Formulation, invitro evaluation & stability studies of the bilayered tablets of combination-glipizide (I.P) & pioglitazone (I.P)

Abstract

The objective of present investigation was to formulate and evaluate bilayered tablets containing Pioglitazone (I.R) & Glipizide (S.R).The Bilayered tablets prepared by direct compression method. The sustained release layer is prepared by wet granulation method using synthetic and natural polymers like HPMC K4M, Ethylcellulose, and Guargum& Xantham gum. The immediate release layer is prepared by direct compression method using superdisintegrants like Crosscamellose sodium; Crosspovidone & Sodium starch glycolate (SSG). The physicochemical evaluation results for the powdered blend of all trials pass the official limits in Bulk density, Tapped density, Compressibility index, Hausner ratio, and Angle of repose. The formulated tablets were evaluated for thickness, weight variation test, hardness test, friability test and drug content. The prepared tablets exhibited satisfactory physico-chemical characteristics. The formulation (F6) having immediate release layer of Pioglitazone showed 100.8%drug release within 60min & the formulation (F4) having sustained release layer of Glipizide showed 100.1% drug release within 12 hours. The drug release from the tablets was sufficiently sustained. The kinetic modeling of in vitro dissolution profiles revealed diffusion release mechanism. The stability studies revealed no significant changes in physical and chemical properties for the optimized formulation.