Abstract
Formulation, Development and Stability of Granisetron Sustained Release Oral Dispersible Tablets
Department of Pharmaceutical Sciences and Technology, Birla Institute of Technology, Mesra, Ranchi-835 215, India
Correspondence Address:
Department of Pharmaceutical Sciences and Technology, Birla Institute of Technology, Mesra, Ranchi-835 215, India, E-mail: kkpradhan@bitmesra.ac.in
Granisetron, a selective 5-HT3 receptor antagonist has a good safety profile but a shorter half-life hence is only suited for a multiple dosage regimen, which increased side effects. Ion-exchange resins were extensively investigated as potential drug release modulators and the ability to get encapsulated along with drugs appeared to be a distinct advantage. Optimized conditions for drug loading using ion-exchange resins Kyron T-114 and Kyron T-134 were evaluated. The microencapsulated drug-resin complexes were incorporated into oral dispersible tablets prepared using crospovidone as a superdisintegrant. The in vitro release profile of the optimized formulation of F4 was investigated, which showed linearity of Higuchi's rate kinetic equation. The shelf life of the optimized formulation was estimated to be 6.7 y, based on accelerated stability study data obtained. The physical and solution 3-month stability studies with the three formulations, F4, F5 and F6, showed better disintegration times.
