Assessment of age-related changes in pediatric gastrointestinal solubility

Anil R. Maharaj , Andrea N. Edginton, Nikoletta Fotaki

Research output: Contribution to journalArticlepeer-review

49 Citations (SciVal)
128 Downloads (Pure)



Compound solubility serves as a surrogate indicator of oral biopharmaceutical performance. Between infancy and adulthood, marked compositional changes in gastrointestinal (GI) fluids occur. This study serves to assess how developmental changes in GI fluid composition affects compound solubility.


Solubility assessments were conducted in vitro using biorelevant media reflective of age-specific pediatric cohorts (i.e., neonates and infants). Previously published adult media (i.e., FaSSGF, FeSSGF, FaSSIF.v2, and FeSSIF.v2) were employed as references for pediatric media development. Investigations assessing age-specific changes in GI fluid parameters (i.e., pepsin, bile acids, pH, osmolality, etc.) were collected from the literature and served to define the composition of neonatal and infant media. Solubility assessments at 37°C were conducted for seven BCS Class II compounds within the developed pediatric and reference adult media.


For six of the seven compounds investigated, solubility fell outside an 80–125% range from adult values in at least one of the developed pediatric media. This result indicates a potential for age-related alterations in oral drug performance, especially for compounds whose absorption is delimited by solubility (i.e., BCS Class II).


Developmental changes in GI fluid composition can result in relevant discrepancies in luminal compound solubility between children and adults.
Original languageEnglish
Pages (from-to)52-71
Number of pages20
JournalPharmaceutical Research
Issue number1
Early online date29 Jul 2015
Publication statusPublished - 1 Jan 2016


  • biopharmaceutics
  • biorelevant
  • pediatric
  • solubility


Dive into the research topics of 'Assessment of age-related changes in pediatric gastrointestinal solubility'. Together they form a unique fingerprint.

Cite this