FORMULATION AND STATISTICAL OPTIMIZATION OF PROPRANOLOL MATRIX TABLET

Matrix system are favored because of their simplicity, patient compliance etc, than traditional drug delivery(TDS) which have many drawbacks like repeated administration, fluctuation in blood concentration level etc. Developing oral sustained release matrix tablets for highly water-soluble drugs with constant release rate has always been a challenge to the pharmaceutical technologist. Most of highly water-soluble drugs, if not formulated properly, may readily release the drug at a faster rate, and are likely to produce toxic concentration of the drug on oral administration. The steady state half lives of propranolol and its derivative are 5 and 11 hours, respectively, necessitating the administration, two or three times daily so as to maintain adequate plasma level of drug. The objective of this study was to investigate extended release formulation of a highly water-soluble drug, propranolol using a wax matrix. Natural waxes such as bees wax and carnauba wax can offer economy. The combination was used to get desired release and physical strength for tablets. Primary studies included the use of various waxes in the formulation development of sustained release formulation out of which beeswax and carnauba wax showed good results and selected for further optimization. A 3? full factorial design was employed for development of sustained release formulation of propranolol tablets in which the amount of beeswax and carnauba wax were taken as formulation variables (factors) for optimizing T50% and release after 12 hours. A mathematical model was generated for each response parameter. Both waxes retarded T50 % and release after 12 h. but bees wax showed significant influence. The optimum formulas were selected by intensive grid search method and their predicted results were found to be in close agreement with experimental findings.