Kottala Yasoda Krishna*1, Dr. Vijay Kumar, Dr. Suresh Mukkamalla
1*Research Scholar, Shri Jagadish Prasad Jhabarmal Tibrewala University, Jhunjhunnu, Rajasthan
2Associate Professor, Shri Jagadish Prasad Jhabarmal Tibrewala University, Jhunjhunnu, Rajasthan
3HOD, Department of Pharmaceutics, Vijaya College of Pharmacy, Hayath Nagar, Hyderabad.
A B S T R A C T
The prasent study was to develop an optimal gastro retentive drug delivery system for administering Losartan and Hydrochlorothiazide as a fixed-dose combination for antihypertensive therapy. The bilayer tablets were prepared by direct compression method. Losartan potassium and Hydrochlorothiazide were formulated and optimized separately as a floating and immediate release layer. Losartan was formulated as a floating layer using hydrophillic swellable polymer HPMC K4M, ethyl cellulose (4cps) as a bouyancy enhancer and sodium bicarbonate as a gas generating agent. The amount of polymer blends was optimized using 23 full factorial design. The influence of experimental factors such as swelling agent concentration, buoyancy enhancer and gas generating agent on floating lag time, total floating time, T 50% and % drug release were investigated to get optimized formulation. The responses were analyzed using ANOVA and polynomial equation was generated for each response using MLRA. All formulations floated for more than 12 hours. The study revealed that the optimized bilayer floating tablet retains in rabbit stomach for 9 h. The optimized formulation was subjected to stability study for three months at 400C /75% RH. The stability study showed no significant change in appearance of tablets, floating characteristics, drug content and in- vitro drug dissolution.
Keywords: Bi-layer floating tablets, Optimization, ANOVA, Superdisintegrants, Release-retarding polymers, in vivo x ray imaging study.