| Literature DB >> 23665448 |
Hannah K Batchelor1, Richard Kendall, Sabine Desset-Brethes, Rainer Alex, Terry B Ernest.
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.Entities:
Keywords: (United States) Food and Drug Administration; Absorption; BCS; Bioavailability; Biopharmaceutics; Biopharmaceutics classification system; Dissolution; EMA; European Medicines Agency; FDA; FaSSIF; Fasted state simulated intestinal fluid; FeSSIF; Fed state simulated intestinal fluid; GI; Gastrointestinal; IVIVR; In vitro in vivo relationship; MAD; Maximum absorbable dose; P-Glycoprotein; P-gp; PBPK; PK; Paediatric; Permeability; Pharmacokinetic; Physiologically based pharmacokinetic; SGF; Simulated gastric fluid; Solubility; USP; United States pharmacopoeia
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Year: 2013 PMID： 23665448 DOI： 10.1016/j.ejpb.2013.04.015
Source DB: PubMed Journal: Eur J Pharm Biopharm ISSN： 0939-6411 Impact factor: 5.571