Romanian Society of Pharmaceutical Sciences

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DESIGN AND DEVELOPMENT OF SUSTAINED RELEASE SWELLING MATRIX TABLETS OF GLIPIZIDE FOR TYPE II DIABETES MELLITUS

PRADUM IGE*, BRAMHANAND SWAMI, TUSHAR PATIL, JITENDRA PRADHAN, PRAMOD PATIL, PANKAJ NERKAR, SANJAY J. SURANA

Department of Pharmaceutics and Quality Assurance, R C Patel Institute of Pharmaceutical Education and Research Shirpur, Dhule, Maharashtra 425405, India

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The aim of the present study was to develop a sustained release monolithic system for the low solubile/low dose glipizide, for the treatment of type II diabetes mellitus. The matrices were prepared by dry blending of polymers hydroxy propyl methyl cellulose (HPMC) or erodible Eudragit (ammonio methacrylate copolymers) and other excipients using direct compression method and were characterized using DSC (differential scanning calorimetry), FTIR (Fourier transform infrared spectroscopy), SEM (scanning electron microscopy), drug content, hardness, friability, in vitro dissolution and stability studies. Hydrophilic matrix tablets exhibited swelling and erosion about 3 fold and 86.23 ±1.5 % after 6 h. In vitro drug release data were analyzed for zero order, first order, Higuchi and Korsemayer-Peppas models. A good linear relationship was observed in the case of release retarding polymer HPMC K100M. A comparison of the prepared and commercial product indicated that the drug release of the formulation GF6 was nearly similar to that of commercial product tested and found to be 98.03±2.51% and 96.05±5.27%, respectively. The GF6 was proven as the optimized swelling matrix tablet and showed non- Fickian diffusion release mechanism with optimum erosion. In conclusion, the rate controlling polymers HPMC K 100M at the 15 percent concentration showed the in vitro release of glipizide sustained for 16 h.