Particulate contamination of lyophilized amphotericin B preparation during reconstitution process

T. Sendo, M. Hirakawa, K. Makino, K. Nakashima, Y. Kataoka, R. Oishi

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective: To investigate the effect of the reconstitution methods for the commercial amphotericin B preparation with respect to particulate contamination. Methods: The particle counts in amphotericin B solutions reconstituted according to three different methods and amphotericin B fluids made with intravenous fluids after reconstitution were performed using a light extinction method. The particle contaminants were identified with X-ray emission spectrometry attached to a scanning electron microscope. Results: Amphotericin B in a vial induced particle contamination during the reconstitution process, and the contamination was especially marked by shaking vigorously after injecting water into the vial. From the X-ray analysis, it appeared that the increased number of particles was derived from the amphotericin B-deoxycholate complex containing substances such as silicone released from the vial components. Amphotericin B fluid made with intravenous fluids after reconstitution also contained particles over the acceptable limits according to the Japanese or US pharmacopoeia. Conclusion: These findings suggest that reconstituted solutions should be filtered with membrane filters and diluted fluids with in-line filters.

Original languageEnglish
Pages (from-to)87-91
Number of pages5
JournalJournal of Clinical Pharmacy and Therapeutics
Volume26
Issue number2
DOIs
Publication statusPublished - May 3 2001
Externally publishedYes

Keywords

  • Amphotericin B
  • Particulate contamination
  • Silicone
  • X-ray analysis

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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