DESIGN AND EVALUATION OF PIOLGLITAZONE HCL SUSTAINED RELEASE TABETS FOR TYPE 2 DIABETES MELLITUS

The objective of this study is to formulate and evaluate sustained release tablets of Pioglitazone HCl, which were developed to prolong the action leading to an increase in drug bioavailability and reduced dosing frequency. Sustained release (SR) drug delivery systems are developed to modulate the release of drug, in order to achieve specific clinical objectives that cannot be attained with conventional dosage forms. Possible therapeutic benefits of a properly designed SR dosage form include low cost, simple processing, improved efficacy, reduced adverse events and flexibility in terms of the range of release profiles attainable. Two different grades of HPMC K 100M, HPMC K15M and PEO, carbopol, Xanthum gum, MCC, Magnesium stearate and talc were used as variants along with pioglitazone HCl as active pharmaceutical ingredient. All these polymers are used in different concentrations to sustain the action. The tablets were prepared by direct compression method and are evaluated for pre compressional studies like bulk density, tapped density, compressibility index, Hausner ratio and angle of repose; all the values were found within limits of standard. In vitro release studies were carried out by USP type II paddle apparatus. The interaction of polymer and drug ruled out by FTIR studies. The FTIR studies confirmed that there is no interaction between the drug and polymer. Data of in-vitro release of tablets were fit in different equations and kinetic models to explain release kinetics the models used were zero order and first order equations. Higuchi and Korsmeyer peppas models based on physiochemical properties and in vitro release studies. The results showed that HPMC K15M produce sustained release of drug. The formulation F10 (HPMCK15M) with 1:3 ratio produced 99% drug release at 12 h.