Pediatric Formulations (eBook)

A Roadmap

Daniel Bar-Shalom, Klaus Rose (Herausgeber)

eBook Download: PDF

2014 | 2014
XV, 439 Seiten
Springer New York (Verlag)
978-1-4899-8011-3 (ISBN)

Infos

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.

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.

Inhalt

Part I: The Patient 1. Pediatric Development: Anatomy. Age, Weight, Body Surface and Stature, Organ DevelopmentHannah Bachelor  2. Pediatric Development: Physiology. Enzymes; Drug Metabolism; Pharmacokinetics & PharmacodynamicsGeert ‘t Jong 3. Pediatric Development – Gastrointestinal  Hannah Batchelor 4. How to Estimate the Dose to be Given for the First Time to Pediatric PatientsGerard Greig5. 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 FormulationValentina Shakhnovich and  Susan M. Abdel-Rahman7. Orosensory PerceptionPer Møller8. Flavor Is Not Just Taste: Taste ConcealingCharles R. Frey9. Liquid FormulationsCharles R. Frey and J. Scott Madsen10. Paediatric Solid FormulationsSejal Ranmal and Catherine Tuleu11. Semi-Solid FormulationsDaniel Bar-Shalom and Irwin C. Jacobs12. The Challenge of Automated Compounding Daniel Bar-Shalom13. Pediatric Formulations in Clinical Testing and the Challenge of Final Market Formulation Norbert Pöllinger14. Buccal/Sublingual Drug Delivery for the Paediatric PopulationViralkumar F. Patel, Darragh Murnane, Marc B. BrownPart 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 UseUtpal U. Shah and Matthew Roberts17. The Challenges of Paediatric Pulmonary Drug Delivery Darragh Murnane and Marc B Brown18. Nasal, Ocular,and Otic Drug Delivery Hannah Batchelor19. Rectal Drug Delivery Hannah Batchelor20. Intraosseous Infusions in Infants and NeonatesJose Ramet, Maria A.L.J. Slaats Mst, Catharina J. Elsing MstPart IV: Compounding 21. Compounding for Children – The Compounding PharmacistLinda F. McElhineyPart V: Materials 22. Food IngredientsParnali Chatterjee and Marie Ojiambo23. Excipients and Active Pharmaceutical Ingredients (APIs) Parnali Chatterjee and Mohammed M AlviPart 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 Selen26. Pediatric Pharmaceutical Legislation and its impact on Adult and Pediatric Drug Development: The EU Regulatory ViewSiri Wang & Karl-Heinz Huemer27. 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 RegulationRosita AgnewPart 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

Produkt-Details

• Erscheint lt. Verlag: 30.1.2014
• Reihe/Serie: AAPS Advances in the Pharmaceutical Sciences Series
• Reihe/Serie: AAPS Advances in the Pharmaceutical Sciences Series
• Zusatzinfo: XV, 439 p. 76 illus., 36 illus. in color.
• Verlagsort: New York
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pädiatrie
• Themenwelt: Medizin / Pharmazie ► Pflege
• Themenwelt: Medizin / Pharmazie ► Pharmazie ► PTA / PKA
• Themenwelt: Studium ► 1. Studienabschnitt (Vorklinik) ► Biochemie / Molekularbiologie
• Themenwelt: Naturwissenschaften ► Chemie
• Themenwelt: Technik
• Schlagworte: Compounding • Legislation • oral delivery • taste masking
• ISBN-10: 1-4899-8011-3 / 1489980113
• ISBN-13: 978-1-4899-8011-3 / 9781489980113