1. Ann Pharm Fr. 2011 Nov;69(6):296-301. Epub 2011 Oct 29.

Long-term stability of temocillin in dextrose 5% and in sodium chloride 0.9%
polyolefin bags at 5±3°C after freeze-thaw treatment.

Rolin C, Hecq JD, Tulkens P, Vanbeckbergen D, Jamart J, Galanti L.

Medical Laboratory, CHU Mont-Godinne, Catholic university of Louvain, 1, avenue
Therasse, 5530 Yvoir, Belgium.

INTRODUCTION: The aim of this study was to investigate the stability of a mixture
of temocillin 20mg/ml in 5% dextrose and in 0.9% sodium chloride polyolefin bags 
after freezing, microwave thawing and long-term storage at 5±3°C.
METHODS: The stability of ten polyolefin bags containing 20mg/ml of temocillin,
five bags in 5% dextrose and five bags in 0.9% sodium chloride, prepared under
aseptic conditions was studied after freezing for 1 month at -20°C, thawing in a 
microwave oven with a validated cycle, and stored at 5±3°C. Over 30 days,
temocillin concentrations were measured by high-pressure liquid chromatography.
Visual inspections, microscope observation, spectrophotometric measurements and
pH measurements were also performed.
RESULTS AND DISCUSSION: No precipitation occurred in the preparations but minor
colour change was observed. No microaggregate was observed with optical
microscopy or revealed by a change of absorbance. Based on a shelf life of 95%
residual potency, temocillin infusions were stable at least 11 days in 5%
dextrose and 14 days in 0.9% sodium chloride after freezing and microwave thawing
(corresponding at the period where 95% lower confidence limit of the
concentration-time profile remained superior to 95% of the initial
concentration). During this period, the pH values of drug solutions have been
observed to decrease without affecting chromatographic parameters.
CONCLUSION: Within these limits, temocillin in 5% dextrose and in 0.9% sodium
chloride infusions may be prepared and frozen in advance by a centralized
intravenous admixture service then thawed before use in clinical units.

Copyright © 2011 Elsevier Masson SAS. All rights reserved.

PMID: 22115132  [PubMed - in process]