Particulate contamination of lyophilized amphotericin B preparation during reconstitution process.

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.

journal_name

J Clin Pharm Ther

authors

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

doi

10.1046/j.1365-2710.2001.00328.x

subject

Has Abstract

pub_date

2001-04-01 00:00:00

pages

87-91

issue

2

eissn

0269-4727

issn

1365-2710

pii

jcp328

journal_volume

26

pub_type

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