Formulation and Evaluation of Alogliptin 12.5mg Immediate Release Tablets

Abstract

The current research work predicts the applicability of QbD in manufacturing Alogliptin 12.5mg Tablets by using rate Disintegrants and diluent. From the results it was clearly apparent that as the disintegrate concentration increases. Grouping of disintegrate with other excipients do not interact with drug and vice versa, which informations to immediate delivery of drug. The improved formulation from factorial design can be used as a single dose per day. Bentonite was used successfully in preparing immediate release tablets containing alogliptin. However, this was possible only with aid of hydroxypropyl methylcellulose (HPMC). Furthermore, this study revealed the effect of benzoate on the crystalline bentonite structure and, as a result, the building gel structure of bentonite in water was hindered. Different used binders did not help to maintain the gel structure except by using HPMC. Dry and wet granulation procedure was the chosen technology for the preparation of tablet. Based on the preliminary studies, different formulation trials (F1-F7) were carried out with different concentrations of disintegrants, diluents. From the various formulations it was decided that the formulation batch of F7 was finalized as the optimized formula. Formulation F7 showed satisfactory results with various physicochemical evaluation parameters like Disintegration time, Dissolution profile, Assay when matched with that of the marketed product. The stability studies at all condition, indicates that the formulated capsules were found to be stable. Hence, it is finally concluded that, tablet are pharmaceutically comparable, low cost, quality improved and stable formulation.