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Mean Kinetic Temperature (MKT) is used in the pharmaceutical industry to evaluate the effect fluctuating temperatures have over time on the efficacy and safety of a drug product. In 1971, J.D. Haynes calculated a “Virtual Temperature” to predict product expiration when considering temperature variability in a given region. The formula uses the Arrhenius equation, which identifies the temperature dependence on chemical reaction rates.
MKT is a weighted average temperature (one single number) which summarizes (or simulates) the thermal challenge a drug substance (or drug product) would experience over a range of various temperatures for a defined period of time. The MKT is by definition higher than the arithmetic average temperature since it takes into consideration the Arrhenius equation.
The U.S. Food and Drug Administration (FDA) and European Commission recognizes MKT as a mathematical tool to help identify safe shipping and storage conditions within specific climatic zones.
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When is MKT Used?
- Stability Study: MKT can be used to simulate (predict) the decomposition of a drug substance during a stability study.
- Storage: In regulatory documents, there is a wide consensus that MKT can be used to assess temperature excursions outside specified storage conditions of refrigerated and room temperature products.
- Transport: Some suggest using MKT in transport environments, but the value does not account for effects that could lead to irreversible quality defects, effects of freezing temperatures, or transport temperatures that have not been captured.
The higher (and longer) a drug product is exposed to high temperatures, the faster it decomposes.
Mean Kinetic Temperature Rules:
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Mainly use MKT for storage – the longer the time period, the more informative MKT.
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Only use MKT where you have temperature control (refrigerated or room temperature).
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MKT does not work for frozen products.
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Use MKT to evaluate temperature excursions but not to compensate for earlier excursions.
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MKT does not consider freeze and thaw cycles.
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