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Paediatric oral biopharmaceutics: key considerations and current challenges
Hannah K Batchelor1, Nikoletta Fotaki2, Sandra Klein3
1Pharmacy, Pharmacology and Therapeutics Section, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, Medical School Building, University of Birmingham, Edgbaston B15 2TT, United Kingdom.
Developing effective pediatric drug formulations requires specialized biopharmaceutical tools. Current methods for adults need adaptation for children, especially neonates and infants, due to significant gastrointestinal differences.
Area of Science:
- Pharmacology
- Pharmaceutical Sciences
- Pediatrics
Background:
- Oral drug absorption is complex, affected by drug properties and the gastrointestinal environment.
- Biopharmaceutical tools are established for adult drug development but less so for pediatric populations.
- Paediatric drug development faces unique challenges due to physiological differences.
Purpose of the Study:
- To review current literature on biopharmaceutical tools for pediatric drug development.
- To assess the suitability of extrapolating adult methodologies to pediatric populations.
- To identify gaps in knowledge regarding the pediatric gastrointestinal tract for drug absorption prediction.
Main Methods:
- Literature review of existing biopharmaceutical tools and their application in pediatrics.
- Analysis of clinical testing data and in silico models for pediatric drug absorption.
- Evaluation of physiological differences in the pediatric gastrointestinal tract.
Main Results:
- Significant differences exist in the pediatric gastrointestinal tract compared to adults, impacting drug absorption.
- Current biopharmaceutical tools require adaptation for accurate prediction in pediatric populations.
- Neonates and infants up to 6 months show the greatest physiological variations, posing the highest risk.
Conclusions:
- Further research is essential to characterize the pediatric gastrointestinal tract for improved drug absorption prediction.
- Bespoke biopharmaceutical tools are needed for safe and effective pediatric drug development.
- Extrapolation of adult data requires careful consideration, particularly for the youngest age groups.
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