Purpose: The objective of the current study is to develop gastroretentive formulation for moxifloxacin HCl (hydrochloride) using various drug release modifiers and performing in vitro and in vivo evaluations. Moxifloxacin is a novel synthetic compound having antibacterial activity. Materials and Methods: Floating and mucoadhesive tablets of moxifloxacin HCl were prepared using variable amounts of HPMC K100M and Lannea coromandelica gum (LCG) by direct compression technique and wet granulation technique, respectively. Results and Discussion: Formulations were developed, optimized and are checked for pharmacopoeial tests. Results show that all the factorial batches were lying 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 HPMC K100M 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 and non-Fickian diffusion first-order kinetics (n = 0.717). In vivo studies were performed for the GRSOF with six 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 International Conference on Harmonization (ICH) guidelines. Results found to be satisfactory. Conclusion: GRSOF expected to improve patient compliance by means of providing good clinical outcome.
Keywords
Gastroretentive, HPMC K100M, in vitro, in vivo, Lannea coromandelica gum, moxifloxacin hydrochloride
THE THAI JOURNAL OF PHARMACEUTICAL SCIENCES
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