Companion Animal Landscape

Advances in Delivery Science and Technology Series Editor Michael J. Rathbone For further volumes: http://www.springer.com/series/8875 Michael J. Rathbone Arlene McDowell Editors Long Acting Animal Health Drug Products Fundamentals and Applications Editors Michael J. Rathbone Arlene McDowell Division of Pharmacy New Zealand’s National School of Pharmacy International Medical University University of Otago Bukit Jalil, Kuala Lumpur , Malaysia Dunedin , New Zealand ISSN 2192-6204 ISSN 2192-6212 (electronic) ISBN 978-1-4614-4438-1 ISBN 978-1-4614-4439-8 (eBook) DOI 10.1007/978-1-4614-4439-8 Springer New York Heidelberg Dordrecht London Library of Congress Control Number: 2012948612 © Controlled Release Society 2013 This work is subject to copyright. 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Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com) This book is dedicated to my father George Frederick Rathbone who recently passed away… the man who gave me the wisest of my education Preface Long-acting veterinary formulations play a signi fi cant role in animal health, production, and reproduction within the animal health industry. Such technologies offer bene fi cial advantages to the veterinarian, farmer, and pet owner. These advantages have resulted in long-acting formulations growing in popularity in recent years. The pharmaceutical scientist is faced with many challenges when innovating new products in this demanding fi eld of controlled release. This volume provides the reader with a comprehensive guide on the theories, applications, and challenges associated with the design and development of long-acting veterinary formulations. The authoritative chapters of the book are written by some of the leading experts in the fi eld. It covers a wide scope of areas including the market in fl uences, preformu- lation, biopharmaceutics, in vitro drug release testing, and speci fi cation setting to name a few. It also provides a detailed overview of the major technological advances made in this area. As a result, Long Acting Animal Health Drug Products covers everything a formulation scientist in industry or academia or a student needs to know about this unique drug delivery fi eld to advance health, production and reproduction treatment options, and bene fi ts for animals worldwide. In chapter 1 Sabnis and Rathbone de fi ne the current animal health markets for farmed animals and evaluate the opportunities that exist. The chapter provides an outlook for future projections of growth in the livestock industry and the likely resultant demands of the farmed animal health market. In the second chapter Linda Hoorspool conducts a similar analysis (with quite different conclusions) for the companion animal market. The anatomy and physiology of the farmed and companion animals are provided by Ellis and Sutton, respectively. These chapters describe the large differences between ruminant (cattle and sheep) and monogastric animals (speci fi cally cats and dogs) and highlight the different challenges (and opportunities) faced by formulation scientists in designing and developing long-acting veterinary products for these two physiologically and anatomically different types of animals. Chapter 5 provides a comprehensive overview of the physicochemical principles of controlled release veterinary pharmaceuticals. In this contribution Fletcher et al. describe the basic physical and chemical properties relevant to drug formulation vii viii Preface which includes the active pharmaceutical ingredient, excipients, and fi nal product. The chapter also highlights the importance of physical and chemical attributes of compounds in the selection of ingredients; development of dosage forms; and their signi fi cance with respect to active and fi nal product assessment, characterization, per- formance, and quality. Sutton describes the basics of biopharmaceutics and its rele- vance in veterinary drug delivery. This chapter discusses studies that emphasize the similarities and differences in species and routes of administration. From nasal and ocular to transdermal and oral, examples of formulations for veterinary practice are discussed. The main concepts related to analytical testing of veterinary drug products and the development of speci fi cations for critical quality attributes are addressed by Brum fi eld. This excellent and comprehensive chapter will be of value to anyone working in the industrial setting. Brum fi eld describes pragmatic strategies for the development and use of analytical speci fi cations throughout the veterinary product development and commercialization life cycle. Also presented are typical analytical testing requirements for quality assessment and registration of selected types of products in major markets (USA, EU, and Japan), and unique challenges related to several veterinary-centric dosage forms including medicated articles for preparation of feeds and drinking waters, and topical parasiticide preparations. The challenges of developing and undertaking in vitro drug release testing of veterinary pharmaceuticals are described in the following chapter by Higgins-Gruber. Long-acting veterinary dosage forms tend to be more complex and varied because of the diversity of species and size of the animals. Therefore, the development of in vitro drug release tests for such products can be challenging and unconventional with respect to the expectations from the regulatory agencies. Higgins-Gruber describes the principles taken into consideration when developing an in vitro drug release test for long-acting veterinary pharmaceuticals that is easy to perform in a quality control environment whilst being discriminat- ing with respect to the impact of critical quality attributes on in vivo behavior. The remaining contributions of the book describe technological advances in the fi eld of long-acting veterinary products. Chapters devoted to long-acting rumen drug delivery systems (Vandamme), intravaginal veterinary drug delivery (Rathbone), long-acting injections and implants (Cady), intramammary delivery technologies (Alany), veterinary vaccines (Elhay), and delivery systems for wildlife (McDowell) all provide a wealth of information and insight into the current strategies and contemporary research adopted in the development of long-acting veterinary drug delivery systems. In the fi nal chapter of the book Baird examines the emerging drug discovery technologies in both the human and animal drug delivery fi elds and discusses the potential for cross over of the learnings, technologies, and outcomes from these areas that result in “spin off” bene fi ts for veterinary medicine. The chapter makes for some interesting reading. We thank all the authors for their time and effort to put pen to paper to share their experiences and knowledge in this volume. Without their interest and commitment to the area of long-acting animal health products this book would not be the treasury of knowledge that it is. Kuala Lumpur, Malaysia Michael J. Rathbone Dunedin, New Zealand Arlene McDowell Contents 1 Animal Health Markets and Opportunities: Farmed Animal Landscape ................................................................... 1 Shobhan Sabnis and Michael J. Rathbone 2 Animal Health Markets and Opportunities: Companion Animal Landscape ............................................................. 15 Linda J.I. Horspool 3 Anatomy and Physiology of the Farmed Animal ................................ 47 Keith J. Ellis 4 Oral Anatomy and Physiology in the Companion Animal ................. 59 Steven C. Sutton 5 Physicochemical Principles of Controlled Release Veterinary Pharmaceuticals .................................................................. 69 John G. Fletcher, Michael J. Rathbone, and Raid G. Alany 6 Biopharmaceutics and Veterinary Drug Delivery ............................... 97 Steven

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