Scott E Walker1, John Iazzetta, Shirley Law, Kristof Biniecki. 1. , MScPhm, FCSHP, is Co-ordinator, Research and Quality Control, Department of Pharmacy and Division of Pharmacology, Sunnybrook Health Sciences Centre and Associate Professor, Faculty of Pharmacy, University of Toronto, Toronto, Ontario.
Abstract
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.
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.
Authors: L Herrera-Hidalgo; L E López-Cortes; R Luque-Márquez; J Gálvez-Acebal; A de Alarcón; L F López-Cortes; A Gutiérrez-Valencia; M V Gil-Navarro Journal: Antimicrob Agents Chemother Date: 2020-06-23 Impact factor: 5.191
Authors: Szymon Tomczak; Aleksandra Gostyńska; Malwina Nadolna; Karolina Reisner; Marta Orlando; Anna Jelińska; Maciej Stawny Journal: Antibiotics (Basel) Date: 2021-05-09
Authors: Beatriz Fernández-Rubio; Paula Del Valle-Moreno; Laura Herrera-Hidalgo; Alicia Gutiérrez-Valencia; Rafael Luque-Márquez; Luis E López-Cortés; José María Gutiérrez-Urbón; Sonia Luque-Pardos; Aurora Fernández-Polo; María V Gil-Navarro Journal: Antibiotics (Basel) Date: 2021-12-30