title: Considerations for the development of in vitro dissolution tests to reduce or replace preclinical oral absorption studies.
abstract: The pharmaceutical development of new chemical entities can be hampered by their solubility and/or dissolution limitations. Currently, these properties are characterised mostly during in vivo pre-clinical studies. The development of appropriate in vitro methods to study the solubility and dissolution properties in preclinical species would lead to a significant reduction or replacement of the animal experiments at this stage of development. During clinical development, media simulating the human gastrointestinal tract fluids are commonly used and a similar approach mimicking laboratory animals' gastrointestinal tract fluids would impact on the preclinical stage of development. This review summarises the current knowledge regarding the gastrointestinal physiology of the most common laboratory animals, and animal simulated gastric and intestinal media are proposed.
authors.affiliation: Department of Pharmacy and Pharmacology, University of Bath, UK.
authors.forename: Elise
authors.initials: E
authors.lastname: Grignard
authors.affiliation: Sirius Analytical Instruments Ltd., East Sussex, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Taylor
authors.affiliation: Pfizer Drug Product Design, Sandwich, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: McAllister
authors.affiliation: Sirius Analytical Instruments Ltd., East Sussex, UK.
authors.forename: Karl
authors.initials: K
authors.lastname: Box
authors.affiliation: Department of Pharmacy and Pharmacology, University of Bath, UK. Electronic address: n.fotaki@bath.ac.uk.
authors.forename: Nikoletta
authors.initials: N
authors.lastname: Fotaki
mesh_terms: D000284:Administration, Oral; D000818:Animals; D041981:Gastrointestinal Tract / Q000378:metabolism; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects*; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000378:metabolism*; D012995:Solubility
chemical_list: D004364:Pharmaceutical Preparations
keywords: Animal; Biorelevant media; Dissolution testing; Gastrointestinal physiology; In vitro