Abstract

FORMULATION DEVELOPMENT AND IN VITRO EVALUATION OF PULSATILE RELEASE TABLET OF BUDESONIDE

S. Jeganath * and K. Senthilkumaran

Abstract

The objective of this study was to develop a ileo caecal targeted drug delivery of budesonide for the treatment of IBD. Budesonide were selected as model standard drugs to treat IBD. Budesonide is a potent, synthetic non-halogenated corticosteroid with high topical antiinflammatory effect and little systemic effects. Tablets were prepared by using Crospovidone and Eudragit L30D coating for the burst release in the ileo caecal region. The formulations were evaluated for pharmacopoeial quality control tests and all the physical parameters evaluated were within the acceptable limits. Formulation F11 was proved to be good drug content, dimensional stability, lag time and drug release in the ileo caecal region as compared to the other formulations. Stability studies were carried out on the optimized formulation F11 for period of 3 months at 400c/75 %RH. Finally it was observed that there was no change in physiochemical and physical properties as well as in drug release profile even after storage at 45 °C and 75 % for three months.

Keywords: Budesonide. ileo caecal, Lag time, Stability study.