Formulation and in vitro studies of a fixed-dose combination of a bilayer matrix tablet containing metformin HCl as sustained release and glipizide as immediate release.
The emerging new fixed dose combination of metformin hydrocholride (HCl) as sustained release and glipizide as immediate release were formulated as a bilayer matrix tablet using hydroxy propyl methyl cellulose (HPMC) as the matrix-forming polymer, and the tablets were evaluated via in vitro studies. Three different grades of HPMC (HPMC K 4M, HPMC K 15M, and HPMC K 100M) were used. All tablet formulations yielded quality matrix preparations with satisfactory tableting properties. In vitro release studies were carried out at a phosphate buffer of pH 6.8 with 0.75% sodium lauryl sulphate w/v using the apparatus I (basket) as described in the United States Pharmacopeia (2000). The release kinetics of metformin were evaluated using the regression coefficient analysis. There was no significant difference in drug release for different viscosity grade of HPMC with the same concentration. Tablet thus formulated provided sustained release of metformin HCl over a period of 8 hours and glipizide as immediate release.
Mandal
Uttam
U
Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
Pal
Tapan Kumar
TK
D002626:Chemistry, Pharmaceutical / Q000379:methods; D003692:Delayed-Action Preparations; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D004338:Drug Combinations; D005079:Excipients / Q000737:chemistry*; D005913:Glipizide / Q000737:chemistry*; D007004:Hypoglycemic Agents / Q000737:chemistry*; D065347:Hypromellose Derivatives; D008687:Metformin / Q000737:chemistry*; D008747:Methylcellulose / Q000031:analogs & derivatives / Q000737:chemistry; D012967:Sodium Dodecyl Sulfate / Q000737:chemistry; D013607:Tablets; D013678:Technology, Pharmaceutical; D014783:Viscosity
D003692:Delayed-Action Preparations; D004338:Drug Combinations; D005079:Excipients; D007004:Hypoglycemic Agents; D013607:Tablets; D012967:Sodium Dodecyl Sulfate; D065347:Hypromellose Derivatives; D008747:Methylcellulose; D008687:Metformin; D005913:Glipizide