Establishing a Relationship between Disintegration and Dissolution
Establishing a Relationship between Disintegration and Dissolution
Establishing a Relationship between Disintegration and Dissolution
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Results: amount dissolved at<br />
time of disintegration at pH 1.2<br />
tablets<br />
in the<br />
dissolution<br />
apparatus<br />
at pH 1.2<br />
product d t name/ /<br />
geometry<br />
index<br />
disintegration<br />
time dissolution<br />
apparatus [s]<br />
amount<br />
dissolved [%]<br />
M 1.25 / 1 60.0 64.8<br />
2 65.0 89.2<br />
3 60.0 87.5<br />
4 60.0 78.9<br />
5 60.0 91.7<br />
6 60.0 79.0<br />
7 55.0 86.2<br />
© PHAST GmbH, www.phast.de 27<br />
Amount dissolved app.<br />
pH 1.2, 4.5, <strong>and</strong> 6.8 vs. disintegration<br />
time in water (mean, n=12)<br />
dissolved API [%]<br />
120<br />
100<br />
80<br />
60<br />
40<br />
20<br />
8 55.0 87.8<br />
9 55.0 91.5<br />
10 60.0 98.3<br />
11 65.0 85.7<br />
12 65.0 89.6<br />
<strong>Dissolution</strong> [%] / <strong>Disintegration</strong> time [s] (dissolution apparatus)<br />
0<br />
0 50 100 150 200 250<br />
<strong>Disintegration</strong> time [s]<br />
pH 6.8<br />
pH 4.5<br />
pH 1.2<br />
© PHAST GmbH, www.phast.de 28<br />
12/18/2009<br />
14
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