The use of a factorial design to evaluate the physical stability of tablets after storage under tropical conditions.

Publisher Summary This chapter describes studies that are restricted to the physical stability of tablets. Physical properties that are of interest are crushing strength, friability, disintegration time, and dissolution profile. One of the causes of changes in physical properties is water uptake or loss during storage. The extent of this effect depends, among others, on the amount of water present at the moment of preparation, the tablet composition (presence of hygroscopic materials, such as disintegrants) and packaging and storage conditions (temperature and relative humidity). Especially when used in tropical countries, tablets are frequently exposed to extreme climate conditions, with both high temperatures and high relative humidities. This is especially the case when tablets are stored under consumer conditions, because tablets are frequently dispensed in non-protective packaging or without any packaging at all. The effect of storage conditions on the physical tablet parameters is also described in the chapter. To develop physically stable preparations, the effect of tablet composition as well as the effect of storage conditions on the behavior of physical tablet properties during storage must be studied.