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  • Book
  • © 2014

Pediatric Formulations

A Roadmap

  • Provides a comprehensive treatment of pediatric drug development

  • Highlights the anatomical, physiological and developmental differences between adults and children

  • Draws a roadmap to better, innovative formulations, in particular for oral administration

  • Includes supplementary material: sn.pub/extras

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series (AAPS, volume 11)

Buying options

eBook USD 169.00
Price excludes VAT (USA)
  • ISBN: 978-1-4899-8011-3
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
Softcover Book USD 219.99
Price excludes VAT (USA)
Hardcover Book USD 219.99
Price excludes VAT (USA)

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Table of contents (30 chapters)

  1. Front Matter

    Pages i-xv
  2. The Patient

    1. Front Matter

      Pages 1-1
    2. Developmental Changes in the Processes Governing Oral Drug Absorption

      • Barbara A. E. de Koning, Miriam Mooij, Trevor N. Johnson, Saskia N. de Wildt
      Pages 25-42
    3. Paediatric Development: Gastrointestinal

      • Hannah Batchelor
      Pages 43-54
    4. The Clinical Relevance of Pediatric Formulations

      • Karel Allegaert, Pieter De Cock, Johannes N. van den Anker
      Pages 69-85
  3. Formulating for Children I, the Oral Route

    1. Front Matter

      Pages 87-87
    2. General Considerations for Pediatric Oral Drug Formulation

      • Valentina Shakhnovich, Susan M. Abdel-Rahman
      Pages 89-104
    3. Orosensory Perception

      • Per Møller
      Pages 105-121
    4. Flavor Is Not Just Taste: Taste Concealing

      • Charles R. Frey
      Pages 123-139
    5. Liquid Formulations

      • Charles R. Frey, J. Scott Madsen
      Pages 141-151
    6. Paediatric Solid Formulations

      • Sejal R. Ranmal, Susan A. Barker, Catherine Tuleu
      Pages 153-170
    7. Semi-solid Formulations

      • Irwin C. Jacobs
      Pages 171-179
    8. The Challenge of Automated Compounding

      • Daniel Bar-Shalom
      Pages 181-191
    9. Buccal/Sublingual Drug Delivery for the Paediatric Population

      • Viralkumar F. Patel, Darragh Murnane, Marc B. Brown
      Pages 205-215
  4. Formulating for Children II, Non-oral Routes

    1. Front Matter

      Pages 217-217
    2. Topical and Transdermal

      • William J. McAuley, Matthew Traynor, Marc B. Brown
      Pages 219-238

About this book

As the first book that specifically addresses pediatric formulations in the context of drug development, Pediatric Formulations: A Roadmap covers anatomy and physiology of children as well as the technical state of the art, gives hints about where to find inspiration, and provides a suitable background on the regulatory framework. Existing books on pediatric formulations mainly discuss compounding at the pharmacy. This is not a “how to formulate” textbook for pharmaceutical scientists; the subtitle “A Roadmap” indicates that we are on a path in largely unexplored territory. It is an attempt to equip the reader with necessary information on how to get started with the appropriate mindset.

Among medicinal specialties, pediatrics is a young discipline. The potential dangers of medicine were often underestimated in earlier times. Cough suppressants labeled as “suitable for children and adults” a hundred years ago could kill children as they contained opioids. Since then, a complex framework has evolved, with physicians, pharmacists, drug development companies, generic companies, academic scientists, regulatory authorities, reimbursement organizations, patients and children’s parents as key players. The position of children in our society has changed dramatically during the last century. Children were protected against clinical trials, yet thanks to clinical trials, many more children with cancer survive today. The development of age-adjusted drug formulations is not only a technical challenge. For new drugs today, there are laws both in the United States and the European Union that compel the research-based pharmaceutical industry to also consider children during drug development. One of the major demands of authorities is the development of age-appropriate formulations.

Daniel Bar-Shalom is an Associate Professor in Drug Delivery at The Faculty of Health and Medical Sciences, University of Copenhagen. He has a degree in Biology from The Tel-Aviv University (1975), carried research in botany and then graduated from the School of Pharmacy, Hebrew University of Jerusalem (1982). He is a qualified pharmacist and has managed and owned a pharmacy in Haifa where he gained insight into the needs and idiosyncrasies of patients. He moved to Denmark in 1986 and founded Egalet, a drug delivery company where he served until 2007 as Vice President, R&D. He has been a consultant for various pharmaceutical and medical device companies. He is also the inventor of various technologies, holds many patents and has formulated marketed products. His main interests are controlled drug delivery and in particular oral pediatric formulations and geriatric formulations addressing the problem of polypharmacy.

Dr. Klaus Rose is CEO of Klausrose Consulting, Switzerland and advises on pediatric drug development and how to comply with FDA and EMA pediatric requirements. He has studied Latin languages, psychology and medicine. After postgraduate clinical training in general medicine in Germany and England, he joined the pharmaceutical industry. He has held various positions in R&D and medical affairs, was Global Head Pediatrics Novartis from 2001 to 2005 and was Global Head Pediatrics Roche from 2005 to 2009. After a year with a regulatory consultancy, he established his own business. Dr. Rose is a frequent speaker on international conferences on pediatric drug development, organizes trainings and publishes on a regular base.

Keywords

  • compounding
  • legislation
  • oral delivery
  • taste masking

Reviews

From the reviews:

“This book can be useful not only for those in drug development, but also for pharmacists who work in pediatrics (either hospital or community pharmacists), compounding pharmacists, pediatricians, nurses who specialize in this area, and certainly students or residents in any of these disciplines who plan to focus on pediatrics. … I have reviewed and used many books on drug formulations and pharmaceutics, but I have not seen such a complete book devoted specifically to pediatrics.” (Patrick J. McDonnell, Doody’s Book Reviews, July, 2014)

Editors and Affiliations

  • Department of Pharmaceutics Department of Analytical Chemistry, University of Copenhagen, Denmark

    Daniel Bar-Shalom

  • Pediatric Drug Development & More, klausrose Consulting, Riehen, Switzerland

    Klaus Rose

About the editors

Daniel Bar-Shalom is an Associate Professor in Drug Delivery at The Faculty of Health and Medical Sciences, University of Copenhagen. He has a degree in Biology from The Tel-Aviv University (1975), carried research in botany and then graduated from the School of Pharmacy, Hebrew University of Jerusalem (1982). He is a qualified pharmacist and has managed and owned a pharmacy in Haifa where he gained insight into the needs and idiosyncrasies of patients. He moved to Denmark in 1986 and founded Egalet, a drug delivery company where he served until 2007 as Vice President, R&D. He has been a consultant for various pharmaceutical and medical device companies. He is also the inventor of various technologies, holds many patents and has formulated marketed products. His main interests are controlled drug delivery and in particular oral pediatric formulations and geriatric formulations addressing the problem of polypharmacy.

Dr. Klaus Rose is CEO of Klausrose Consulting, Switzerland and advises on pediatric drug development and how to comply with FDA and EMA pediatric requirements. He has studied Latin languages, psychology and medicine. After postgraduate clinical training in general medicine in Germany and England, he joined the pharmaceutical industry. He has held various positions in R&D and medical affairs, was Global Head Pediatrics Novartis from 2001 to 2005 and was Global Head Pediatrics Roche from 2005 to 2009. After a year with a regulatory consultancy, he established his own business. Dr. Rose is a frequent speaker on international conferences on pediatric drug development, organizes trainings and publishes on a regular base.

Bibliographic Information

Buying options

eBook USD 169.00
Price excludes VAT (USA)
  • ISBN: 978-1-4899-8011-3
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
Softcover Book USD 219.99
Price excludes VAT (USA)
Hardcover Book USD 219.99
Price excludes VAT (USA)