Heating and Cooling Rate Coefficients and Related Factors Affecting Procedures for Tablet Shelf Life Prediction*

Abstract

Data are presented for the heating and cooling rate coefficients of tablets under the usual conditions of exaggerated temperature hot air oven stability studies. The interrelationships of tablet composition, container dimensions, the drug activation energy and the probability factor of the Arrhenius equation, the storage oven temperature, time of storage, and sample heating and cooling rate coefficients are noted as they influence the programming and results of short term, high temperature thermal degradation studies. Also discussed is the possible influence of other factors within the control of the development pharmacist which may affect the validity of exaggerated temperature thermal drug degradation data used in room temperature shelf life prediction of products.