Pediatric Formulations

1. Front Matter

   Pages i-xv

   PDF

2. The Patient

   1. Front Matter

      Pages 1-1

      PDF

   2. Paediatric Development: Anatomy. Age, Weight, Body Surface and Stature, Organ Development

      • Hannah Batchelor

      Pages 3-7

   3. Pediatric Development: Physiology. Enzymes, Drug Metabolism, Pharmacokinetics and Pharmacodynamics

      • Geert ‘t Jong

      Pages 9-23

   4. 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

   5. Paediatric Development: Gastrointestinal

      • Hannah Batchelor

      Pages 43-54

   6. How to Estimate the Dose to Be Given for the First Time to Pediatric Patients

      • Gerard Greig

      Pages 55-67

   7. 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

      PDF

   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. Pediatric Formulations in Clinical Testing and the Challenge of Final Market Formulation

      • Norbert Pöllinger

      Pages 193-203

   10. 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

      PDF

   2. Topical and Transdermal

      • William J. McAuley, Matthew Traynor, Marc B. Brown

      Pages 219-238

Until the 1990s, it was generally accepted that medicines were first developed for adults and their use in children was investigated later, if at all. One of the main tasks of hospital pharmacies was the manufacturing of child-appropriate formulations in a more or less makeshift way. The first change came in 1997 with U.S. legislation that rewarded manufacturers to do voluntary pediatric research. Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure. In consequence, manufacturers must now cover all age groups, including the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed.

• compounding
• legislation
• oral delivery
• taste masking

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)

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

  Daniel Bar-Shalom

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

  Klaus Rose

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.

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