Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8414248 | European Journal of Pharmaceutics and Biopharmaceutics | 2013 | 10 Pages |
Abstract
Biopharmaceutics is routinely used in the design and development of medicines to generate science based evidence to predict in vivo performance; the application of this knowledge specifically to paediatric medicines development is yet to be explored. The aim of this review is to present the current status of available biopharmaceutical tools and tests including solubility, permeability and dissolution that may be appropriate for use in the development of immediate release oral paediatric medicines. The existing tools used in adults are discussed together with any limitations for their use within paediatric populations. The results of this review highlight several knowledge gaps in current methodologies in paediatric biopharmaceutics. The authors provide recommendations based on existing knowledge to adapt tests to better represent paediatric patient populations and also provide suggestions for future research that may lead to better tools to evaluate paediatric medicines.
Keywords
Maximum absorbable doseFeSSIFFDAFaSSIFUSPEMASGFP-gpPBPKMADP-glycoproteinEuropean Medicines agencyDissolutionSolubilityUnited States pharmacopoeiaBiopharmaceuticsAbsorptionfasted state simulated intestinal fluidGastrointestinalfed state simulated Intestinal fluidBCsbiopharmaceutics classification systemsimulated gastric fluidpharmacokineticPhysiologically based pharmacokineticBioavailabilityPermeabilitypaediatric
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Authors
Hannah K. Batchelor, Richard Kendall, Sabine Desset-Brethes, Rainer Alex, Terry B. Ernest, on behalf of the European Paediatric Formulation Initiative (EUPFI) on behalf of the European Paediatric Formulation Initiative (EUPFI),