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Development of ready-to-use ketamine hydrochloride syringes for safe use in post-operative pain
M Cyril Stucki, PharmD; Sandrine Fleury-Souverain, PhD; Anna-Maria Sautter, PhD; Farshid Sadeghipour, PhD; Pascal Bonnabry, PhD
ABSTRACT: Study objectives: To increase safety in use of ketamine. This would be achieved by introducing a ready-to-use (RTU) intravenous syringe of ketamine hydrochloride, which would be prepared under aseptic conditions in the hospital pharmacy, for post-operative pain.
Methods: The chemical stability of ketamine hydrochloride solution (1 mg/mL) in 0.9% sodium chloride was determined at 4°C, 25°C and 40°C by means of a stability-indicating capillary electrophoresis method. Changes in pH and the presence
of non-visible particulate matter were measured throughout the study. Sterility testing was performed to check the integrity of the syringes.
Results: The loss in potency was less than 8% after 12 months at the three temperatures, and no degradation products were detected. The pH values did not change appreciably and the syringe contents remained sterile throughout the study. Each syringe fulfilled all US Pharmacopeia criteria in terms of non-visible particles.
Conclusion: RTU syringes of ketamine hydrochloride with a shelf life of one year can be manufactured and supplied by the hospital pharmacy for use in post-operative pain. This product will help reduce the risk of dilution errors and lead to
significant economic advantages.
M Cyril Stucki, PharmD
Pharmacy Department
University Hospitals of Geneva
24 Rue Micheli du Crest
CH-1211 Geneva 14, Switzerland
Tel: +41 22 382 39 74
Fax: +41 22 382 39 40
cyril.stucki@hcuge.ch
www.hcuge.ch/Pharmacie
Reference: EJHP Science • Volume 14 • 2008 • Issue 1 • P. 14-18
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