Vehicle Systems and Excipients Used in Minipig Drug Development Studies

Area of Science:

• Pharmacology
• Toxicology
• Veterinary Medicine

Background:

• Minipigs are increasingly used in nonclinical drug development as a second nonrodent species.
• Limited data exists on the tolerability of various excipients in minipigs for different administration routes.
• Sharing knowledge on excipient tolerability can prevent the use of inadequate formulations, reducing animal testing.

Purpose of the Study:

• To review and consolidate information on excipient vehicles tolerated by the Göttingen minipig.
• To provide data on excipient tolerability across dermal, oral, subcutaneous, and intravenous routes.
• To facilitate informed formulation selection and potentially reduce animal usage in nonclinical studies.

Main Methods:

• Compilation of data from pharmaceutical companies and contract research organizations.
• Review of vehicles previously used in Göttingen minipigs for single or multiple dosing.
• Inclusion of data specific to Göttingen minipig tolerability, noting species-specific differences.

Main Results:

• Identified various vehicles tolerated by Göttingen minipigs for different routes of administration.
• Highlighted excipients suitable for minipigs, some not appropriate for other species like dogs.
• Provided a basis for minimizing or avoiding specific vehicle qualification studies in minipigs.

Conclusions:

• Knowledge of excipient tolerability in Göttingen minipigs is crucial for efficient nonclinical drug development.
• This review supports the wider adoption of minipigs in place of other nonrodent species by providing essential formulation data.
• Reduced reliance on animal testing through informed formulation choices is a key outcome.