Volume 7

April-June 2015

Formulation design and in vitro evaluation of control release tablet of pioglitazone HCl solid dispersion

Sruti Ranjan Mishra, Bhabani Shankar Nayak, Suprava Sethy, P Ellaiah, Gitanjali Mishra

Abstract:
The primary objective of the study is to enhance the bioavailability of pioglitazone HCl by kneading technique using pioglitazone HCl as drug and β-cyclodextrine as carrier in the ratios of 1:1, 1:2, 1:3 and 1:5 respectively. The prepared kneaded complexes were characterized for flow properties, drug content and in vitro drug release studies. The kneaded complex of pioglitazone is releasing 100 % drug within 45 min where as pure drug is releasing drug within 150 min. The kneaded complex formulation F1 of drug carrier ratio 1:1 was found to be best for excellent flow property, maximum drug content (88.76±0.23 %) and releasing maximum drug with least time. The drug excipient interaction study was carried out by Fourier Transform Infrared Spectroscopy (FTIR) and differential scanning colorimetric study. The solid dispersion formulation (F1) was used in preparation of control release tablet by direct compression method using hydroxyl propyl methyl cellulose (HPMC K4M) and ethyl cellulose as rate controlling polymers. The tablets were evaluated for thickness, diameter, weight variation, hardness, friability, in vitro drug dissolution and drug release kinetic studies. In vitro experiments indicated a sustained release over 11 h and acceptable tablet parameters as per USP-NF for formulation T9. Hence, it can be concluded that the formulation T9 containing HPMCK4M and ethyl cellulose (80 & 70 mg) has potential to deliver pioglitazone in a controlled and constant manner for prolong period over other formulations and can be adopted for a successful delivery of pioglitazone for oral use.

Keywords: Pioglitazone HCl, β-cyclodextrin, Kneading, Antidiabetic, Bioavailability, Control Release, Tablet.