title: Vehicle Systems and Excipients Used in Minipig Drug Development Studies.
abstract: Minipigs have been used for dermal drug development studies for decades, and they are currently more frequently considered as the second nonrodent species for pivotal nonclinical studies, in lieu of the dog or nonhuman primate, for compounds delivered via standard systemic routes of administration. Little is known about the tolerability of different excipients in minipigs; sharing knowledge of excipient tolerability and compositions previously used in nonclinical studies may avoid testing of inadequate formulations, thereby contributing to reduced animal usage. This article reviews vehicles employed in the Göttingen(®)minipig based on the combined experience from a number of pharmaceutical companies and contract research organizations. The review includes vehicles tolerated for single or multiple dosing by the Göttingen minipig, some of which are not appropriate for administration to other common nonrodent species (e.g., dogs). By presenting these data for dermal, oral, subcutaneous, and intravenous routes of administration, studies to qualify these vehicles in minipigs can be minimized or avoided. Additionally, investigators may more frequently consider using the minipig in place of higher species if the tolerability of a vehicle in the minipig is known.
authors.affiliation: Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA margaret.weaver@novartis.com.
authors.forename: Margaret L
authors.initials: ML
authors.lastname: Weaver
authors.affiliation: Ellegaard Göttingen Minipigs A/S, Dalmose, Denmark.
authors.forename: Anette Blak
authors.initials: AB
authors.lastname: Grossi
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: Jorgen
authors.initials: J
authors.lastname: Schützsack
authors.affiliation: Covance Laboratories Limited, Harrogate, UK.
authors.forename: Joanna
authors.initials: J
authors.lastname: Parish
authors.affiliation: CiToxLAB, Scantox A/S, Lille Skensved, Denmark.
authors.forename: Jeanet
authors.initials: J
authors.lastname: Løgsted
authors.affiliation: Novo Nordisk A/S, Gentofte, Denmark.
authors.forename: Ingrid Brück
authors.initials: IB
authors.lastname: Bøgh
authors.affiliation: Huntingdon Life Sciences, Cambridgeshire, UK.
authors.forename: David
authors.initials: D
authors.lastname: Cameron
authors.affiliation: Charles River Laboratories, Edinburgh, UK.
authors.forename: Warren
authors.initials: W
authors.lastname: Harvey
authors.affiliation: F Hoffman-La Roche Ltd, Roche Innovation Center, Basel, Switzerland.
authors.forename: Matthias
authors.initials: M
authors.lastname: Festag
authors.affiliation: Sequani Limited, Herefordshire, UK.
authors.forename: Noel
authors.initials: N
authors.lastname: Downes
authors.affiliation: Research Toxicology Centre S.p.A., Pomezia, Italy.
authors.forename: Silvana
authors.initials: S
authors.lastname: Venturella
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Schlichtiger
authors.affiliation: Galderma Research & Development, Biot, France (current address Villeneuve Loubet, France).
authors.forename: Sofiene
authors.initials: S
authors.lastname: Mhedhbi
authors.affiliation: Huntingdon Life Sciences, Huntingdon, Cambridgeshire, UK.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Ross
authors.affiliation: Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Kissner
authors.affiliation: Bayer HealthCare, Berlin, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Stark
authors.affiliation: WIL Research Europe BV, Lyon, France.
authors.forename: Stephane
authors.initials: S
authors.lastname: Milano
authors.affiliation: Novartis Institutes for BioMedical Research, Basel, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Heining
authors.affiliation: Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.
authors.forename: Manual
authors.initials: M
authors.lastname: Sanchez-Felix
mesh_terms: D000818:Animals; D035843:Biomedical Research; D004333:Drug Administration Routes; D055808:Drug Discovery; D005079:Excipients; D014677:Pharmaceutical Vehicles; D013552:Swine; D013556:Swine, Miniature
chemical_list: D005079:Excipients; D014677:Pharmaceutical Vehicles
keywords: dermal; excipients; intravenous; minipig; oral; subcutaneous; vehicles