Abstract

Long-term Stability of Vancomycin Hydrochloride in Glucose 5% Polyolefin Bags: The Brand Name Versus a Generic Product

Author(s): Huvelle Sophie, Godet Marie, Hecq Jean-Daniel, Gillet Patricia, Jamart Jacques, Galanti Laurence M

Issue: Sep/Oct 2016 - Volume 20, Number 5

Page(s): 416-420

Download in electronic PDF format for $75
  • Long-term Stability of Vancomycin Hydrochloride in Glucose 5% Polyolefin Bags: The Brand Name Versus a Generic Product Page 1
  • Long-term Stability of Vancomycin Hydrochloride in Glucose 5% Polyolefin Bags: The Brand Name Versus a Generic Product Page 2
  • Long-term Stability of Vancomycin Hydrochloride in Glucose 5% Polyolefin Bags: The Brand Name Versus a Generic Product Page 3
  • Long-term Stability of Vancomycin Hydrochloride in Glucose 5% Polyolefin Bags: The Brand Name Versus a Generic Product Page 4
  • Long-term Stability of Vancomycin Hydrochloride in Glucose 5% Polyolefin Bags: The Brand Name Versus a Generic Product Page 5

Abstract

The objectives of this study were to determine if the preparation of vancomycin hydrochloride in advance of infusion could improve the quality of the drug, time management of drug delivery, cost savings of drug delivery, and to investigate the long-term stability of vancomycin hydrochloride (brand name Vancocin®) infusion in glucose 5% polyolefin bags versus the generic (Vancomycine®) at 5°C ± 3°C. Five bags of each infusion 1 g/100 mL vancomycin hydrochloride in 5% glucose (Vancocin ® and Vancomycine®) were stored up to 57 days at 5°C ± 3°C. A visual inspection and pH measurement were performed periodically during the storage, and the concentrations were measured by high-performance liquid chromatography-diode array detection. No color change or precipitation in the solution was observed throughout the study period. As recommended by the U.S. Food and Drug Administration, the lower confidence limit at 95% of the concentration for the solutions remained superior to 90% of the initial concentration up to 43 days for the brand vancomycin (Vancocin®) infusion (96% ± 2%) and up to 57 days for the generic (Vancomycine®) (95% ± 4%). The solutions prepared either from brand or generic vancomycin hydrochloride were chemically stable more than one month (43 days for the brand and 57 days for the generic solution) and could be prepared in advance in a centralized intravenous additive service facility.

Related Keywords

Related Categories

Printer-Friendly Version

Related Articles from IJPC

Issue/Page
View/Buy
Title/Author
(Click for Abstract / Details / Purchase)
Sep/Oct 2016
Pg. 416-420
Jul/Aug 2016
Pg. 347-350
Jan/Feb 2014
Pg. 78-82
Mar/Apr 2004
Pg. 156-159
Nov/Dec 2015
Pg. 521-524
Sep/Oct 2008
Pg. 456-459
Sep/Oct 2002
Pg. 391-394
Nov/Dec 2016
Pg. 514-516
Author(s): Donnelly Ronald F
Sep/Oct 2015
Pg. 432-436
May/Jun 2004
Pg. 231-235
Jan/Feb 1997
Pg. 49-53
Jul/Aug 2022
Pg. 336-341
Sep/Oct 2018
Pg. 417-423
Mar/Apr 2025
Pg. 141-149
Mar/Apr 2002
Pg. 152-154
Jul/Aug 2018
Pg. 345-349
Jul/Aug 2021
Pg. 330-335
Mar/Apr 2008
Pg. 170-173
Sep/Oct 2017
Pg. 436-439
May/Jun 2003
Pg. 230-232