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Development of Novel Budesonide Pellets Based on Codes™ Technology: In Vitro/In Vivo Evaluation in Induced Colitis in Rats



Varshosaz J1 ; Emami J1 ; Tavakoli N1 ; Minaiyan M2 ; Rahmani N1 ; Dorkoosh F3 ; Mahzouni P4
Authors
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Authors Affiliations
  1. 1. Department of Pharmaceutics, Isfahan, Iran
  2. 2. Department of Pharmacology, Faculty of Pharmacy and Isfahan Pharmaceutical Sciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
  3. 3. Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Department of Pathology, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

Source: DARU, Journal of Pharmaceutical Sciences Published:2011

Abstract

Background and the purpose of the study: Budesonide is the drug of choice for treatment of active inflammatory bowel disease (IBD). The aim of this study was to develop budesonide pellets based on a novel colon drug delivery system (CODES). Methods: Pellet cores containing lactulose or mannitol were prepared by extrusion/spheronization and coated with an acid soluble polymer (Eudragit E100), hydroxypropylmethyl cellulose (HPMC) and an enteric coat (Eudragit FS 30D) sequentially. In vitro drug release of coated pellets was studied using USP dissolution apparatus type II in buffers of pH 1.2 (2 hrs), pH of 7.4 (4 hrs) and pH of 6.8 containing 8% rat cecal contents (RCC) (18 hrs). The efficacy of the optimized formulation (containing 50% lactulose coated with Eudragit E (30% w/w) and Eudragit FS 30D (12% w/w)) was evaluated against 2, 4, 6-trinitrobenzenesulfonic acid (TNBS)-induced colitis in rats. Results: The results of the kind of bacteria in vitro dissolution tests indicated absence of drug release in pHs of 1.2 and 7.4 and controlled release in buffer of pH 6.8 containing RCC. It was found that release rate was controlled by the type and amount of polysaccharide and the thickness of the acid soluble layer. The prepared formulation showed promising results in alleviating the conditions of experimental model of colitis. Conclusion: The results of this study suggest that pellets based on CODES technology could be useful for colonic delivery of budesonide.
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