Pharmaceutical Engineering: A Primer for Advanced Process Development

Pharmaceutical Engineering: A Primer for Advanced Process Development. Volume Two: Solid 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.

• Features engineering principles of pharmaceutical drug product processes
• Includes development and scale-up of pharmaceutical drug product processes
• Defines a robust process via science and engineering-based principles