Formulation and development of multiparticulates dosage form of propranolol hydrochloride

Abstract

Aim: The objective of the present research work was to develop stable extended release (ER) pellets of propranolol hydrochloride, an antihypertensive drug, for which drug release profile is compared with reference to the multiple conventional dosage form i.e. marketed product "Inderal LA" (160 mg). Method: ER formulations were developed using fluid bed layering and coating techniques on sugar spheres. Pellets were characterized in reference to the drug content, size distribution, scanning electron microscopy (SEM); dissolution study of various formulations was performed in 1.2 pH HCl buffer for 1.5 hours followed by testing in 6.8 pH phosphate buffer for 24 hours (USP Criteria). Stability studies of the optimized formulation were carried out for a period of 30 days at 40 ± 2°C and 75 ± 5% relative humidity and were found to be stable. SEM photograph confirmed that the prepared pellets were spherical in nature. The drug content of the formulations was found in the range of 98 to 99.7% and the mean particle size of the drug loaded pellets was in the range of 1190 to 420 μm (F1 to F3 formulation). Result and Conclusion: Results revealed that EC N50: TEC (90:10) is the best combination of polymer which controls the drug release profile up to 24 hours. Moreover similarity of release between optimized formulation and Inderal LA was confirmed by calculation of two factors f1 (difference factor) = 1.95 and f2 (similarity factor) = 99 from the dissolution data. The kinetic data of ER pellets formulation showed good fit in Korsmeyer-Peppas model and followed by Higuchi kinetic drug release.