TY - JOUR
T1 - Paediatric oral biopharmaceutics
T2 - key considerations and current challenges
AU - Batchelor, Hannah K.
AU - Fotaki, Nikoletta
AU - Klein, Sandra
PY - 2014/6/30
Y1 - 2014/6/30
N2 - The complex process of oral drug absorption is influenced by a host of drug and formulation properties as well as their interaction with the gastrointestinal environment in terms of drug solubility, dissolution, permeability and pre-systemic metabolism. For adult dosage forms the use of biopharmaceutical tools to aid in the design and development of medicinal products is well documented. This review considers current literature evidence to guide development of bespoke paediatric biopharmaceutics tools and reviews current understanding surrounding extrapolation of adult methodology into a paediatric population. Clinical testing and the use of in silico models were also reviewed. The results demonstrate that further work is required to adequately characterise the paediatric gastrointestinal tract to ensure that biopharmaceutics tools are appropriate to predict performance within this population. The most vulnerable group was found to be neonates and infants up to 6. months where differences from adults were greatest.
AB - The complex process of oral drug absorption is influenced by a host of drug and formulation properties as well as their interaction with the gastrointestinal environment in terms of drug solubility, dissolution, permeability and pre-systemic metabolism. For adult dosage forms the use of biopharmaceutical tools to aid in the design and development of medicinal products is well documented. This review considers current literature evidence to guide development of bespoke paediatric biopharmaceutics tools and reviews current understanding surrounding extrapolation of adult methodology into a paediatric population. Clinical testing and the use of in silico models were also reviewed. The results demonstrate that further work is required to adequately characterise the paediatric gastrointestinal tract to ensure that biopharmaceutics tools are appropriate to predict performance within this population. The most vulnerable group was found to be neonates and infants up to 6. months where differences from adults were greatest.
KW - dissolution
KW - metabolism
KW - permeability
KW - physiologically based pharmacokinetic modelling
KW - solubility
UR - http://www.scopus.com/inward/record.url?scp=84902344735&partnerID=8YFLogxK
U2 - 10.1016/j.addr.2013.10.006
DO - 10.1016/j.addr.2013.10.006
M3 - Review article
C2 - 24189013
AN - SCOPUS:84902344735
VL - 73
SP - 102
EP - 126
JO - Advanced Drug Delivery Reviews
JF - Advanced Drug Delivery Reviews
SN - 0169-409X
ER -