**5. Stability studies of orally disintegrating tablets**

The chemical and physical properties of the active substance and pharmaceutical excipients, the dosage form and its composition, the manufacturing process, the nature of the container-closure system, and the properties of the packaging materials are all factors that affect the stability of finished pharmaceutical products. In a stability study, the impact of changes in temperature, time, humidity, light intensity, and partial vapor pressure on the product in issue is evaluated. The effective or mean


#### **Table 1.**

*Long-term storage conditions area.*


#### **Table 2.**

*General storage conditions for pharmaceuticals.*

kinetic temperature, rather than the recorded mean temperature, better depicts the actual situation; a product held for one month at 20°C and one month at 40°C will differ from one kept for two months at 30°C. Furthermore, storage circumstances are frequently such that the temperature is higher than the country's average climatic data would indicate as shown in **Tables 1** and **2** [50].

Long-term storage conditions are determined by the climatic condition under which the finished pharmaceutical products (FPP) is intended to be marketed.
