Use of Mean Kinetic Temperature for Pharmaceuticals in Japan and Stability Monitoring in the 21st Century

Abstract

Background: The guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which was established in 1990 to streamline and standardize drug-approval review standards across Japan, the United States, and Europe. The ICH guidelines were established approximately 30 years ago, and, since then, temperatures have risen owing to global warming. Therefore, I verified whether the ICH guidelines correspond to the latest climate by using the Arrhenius equation, which is the basis for the ICH guidelines.

Methods: This study used an excerpt of the test conditions described in the ICH guidelines to calculate the mean kinetic temperature (MKT) for major Japanese cities based on temperature data from 1991 to 2020 (measured by the Japan Meteorological Agency).

Results: The study confirmed that the temperature conditions prescribed by the ICH guidelines for long-term storage tests were satisfied (see Fig. 1). Additionally, as drugs can be exposed to temperatures outside the specified range during distribution from the manufacturer to the final customer, data logs/loggers were utilized to calculate the MKT using the temperature history during transportation and storage.

Keywords: Arrhenius equation; Data loggers; ICH guidelines; Mean kinetic temperature; Pharmaceutical.