Development of a Generic Pharmaceutical Solid Dosage Form Using Quality by Design (QbD)

Abstract

The Pharmaceutical Generic Sector has been growing over the past years and it is expected to surpass brand drugs in sale over next years. The FDA now recommends Quality by Design to develop Generic Drugs. The present work was aim to develop a Generic Version of Polytripcin Immediate Release Tablet (Polytripsin is a given name to protect the identity of the real product) using Quality By Design, equivalent to the Reference Listed Drug (RLD) Brand Polytripcin 600 mg. The physical properties (Flow and Particle Size Distribution) of the Active Substance were evaluated. Two Formulations were proposed based on the physical characteristic of the Active Drug. The formulations were evaluated for blend and tablet physical characterization. Formulation # 2 had a Dissolution Profile Similarity Factor (F2) of 65, indicating similarity to the RLD. A Design of Experiments (DOE) for Process Improvement was also performed to correct flow problems during compression of the blends. Key Terms - Design of Experiment, Generic Drug Pharmaceutical Development, Quality by Design, Reference Listed Drug.