Acta Pharm. 57 (2007) 479-489
Original research paper
Design and evaluation of sustained release bi-layer tablets of propranolol hydrochloride
CHINAM NIRANJAN PATRA, ARETHI BHARANI KUMAR, HEMANT KUMAR PANDIT, SATYA PRAKASH SINGH and MEDURI VIMALA DEVI
P.G. Department of Pharmaceutics, College of Pharmaceutical Sciences, Berhampur-760002, Orissa, India
Accepted August 20, 2007
The objective of the present research was to develop a bilayer tablet of propranolol hydrochloride using superdisintegrant sodium starch glycolate for the fast release layer and water immiscible polymers such as ethyl cellulose, Eudragit RLPO and Eudragit RSPO for the sustaining layer. In vitro dissolution studies were carried out in a USP 24 apparatus I. The formulations gave an initial burst effect to provide the loading dose of the drug followed by sustained release for 12 hrs from the sustaining layer of matrix embedded tablets. In vitro dissolution kinetics followed the Higuchi model via a non-Fickian diffusion controlled release mechanism after the initial burst release. FT-IR studies revealed that there was no interaction between the drug and polymers used in the study. Statistical analysis (ANOVA) showed no significant difference in the cumulative amount of drug release after 15 min, but significant difference (p < 0.005) in the amount of drug released after 12 h from optimized formulations was observed.
Keywords: propranolol hydrochloride, bilayer tablets, sodium starch glycolate, water immiscible polymers, statistical analysis