Do you know interesting things about Pediatric formulations and their dissolution testing?
- Generally, the recommended dissolution volume has been 500 mL, which most closely resembles the GI volume in adults.
- The volume of fluids in pediatric populations in two recent studies showed fasted gastric volume to be a maximum of 8 mL in a population of children ranging from 0 to 16 years, and another study suggested a median volume of 5.0 mL in infants and 26.6 mL in adolescents.
- Corresponding fasted state intestinal fluids have also been reported to reach a maximum of 51 mL in a population of children ranging from 0 to 16 years of age or have a median volume of 23.9 mL in infants and 62.9 mL in adolescents.
- When choosing the dissolution volume to use, an important consideration was the fluid volume administered with a tablet, which is typically 240 mL in adults and usually 120 mL in children.
Pl refer the attached FDA study to get further insights which are really interesting: Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations | FDA
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Sandip Tiwari
Head of Technical Services, Pharma Solutions, NA
BASF Corporation
Tarrytown NY
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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