Concisely reviews important aspects of powder and particle systems
1. Introduction Importance of finely divided solids in pharmaceutical dosage forms - Ease of dose handling - Stability of dosage form - Controlled delivery (deaggregation, dissolution) - Efficacy - Safety 2. Solid State Chemistry - Physical chemistry of solid in molecular state - Crystal System Polymorphism - Crystal Habit - Imperfections 3. Crystallization - Homogeneous composition - Heterogeneous composition - Nucleated/Non-nucleated - Polymorphism - Water of crystallization 4. Physical Properties - Surface area (Gas adsorption) - Charge (zeta potential, electrostatic sampling) - Polymorphism (Thermal analysis DSC) - Moisture content (Thermal analysis TGA, Karl Fischer) - Hygroscopicity (Dynamic Vapor Sorption) - Impurities 5. Particle Size and Size Distribution Definitions/descriptors Statistical methods and descriptors 6. Particle Size Characterization Direct measurement (microscopy) Population based light scattering methods (diffraction) Performance based measures (sedimentation, aerodynamic) 7. Fundamental of particle interactions van der Waals Capillary Forces Electrostatic forces Mechanical Interlocking 8. Powder and particle dependent traditional manufacturing processes (unit operations) Drying Milling Blending Filling (flow properties) Sampling Stability (chemical and physical) 9. Powder and particle dependent biopharmaceutical processes Dissolution Bioavailability 10. Recent and evolving manufacturing processes Spray drying technology Supercritical fluid methods Particle replication in non-wetting templates (PRINT) technology 3-D printing 11. Principles of quality by design Batch processes Continuous Processes Statistical Process Control 12. General Discussion Challenges/ Opportunities API manufacturing controls Particle scale manufacturing control Limits from first principles on statistical process control Drug product manufacturing controls Content uniformity Stability Bioavailability Product considerations Quality (CMC) Performance (Safety/Efficacy)
This first monograph in the new AAPS book series concisely reviews important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance. Drs. Hickey and Giovagnoli have written an essential primer for any scientists involved in powder or particle research and manufacturing. It is appropriate for those just entering the field or as a rapid reference for the experienced pharmaceutical scientist. The authors have both academic and industrial experience and the coverage includes solid state chemistry; crystallization; physical processes; particle size and distribution;particle interaction;manufacturing processes;quality by design;and a general discussion of the industry. Pharmaceutical Powder and Particles is intended to concisely review important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance.