Research and Quality Control

Toronto, Canada

Research and Quality Control

Toronto, Canada
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Walker S.E.,Research and Quality Control | Walker S.E.,University of Toronto | Iazzetta J.,Research and Quality Control | Iazzetta J.,Sunnybrook Health science Center | And 2 more authors.
Canadian Journal of Hospital Pharmacy | Year: 2010

Background: The Accufuser silicone-based elastomeric infusion device has recently been approved for the Canadian market. Objective: To evaluate the stability of 5 antibiotics (cefazolin, ceftazidime, ceftriaxone, clindamycin, and vancomycin) in either 5% dextrose in water (D5W) or 0.9% sodium chloride in water (NS) after storage in Accufuser disposable silicone balloon infusers. Methods: The study drugs were reconstituted, according to the manufacturers' directions, in polyvinyl chloride minibags with either D5W or NS, at 2 different concentrations. The resulting solutions were transferred to disposable silicone balloon infusers for storage at 4°C or at room temperature (23°C). The concentration of each drug in each solution was determined by validated stability-indicating liquid chromatographic methods after storage for 14 to 31 days. Results: Solutions of ceftriaxone in either diluent retained more than 95.2% of the initial concentration for 2 days at room temperature and more than 91.6% of the initial concentration for 14 days at 4°C. Solutions of cefazolin in D5W or NS retained more than 90% of the initial concentration for at least 3 days at room temperature and for at least 26 days at 4°C. Solutions of ceftazidime in D5W or NS retained more than 90% of the initial concentration for only 1 day when stored at room temperature and for at least 4 days at 4°C. Solutions of clindamycin or vancomycin in D5W or NS retained 90% of the initial concentration for at least 7.5 days at room temperature and at least 90% of the initial concentration for at least 27.8 days at 4°C. Conclusions: Previously reported expiration dates for solutions stored in elastomeric infusion devices were not based on 95% confidence intervals and were often longer than expiration dates determined from the studies reported here, which are based on 95% confidence intervals. Comparison of the observed concentrations remaining between previously published studies and the studies reported here indicates that the Accufuser elastomeric infusion device did not adversely affect the stability of these drugs.


Walker S.E.,Research and Quality Control | Walker S.E.,University of Toronto | Law S.,Research and Quality Control | Fung E.,University of Toronto | And 2 more authors.
Canadian Journal of Hospital Pharmacy | Year: 2010

Background: Most previous stability studies for norepinephrine have reported the percentage of drug remaining in IV solutions after only 24 h. No previously published study has evaluated the effect of light on the stability of this drug. Objective: To evaluate the stability of norepinephrine (64 mg/L) in either normal saline (NS; 0.9% sodium chloride) or 5% dextrose in water (D5W) with storage at either 4°C or room temperature (23°C) in polyvinyl chloride (PVC) bags exposed to or protected from normal room lighting for 2 months. Methods: Thirty-two PVC bags were prepared, each containing norepinephrine at 64 mg/L; half of the bags had normal saline as the diluent and the other half had D5W. The bags were stored at either 4°C or room temperature (23°C), with protection from or exposure to ambient fluorescent room light. Overall, there were 4 bags for each combination of diluent, temperature, and light condition. The concentration of norepinephrine in each bag was determined by a validated, stability-indicating liquid chromatographic method on study days 0, 1, 2, 3, 4, 8, 9, 10, 11, 14, 18, 21, 23, 25, 28, 30, 36, 42, and 61. Results: Analysis of variance revealed differences in percentage remaining as a function of study day (p < 0.001) and light conditions (p < 0.001), but not diluent (p = 0.06) or storage temperature (p > 0.99). Conclusions: Solutions of norepinephrine 64 mg/L in NS or D5W can be stored in PVC bags at 4°C for up to 61 days with protection from light. This expiry date allows for up to 24 h storage at 23°C. Solutions that are not protected from light will retain only 90% of the initial concentration after storage for 39 days at 4°C. This storage period could include up to 24 h at room temperature, without protection from light.

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