Abstract

Objective: The primary objective of the study is to enhance the bioavailability of drug, pioglitazone HCl by kneading technique using β-cyclodextrine as carrier in the ratios of 1:1, 1:2, 1:3 and 1:5 (F1 to F5) respectively. Method: The prepared kneaded complexes were characterized for drug content and in vitro drug release studies. The kneaded complex of pioglitazone (F1) is releasing 100 % drug within least time (45 min) with maximum drug content. The drug excipients 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 hardness, friability, drug content and in vitro drug dissolution studies. Results: In vitro experiments indicated a sustained release over 11 h in a controlled and constant manner with acceptable tablet parameters as per USP-NF for formulation T9. The in vivo (Antidiabatic) activity of the optimized controlled release tablet (F9) was evaluated in streptozocine induced diabetic model of Wistar rats using Nicotinamide as standard drug. Conclusion: 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 (11 h) both in case of in vitro and in vivo studies and can be adopted for a successful delivery of pioglitazone for oral use for safe management of diabetes. Keywords: Pioglitazone HCl, β-cyclodextrin

Authors and Affiliations