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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Findings<br />
• MDgT MDgT_Disint Disint shows higher variability than MDT @ pH 11.2 2 -<br />
6.8.<br />
• This identifies the disintegration method as more variable.<br />
• From the MDgT_Dissol at pH 4.5 <strong>and</strong> 6.8 it can be<br />
concluded that the disintegration process is the most<br />
variable sub sub-process process, whereas the MDislnT at pH 4.5 4 5 <strong>and</strong><br />
6.8 are much less variable.<br />
© PHAST GmbH, www.phast.de 29<br />
Summary<br />
Conclusions:<br />
• <strong>Disintegration</strong> is the prerequisite for dissolution<br />
• At the time of complete disintegration a rather constant<br />
amount of drug is being dissolved<br />
• This is valid for the dissolution apparatus <strong>and</strong> the<br />
disintegration apparatus<br />
• The sub-processes are overlapping, with the help of<br />
statistical moment theory the sub-processes can be clearly<br />
ddescribed ib d<br />
• <strong>Disintegration</strong> is the most variable sub-process<br />
The relationship of disintegration <strong>and</strong> dissolution is<br />
a cause <strong>and</strong> effect relation<br />
© PHAST GmbH, www.phast.de 30<br />
12/18/2009<br />
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