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Vehicle Systems and Excipients Used in Minipig Drug Development Studies

Weaver, Margaret and Blak Grossi, Anette and Parish, Joanna and Schützsack, Jorgen and Løgsted, Jeanet and Brück Bøgh, Ingrid and Cameron, David and Harvey, Warren and Festag, Matthias and Downes, Noel and Venturella, Silvana and Schlichtiger, Julia and Mhedhbi, Sofiene and Ross, Vanessa and Kissner, Thomas and Stark, Claudia and Milano, Stephane and Heining, Peter and Sanchez-Felix, Manuel (2016) Vehicle Systems and Excipients Used in Minipig Drug Development Studies. Toxicologic Pathology, 44 (3). pp. 367-372. ISSN 1533-1601

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.

Item Type: Article
Keywords: dermal excipients intravenous minipig oral subcutaneous vehicles
Date Deposited: 29 Nov 2017 00:45
Last Modified: 25 Jan 2019 00:45
URI: https://oak.novartis.com/id/eprint/26236

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