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

Table 2

Other determined characteristics of investigated samples of APIs AS-1–AS-5: water content [%], wettability (water contact angle [°]), zeta potential ( [mV]), particle size (, , [m]), and specific surface area (SSA [m²/g]). Values are expressed as mean ± SD (see Section 2 for number of experiments for individual methodology). The means followed by different letters are significantly different at .

Sample

Water [%]

[°]

[mV]

Particle size [m]

SSA [m²/g]

AS-1

0.18 ± 0.01^c

35.6 ± 1.7^b

−18.13 ± 1.94^a

0.51 ± 0.01^a

2.12 ± 0.01^a

8.57 ± 0.37^a

42.11 ± 0.03^d

AS-2

0.16 ± 0.01^c

34.9 ± 3.1^b

−17.98 ± 0.34^a

0.49 ± 0.01^a

2.18 ± 0.12^b

9.06 ± 0.39^b

59.65 ± 0.04^e

AS-3

0.13 ± 0.01^b

11.0 ± 6.6^a

−10.36 ± 0.40^b

0.74 ± 0.01^b

3.15 ± 0.08^d

13.36 ± 0.19^d

31.91 ± 0.04^c

AS-4

0.12 ± 0.01^b

35.2 ± 0.7^b

−2.64 ± 0.17^c

0.73 ± 0.06^b

2.36 ± 0.04^c

10.33 ± 0.14^c

23.21 ± 0.05^b

AS-5

0.08 ± 0.01^a

33.4 ± 2.7^b

−10.90 ± 0.37^b

1.02 ± 0.03^c

5.05 ± 0.05^e

15.97 ± 0.24^e

19.69 ± 0.06^a