Download in electronic PDF format for $25

Kalchem International - Chemicals and Compounding Supplies

Search the Complete Journal Archives

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
View All Articles in Issue

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

Related Categories: INFUSION, PARENTERALS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, INFECTIOUS DISEASE, STORAGE

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Stability of Ertapenem in an Elastomeric Infusion Device Phipps Stephen D, Peacock Gina F, Smith Douglas L May/Jun 2011 252-254 Buy
Five Compounds for Treating Diabetes-Related Conditions Meece Jerry May/Jun 2003 170 Buy
In-use Stability of Ceftaroline Fosamil in Elastomeric Home Infusion Systems and MINI-BAG Plus Containers Bhattacharya Sisir, Parekh Satish, Dedhiya Mahendra Sep/Oct 2015 432-436 Buy
Home Infusion Basics for the Non-Infusion Pharmacist Miron Karen E Mar/Apr 2011 94-100 Buy
Stability and Compatibility of Reconstituted Caspofungin in Select Elastomeric Infusion Device Tsiouris Maria, Ulmer Marisa, Yurcho James F, Hooper Kevin L, Gui Min Sep/Oct 2010 436-439 Buy
Home Infusion: Available Vascular Access Devices and Common Therapies Kennedy Steve, Williams LaVonn A May/Jun 2011 183-188 Buy
Disposable Ambulatory Infusion Devices: A Review - Part 3 Ashworth Lisa D Nov/Dec 2000 442 Buy
Physical and Chemical Stability of Urapidil in 0.9% Sodium Chloride in Elastomeric Infusion Pump Tomasello Cristina, Leggieri Anna, Rabbia Franco, Veglio Franco, Baietto Lorena, Fulcheri Chiara, De Nicolò Amedeo, De Perri Giovanni, D'Avolio Antonio Jul/Aug 2016 343-346 Buy
Comparative Stability of Vitamin K1 Oral Liquids Prepared in Sterile Water for Injection and Stored in Amber Glass Bottles and Amber Plastic Syringes Huffman Jessica, Brown Stacy, Lewis Paul, Lawson Sarah, Ogle Amanda, Peacock Gina Jul/Aug 2018 340-344 Buy
Safe Cytotoxic Drug Preparation Using a Closed-system Transfer Device: Technical and Practical Evaluation of a New Device (Vialshield/Texium) Comparatively to a Reference One (Phaseal) Garrigue Philippe, Montana Marc, Ventre Christophe, Savry Amadine, Gauthier-Villano Laurence, Pisano Pascale, Pourroy Bertrand Mar/Apr 2016 148-154 Buy