EFFECT OF NATURAL AND SYNTHETIC POLYMER ON RELEASE OF KETOTIFEN FUMARATE MATRIX TABLETS: A SUSTAINED RELEASE DOSAGE FORM

With the blend of Methocel K15, a synthetic polymer and xanthan gum, a natural polymer (3:1) was used in the formulation of matrix tablets to find out the effect of natural polymer in the sustained release dosage form. Direct compression process was applied for the preparation of Ketotifen fumarate tablets. The dissolution profiles were carried out by USP apparatus 2 (paddle) at 50 rpm in 500 ml 0.1 N HCl and distilled water. For interpreting the results a one way analysis of variance (ANOVA) was exploited. Statistically significant differences were found among the drug release profile from different matrices. At a higher polymeric content (60% of the total tablet weight), drug release from the combination of Methocel K15M and xanthan gum (3:1) was slower. On the contrary, at a lower polymeric level (30% of the total tablet weight); the rate of drug release was prominent. The best-fit release kinetics was accomplished with the Higuchi model followed by the zero-order plot, Korsmeyer and Hixson Crowell equations. One formulation showed drug release is more controlled. The data obtained proved that the formulations are useful for a sustained release of ketotifen fumarate. From these formulations corresponded more controlled of the drug release by the higher polymeric level of methocel K15M & xanthan gum and vice versa. The extended release of the model drug found from the higher proportion of methocel K15M and xanthan gum. As a result, the frequency of administration of such type of drug reduced.