Lam J., Kwok P. (eds.) Respiratory Delivery of Biologics, Nucleic Acids, and Vaccines

Springer, 2023. — 308 p.Respiratory Delivery of Biologics, Nucleic Acids, and Vaccines (AAPS Introductions in the Pharmaceutical Sciences, 8) Edition edited by Jenny Lam and Philip Chi Lip Kwok argues that therapeutic macromolecules and biologics have gained increasing importance in the last decade. Pulmonary and intranasal delivery of these therapeutic modalities, which have poor oral bioavailability, could constitute an attractive, non-invasive alternative to parenteral delivery. They can be considered for either topical use for treating diseases affecting the airways or for systemic use for treating a variety of other diseases. Therefore, this book is a readable, thoughtful, and useful guide on the latest research developments and the best options that people involved with pulmonary and intranasal route of administration and biologically active agents can bring to their practices. Furthermore, it explores the underlying scientific rationale for the strategies applied to overcome drug delivery challenges and provides insights to inspire further research in this growing area.Biologics have emerged as an increasingly important class of therapeutics. Owing to their high specificity and ability to target specific components of the immune system, biologics are particularly useful in the treatment of cancers and immune-mediated diseases. In 2022, biologics accounted for over 40% of approvals by the Centre for Drug Evaluation and Research (CDER) of the United States Food and Drug Administration, a record high percentage of biologics to date. Although not classified as biologics, nucleic acids such as small interfering ribonucleic acid (siRNA) and messenger ribonucleic acid (mRNA) also gained much attention in recent years. Their capability to manipulate the expression of virtually any gene makes them remarkably powerful therapeutic modalities to exploit “undruggable targets” to treat a wide range of diseases. The COVID-19 pandemic that began in 2020 has accelerated the development of new vaccine platforms that prominently feature viral vectors and mRNA vaccines. The landscape of pharmaceutical development is rapidly evolving, so biologics are expected to overtake small molecules and dominate the market in the foreseeable future. Despite many biologics and vaccines already approved for treating or preventing lung diseases such as lung cancer, asthma, and respiratory viral infections, nearly all of them are parenterally administered. In contrast, administration through inhalation can directly target therapeutics to the site of action in the airways to maximise efficacy. This non-invasive route overcomes many drawbacks associated with parenteral routes, such as the requirement of trained personnel for administration, sterile formulations, and the risks of needlestick injuries and blood-borne diseases. Intranasal and orally inhaled vaccines can trigger mucosal immune response, which is lacking in conventional injected vaccines, and provide better protection against respiratory infections. Moreover, the high vascularisation of the lungs and nasal cavity can serve as an entry portal for the systemic delivery of small proteins and peptides. The potential of biologics, nucleic acids, and vaccines could be expanded to benefit more patients by developing formulations beyond parenteral administration, as the orally inhaled and nasal routes are already wellestablished for small drug molecules against respiratory diseases. This book consists of nine chapters which give a comprehensive overview of the challenges and strategies in delivering a wide range of biologics and macromolecules to the respiratory tract, including antibodies, proteins, peptides, nucleic acids, and vaccines. It also
covers the respiratory delivery of probiotics and bacteriophages, which have not yet been extensively studied but have shown promising potentials in improving health and fighting against infections. The pharmacokinetics of inhaled biological macromolecules, which is a poorly understood topic, are also discussed. We hope this book provides invaluable insights for readers who are working towards the goal of developing orally inhaled and nasal biologics, nucleic acids, and vaccines.Table of ContentsDesign Strategies of Dry Powders for Pulmonary Delivery of Pharmaceutical Peptides
Hideyuki SatoPulmonary Delivery of Antibody for the Treatment of Respiratory Diseases
Thomas Sécher and Nathalie Heuzé-Vourc’hDry Powder Formulation of Monoclonal Antibodies for Pulmonary Delivery
Kimberly B. Shepard, David Zeigler, W. Brett Caldwell and Matthew FergusonAntimicrobial Peptides and Proteins for Inhalation
Yuncheng Wang, Rachel Y. K. Chang, Warwick J. Britton and Hak-Kim ChanPulmonary Delivery of Nucleic Acids
Gemma Conte, Ivana d’Angelo, Joschka Müller, Benjamin Winkeljann, Simone Carneiro, Olivia M. Merkel and Francesca UngaroIntranasal and Inhaled Vaccines
Michael Yee-Tak Chow and Jenny Ka Wing LamRespiratory Delivery of Probiotics to Improve Lung Health
Alex Seungyeon Byun, Luis Vitetta, Hak-Kim Chan and Philip Chi Lip KwokRespiratory Delivery of Bacteriophages for the Treatment of Lung Infections
Alex Seungyeon Byun, Hak-Kim Chan and Philip Chi Lip KwokPharmacokinetics of Inhaled Medications – What Do We Know About Biological Macromolecules?
Audrey Huili Lim, Jinxin Zhao, Nusaibah Abdul Rahim, Jing Zhao, Haiting Liu, Xiaoyan Yang and Yu-Wei LinIndex