Pediatric Formulations

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.

Provides a comprehensive treatment of pediatric drug development Highlights the anatomical, physiological and developmental differences between adults and children Draws a roadmap to better, innovative formulations, in particular for oral administration Includes supplementary material: sn.pub/extras

Autorentext

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

Pediatric Development: Anatomy.- Age, Weight, Body Surface and Stature, Organ Development.- Pediatric Development: Physiology. Enzymes, Drug Metabolism, Pharmacokinetics and Pharmacodynamics.- Pediatric Development Gastrointestinal.- How to Estimate the Dose to be Given for the First Time to Pediatric Patients.- The Clinical Relevance of Pediatric Formulations.- General Considerations for Pediatric Oral Drug Formulation.- Orosensory Perception.- Flavor Is Not Just Taste: Taste Concealing.- Liquid Formulations.- Paediatric Solid Formulations.- Semi-Solid Formulations.- The Challenge of Automated Compounding.- Pediatric Formulations in Clinical Testing and the Challenge of Final Market Formulation.- Buccal/Sublingual Drug Delivery for the Paediatric Population.- Topical and Transdermal.- Parenteral Liquids for Intravenous and Transdermal Use.- The Challenges of Paediatric Pulmonary Drug Delivery.- Nasal, Ocular and Otic Drug Delivery.- Rectal Drug Delivery.- Intraosseous Infusions in Infants and Neonates.- Compounding for Children The Compounding Pharmacist.- Food Ingredients.- Excipients and Active Pharmaceutical Ingredients (APIs).- Clinical Testing in Children.- Pediatric Formulations and Dosage Forms and Future Opportunities: Impact of Regulations in the United States and Implementation of Quality by Design.- Pediatric Pharmaceutical Legislation and its impact on Adult and Pediatric Drug Development: The EU Regulatory View.- Pediatric Pharmaceutical Legislation in USA and EU and their impact on Adult and Pediatric Drug Development.- Checks and Balances in the EU: The Role of the European Ombudsman, with a Focus on the Paediatric Regulation.- The Dangerous Business Of Predicting The Future.