FORMULATION DEVELOPMENT AND IN-VIVO RADIOGRAPHIC STUDIES OF DILTIAZEM HYDROCHLORIDE LOADED FLOATING CAPSULES PREPARED BY MODIFIED PULSINCAP TECHNOLOGY

Oral extended release formulation with site-specific drug delivery formulations has been of greater importance in the field of drug delivery system to achieve adequate therapeutic results. The concept of novel gastro-retentive drug delivery system aroused due to site specificity behavior of the drug concerning drug absorption and solubility. The objective of the research work is to develop and evaluate gastro-retentive diltiazem hydrochloride modified pulisincap floating capsules. Diltiazem hydrochloride modified pulsincap floating capsules were formulated by filling the drug-polymer and diluents mixture in cross-linked hard gelatin capsules. Total of 15 formulations was developed and evaluated for pre capsule filling and post capsule filling parameters. Before development of formulation with different polymers, the cross-linked hard gelatin capsules were filled with only pure drug to carry out the diffusion studies of the drug through the cross-linked hard gelatin capsules among the developed, formulation containing carbopol 934p, i.e. F12 formulation was considered to be optimized based on its in-vitro drug release data and have shown the in-vitro drug release of 97.64 ± 3.45% at the end of 12^th  h, in-vitro drug release data were fitted into different kinetic models, optimized formulation has shown the zero order drug release with a mechanism of non-fickian diffusion, radiographic studies confirmed that  optimized formulation with BaSO₄ administered to the healthy volunteer with food have shown more gastric residence time than that  of  the optimized formulation with BaSO₄ administered to the healthy volunteer in fasting condition.