ABSTRACT:
In the present study an effort has been made to evaluate the effect of hydrophilic polymer as a rate retarding material to sustain the release of Salbutamol Sulphate from the sustained release tablet. Formulation of salbutamol sulphate sustained release tablet were made by direct compression method, using hypromellose 15,000 cps, hypromellose 4000 cps and carbomer 934P as release rate controlling polymer. These polymers were used at different concentration. Physical parameters of the prepared tablets were evaluated. To find out the appropriate dissolution media upon solubility, different media (distilled water, 0.9% NaCl, 0.1 N HCl, Phosphate buffer) were used for preparation of standard solution and dissolution media. The maximum absorbance was observed at 276nm for each preparation using UV-Visible spectroscopy. Release profile of sulbutamol sulphate from this sustained release tablet at dissolution media (pH-7.4 phosphate buffer) was investigated using USP apparatus-II paddle method for eight hours and the drug content was measured by UV-Visible Spectroscopy. The release rate, extent and mechanisms were found to be governed by polymer type and their content. Highly viscous and higher content of hypromellose 15,000 cps (40%) in the F-3 was shown comparatively slower rate and extent of drug release than other formulations. The release mechanism was explored and explained with Zero order, Higuchi, First order and Korsmayer equation. Release profile of sulbutamol sulphate from F-1, F-2 F-3, F-5, F-6, F-7, F-8, F-9, F-10, F-11 and F-12 showed a tendency to follow Zero order Kinetics. F-1, F-2 F-3, F-4, F-7, F-8, F-9, F-10 and F-13 followed Higuchi Kinetics. Most of the formulations follow non-Fickian (anomalous) release except F-7, F-8, F-10, F-11, and F-13 which show Fickian (Case ?) release. The higher MDT value of F-3 indicates a higher drug retaining ability of Hypromellose 15,000 cps. Two market preparations were taken to compare release profile with the prepared tablets. Result showed that tablet formulated with hypromellose 15000 cps exit sustaining effect comparatively better than market preparation.