In vitro Comparative Dissolution Studies of Different Propranolol Generic Tablets Available in Bangladesh

The present study focused to assess in vitro dissolution profiles of four different products of propranolol 10 mg Tablets (Randomly coded as PRP1-PRP4) available in Bangladesh comparing with the reference brand (coded as REF). Propranolol is a competitive non selective beta-adrenergic receptor antagonist used to amend or restore normal heart rhythm in cardiovascular diseases. An in vitro dissolution study was carried out using the United States Pharmacopoeia (USP) paddle method at 75 rpm with 500 mL of 0.1N HCl dissolution media at 37.0± 0.5 0C. All the tested locally manufactured propranolol products; PRP1, PRP2, PRP3, PRP4 showed compatible dissolution (87%, 86%, 87%, and 80%, respectively) pattern (dissolution criterion Q=80% in 30 minutes) compared with the reference brand (88% dissolution in 30 minutes). The dissolution behavior was estimated with the reference brand using a model dependent and model-independent approach (f2>50, f1 < 15). A mechanistic mathematical release kinetics was also evaluated. The best-fit kinetic model was Hixon-Crowell release kinetics for reference brand and PRP1; and first order release kinetics was predominant for PRP2, PRP3 and PRP4. Keywords: propranolol, dissolution, similarity factor, difference factor, dissolution kinetics