Pediatric Formulations: A Roadmap

✍ Scribed by Hannah Batchelor (auth.), Daniel Bar-Shalom, Klaus Rose (eds.)

• Publisher: Springer-Verlag New York
• Year: 2014
• Tongue: English
• Leaves: 429
• Series: AAPS Advances in the Pharmaceutical Sciences Series 11
• Edition: 1
• Category: Library

✦ Synopsis

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.

✦ Table of Contents

Front Matter....Pages i-xv
Front Matter....Pages 1-1
Paediatric Development: Anatomy. Age, Weight, Body Surface and Stature, Organ Development....Pages 3-7
Pediatric Development: Physiology. Enzymes, Drug Metabolism, Pharmacokinetics and Pharmacodynamics....Pages 9-23
Developmental Changes in the Processes Governing Oral Drug Absorption....Pages 25-42
Paediatric Development: Gastrointestinal....Pages 43-54
How to Estimate the Dose to Be Given for the First Time to Pediatric Patients....Pages 55-67
The Clinical Relevance of Pediatric Formulations....Pages 69-85
Front Matter....Pages 87-87
General Considerations for Pediatric Oral Drug Formulation....Pages 89-104
Orosensory Perception....Pages 105-121
Flavor Is Not Just Taste: Taste Concealing....Pages 123-139
Liquid Formulations....Pages 141-151
Paediatric Solid Formulations....Pages 153-170
Semi-solid Formulations....Pages 171-179
The Challenge of Automated Compounding....Pages 181-191
Pediatric Formulations in Clinical Testing and the Challenge of Final Market Formulation....Pages 193-203
Buccal/Sublingual Drug Delivery for the Paediatric Population....Pages 205-215
Front Matter....Pages 217-217
Topical and Transdermal....Pages 219-238
Parenteral Liquids for Intravenous and Transdermal Use....Pages 239-252
The Challenges of Paediatric Pulmonary Drug Delivery....Pages 253-272
Nasal, Ocular and Otic Drug Delivery....Pages 273-301
Rectal Drug Delivery....Pages 303-310
Front Matter....Pages 217-217
Intraosseous Infusions in Infants and Neonates....Pages 311-325
Front Matter....Pages 327-327
Compounding for Children: The Compounding Pharmacist....Pages 329-334
Front Matter....Pages 335-335
Food Ingredients....Pages 337-345
Excipients and Active Pharmaceutical Ingredients....Pages 347-361
Front Matter....Pages 363-363
Clinical Testing in Children....Pages 365-376
Pediatric Formulations and Dosage Forms and Future Opportunities: Impact of Regulations in the USA and Implementation of Quality by Design....Pages 377-393
Paediatric Pharmaceutical Legislation and Its Impact on Adult and Paediatric Drug Development: The EU Regulatory View....Pages 395-404
Pediatric Pharmaceutical Legislation in the USA and EU and Their Impact on Adult and Pediatric Drug Development....Pages 405-419
Checks and Balances in the EU: The Role of the European Ombudsman, with a Focus on the Paediatric Regulation....Pages 421-426
Front Matter....Pages 427-427
The Dangerous Business of Predicting the Future....Pages 429-431
Back Matter....Pages 433-439

✦ Subjects

Pharmaceutical Sciences/Technology; Pharmacy; Pediatrics