Suppositories
Suppository Testing
Test Apparatus & Method
The rate of drug release (dissolution) for hydrophilic suppositories can be measured using the standard basket, paddle or flow through methods described in USP Chapter <711> and Ph. Eur. 2.9.3 (see Page 24-25). Methods for lipophilic suppositories include: • a modified basket method (see Page 39) • a paddle method (see Page 24) • a modified flow method (see Ph. Eur. 2.9.42) In addition to this, the European Pharmacopeia references two other technical procedures relating to disintegration and softening time of suppositories: The suppository is a more common and accepted dosage form in Europe than in the USA which may explain why references to specific test methods relating to suppositories and associated dosage forms are mainly confined to the European Pharmacopoeia.
2.9.2 Disintegration of suppositories and pessaries 2.9.22 Softening time determination of lipophilic suppositories
A
B
Sample holder (side view)
Sample holder (top view)
15
50
4
30
15
5
12
50
24 36
52
85
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