Age-related changes in pediatric gastrointestinal solubility: a new approach in the development of new and reformulated pediatric dosage forms
Publication Type
Conference Paper

Background: 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.

Objective: 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.

Methods: 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 months old infants and children aging 1 year through adulthood.

Results: 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 years 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.

Conclusions: 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. 

Conference Title
4th International Conference and the 2nd Conference of the Association of Faculties of Pharmacy at Jordanian Universities. Excellence in Pharmacy Education & Research: A Quality Approach
Conference Country
Conference Date
Oct. 25, 2016 - Oct. 28, 2016
Conference Sponsor
Jordan University
Additional Info
Conference Website