Affiliation: Department of Pharmaceutics, MAEER’s Maharashtra Institute of Pharmacy, MIT Campus, S.No. 124, Kothrud, Pune- 411 038, Maharashtra, India.
Purpose: The objective of the present work was to develop a site specific gastro-retentive floating tablet of Troxipide for the treatment of peptic ulcer. Troxipide is a novel anti-ulcer agent having an elimination half-life of 7.4 hrs and mainly absorbed from the gastrointestinal tract.
Methods: 32 factorial design was applied. Dependant variables were swelling index, hardness and % drug release. Pluronic acid F127 and HPMC K 15M were used as rate controlled polymer. Optimized formulations were evaluated for physical characteristics, buoyancy, buoyancy lag-time, drug content, in- vitro drug release, floating behavior and in-vivo X-ray study.
Results: Formulation H5 (20% Pluronic acid F127 and 78% HPMC K 15M) showed a floating lag time 60 ±2 sec with a desired controlled release profile over a period of 10 hrs. FTIR and DSC studies confirmed no chemical interactions. In-vivo X-ray study for optimized formulations showed gastro retention for 6 hrs.
Conclusion: Results demonstrate feasibility of development of gastroretentive floating tablet of Troxipide.