A Comparative Study of Propranolol Release by In Vitro Dissolution Profiles in Pharmaceutical Formulations

Propranolol is a [beta]-blocker used to modify or restore normal heart rhythm in cardiovascular diseases. The aim of this study was to compare the dissolution profiles of 40-mg tablets of propranolol available as a reference, generic, and similar drug product, sold commercially in Bahia, Brazil, using a sensitive and rapid ultraviolet spectrophotometric method. The dissolution test was used to obtain and compare dissolution profiles and establish similarities of pharmaceutical formulations in compliance with the Brazilian and United States Pharmacopoeias (USP type 1 apparatus at 100 rpm with 1000 mL 0.1 mol/L HCI at 37.0 [+ or -] 0.5 [degrees]C for 1 h). The similar and generic products showed rapid drug release (> 75% after 1 min of dissolution). The reference product showed a controlled drug release profile (> 75% after 15 min). In presence of sodium lauryl ether sulfate (SLES) 1% (v/v) with propranolol, drug release profiles were slower, likely by chemical interactions between SLES and propranolol. Drug release profiles were satisfactory for all products, because at least 75% of propranolol was dissolved in the medium within 30 minutes. KEYWORDS: Propranolol, dissolution, in vitro dissolution profiles, quality control