Himankar Baishya
Beijing Sciecure Pharmaceuticals, China
Title: The influence of polyvinyl Pyrrolidone as hydrophilic pore formers on the release of water insoluble Ketoprofen from Ethyl cellulose coated pellets
Biography
Biography: Himankar Baishya
Abstract
Delivering water-insoluble drugs from Ethylcellulose (EC) coated pellets in a controlled-release pattern is very challenging. In the present study, hydrophilic polyvinylpyrrolidone (PVP) was used as a pore-former in EC coated pellets to deliver practically water-insoluble ketoprofen and the key factors that influenced drug release were identified. The effect of using PVP at different level in polymer coating part was studied and it was found that a certain level of PVP is required as channeling or pore forming agent to control drug release from the EC coated pellets to achieve target level of dissolution profile with the sensitivity ranging from 10% to 20%. PVP leaching rate and water permeability from EC/PVP film increased with the PVP level, which was perfectly correlated with drug release rate. PVP % was optimized with the application of Design of Experiments (DOE) and other process controls was evaluated during scale-up batches.