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.