Pharmaceutical Drug Product Development and Process Optimization, Effective Use of Quality by Design

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding.

This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

Table of Contents

1. Introduction to Pharmaceutical Product Development

2. Systematic Product and Process Development Tools in Life Cycle Management

3. Recent Advances in the Development of Solid Oral Dosage Forms

4. Recent Advances in the Development of Modified Release Oral Dosage Forms

5. Recent Advances in the Development of Parenteral Dosage Forms

6. Recent Advances in the Development of Semisolid Dosage Forms

7. Recent Advancements in Transdermal Drug Delivery Systems

8. Recent Advances in the Formulation Development of Inhalational Dosage Forms

9. QBD-Based Novel Ocular Drug Delivery Systems

10. Recent Advances in the Development of Nanopharmaceutical Products

11. Recent Advances in the Development of Nanoparticles for Oral Delivery