• Sara Houlihan, Diane Decarie, Cindy Benes, Richard Cleve, Marianne Vidler, Laura A Magee, Ensom Mary H H MHH Department of Pharmacy, Children's and Women's Health Centre of BC, Vancouver BC; Faculty of Pharmaceutical Sciences, University of British Columbia, V, and Peter von Dadelszen.
• Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver BC.
• J Obstet Gynaecol Can. 2016 Oct 1; 38 (10): 936-944.e3.

ObjectiveTo evaluate the physical compatibility and chemical stability of mixtures of magnesium sulphate and lidocaine in order to determine the feasibility of manufacturing a prefilled syringe combining these two drugs for use as an intramuscular (IM) loading dose for eclampsia prevention and/or treatment. This ready-to-use mixture will provide a more tolerable and accessible route of administration appropriate for widespread use.MethodsPhysical compatibility (pH, colour, and formation of precipitate) and chemical stability (maintaining > 90% of initial concentrations) of mixtures of MgSO4, using both commercially available MgSO4 (50%) and MgSO4 reconstituted from salt (61%), with lidocaine hydrochloride (2%) were evaluated every 14 days over six months. The concentration of lidocaine was determined by a stability indicating high performance liquid chromatographic method, while the concentration of magnesium was determined by an automated chemistry analyzer.ResultsNo changes in pH, color or precipitates were observed for up to 6 months. The 95% confidence interval of the slope of the curve relating concentration to time, determined by linear regression, indicated that only the admixtures of commercially-available magnesium sulfate and lidocaine as well as the 61% magnesium sulfate solution (reconstituted from salt) maintained at least 90% of the initial concentration of both drugs at 25°C and 40°C at 6 months.ConclusionsCommercially available MgSO4 and lidocaine hydrochloride, when combined, are stable in a pre-filled syringe for at least six months in high heat and humidity conditions. This finding represents the first step in improving the administration of magnesium sulphate in the treatment and prevention of eclampsia in under-resourced settings.Copyright © 2016 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

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