A Guide to Particulate Science in Pharmaceutical Product Development
Gebonden Engels 2025 2e druk 9781032731827Samenvatting
The pharmaceutical applications of powder technology have long been recognized. Yet while many books focus on aspects of powder formation and behavior, there are few texts that explore the power of particulate science in the design, manufacture, and control of quality medicines. This revision discusses key principles and practical applications. The authors cover particulate material, its form and production, sampling from bodies of powder, particle size descriptors and statistics, behavior of particles and powder, instrumental analysis, particle size measurement and synergy of adopted techniques, and in vitro and in vivo performance criteria. Case studies are included in this new edition.
This fully revised edition: Provides an essential account of particulate science including several new chapters on multicomponent particles, regulatory considerations and product development Presents a variety of topics ranging from the quality of published data on particle size in pharmaceuticals to the future of crystal engineering Reviews methods of particle measurement and their importance for specific applications Discusses misconceptions and misunderstandings of particulate science together with lessons from other industries
Specificaties
Lezersrecensies
Inhoudsopgave
ii Preface
iii Table of Contents
1. Introduction
2. Particulate Systems: Foundational Principles
3. Primary Particle Manufacturing
4. Sampling Techniques, Errors, and Measurement Bias
5. Particle Characterization and Data Expression
6. Particle and Powder Behavior
7. Particulate Pharmaceutical Products
8. Regulatory Considerations for Pharmaceutical Development
9. Clinical Applications of Pharmaceutical Particulate Systems
10. General Conclusion
Index
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