Development and evaluation of gastroretentive formulations for moxifloxacin hydrochloride

Abstract

Purpose: The objective of current study is to develop gastro retentive formulation for Moxifloxacin .HCl using various drug release modifiers and performing In-vitro, In-vivo evaluations. Moxifloxacin, novel synthetic fluoro quinolone, antibacterial agent. Methods: Floating, Muco Adhesive tablets of Moxifloxacin.HCl were prepared using variable amounts of HPMCK100M, Lannea coromandelica gum (LCG) by direct compression technique, Wet Granulation technique respectively. Results and Discussion: Formulations were developed, optimized and are checked for pharmacopoeial tests. Results shows that all the factorial batches were lie within the standard limits. Dissolution parameters of all formulations were subjected to kinetic fitting, various statistical parameters were determined. Formulation (GRSOF) containing 50 mg of HPMCK100M and 50 mg of LCG, is the best formulation showing similarity f2=71.734, f1= 4.271 with the marketed product (AVELOX). It follows Higuchi’s kinetics, Non-Fickian Diffusion first order kinetics (n= 0.717). In-vivo studies were performed for the GRSOF with 6 healthy rabbits and pharmacokinetic parameters were determined, compared with Avelox and found that GRSOF produced similar results. Stability studies were performed for GRSOF as per ICH guidelines. Results found to be satisfactory. Conclusion: GRSOF expected to improve patient compliance by means of providing good clinical outcome.