Pediatric formulations : a roadmap [electronic resource]
- Pediatric formulations :a roadmap[electronic resource] / Daniel Bar-Shalom, Klaus Rose, editors.
- New York : AAPS Press, 2014.
- 1 online resource.
- AAPS Advances in the Pharmaceutical Sciences Series ; v.11
- Includes bibliographical references and index.
- 9781489980106(pISBN), 9781489980113(eISBN)
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.
2. Pediatric Development: Physiology. Enzymes, Drug Metabolism, Pharmacokinetics and Pharmacodynamics
3. Developmental Changes in the Processes Governing Oral Drug Absorption
4. Paediatric Development: Gastrointestinal
5. How to Estimate the Dose to Be Given for the First Time to Pediatric Patients
6. The Clinical Relevance of Pediatric Formulations
2. Formulating for Children I, the Oral Route
8. Orosensory Perception
9. Flavor Is Not Just Taste: Taste Concealing
10. Liquid Formulations
11. Paediatric Solid Formulations
12. Semi-solid Formulations
13. The Challenge of Automated Compounding
14. Pediatric Formulations in Clinical Testing and the Challenge of Final Market Formulation
15. Buccal/Sublingual Drug Delivery for the Paediatric Population
3. Formulating for Children II, Non-oral Routes
17. Parenteral Liquids for Intravenous and Transdermal Use
18. The Challenges of Paediatric Pulmonary Drug Delivery
19. Nasal, Ocular and Otic Drug Delivery
20. Rectal Drug Delivery
21. Intraosseous Infusions in Infants and Neonates
24. Excipients and Active Pharmaceutical Ingredients
6. Clinical Development and Regulatory Aspects
26. Pediatric Formulations and Dosage Forms and Future Opportunities: Impact of Regulations in the USA and Implementation of Quality by Design
27. Paediatric Pharmaceutical Legislation and Its Impact on Adult and Paediatric Drug Development: The EU Regulatory View
28. Pediatric Pharmaceutical Legislation in the USA and EU and Their Impact on Adult and Pediatric Drug Development
29. Checks and Balances in the EU: The Role of the European Ombudsman, with a Focus on the Paediatric Regulation
7. Concluding Remarks: The Future of Pediatric Formulations