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Stability of Ertapenem in an Elastomeric Infusion Device

Author(s):  Phipps Stephen D, Peacock Gina F, Smith Douglas L

Issue:  May/Jun 2011 - Volume 15, Number 3
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Abstract:  Ertapenem is an intravenous antibiotic that is dosed once daily and is utilized in the home infusion setting for parenteral antibiotic therapy. Thepurpose of this study was to evaluate the stability of ertapenem in an elastomeric infusion device over a one-week period. A stability-indicating high-performance liquid chromatographic method for ertapenem was identified from the literature and evaluated in our laboratory. Under our experimental conditions, the method demonstrated acceptable precision (1.8% relative standard deviation) and linearity (r2 = 0.998). Five 1-g vials of commercial grade ertapenem were reconstituted with 10 mL of sterile water for injection according to the manufacturer’s directions and then transferred into an elastomeric infusion device along with 90 mL of 0.9% sodium chloride solution (concentration of 10 mg/mL). After preparation of the ertapenem solutions, the five elastomeric infusion devices were stored under refrigerated conditions (5oC). Ertapenem concentrations were assayed in duplicate at the time of initial preparation and at subsequent 24-hour intervals throughout the study. Ertapenem concentrations were quantified by interpolation from a standard curve; ertapenem standard curves were generated each day of the study from solutions of known ertapenem concentration that were prepared from ertapenem analytical standard. At the 72-hour time point, ertapenem concentrations from each of the five elastomeric infusion pumps remained greater than 90% of initial concentration. At the 120-hour time point, the overall average ertapenem concentration was 90.4% of initial concentration, but two out of the five concentrations were below 90% of initial concentration. At the end of the 7-day study, the overall average ertapenem concentration was 88.9% of initial concentration and only one concentration was greater than 90% of initial concentration. Based on the results from this study, a beyond-use date of 3 days (72 hours) is conservatively recommended for ertapenem solutions prepared in Homepump ECLIPSE elastomeric infusion devices that are stored under refrigerated conditions.

Related Keywords: Stephen D. Phipps, PharmD, PhD, Gina F. Peacock, PhD, Douglas L. Smith, PharmD, BCNSP, BCOP, ertapenem, antibiotic, stability, intravenous administration, home infusion, elastomeric infusion device, storage conditions


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