Prediction of the changes in drug dissolution from an immediate-release tablet containing two active pharmaceutical ingredients using an accelerated stability assessment program (ASAPprime®)

AAPS Open

Table 1 ^a Temperature (T) and relative humidity (RH) conditions used in ASAP modeling

Experiment	T (°C)	RH (%)	Sampling Points (days)
1	60	30	0, 7, 14
2	60	50	0, 3, 7
3	60	60	0, 3
4	60	65	0, 3, 7
5	60	75	0, 3
6	50	60	0, 7, 14
7	50	65	0, 7, 14
8^b	40	75	0, 3, 6^c months

^aAdditional stability data at 40 °C/60%RH for API 1 from a separate, unrelated study were also included in the modeling for API 1. The inclusion of the data does not change the overall conclusion for API 1. Data for API 2 at 40 °C/60%RH were not available
^bOpen Dish Study
^cOnly API 1 was tested at 6 months