Pharmaceutical Engineering: A Primer for Advanced Process Development. Volume One: Liquid Dosage form Process Design provides a comprehensive, engineering-focused description of pharmaceutical dosage form process development and manufacturing. The set is split into two volumes where Volume One focuses on liquids and Volume Two on solids. Each volume introduces the most commonly used manufacturing processes for pharmaceutical dosage forms and addresses critical formulation and process parameters that influence drug product process performance and product quality. This is supplemented with detailed descriptions of engineering models as well as tools that can be used to support their development and verification (such as process analytical technology (PAT)) as well as the appropriate utilization of process and equipment knowledge. Typical scale-up challenges inspired by real industrial examples will be presented as well as a review of the latest correlations, theories and models that can form the basis for science-based scale-ups and transfers.
Table of Contents
Section 1: The Basics 1. Introduction 2. General introduction to the field of drug product design and development, including current challenges and recent trends. 3. Regulatory considerations for pharmaceutical process development 4. A description of ICH Q8 (R2) in the relevant context, including process requirements, QbD options and experimental/computational approaches, as well as a description of pharmaceutical process validation 5. Engineering fundamentals 6. The basic components needed to understand and build an engineering approach to a pharmaceutical drug product process, including and not limited to: material and energy balances, heat and mass transfer, dimensional analysis, flow of fluids and powders, scale-up approaches and workflows. This will be an introductory chapter and will be covered in more detail in section 2. 7. In process analysis 8. A description of some of the general analytical options that can be used for experimental characterization of drug product processes and the link to subsequent chapters, including the PAT regulatory status. The analytical principles behind common measurements across the different unit operations will be presented here Section 2: Unit Operations 9. Mixing processes 10. Conventional dispersed systems suspensions and emulsions 11. Advanced drug delivery systems microparticles, liposomes, LNP and similar platforms 12. Lyophilization 13. Capsule filling liquid 14. Engineering of sterilization processes
