Particulate contamination of lyophilized amphotericin B preparation during reconstitution process

Toshiaki 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 - 2001
Externally publishedYes

Fingerprint

Amphotericin B
X-Ray Emission Spectrometry
Pharmacopoeias
Silicones
X-Rays
Electrons
Light
Membranes
Water

Keywords

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

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Particulate contamination of lyophilized amphotericin B preparation during reconstitution process. / Sendo, Toshiaki; Hirakawa, M.; Makino, K.; Nakashima, K.; Kataoka, Y.; Oishi, R.

In: Journal of Clinical Pharmacy and Therapeutics, Vol. 26, No. 2, 2001, p. 87-91.

Research output: Contribution to journalArticle

Sendo, Toshiaki ; Hirakawa, M. ; Makino, K. ; Nakashima, K. ; Kataoka, Y. ; Oishi, R. / Particulate contamination of lyophilized amphotericin B preparation during reconstitution process. In: Journal of Clinical Pharmacy and Therapeutics. 2001 ; Vol. 26, No. 2. pp. 87-91.
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AU - Oishi, R.

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