Pharmaceutical Drug Product Development and Process Optimization

This volume explores essential principles for developing pharmaceutical drug products efficiently and cost-effectively, emphasizing systematic quality approaches and the Quality by Design (QbD) concept to enhance product consistency and regulatory compliance.

Pharmaceutical Drug Product Development and Process Optimization delves into the essential principles that underpin the efficient and cost-effective creation of pharmaceutical products. The text emphasizes the importance of adopting systematic quality principles throughout the development process, which are crucial for achieving ongoing improvements in product quality. By addressing these principles, the book aims to help pharmaceutical manufacturers navigate the frequent quality crises that lead to product recalls and rejections.

The challenge of maintaining consistent product quality is multifaceted, often complicated by various influencing factors. This volume tackles these challenges through the Quality by Design (QbD) framework, which promotes a structured approach to drug product development with clearly defined objectives. By enhancing understanding of both the product and process, QbD aims to streamline development efforts and improve overall outcomes.

Additionally, the book explores significant advancements in the development of various dosage forms, including solid and modified release oral formulations, parenteral and semisolid forms, as well as innovative drug delivery systems such as transdermal, inhalational, and ocular methods. It also discusses the role of nanotechnology in pharmaceutical development, particularly concerning nanoparticles for oral delivery. Overall, this comprehensive resource serves as a guide for pharmaceutical scientists seeking to optimize their processes while adhering to regulatory standards and improving product quality.