4. Pharmacotechnical testing of suppositories
The European Pharmacopoeia describes specific tests for suppositories. These pharmacotechnical tests are used to verify the ability of preparations to rapidly disintegrate, dissolve on contact with water (disintegration test) or soften at rectal temperature (softening time) in order to release the active substance (dissolution test).
Two other tests not described in the latest edition of the EP are classically performed for suppositories: crush resistance and melting point in a U-tube.
4.1 Disintegration of suppositories
The suppository disintegration test (PE 01/2008 20902) verifies whether the pharmaceutical form softens (for lipophilic suppositories) or disintegrates (for hydrophilic suppositories) in water at 36-37°C within the...
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Pharmacotechnical testing of suppositories
Biopharmaceutical aspects
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