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Context: Ensuring the quality of a generic drug is essential for its commercialization. Propranolol hydrochloride is a drug in great demand on the market as it is widely used as an antihypertensive, antianginal, antiarrhythmic, and for the treatment of migraine, requiring a complete evaluation to determine equivalence. Aims: To evaluate the dissolution biopharmaceutical characteristic in multisource products marketed in the Peruvian market, taking Inderal® as a reference product. Methods: In vitro conditions are simulated using the USP apparatus II at 50 rpm and 900 mL of the dissolution media pH 1.2, 4.5, and 6.8 at 37°C. The dependent mathematical models were characterized by the Akaike information criterion, and the similarity was evaluated using the independent parameters (MDT, DE, and the similarity factor f2). Results: The average dissolution percentages demonstrate a difference between the multisource and the innovator in the three-dissolution media. The model that best characterizes the dissolution kinetics in all products is that of Hixson–Crowell. A significant difference was obtained in the MDT and DE between the innovative and multisource products and in the three-dissolution media. The similarity factor was not within the acceptable range for multisource products in the three-dissolution media. Conclusions: The 40 mg propranolol hydrochloride tablets included in the study are not equivalent in vitro to the innovative product and, therefore, are not interchangeable.
Saavedra et al. (Mon,) studied this question.