Main description:

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.

Contents:

1. IntroductionImportance of finely divided solids in pharmaceutical dosage forms- Ease of dose handling- Stability of dosage form- Controlled delivery (deaggregation, dissolution)- Efficacy- Safety2. Solid State Chemistry- Physical chemistry of solid in molecular state- Crystal SystemPolymorphism- Crystal Habit- Imperfections3. Crystallization- Homogeneous composition- Heterogeneous composition- Nucleated/Non-nucleated- Polymorphism- Water of crystallization4. 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)- Impurities5. Particle Size and Size Distribution Definitions/descriptors Statistical methods and descriptors6. Particle Size CharacterizationDirect measurement (microscopy)Population based light scattering methods (diffraction) Performance based measures (sedimentation, aerodynamic)7. Fundamental of particle interactions van der Waals Capillary ForcesElectrostatic forces Mechanical Interlocking8. Powder and particle dependent traditional manufacturing processes (unitoperations) Drying Milling Blending Filling (flow properties)SamplingStability (chemical and physical)9. Powder and particle dependent biopharmaceutical processesDissolutionBioavailability10. Recent and evolving manufacturing processesSpray drying technologySupercritical fluid methodsParticle replication in non-wetting templates (PRINT) technology3-D printing11. Principles of quality by designBatch processesContinuous ProcessesStatistical Process Control12. General DiscussionChallenges/ OpportunitiesAPI manufacturing controlsParticle scale manufacturing controlLimits from first principles on statistical process controlDrug product manufacturing controlsContent uniformityStabilityBioavailabilityProduct considerationsQuality (CMC)Performance (Safety/Efficacy)