Pharmaceutical Engineering: A Primer for Advanced Process Development
- 1st Edition - July 1, 2025
- Editors: René Holm, Noor Al-Rifai, Ashish Kumar
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 1 5 6 9 8 - 4
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 1 5 6 9 9 - 1
Pharmaceutical Engineering: A Primer for Advanced Process Development provides a comprehensive, engineering-focused description of pharmaceutical dosage form process developme… Read more
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Request a sales quotePharmaceutical Engineering: A Primer for Advanced Process Development provides a comprehensive, engineering-focused description of pharmaceutical dosage form process development and manufacturing. This 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
Professionals in the pharmaceutical or related industries working with drug formulation, process design or manufacturing, Academics and postgraduate students researching or studying in chemical and biochemical engineering, pharmaceutical engineering or pharmacy, People working in food or consumer goods industries, either academically or industrially. The book can be used in advanced pharmaceutical engineering courses (MSc), particularly for courses in pharmaceutical product manufacturing delivered by pharmacy and chemical engineering schools. The material in the book can also become handy to academics who are teaching pharmacy or chemical/biochemical engineering degrees, and who may want to integrate diversified problem-based industrial examples in undergraduate and postgraduate teaching.
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
- No. of pages: 300
- Language: English
- Edition: 1
- Published: July 1, 2025
- Imprint: Elsevier
- Paperback ISBN: 9780443156984
- eBook ISBN: 9780443156991
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René Holm
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Noor Al-Rifai
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