Development and Optimization for Generic Capsule Solid Oral Dosage Formulation Using Quality by Design (QbD) Principles

Abstract

Traditionally, the development and formulation of generic drugs has focused on the delivery of the product to the next phase of clinical study making the formulation design iterative and empirical. Furthermore, pharmaceutical companies have ensured quality and performance on their product by raw material testing, in-process material testing and end product testing. This traditional approach has induced a knowledge gap in understand the relationship between product quality attributes and their clinical performance. As a result of this approach, regulatory bodies are encouraging the generic companies to include QbD elements in their filling applications with the intention of improve their process understanding. This project design presents an overview of implementation of key elements of Quality by Design to develop a pharmaceutical formula for a generic product. Key Terms - Critical Quality Attributes, Design of Experiment, Quality by Design, Quality Risk Management, Quality Target Product Profile