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Journal of Antimicrobial Chemotherapy (1995) 36, 119-128
© 1995 The British Society for Antimicrobial Chemotherapy

research-article

Structure and toxicity of amphotericin B/triglyceride emulsion formulations

M. R. Lance, C. Washington* and S. S. Davis

Department of Pharmaceutical Sciences, University of Nottingham, University Park Nottingham NG72RD, UK

Received 10 March 1994; returned 19 October 1994; accepted 18 January 1995

*Corresponding author.

This paper investigates the relationship between the in-vitro toxicity of amphotericin B/triglyceride emulsion formulations, and their phospholipid composition and method of manufacture. Emulsion toxicity, as measured by the erythrocyte potassium leakage assay, was found to be dependent on the transition temperature of the phospholipid emulsifier, and the thermal history of the emulsion. Emulsions made using unsaturated phospholipids showed a low toxicity irrespective of the method of manufacture. Emulsions made using phospholipids with phase transition temperatures above the maximum process temperature displayed a toxicity comparable to the deoxycholate-solubilized formulation. This toxicity was significantly reduced when such formulations were heated to a temperature above the phase transition temperature for the phospholipid. We interpret these data as demonstrating that the amphotericin molecule must be inserted fully into the phospholipid emulsifier in order to produce a low toxicity emulsion, and that this insertion is critically dependent on the composition of the emulsifier and its phase transition properties.


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