![]() The MKT has been found to be useful in a number of pharmaceutically relevant applications, such as providing a scientific means of summarizing variable climatic temperatures (5), handling storage and distribution of pharmaceuticals (6), and for handling temperature excursions (7). Thus, MKT may be considered as an isothermal storage temperature that simulates the effects of variable storage temperature. MKT can be defined as 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 (4). The concept of mean kinetic temperature (MKT) was first introduced in 1971 (2) and was further developed in the 1990s (3). Indeed, this concept is the underpinning theoretical basis for the pharmaceutical industry guidelines that provide recommendations for long-term, intermediate, and accelerated storage conditions and for establishing expiration dates (1). It is well established that the rate of chemical degradation of solid-state pharmaceutical products, such as tablets and capsules, is highly dependent upon the environmental temperature and humidity. ![]()
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