Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Development of an in vitro Endotoxin Test for Monoolein - Water Liquid Crystalline Gel for Use as an Implant

Moustapha Ouédraogo¹ , Rasmané Semdé¹, Issa T Somé¹, Moussa Ouédraogo¹, Rasmata Ouédraogo¹, Viviane Henschel², Brigitte Evrard³, Jacques Dubois², Karim Amighi², Innocent P Guissou¹

¹UFR - Sciences de la SantÃ©, UniversitÃ© de Ouagadougou, 03 BP 7021 Ouagadougou 03, Burkina Faso; ²Pharmacy Institute, UniversitÃ© Libre de Bruxelles, Campus Plaine, Boulevard du Triomphe, B 1050 Bruxelles; ³Pharmacy Institute, UniversitÃ© de LiÃ¨ge, CHU Tour 4, Av. de lâ€™HÃ´pital, B 4000 LiÃ¨ge 1, Belgium.

For correspondence:- Moustapha Ouédraogo Email: moustaphaouedraogo@univouaga.bf

Received: 27 March 2009 Accepted: 20 September 2009 Published: 21 December 2009

Citation: Ouédraogo M, Semdé R, Somé IT, Ouédraogo M, Ouédraogo R, Henschel V, et al. Development of an in vitro Endotoxin Test for Monoolein - Water Liquid Crystalline Gel for Use as an Implant. Trop J Pharm Res 2009; 8(6):501-508 doi: 10.4314/tjpr.v8i6.4

© 2009 The authors.
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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; monooleinâ€“water