Formulation and Evaluation of Budesonide Controlled Release Capsules by Suspension Layering Method

Multiunit pellet systems (MUPS) are an approach to develop capsule formulation for controlled release. Capsule containing MUPS, when administered rapidly disperses in the GIT, each pellet act as a sub unit, consequently as a separate drug delivery system. Controlled release pellets which delivers the drug at a predetermined rate, at a predetermined region, reduces peak plasma fluctuations, consequently potential side effects can be minimized. MUPS have good desirable transit time and reduced chance of gastric irritation owing to the localization of drug delivery. Budesonide rapidly absorbed after oral administration, but has poor systemic availability (about 10%) due to extensive first pass metabolism in the liver by Cyp3A4. by using controlled release form which release the drug at ileum or ascending colon region (pH>5.5) by minimizing the drug release in the stomach. By using extended release form there is a reduction in dosing frequency, reduction in plasma fluctuations consequently potential side effects can be minimized.