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Considerations for a Pediatric Biopharmaceutics Classification System (BCS): application to five drugs
Shivani V Gandhi1, William Rodriguez, Mansoor Khan
1University of Maryland School of Pharmacy, Baltimore, Maryland, 21201, USA.
AAPS Pharmscitech
|February 22, 2014
Summary
Developing a Biopharmaceutics Classification System (BCS) for pediatric drug development is crucial. This study classified five drugs, revealing discrepancies in BCS classification between adults and pediatric populations, highlighting key factors for pediatric BCS.
Area of Science:
- Pharmacology
- Drug Development
- Pediatric Medicine
Background:
- Biopharmaceutic risk assessment is recommended early in pediatric drug development.
- No established Biopharmaceutics Classification System (BCS) framework exists for pediatric patients.
- Classifying drugs into a pediatric BCS is essential for risk assessment.
Purpose of the Study:
- To classify five selected drugs into a potential pediatric Biopharmaceutics Classification System (BCS).
- To compare adult and pediatric BCS classifications for selected drugs.
- To identify critical factors for establishing a pediatric BCS framework.
Main Methods:
- Literature searches (Medline) were conducted for five drugs with available oral and intravenous pharmacokinetic data.
- Drugs were classified based on pediatric solubility and permeability across four subpopulations (neonates, infants, children, adolescents).
- Dose numbers were calculated using pediatric body surface area (BSA) and subpopulation volumes; permeability was assessed using pharmacokinetic data.
Main Results:
- Two drugs, azithromycin (class 3) and ciprofloxacin (class 4), showed agreement between adult and pediatric BCS classifications.
- Three drugs (dolasetron, ketoprofen, voriconazole) exhibited discordance, with high adult permeability but low pediatric permeability, leading to different pediatric BCS classifications.
- Pediatric BCS classification revealed lower permeability for drugs with high adult permeability, impacting their classification.
Conclusions:
- A pediatric Biopharmaceutics Classification System (BCS) framework is feasible but requires careful consideration of pediatric-specific factors.
- Significant differences in drug permeability exist between adult and pediatric populations, necessitating a distinct pediatric BCS.
- Identification of critical factors influencing pediatric drug solubility and permeability is key for accurate BCS classification in children.
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