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). The arithmetic mean of the weekly high and low temperatures is then used in the calculation of MKT.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. For dispensing sites, such as pharmacies and hospitals, where the use of such instruments may not be feasible, devices such as high-low thermometers capable of indicating weekly high and low temperatures over a 52-week period may be employed. MKT can be calculated directly or the data can be downloaded to a computer for processing. The temperatures for calculating MKT can be conveniently collected using electronic devices that measure temperatures at frequent intervals (e.g., every 15 minutes). MKT is calculated from temperatures in a storage facility. Thus, MKT may be considered as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variation. Mean Kinetic Temperature (MKT) is 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. Accelerated studies also allow the interpretation of data and information on short-term spikes in storage conditions in addition to the excursions allowed by controlled room temperature.
Accelerated studies are specified at 40 ± 2 and at 75 ± 5% relative humidity. The common international guideline for long-term stability studies specifies 25 ± 2 at 60 ± 5% relative humidity. Controlled room temperature limits the permissible excursions to those consistent with the maintenance of a mean kinetic temperature calculated to be not more than 25. Products may be labeled either to store at ∼ontrolled room temperature or to store at temperatures up to 25 where labeling is supported by long-term stability studies at the designated storage condition of 25. This terminology also allows patients or consumers to be counseled as to appropriate storage for the product.
Controlled room temperature (see Storage Temperature and Humidity in Preservation, Packaging, Storage, and Labeling under General Notices and Requirements) delineates the allowable tolerance in storage circumstances at any location in the chain of distribution (e.g., pharmacies, hospitals, and warehouses).
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