Main description:

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.

Contents:

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 Moller

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 Poellinger

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

18. Nasal, Ocular,and Otic Drug Delivery Hannah Batchelor

19. Rectal Drug Delivery Hannah Batchelor

20. Intraosseous Infusions in Infants and NeonatesJose 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