Stability Study: MKT can be used to simulate (predict) the decomposition of a drug substance during a stability study. MKT may be considered as an isothermal storage temperature that simulates the non-isothermal effects of storage temperature variation. MKT is the single calculated temperature at which the total amount of degradation over a particular period is equal to the sum of the individual degradations that would occur at various temperatures. Storage conditions Ģ0-25 0C (in exceptional cases: 15-30 0C -> related to MKT) 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.
The higher (and longer) a drug product is exposed to high temperatures, the faster it decomposes. The formula uses the Arrhenius equation, which identifies the temperature dependence on chemical reaction rates. Haynes calculated a “Virtual Temperature” to predict product expiration when considering temperature variability in a given region. 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.
