ABSTRACT:
The objective of this study was to develop the Candesartan celexitil gastro retentive sustained release floating matrix tablet using gas generating approach to prolong the gastric residence time. This can be achieved by formulating modified gastro retentive sustained release dosage forms which resides in the stomach for the sufficient time to release the drug in vicinity of the absorption zone. The tablet were prepared by direct compression, by employing semi-synthetic polymer like HPMC K15M and HPMC K100M in various concentrations. Sodium bicarbonate was employed as gas generating agent. The powdered blend evaluated for angle of repose, bulk density, tapped density, compressibility index, Hausner ratio. The results obtained were satisfactory. Compressed formulation were further evaluated for thickness, friability, hardness, swelling index, and In-vitro dissolution studies. All the formulations showed good results which were in compliance with Pharmacopoeia standards. A 32 Factorial design was used to select the optimized formulation wherein HPMC K15(X1) and HPMC K100M were taken as a independent variables and floating lag time(FLT), Floating time(FT), Percentage Drug Release(%) after 12hrs,were taken as dependent variables. Optimization studies were carried out by using the Design Software Version 8.0.1. The in-vitro cumulative % drug release of all formulations ranged from F5 at the end of 12hrs. The in-vitro drug release followed by Higuchi model and the drug release mechanism was found to be non-fickian type. This kinetic studies were carried out by using the PCP Disso Version 2.08 software, and the model with the higher correlation was considered to be the best model .