Inhaled Medicines

Optimizing Development Through Integration of in Silico, in Vitro and in Vivo Approaches
Erscheinungsjahr 2021
ISBN: 978-0-12-814974-4
Verlag: Elsevier Science

Buch, Englisch, 438 Seiten, Format (B × H): 191 mm x 231 mm, Gewicht: 885 g

Inhaled medicines are widely used to treat pulmonary and systemic diseases. The efficacy and safety of these medicines can be influenced by the deposited fraction, the regional deposition pattern within the lungs and by post-depositional events such as drug dissolution, absorption and clearance from the lungs. Optimizing performance of treatments thus requires that we understand and are able to quantify these product and drug attributes.

Inhaled Medicines: Optimizing Development through Integration of In Silico, In Vitro and In Vivo Approaches explores the current state of the art with respect to inhalation drug delivery, technologies available to assess product performance, and novel in silico methods now available to link in vitro product performance to clinical performance. Recent developments in the latter field, especially the prospect of integration of three-dimensional Computational Fluid Particle Methods (3D-CFPD) with physiologically based pharmacokinetic (PBPK models), unlocks the potential for in silico population studies that can help inform and optimize treatment and product development strategies. In this highly multidisciplinary field, where progress occurs at the intersection of several disciplines of engineering and science, this work aims to integrate current knowledge and understanding and to articulate a clear vision for future developments.

Zielgruppe

<p>pharmaceutical scientists and engineers working on inhalation products: including researchers in basic research and development, academic researchers, industrial researchers, doctoral researchers, and senior researchers; Regulators, policy makers, and funding agencies who require an overview of the potential of the technologies involved with inhaled medicines. </p>

Autoren/Hrsg.

Kassinos, Stavros

Bäckman, Per

Conway, Joy

Hickey, Anthony J. J.

Fachgebiete

• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

1. Historical perspective - Disruptive technologies and strategies 2. The API 3. Devices and formulations: General introduction and wet aerosol delivery systems 4. Metered dose inhalers (MDIs) 5. Dry powder inhalers (DPIs) 6. In vitro methods to study dose deposition 7. In silico methods to model dose deposition 8. Non-absorptive clearance from airways 9. Dissolution and drug release 10. Epithelial permeability and drug absorption in the lungs 11. Drug distribution in lung tissue 12. Physiologically-based pharmacokinetic modeling after drug inhalation 13. Inhaled aerosols: Emerging clinical methods 14. Machine learning and in silico methods 15. The emerging state of the art

Über Autor(innen)

Bäckman, Per
Dr Bäckman is senior inhalation consultant at Emmace Consulting AB in Lund Sweden. He is currently focused on the development and application of computer based mechanistic models and in vivo predictive test methods to understand critical product attributes and their influence on the disposition of orally inhaled therapeutics. This includes the impact of dose, aerosol quality and drug dissolution on the rate and extent of drug absorption from the airways. Dr Bäckman holds a PhD from the University of Lund and has been actively engaged in research and development of inhaled therapeutics since 1995. He is also the current co-chair of the Product Quality Research Institute (PQRI) sponsored working group laying the foundation for an inhaled biopharmaceutical classification system.

Conway, Joy
Professor Joy Conway is the Professor of Respiratory Sciences, Centre for Health, Medicine and Life Sciences, Brunel University London. Joy has extensive experience as a reseracher and educator with over 25 years in UK Higher Education Institutions. Joy has a strong interest in lung disease, care of those with lung disease, respiratory physiology and pathophysiology and lung imaging. Following qualification as a chartered physiotherapist and a Masters in Rehabilitation (University of Southampton) her PhD (University of Southampton) investigated the use of three-dimensional lung imaging techniques to quantify inhaled aerosol deposition in the lung and structural and functional changes that occur with disease. Joy then progressed through to a personal Chair at the University of Southampton in 2009. In 2019 Joy was appointed as Professor at Brunel University London. At Brunel she is divisional research lead and a Director of the Smart Technologies Advancements for Health and Rehabilitation (STAHR) Research Centre. She is also the national research lead for advancing practice for Health Education England (2019 -) and maintains visiting Professor status with the NIHR Southampton Biomedical Research Centre for Respiratory and Critical Care (2019 -). Joy has extensive expertise in multi-modality, clinical imaging technologies and taking innovations to prototype and patent development. She brings experience in the integration of advanced technologies in healthcare, bridging the academic and health divide. Joy has acted as scientific advisor to several companies.

Hickey, Anthony J. J.
Dr. Hickey is Distinguished RTI Fellow, at the Research Triangle Institute and Director of the UNC Catalyst for Rare Diseases of the Eshelman School of Pharmacy He obtained Ph.D. and D.Sc. degrees in pharmaceutical sciences from Aston University, Birmingham, UK. He is a Fellow of the Royal Society of Biology, the American Association of Pharmaceutical Scientists, the American Association for the Advancement of Science and the Royal Society of Medicine. He received the Research Achievement Award of the Particulate Presentations and Design Division of the Powder Technology Society of Japan, the Distinguished Scientist Award of the American Association of Indian Pharmaceutical Scientists; the David W Grant Award in Physical Pharmacy of the American Association of Pharmaceutical Scientists; Thomas T Mercer Joint Prize for Excellence in Inhaled Medicines and Pharmaceutical Aerosols of the American Association for Aerosol Research and the International Society for Aerosols in Medicine and the Ralph Shangraw Memorial Award for Excipient and Excipient Technology of the International Pharmaceutical Excipient Consortium Foundation. He is founder (and formerly President and CEO) of Cirrus Pharmaceuticals, Inc., acquired by Kemwell Pharma; founder (formerly CSO, 2002-2007) of Oriel Therapeutics, Inc, acquired by Sandoz and founder and CEO of Astartein, Inc.; member of the Pharmaceutical Dosage Forms Expert Committee of the United States Pharmacopeia and formerly Chair of the Aerosols Expert Committee of the USP. Dr. Hickey conducts multidisciplinary research programs in the field of pulmonary drug and vaccine delivery for the treatment and prevention of a variety of diseases and oversees research in target and candidate therapeutic agent identification for rare and neglected diseases.