Formulation and Evaluation of Gastro Resistant Extended Release Formulation for Colon Targeted Drug Delivery System

Budesonide is a locally-acting glucocorticosteroid with an extensive, primarily hepatic, metabolism after oral administration. Budesonide, a pH- and time-dependent oral formulation of Budesonide, was developed to optimise drug delivery to the ileum and throughout the colon. The objective of the proposed research work has been designed to targeted at the particular action site to overcome the topical actions like inflammatory bowel disease like Crohn's disease, ulcerative colitis and to improved the dissolution rate and enhance the bioavailability. Budesonide capsule was prepared by varying the concentration of plasticizer like ethyl cellulose and evaluated for physico-chemical evaluation parameter such as Description, Identification, %LOD, Assay and In-vitro dissolution studies. The market formulation was formulated and evaluated and was used for comparison. The six formulations, P*1 to P*6 were formulated and among these formulations, P*6 was optimized. The results of all formulation for Description, Identification, %LOD, Assay and In-vitro dissolution were found to be within the standard pharmacopeia limit. Overall, the formulation P*6 containing 21 gm of Aquacoat ECD (Ethyl Cellulose) was found to be promising and it’s in vitro dissolution time was found to be 3.8% drug release in 0.1 N HCL, 90.2% drug release in 16 hours in pH 7.5 phosphate buffer and in Cumulative drug released by addition of 0.1N HCL drug released was found to be 94% in 18 hours, % LOD was found to be 1.03% and amount of assay was found to be 101.5% when compared to marketed formulation which show vitro dissolution time of 3.6% drug release in 0.1 N HCL, 90.5% drug release in 16 hours in pH 7.5 phosphate buffer and in Cumulative drug released by addition of 0.1N HCL drug released was found to be 94.16% in 18 hours, % LOD was found to be 1.5% and amount of assay was found to be 102.1% respectively for above parameter. Thus from above result optimized formulation P*6 show better result as compared with marketed formulation. The stability study was also conducted the best formulation, P*6 and it indicates that there was no significant change in any parameters. Hence the formulation P*6 was considered to be highly stable.