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THERMAL SINTERING: A NOVEL TECHNIQUE USED IN THE DESIGN OF GASTRORETENTIVE FLOATING TABLETS OF PROPRANOLOL HCl AND ITS STATISTICAL OPTIMIZATION USING BOX-BEHNKEN DESIGN

M V SRIKANTH^*, S A SUNIL, N SREENIVASA RAO, B JANAKI RAM, K V RAMANA MURTHY

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The objective of the present investigation was to formulate thermally sintered floating tablets of propranolol HCl using experimental design (Box Behnken) to study the effect of sintering conditions on drug release as well as buoyancy properties. Formulations were prepared using four independent variables namely polymer quantity, sodium bicarbonate concentration, sintering temperature and sintering time, where as floating lag time, and t95 are taken as dependent variables. The formulations were prepared by the direct compression method using polyethylene oxide (PEO) as release retarding polymer and were evaluated for in vitro dissolution studies. It was confirmed that the Quadratic model is suggested for floating lag time and the linear model is suggested for t95. In vitro dissolution studies were carried out on the optimized formulation for verification of the theoretical prediction and found that experimental findings are in close agreement with the model predictions. The % relative error between the predicted values and experimental values of each response was found to be < 5%. The optimized formulation (PTSso) followed first order kinetics with erosion mechanism. The statistically optimized formulation was characterized with FTIR (Fourier transformation - infrared spectroscopy) and DSC (differential scanning calorimetry) studies and found no chemical interactions between drug and polymer.