Description

The aim of work entitled "To Develop a Delayed release Capsule Formulation of Antidepressant Drug" was to formulate a stable as well as robust dosage form. The basic objective was to develop a Delayed Release Formulation of Antidepressant Drug. It is a generic version of Antidepressant capsules in line with the innovator. A generic version of Capsule was developed that is safe, efficacious and bioequivalent to the reference product. The compatibility parameters characterization of Antidepressant drug and excipients were done by chemical method and found interaction between Antidepressant drug and free acid present in enteric polymers hydroxypropyl methylcellulose phthalate, which forms phthalamide impurities under stress conditions .So the enteric layer must be separated from the drug layer by a barrier layer.The Antidepressant Drug was evaluated for bulk density, tapped density, Carr's index and Hausner's Ratio. It was found that the drug has good flow properties.The formulation of Delayed release pellets was done in Fluidized bed Processor(GPCG 1.1) in 3 steps. 1. Drug layering on Sugar spheres. 2. Barrier Coating on drug layered pellets. 3. Enteric Coating on pellets.