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Published on:July 2017
Indian Journal of Pharmaceutical Education and Research, 2017; 51(4):551-561
Original Article | doi:10.5530/ijper.51.4.84

Development and Evaluation of a System for Colonic Delivery of Budesonide


Authors and affiliation (s):

Nikita Maruti Gaikwad*, Karimunnisa Sameer Shaikh, Pravin Digambar Chaudhari

Department of Pharmaceutics, Modern College of Pharmacy, Sector 21, Yamuna Nagar, Nigdi, Pune, Maharashtra 411044, INDIA.

Abstract:

Introduction: Budesonide, a locally acting corticosteroid, has poor aqueous solubility which limits its dissolution, bioavailability and therapeutic action. There is a need to enhance its solubility as well as target drug to colon to attenuate it’s potential in treatment of ulcerative colitis. Aim: For enhancement of its therapeutic potential, this study attempts a self nano-emulsifying drug delivery system (SNEDDS) which addresses issues of both solubility enhancement and targeted action to colon. Methods: Drug solubility was determined in different oils, surfactants and co-surfactants. Ternary phase diagrams were constructed to obtain maximum nano-emulsion area. SNEDDS containing Capmule® MCM L8 as oil, Tween-80 as surfactant and polyethylene glycol 400 as cosurfactant were formulated to get maximum nano-emulsion in the ternary phase diagram. Herein, the formulated liquid SNEDDS was transformed to a solid form by spray draying method. Subsequently, it was filled into capsules coated with pH sensitive polymer, Eudragit S- 100 along with band sealing. Result: The SNEDDS was increased the solubility of Budesonide by two fold. In vitro drug release of the optimized SNEDDS (particle size 116.32 nm) revealed enhanced drug release in colonic pH as compared to pure drug. The developed SNEDDS of Budesonide also demonstrated better activity against ulcerative colitis as evidenced by the gradually diminishing morphological damages in the histopathological studies in the TNBS induced ulcerative colitis in rats. Conclusion: Thus, SNEDDS enhanced the solubility of Budesonide while the enteric coating provided its colonic release. Such a system shall reform treatment of ulcerative colitis.

Key words: SNEDDS, Colonic Release, Budesonide, Solubility, in vitro, in-vivo, Ulcerative Colitis.

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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