Formulation and In vitro Evaluation of Colon Specific Drug Delivery of Budesonide

The objective of this study was to develop a colon targeted drug delivery of budesonide for the treatment of Ulcerative Colitis (UC). Budesonide were selected as model standard drugs to treat UC. Budesonide is a potent, synthetic non-halogenated corticosteroid with high topical antiinflammatory effect and little systemic effects. Tablets were prepared by using HPMC K4M and Eudragit L30D coating for the sustained release in the entire colon region. The formulations were evaluated for pharmacopoeial quality control tests and all the physical parameters evaluated were within the acceptable limits. Formulation S15 was proved to be good drug content, dimensional stability, lag time and drug release in the colonic region as compared to the other formulations. Stability studies were carried out on the optimized formulation S15 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.

Author(s): S. Jeganath and K. Senthilkumaran

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