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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5642_Библиотеки_им_академика_М_И_Перельмана
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Volume 8
AAPSIntroductionsinthe
PharmaceuticalSciences
SeriesEditor
Claudio Salomon
NationalUniversityofRosario,Rosario,Argentina
FoundingEditor
Robin Zavod
ChicagoC ollegeofPha rmacy,MidwesternUniversity,DownersGrove,IL,
USA
The AAPSIntroductionsinthePharmaceuticalSciences book series is
designed to support pharmaceutical scientists at the point of
knowledge transition. Springer and the American Association of
Pharmaceutical Scientists (AAPS) have partnered again to produce a
second series that juxtaposes the AAPSAdvancesinthePharmaceutical
Sciences series. Whether shifting between positions, business models,
research project objectives, or at a crossroad in professional
development, scientists need to retool to meet the needs of the new
scientiic challenges ahead of them. These educational pivot points
require the learner to develop new vocabulary in order to effectively
communicate across disciplines, appreciate historical evolution within
the knowledge area with the aim of appreciating the current
limitations and potential for growth, learn new skills and evaluation
metrics so that project planning and subsequent evolution are
evidence-based, as well as to simply “dust the rust off” content learned
in previous educational or employment settings, or utilized during
former scientiic explorations. The Introductions book series will meet
these needs and serve as a quick and easy-to-digest resource for
contemporary science.
Editors
Jenny Ka Wing Lam and Philip Chi Lip Kwok
RespiratoryDeliveryofBiologics,
NucleicAcids,andVaccines
First Edition
Editors
Jenny Ka Wing Lam
Department of Pharmaceutics UCL School of Pharmacy, University
College London, Brunswick Square, London, UK
Philip Chi Lip Kwok
Advanced Drug Delivery Group, Sydney Pharmacy School, Faculty of
Medicine and Health, The University of Sydney, Camperdown, NSW,
Australia
ISSN 2522-834X e-ISSN 2522-8358
AAPS Introductions in the Pharmaceutical Sciences
ISBN 978-3-031-47566-5 e-ISBN 978-3-031-47567-2
https://doi.org/10.1007/978-3-031-47567-2
Jointly published with American Association of Pharmaceutical
Scientists
© American Association of Pharmaceutical Scientists 2023
This work is subject to copyright. All rights are reserved by the
Publisher, whether the whole or part of the material is concerned,
speciically the rights of translation, reprinting, reuse of illustrations,
recitation, broadcasting, reproduction on microilms or in any other
physical way, and transmission or information storage and retrieval,
electronic adaptation, computer software, or by similar or dissimilar
methodology now known or hereafter developed.
The use of general descriptive names, registered names, trademarks,
service marks, etc. in this publication does not imply, even in the
absence of a speciic statement, that such names are exempt from the
relevant protective laws and regulations and therefore free for general
use.
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The publishers, the authors, and the editors are safe to assume that the
advice and information in this book are believed to be true and
accurate at the date of publication. Neither the publishers nor the
authors or the editors give a warranty, express or implied, with respect
to the material contained herein or for any errors or omissions that
may have been made. The publishers remain neutral with regard to
jurisdictional claims in published maps and institutional afiliations.
This Springer imprint is published by the registered company Springer
Nature Switzerland AG
The registered company address is: Gewerbestrasse 11, 6330 Cham,
Switzerland
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Preface
Biologics have emerged as an increasingly important class of
therapeutics. Owing to their high speciicity and ability to target
speciic 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 classiied 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 eficacy. 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
beneit more patients by developing formulations beyond parenteral
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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 ighting 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.
JennyKaWingLam
PhilipChiLipKwok
BrunswickSquare,London,UK
Camperdown,NSW,Australia
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Con tents
DesignStrategiesof DryPowdersforPulmonaryDeliveryof
PharmaceuticalPeptides
Hideyuki Sato
PulmonaryDeliveryofAntibodyfortheTreatmentofRespiratory
Diseases
Thomas Secher and Nathalie Heuze-Vourc’h
DryPowderFormulationofMonoclonalAntibodiesforPulmonary
Delivery
Kimberly B. Shepard, David Zeigler, W. Brett Caldwell and
Matthew Ferguson
AntimicrobialPeptidesandProteinsforInhalation
Yuncheng Wang, Rachel Y. K. Chang, Warwick J. Britton and Hak-
Kim Chan
PulmonaryDeliveryofNucleicAcids
Gemma Conte, Ivana d’Angelo, Joschka Mu ller, Benjamin Winkeljann,
Simone Carneiro, Olivia M. Merkel and Francesca Ungaro
IntranasalandInhaledVaccines
Michael Yee-Tak Chow and Jenny Ka Wing Lam
RespiratoryDeliveryofProbioticstoImproveLungHealth
Alex Seungyeon Byun, Luis Vitetta, Hak-Kim Chan and
Philip Chi Lip Kwok
RespiratoryDeliveryofBacteriophagesfortheTreatmentofLung
Infections
Alex Seungyeon Byun, Hak-Kim Chan and Philip Chi Lip Kwok
PharmacokineticsofInhaledMedications–WhatDoWeKnow
AboutBiologicalMacromolecules?
Audrey Huili Lim, Jinxin Zhao, Nusaibah Abdul Rahim, Jing Zhao,
Haiting Liu, Xiaoyan Yang and Yu-Wei Lin
Index
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AbouttheEditors
JennyKaWingLam
is an Associate Professor of Pharmaceutics at the UCL School of
Pharmacy, University College London. Dr Lam obtained her MPharm
and PhD from The University of Nottingham, UK. In her PhD study, she
investigated the use of non-viral vectors for gene delivery. Dr Lam was
then awarded the Maplethorpe Fellowship and continued her research
in nucleic acid delivery in the Department of Pharmacy at King’s
College London. She then joined the Department of Pharmacology and
Pharmacy in the University of Hong Kong as Assistant Professor, and
returned to the UK in 2022. Dr Lam’s research is focused on the
development of novel delivery system for a wide range of therapeutics
including small molecules, nucleic acids, and biologics, with special
interest in the use of particle engineering methods to produce aerosol
formulations for the treatment/prevention of respiratory diseases. She
is the Principal Investigator of a number of competitive grants. She has
published over 90 peer-reviewed articles and iled a number of patent
applications on pulmonary drug delivery systems. In 2020, she was
awarded the DDL (Drug Delivery to the Lung) Emerging Scientist
Award which recognised her signiicant accomplishment and
innovation in inhalation science.
PhilipChiLipKwok
is a Senior Lecturer in Pharmaceutical Sciences at the School of
Pharmacy, The University of Sydney. He obtained his Bachelor of
Pharmacy degree with First Class Honours in 2002 from this Faculty.
He became a registered pharmacist after one year of training in a
community pharmacy. Dr Kwok then undertook his PhD studies on
pharmaceutical aerosol electrostatics in the Faculty of Pharmacy at
The University of Sydney and graduated in 2007. He was a Research
Associate in the same group until August 2011 and became an
Assistant Professor in the Department of Pharmacology and Pharmacy
at The University of Hong Kong in September 2011. Dr Kwok returned
to The University of Sydney as a Lecturer in Pharmaceutical Sciences at
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