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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
Bibliography
Websites
GATTEFOSSE, Hemisynthetic glycerides for suppositories and ovules with solid or liquid active ingredients, Internet http://www.gattefosse.com/fr/applications/?voie-d-administration,rectale-et-vaginale (page consultée le 11/06/2013)
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Norms and standards
- Classification biophamarceutique BCS - Pharmacopée Européenne 7.0 - . 2012
Patents
STEVENSON (W.G) and MACKINNON (W.E.) (5-2-1952) US Patent US 2,584,166, Deposited it 25-5-1948, Suppository.
SCHLUETER (K.W.) and SCHULTZ-KAISER (E.) (24-4-1979) US Patent US 4,151,274, Deposited it 15-11-1976, Process and composition for the production of suppositories.
GOYAN (J.E.) and WRABLE (M.) (14-3-1961) US Patent US 2,975,099, Deposited it 25-6-1958, Polyethylene glycol...
Directory
Manufacturers – Suppliers – Distributors (non-exhaustive list)
Dow for polyethylene glycols http://www.dow.com/polyglycols/polyethylene/products/carbowaxp.htm
Gattefossé for suppositories http://www.gattefosse.com/fr/applications/?voie-d-administration, rectal and vaginal masses
Cremer oleo for suppository masses http://www.cremeroleo.de/en/produktbereiche/cremer-health/index.php...
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