Biopharmaceutics. Группа авторов

United Kingdom

      James Butler Biopharmaceutics, Product Development and Supply, GlaxoSmithKline R&D, Ware, United Kingdom

      Paul A. Dickinson Seda Pharmaceutical Development Services, Alderley Edge, Alderley Park, Cheshire, United Kingdom

      Talia Flanagan UCB Pharma S.A., Avenue de l’industrie, 1420Braine l’Alleud, Belgium

      Ben Forbes Institute of Pharmaceutical Sciences, King’s College London, London, United Kingdom

      Nikoletta Fotaki Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom

Simon Gaisford Department of Pharmaceutics, UCL School of Pharmacy, University College London, London, United Kingdom

      Francesca K. H. Gavins Department of Pharmaceutics, UCL School of Pharmacy, University College London, London, United Kingdom

      Pavel Gershkovich School of Pharmacy, Centre for Biomolecular Sciences, The University of Nottingham, Nottingham, United Kingdom

      Wang Wang Lee Seda Pharmaceutical Development Services, Alderley Edge, Alderley Park, Cheshire, United Kingdom

      Christine M. Madla Department of Pharmaceutics, UCL School of Pharmacy, University College London, London, United Kingdom

      Mark McAllister Pfizer Drug Product Design, Sandwich, United Kingdom

      Laura E. McCoubrey Department of Pharmaceutics, UCL School of Pharmacy, University College London, London, United Kingdom

      Hamid A. Merchant Department of Pharmacy, School of Applied Sciences, University of Huddersfield, Huddersfield, United Kingdom

      Mine Orlu Department of Pharmaceutics, UCL School of Pharmacy, University College London, London, United Kingdom

      Claire M. Patterson Seda Pharmaceutical Development Services, Alderley Edge, Alderley Park, Cheshire, United Kingdom

      Chris Roe Quotient Sciences, Mere Way, Ruddington, Nottingham, United Kingdom

      Linette Ruston Advanced Drug Delivery, Pharmaceutical Sciences, R&D AstraZeneca, Macclesfield, United Kingdom

      Konstantinos Stamatopoulos Biopharmaceutics, Pharmaceutical Development. PDS, MST, RD Platform Technology and Science, GSK, Ware, Hertfordshire, United Kingdom

      Magda Swedrowska Institute of Pharmaceutical Sciences, King’s College London, London, United Kingdom

      Sarah J. Trenfield Department of Pharmaceutics, UCL School of Pharmacy, University College London, London, United Kingdom

      Vanessa Zann Quotient Sciences, Mere Way, Ruddington, Nottingham, United Kingdom

      Panagiota Zarmpi Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom

Foreword

      The term biopharmaceutics causes confusion, particularly with the advent of biopharmaceutical drug products. However, the origins of the word come from the combination of the prefix ‘bio’ from the Greek, ‘relating to living organisms and tissues’ where the patient is the organism (or owns the tissues) and pharmaceutics defined as the science relating to the preparation of medicines. Biopharmaceutics encompasses the physical/chemical properties of the drug, the dosage form (drug product) in which the drug is given, and the route of administration to better understand the rate and extent of systemic drug absorption.

      Since its introduction in 1970, biopharmaceutics knowledge and testing has enabled scientists to predict drug absorption using a range of in vitro and in silico tools ensuring that the development of new pharmaceutical products is efficient by refining or reducing the burden of clinical testing. Technological advances during this period have resulted in changes in testing based both on scale, where understanding is now sought at the molecular level and also by the use of dynamic testing systems rather than static apparatus.

      The application of biopharmaceutics has reformed the pharmaceutical development process, most notably allowing for clinically relevant risk assessments against formulation and processes changes. Recent advances have witnessed the extension of biopharmaceutics tools towards the earliest and latest stages in product development. Most major pharmaceutical companies have dedicated biopharmaceutics team, invested in improving the predictive power of the suite of tools available to minimise risks of clinical impact of formulation‐based changes. As the pharmaceutical industry seeks to accelerate the timelines for drug discovery and development, there is a need for efficient and robust formulations and manufacturing processes to meet the needs of the clinical programme. The biopharmaceutics teams must therefore rise to the challenge of ensuring that formulations used in the clinical programme provide the necessary exposure of drug and are adequately risk assessed.

The Academy of Pharmaceutical Sciences (APS) is a UK‐based professional membership body for pharmaceutical scientists. The biopharmaceutics focus group within the APS has a mission to promote scientific education and training in the field of biopharmaceutics to meet the needs of scientists working in both industrial and academic sectors. This book arose as a result of this mission where the members of the focus group recognised the need to provide training for those wanting to better understand biopharmaceutics and serves as a handbook to introduce the tools used within biopharmaceutics as applied to drug development.

      The first six chapters cover the basics of biopharmaceutics and provide the context that underpins the later chapters. Chapters 7 and 8 specifically deal with how biopharmaceutics is integrated into product development within the pharmaceutical industry. Chapters 9 and 10 provide information on the regulatory aspects of biopharmaceutics. Chapter 11 highlights the impact of physiology and anatomy and how this can affect the rate and extent of drug absorption. Physiologically based modelling is a valuable asset in the biopharmaceutics toolkit, and this is introduced in Chapter 12. Chapter 13 provides information on a more advanced topic, the application of biopharmaceutics to special populations. Although oral administration remains the mainstay of drug therapy, it is not the exclusive route of administration, Chapters 14–16 cover alternative routes of administration. A newly emerging topic that considers the impact of the microbiome on the rate and extent of drug absorption is included as the final chapter in this book.

      The chapters are written by members of the APS Biopharmaceutics focus group and includes academic and industrial authors with a diverse range of experience from those currently undertaking a PhD to those with more than 20 years of experience in this field.

      It has been a real joy and privilege to bring this book together, and I thank all of the authors and the editorial team for their dedication in producing this book. I truly hope that this book is useful for those who want to explore biopharmaceutics in the future.

      Hannah Batchelor

      Strathclyde Institute of Pharmacy and Biomedical Sciences,Glasgow, United Kingdom

1 An Introduction to Biopharmaceutics

       Hannah Batchelor