Author(s): Verma Mithun and Gupta Vishvnath

The study was undertaken with an aim to formulate budesonide controlled release capsules. The drug budesonide is corticosteroid and used for the treatment of Crohn’s disease. Before going to develop the formulation, a detail product literature review was carried out to know about the innovator’s product and the patent status of the drug. Preformulation study involving drug -excipients compatibility was done initially and results indicated the compatibility with all the tested excipients. The study was carried out by solution/suspension matrix layering method. In this method first drug and polymer solutions were mixed, coating was done on the sugar spheres; further enteric coating was done on polymer matrix coated pellets. Different trials were conducted with various percentages of polymer in first stage and second stage (during enteric coating), and the formulation was finally optimized based on the drug release profile. Pellets were evaluated by in vitro dissolution. These studies revealed that the F6 pellets were found to be release the drug almost comparable to that of innovator’s product. Further, the F6 formulation was subjected to release studies at different pH conditions and found to have similar release profile as that of innovator. The in vitro dissolution tests were performed and f2 values were calculated for all trials. Dissolution profile of formulation F6 matched with that of the innovator’s product and f2 value was satisfactory. Stability studies were also performed; both accelerated and long term stability studies were conducted for two months. During this study, the formulation F6 was found to be stable and no differences in the assay and release characteristics were noticed.