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Pediatric Biopharmaceutical Classification System: Using Age-Appropriate Initial Gastric Volume
1Department of Physiology, Pharmacology and Toxicology, Faculty of Medicine & Health Sciences, An-Najah National University, New Campus, Building: 19, Office: 1340, P.O. Box 7, Nablus, Palestine. ramzi_shawahna@hotmail.com.
Insights
Developing pediatric oral drug formulations is complex. This study adapted the biopharmaceutical classification system (BCS) for children, revealing age-dependent shifts in drug solubility classes, crucial for formulation development.
Area of Science:
- Pharmacokinetics and Drug Development
- Pediatric Pharmacology
- Biopharmaceutical Sciences
Background:
- Optimizing pediatric oral formulations presents significant challenges.
- The biopharmaceutical classification system (BCS) aids adult oral drug formulation but lacks comprehensive pediatric adaptation.
- Existing biowaiver criteria may not be universally applicable to pediatric populations.
Purpose of the Study:
- To provisionally classify drugs from the WHO Essential Medicines List for Children using an age-appropriate BCS.
- To investigate age-related shifts in drug solubility classes within pediatric subpopulations.
- To highlight knowledge gaps in pediatric biopharmaceutics.
Main Methods:
- Classified 38 orally administered drugs from the WHO Essential Medicines List for Children.
- Calculated dose numbers using age-appropriate gastric volumes (neonates to adults).
- Applied British National Formulary age-specific dosing recommendations.
Main Results:
- Identified age-dependent shifts in BCS solubility classes for several drugs, including amoxicillin, cephalexin, chloramphenicol, diazepam, doxycycline, erythromycin, phenobarbital, prednisolone, and trimethoprim.
- Demonstrated that solubility classifications can change significantly in pediatric subpopulations compared to adults.
- Highlighted the need for age-specific biopharmaceutical considerations.
Conclusions:
- An age-appropriate BCS is essential for pediatric drug formulation development.
- Current biowaiver strategies require re-evaluation for pediatric use.
- Further research is needed to address knowledge gaps in pediatric biopharmaceutics.
Abstract:
Development of optimized pediatric formulations for oral administration can be challenging, time consuming, and financially intensive process. Since its inception, the biopharmaceutical classification system (BCS) has facilitated the development of oral drug formulations destined for adults. At least theoretically, the BCS principles are applied also to pediatrics. A comprehensive age-appropriate BCS has not been fully developed. The objective of this work was to provisionally classify oral drugs listed on the latest World Health Organization's Essential Medicines List for Children into an age-appropriate BCS. A total of 38 orally administered drugs were included in this classification. Dose numbers were calculated using age-appropriate initial gastric volume for neonates, 6-month-old infants, and children aging 1 year through adulthood. Using age-appropriate initial gastric volume and British National Formulary age-specific dosing recommendations in the calculation of dose numbers, the solubility classes shifted from low to high in pediatric subpopulations of 12 years and older for amoxicillin, 5 years, 12 years and older for cephalexin, 9 years and older for chloramphenicol, 3-4 years, 9-11 and 15 years and older for diazepam, 18 years and older (adult) for doxycycline and erythromycin, 8 years and older for phenobarbital, 10 years and older for prednisolone, and 15 years and older for trimethoprim. Pediatric biopharmaceutics are not fully understood where several knowledge gaps have been recently emphasized. The current biowaiver criteria are not suitable for safe application in all pediatric populations.
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