A Guide to Pharmaceutical Particulate Science

ISBN-13: 9781574911428 / Angielski / Twarda / 2003 / 256 str.

Ned Vizzini; Anthony Hickey; Margaret D. Louey

Opis

The pharmaceutical applications of powder technology have long been recognized. Yet while many books focus on aspects of powder formation and behavior, there has been no text that explores the power of particulate science in the design, manufacture, and control of quality medicines. Until now. A Guide to Pharmaceutical Particulate Science discusses key principles of particulate science and their practical applications.

The authors cover particulate material, its form and production, sampling from bodies of powder, particle size descriptors and statistics, behavior of particles, instrumental analysis, particle size measurement and synergy of adopted techniques, physical behavior of a powder, and in vitro and in vivo performance criteria. They draw the components of particulate science into a single concise description of their current and potential uses in product development. Exploring the growth in knowledge of particle properties and the variety of technological advances in particle manufacture, A Guide to Pharmaceutical Particulate Science gives readers the tools they need to grasp the science and its use in the industry.

Recenzje

"[This book] treats … various topics … in a logical sequence. The references are extensive and provide the reader with valuable guidance to the relevant literature, especially in the pharmaceutical sciences. … [T]his book provides an excellent foundation for a didactic course in particulate science or powder technology. … [It] will likewise be valuable to scientists who are eager to acquire basic knowledge of particulate science in pharmaceutics."
- Pharmaceutical Research

"A useful guide to the subject…the volume covers a gap in the existing literature and should be on the shelves of company libraries."
- Organic Process Research and Development Journal

Spis treści

INTRODUCTION AND OVERVIEW
Situation Analysis
Quality of Published Data on Particle Size in Pharmaceuticals
The Future of Crystal Engineering
Chemistry and Pharmacy Regulatory Submissions
Misconceptions and Misunderstandings of Particulate Science
Powerful Methods Complementary to Particle Sizing
Integration of Particle Sizing Methods with their In-Use Situation
Adjacencies and Interactions Between Particles
Lessons from Other Industries
Pharmaceutical Particulate Science as a Core Educational Requirement
Particle Characterization and its Impact on Regulatory Submissions from Formulation through Toxicology and Efficacy
Conclusion

PARTICULATE SYSTEMS: MANUFACTURE AND CHARACTERIZATION
States of Matter
Crystalline Solids
Crystal Symmetry
Euler's Relationship
Crystal Systems
Miller Indices
Space Lattices
Solid State Bonding
Isomorphs and Polymorphs
Enantiomorphs and Racemates
Crystal Habit
Crystal Imperfections
Methods of Particulate Production
Particulate Systems
Conclusion

SAMPLING AND MEASUREMENT BIASES
Sampling Strategies
Statistical Analyses
Sampling Techniques
Segregation
Sampling
Sampling Errors
Preparation Errors
Particle Size Measurements Errors
Conclusions

PARTICLE SIZE DESCRIPTIONS AND STATISTICS
Particle Size Descriptions
Particle Size Statistics
Mathematical Distributions
Applications
Conclusion

BEHAVIOR OF PARTICLES
Physical Properties
Particle Adhesion
Particle Motion in Bulk Powders
Particle Motion in Gaseous Dispersions
Particle Motion in Liquid Media
Conclusion

INSTRUMENTAL ANALYSIS
Direct Imaging
Indirect Imaging
Physical Methods of Particle Size Separation
Approaches to Calibration
Conclusions

METHODS OF PARTICLE SIZE MEASUREMENT AND THEIR IMPORTANCE FOR SPECIFIC APPLICATIONS (INSTRUMENT SYNERGY)
An Essay on Measures of Diameters
Conclusion

PARTICLE SIZE BEHAVIOR AND PHYSICAL BEHAVIOR OF A POWDER
Selection of the Appropriate Particle Size Expression
Powder Flow and Mixing
Dispersion
Granulation and Compression
Conclusion

CLINICAL EFFECT OF PHARMACEUTICAL PARTICULATE SYSTEMS
Oral Delivery
Parenteral Delivery
Respiratory Delivery
Nasal Delivery
Transdermal and Topical Delivery
Ocular Delivery
Otic Delivery
Buccal and Sublingual Delivery
Rectal Delivery
Vaginal Delivery
Conclusions

GENERAL CONCLUSIONS
REFERENCES
INDEX

O autorze

Anthony J. Hickey, Timothy M. Crowder, Margaret D. Louey