256 Pages 19 B/W Illustrations
    by CRC Press

    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.

    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

    Biography

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

    "[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