Particulate contamination of lyophilized amphotericin B preparation during reconstitution process.
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.


CONCLUSIONS
These findings suggest that reconstituted solutions should be filtered with membrane filters and diluted fluids with in-line filters.
Sendo
T
T
The Department of Hospital Pharmacy, Faculty of Medicine, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
Hirakawa
M
M
Makino
K
K
Nakashima
K
K
Kataoka
Y
Y
Oishi
R
R
D000666:Amphotericin B / Q000008:administration & dosage* / Q000737:chemistry / Q000592:standards*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000737:chemistry / Q000592:standards*; D002626:Chemistry, Pharmaceutical; D004340:Drug Contamination; D005374:Filtration; D008855:Microscopy, Electron, Scanning; D010316:Particle Size; D012828:Silicones; D012995:Solubility; D013052:Spectrometry, X-Ray Emission
D000900:Anti-Bacterial Agents; D012828:Silicones; D000666:Amphotericin B