Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

Table 1

Dissolved amounts [%] of pure API and API from tablets. values are expressed as mean ± SD ( units). The means followed by different letters are significantly different at .

Sample	Dissolved amounts [%]
	5 min	10 min	20 min	30 min	45 min	60 min
AS-1	28.5 ± 3.2^a	31.6 ± 4.0^a	37.8 ± 4.0^a	43.0 ± 4.3^a	48.2 ± 3.9^a	51.4 ± 4.0^a
AS-2	24.3 ± 3.9^a	28.2 ± 4.0^a	34.5 ± 4.8^a	40.1 ± 5.0^a	45.2 ± 6.1^a	48.4 ± 5.7^a
AS-3	41.7 ± 0.3^c	48.5 ± 0.4^b	55.8 ± 0.5^b	60.7 ± 0.5^b	65.7 ± 0.3^c	70.1 ± 0.4^c
AS-4	54.8 ± 0.4^e	57.9 ± 2.5^c	66.5 ± 2.7^cd	69.8 ± 1.5^c	75.2 ± 0.9^d	79.3 ± 1.3^d
AS-5	37.3 ± 0.3^b	49.3 ± 0.5^b	54.6 ± 2.3^b	58.5 ± 1.6^b	62.4 ± 1.1^b	66.6 ± 1.1^b
TS-1	49.3 ± 3.2^d	54.3 ± 2.1^c	63.4 ± 2.2^c	70.4 ± 2.3^c	73.7 ± 2.7^d	76.9 ± 2.0^d
TS-2	57.5 ± 1.2^f	62.9 ± 1.1^d	70.4 ± 1.2^cd	76.2 ± 1.4^d	83.0 ± 1.5^e	87.8 ± 1.9^e
TS-3	84.6 ± 1.9^h	96.4 ± 2.1^e	98.8 ± 2.2^g	99.7 ± 2.1^f	100.7 ± 2.4^g	101.4 ± 2.1^g
TS-4	86.2 ± 1.2^h	91.8 ± 0.9^f	95.4 ± 0.8^f	97.2 ± 0.8^f	98.8 ± 0.9^g	100.0 ± 0.8^g
TS-5	78.4 ± 1.7^g	87.4 ± 2.4^e	90.7 ± 2.1^e	93.1 ± 1.8^e	95.1 ± 1.8^f	96.3 ± 1.6^f