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Table 5 Predicted and observed dissolution of the two active pharmaceutical ingredients after 20 min at different storage conditions of temperature (T) and relative humidity (RH)

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

Study	Storage Conditions			Amount Dissolved (LC%)
	T (°C)	RH (%)	Time (months)	API 1			API 2
	T (°C)	RH (%)	Time (months)	Initial (T0)	Final (6 or 12 mo)		Initial	Final (6 or 12 mo)
					Predicted	Observed		Predicted	Observed
1^a	25	60	12	95.9	95.9	95.7	85.5	84.9	87.4
	30	65	12		95.8	96.4		84.8	86.7
	40	75	6		94.7	92.5		84.6	85.6
	40	75	12		92.7	92.5		83.9	84.8
2^b	25	60	6	92.9	92.8	94.1	86.3	NT^c	NT^c
2^b	25	60	12	92.9	92.7	93.2	86.3	84.8	87.1

^aTablets packaged in Aclar® blisters. Initial water content 2.1 %
^bOpen dish study. Initial water content 4.1 %
^cNot tested

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