Pediatric Formulations

Part I: The Patient

1. Pediatric Development: Anatomy. Age, Weight, Body Surface and Stature, Organ Development

Hannah Bachelor

2. Pediatric Development: Physiology. Enzymes; Drug Metabolism; Pharmacokinetics & Pharmacodynamics

Geert 't Jong

3. Pediatric Development - Gastrointestinal

Hannah Batchelor

4. How to Estimate the Dose to be Given for the First Time to Pediatric Patients

Gerard Greig

5. The Clinical Relevance of Pediatric Formulations

Karel Allegaert, Pieter De Cock, Johannes N van den Anker

Part II: Formulating for Children I, The Oral Route

6. General Considerations for Pediatric Oral Drug Formulation

Valentina Shakhnovich and Susan M. Abdel-Rahman

7. Orosensory Perception

Per Møller

8. Flavor Is Not Just Taste: Taste Concealing

Charles R. Frey

9. Liquid Formulations

Charles R. Frey and J. Scott Madsen

10. Paediatric Solid Formulations

Sejal Ranmal and Catherine Tuleu

11. Semi-Solid Formulations

Daniel Bar-Shalom and Irwin C. Jacobs

12. The Challenge of Automated Compounding

Daniel Bar-Shalom

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

Norbert Pöllinger

14. Buccal/Sublingual Drug Delivery for the Paediatric Population

Viralkumar F. Patel, Darragh Murnane, Marc B. Brown

Part III: Formulating for Children II, Non-Oral Routes

15. Topical and Transdermal

William McAuley, Matthew Traynor and Marc Brown

16. Parenteral Liquids for Intravenous and Transdermal Use

Utpal U. Shah and Matthew Roberts

17. The Challenges of Paediatric Pulmonary Drug Delivery

Darragh Murnane and Marc B Brown

Hannah Batchelor

Hannah Batchelor

Jose Ramet, Maria A.L.J. Slaats Mst, Catharina J. Elsing Mst

Part IV: Compounding

21. Compounding for Children - The Compounding Pharmacist

Linda F. McElhiney

Part V: Materials

22. Food Ingredients

Parnali Chatterjee and Marie Ojiambo

23. Excipients and Active Pharmaceutical Ingredients (APIs)

Parnali Chatterjee and Mohammed M Alvi

Part VI: Clinical Development and Regulatory Aspects

24. Clinical Testing in Children

Klaus Rose

25. Pediatric Formulations and Dosage Forms and Future Opportunities: Impact of Regulations in the United States and Implementation of Quality by Design

Arzu Selen

26. Pediatric Pharmaceutical Legislation and its impact on Adult and Pediatric Drug Development: The EU Regulatory View
Siri Wang & Karl-Heinz Huemer

27. Pediatric Pharmaceutical Legislation in USA and EU and their impact on Adult and Pediatric Drug Development

Klaus Rose

28. Checks and Balances in the EU: The Role of the European Ombudsman, with a Focus on the Paediatric Regulation

Rosita Agnew

Part VII: Concluding Remarks - The Future of Pediatric Formulations

29. The Dangerous Business Of Predicting The Future

Daniel Bar-Shalom. Hannah Batchelor, Linda F. McElhiney, 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.