Microbiological and Physico-Chemical Stability of Ketamine Solution for Patient-Controlled Analgesia Systems
Ketamine solution is regularly used along with opioids to treat patient suffering from refractory cancer pain. The aim of this study was to determine the expiry date of solutions of ketamine, by conducting microbiological and physicochemical stability assay. Five series of six ketamine solutions at 1 mg/mL in the portable PCA systems were stored at room temperature or at +33°C for respectively 28 days and 7 days. They were sampled immediately after preparation, and some day of the following weeks. According to European Pharmacopoeia VIIIth edition, microbiological stability was assessed by the research of antimicrobial activity of the product and sterility tests. The physico-chemical study was performed by determining aspect, pH, osmolality and loss of weight evolution. All samples were tested to follow variation of drug concentrations by high performance liquid chromatography coupled to an ultraviolet detector. A study of degradation forced was realized to separate degradation product. There were changes in pH and loss of weight values after 28 days. No precipitation or change in color was observed in any of the sample solutions. There was no significant loss of ketamine over 28 days at +20°C and over 7 days at +33°C. No degradation product was found during the study. This study indicates that ketamine solutions in the PCA systems are stable for a minimum of 28 days at room temperature.
Gabrielle Foy, Vianney Poinsignon, Lionel Mercie, Sophie Laurent, Angelo Paci*
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