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Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
ISSN: 1596-5996 EISSN: 1596-5996
Vol. 8, No. 6, 2009, pp. 501-508
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Bioline Code: pr09064
Full paper language: English
Document type: Research Article
Document available free of charge
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Tropical Journal of Pharmaceutical Research, Vol. 8, No. 6, 2009, pp. 501-508
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Development of an in vitro Endotoxin Test for Monoolein–Water Liquid Crystalline Gel for Use as an Implant
Ouédraogo, Moustapha; Semdé, Rasmané; Somé, Issa T; Ouédraogo, Moussa; Ouédraogo, Rasmata; Henschel, Viviane; Evrard, Brigitte; Dubois, Jacques; Amighi, Karim & Guissou, Innocent P.
Abstract
Purpose:
Drugs that are administered by parenteral route must be apyrogenic. The aim of this study
was to develop an in vitro endotoxin test for liquid crystalline gels for use as implants, using a
monoolein–water liquid crystalline gel as a model.
Methods:
The gel-clot technique was used. The gel was dissolved first in isopropyl myristate, and the
endotoxins were extracted with water for bacterial endotoxin test. Tests for the labelled lysate sensitivity
and interfering factors were performed to validate the developed method. The limit of detection of
endotoxin in the gel was also determined.
Results:
The labelled lysate sensitivity was confirmed. It was not influenced by the presence of extracts
from the gels. Endotoxins in the contaminated test gels were completely extracted. Endotoxin
concentration in the tested gels was below the calculated threshold endotoxin level.
Conclusion:
A method to perform in vitro endotoxins test of liquid crystalline gels was successfully
developed and validated. Application of the technique to gels currently being developed in our
laboratories indicate that the gels were apyrogenic.
Keywords
In vitro bacterial endotoxin test; liquid crystalline gels; test validation; monoolein–water.
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