A Guide to Pharmaceutical Particulate Science

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