Pharmaceutical inhalation aerosol technology

Content: 1. Introduction Anthony J. Hickey and Sandro R.P. da RochaSection I Discovery (pharmacology/physiology/anatomy, etc)2. Physiology of the Airways Anthony J. Hickey and David C. Thompson3. Drug Targeting to the Lung: Chemical and Biochemical Considerations Peter A. Crooks, Narsimha R. Penthala, and Abeer M. Al-GhananeemSection II Aerosol Critical Attributes (aerodynamicbehaviour, lung deposition, and clearance)4. Aerosol Physics and Lung Deposition Modelling Warren H. Finlay5. Practical Aspects of Imaging Techniques Employed to Study Aerosol Deposition andClearance Myrna B. Dolovich6. Pharmacokinetics and Pharmacodynamics of Drugs Delivered to the Lung Stefanie K. Drescher, Mong-Jen Chen, Jurgen B. Bulitta, and Gunther HochhausSection III Active PharmaceuticalIngredient/Drug Product Manufacturing7 Small Molecules: Process Intensification and Continuous Synthesis Thomas D. Roper8 Biologic Drug Substance and Drug Product Manufacture Ajit S. Narang, Mary E. Krause, Shelly Pizarro, and Joon Chong Yee9 Scale-Up Considerations for Orally Inhaled Drug Products Jeremy Clarke and S. van den Ban10 Quality by Control Helen N. Strickland and Beth MorganSection IV Particle Engineering/Processing (milling/blending,spray drying, supercritical fluid, nano, etc.)11. Milling and Blending: Producing the Right Particles and Blend Characteristics forDry Powder Inhalation Bernice Mei Jin Tan, Lai Wah Chan, and Paul Wan Sia Heng12. Engineering Stable Spray Dried Biologic Powder for Inhalation Nicholas Carrigy and Reinhard Vehring13 Supercritical Fluid Manufacture Ana Aguiar-Ricardo and Eunice Costa14 Particle Engineering Technology for Inhaled Therapies David Lechuga-Ballesteros, Susan Hoe, and Ben MaynorSection V Drug Product Formulation15 Emerging Pulmonary Delivery Strategies in Gene Therapy: State of the Art andFuture Considerations G. Costabile and Olivia M. Merkel16 Genome Editing for Genetic Lung Diseases Ying Zhang and Hao Yin17 Inhalation Drug Products Containing Nanomaterials Sandro R.P. da Rocha, Rodrigo S. Heyder, Elizabeth R. Bielski, Ailin Guo, MartinaSteinmaurer, and Joshua J. ReinekeSection VI Devices (design and performance)18. Pressurized Metered-Dose Inhalers Sandro R. P. da Rocha, Balaji Bharatwaj, Rodrigo S. Heyder, and Lin Yang19. Dry Powder Inhalation A. H. de Boer and F. Grasmeijer20. Nebulisers John N. Pritchard, D. von Hollen, and R. H. M. Hatley21. Soft Mist Sprays Stefan Leiner, David Cipolla, Joachim Eicher, Wilbur de Kruijf, and Herbert WachtelSection VII Drug Product Testing (physico-chemical properties,aerodynamic particle size, delivered dose, etc.)22 Quality by Design Considerations William Craig Stagner and Anthony J. Hickey23 Solid State Testing of Inhaled Formulations Philip Chi Lip Kwok and Hak-Kim Chan24 Aerodynamic Particle Size Testing Jolyon MitchellSection VIII Regulatory Considerations (CMC)25. Scanning the Intricate Regulatory Landscape and Trying to Peek Over the Horizon Steve T. Horhota, Stefan Leiner, and A. T. Horhota26. Pharmacopeial and Regulatory Guidances on Product Quality and Performance Anthony J. Hickey27. The European Union Regulatory Scene Steven C. Nichols and Dennis SandellSection IX Preclinical Testing (dosing for cells and animals)28. Cell- and Tissue-Based (Reconstituted) 2D In Vitro Models to Study Drug TransportProcesses across the Air-Blood Barrier Nicole Schneider-Daum, Patrick Carius, Justus C. Horstmann, and Claus-Michael Lehr29. 3D In Vitro/Ex Vivo Systems Bethany M. Young, Alexandria Ritchie, Laleh Golshahi, and Rebecca L. Heise30. Preclinical Models for Pulmonary Drug Delivery J. P. Ibrahim, R. J. Bischof, and M. P. McIntoshSection X Clinical Testing (concepts of bioequivalence)31. Bioequivalence of Orally-Inhaled Drug Products: Challenges and OpportunitiesJayne E. Hastedt and Elise Burmeister Getz32. General Conclusions Anthony J. Hickey and Sandro R. P. da RochaIndex