Purpose of the research was to present Budesonide (BUD), a glucocorticoid, as a novel formulation showing improved aqueous solubility, which may decrease patient to patient absorption variability, and target the drug to colon for the treatment of inflammatory bowel disease. To improve aqueous solubility, solid dispersion (SD) of the BUD with poloxamer 188 was prepared by melting method. Physical characterization of solid dispersion was performed. The tablets containing SD equivalent to 9mg of BUD were prepared by wet granulation. The tablets were coated with pH dependent polymers Eudragit (EUD) S100 & Eudragit (EUD) L100 to achieve colon targeting. The ratio of EUD S100 and EUD L100 and the % weight gain was optimized using factorial design. Factors studied in design were ratio of EUD S100 in combination with EUD L100 and the effect of coating level on in-vitro drug release at 7 & 10 hours. Dissolution studies of coated tablets in with different pH media (1.2, 4.6, 6.8 and 7.4) showed that drug release in colon could be modulated by optimizing the ratio of EUD S100 & EUD L100 (12.15:2.57) and (3.52:11.47) with % weight gain of 6.05% & 9.5% respectively. The study showed that, lag time prior to drug release was highly affected by the coating level. The dissolution data showed that the level of coating and the ratio of polymers are very important to get optimum formulation. Stability study of the optimized formulation indicates no significant change in release after a period of one month.
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