H-imidazol-5-carboxylic acid (RNH-6270), and/or less than 0.4% concentration (w/w) of 3-ethyl-5-methyl-2-[(2-alninoethocy)methyl]-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate (impurity D). Preferably the composition is for use in the treatment or prophylaxis of hypertension and comprises 20 to 40 mg of olmesartan medoxomil, 5 to 10 mg of amlodipine and 12.5 to 25 mg of hydrochlorothiazide. Typically the composition comprises (in mg) olmesartan medoxomil (40), amlodipine (13.89), hydrochlorothiazide (12.5), pregelatinized starch (105), silicified microcrystalline cellulose (112.41), croscarmellose sodium (15) and magnesium stearate (1.2).