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Particulate contamination of lyophilized amphotericin B preparation during reconstitution process
Author(s) -
Sendo T.,
Hirakawa M.,
Makino K.,
Nakashima K.,
Kataoka Y.,
Oishi R.
Publication year - 2001
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1046/j.1365-2710.2001.00328.x
Subject(s) - amphotericin b , vial , chromatography , contamination , chemistry , antifungal , microbiology and biotechnology , ecology , biology
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.