Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Stability of Dexmedetomidine in 0.9% Sodium Chloride in Two Types of Intravenous Infusion Bags

Author(s):  Marquis Kathleen, Hohlfelder Benjamin, Szumita Paul M

Issue:  Sep/Oct 2017 - Volume 21, Number 5
View All Articles in Issue

Page(s):  436-439

Stability of Dexmedetomidine in 0.9% Sodium Chloride in Two Types of Intravenous Infusion Bags Page 1
Stability of Dexmedetomidine in 0.9% Sodium Chloride in Two Types of Intravenous Infusion Bags Page 2
Stability of Dexmedetomidine in 0.9% Sodium Chloride in Two Types of Intravenous Infusion Bags Page 3
Stability of Dexmedetomidine in 0.9% Sodium Chloride in Two Types of Intravenous Infusion Bags Page 4

Download in electronic PDF format for $65

Abstract:  Dexmedetomidine is a frequently used sedative in the critical care setting. It is commercially available as a 4-mg/mL premixed compound or as 200-mcg/2-mL vials that must be further diluted prior to administration. However, limited data exist regarding the stability of dexmedetomidine admixtures compounded from the 200-mcg/2-mL vials, particularly for durations greater than 48 hours. Therefore, we performed stability testing on compounded dexmedetomidine prepared in two types of intravenous infusion bags for 14 days. Dexmedetomidine is available as 200-mcg/2-mL vials for dilution, 80-mcg/20-mL single-dose vials, and as 200-mcg/50-mL and 400-mcg/100-mL glass bottles. The stability of dexmedetomidine admixtures has previously been tested for 48 hours. The purpose of this analysis was to test the stability of dexmedetomidine admixtures for 14 days. Six dexmedetomidine admixtures of 200 mcg/50 mL were compounded in polyvinyl chloride and non-polyvinyl chloride bags, three of which were stored under refrigeration and three of which were kept at room temperature. High-performance liquid chromatography testing was performed to determine the concentration at Days 1 through 14. Stability was determined by taking the mean concentration of samples taken from each bag. All samples were tested in duplicate. A sample was considered stable if the concentration was greater than 90% of the original concentration. All samples retained over 90% of the drug under their respective storage conditions for the duration of the study. At time 0, the concentration of dexmedetomidine was between 3.99 mcg/mL and 4.01 mcg/mL. On Day 14, the mean concentration was between 95.8% and 98.9%, depending on the bag type and storage condition. The pH remained between 4.7 and 5.8 during the study period as has previously been reported in the literature. Dexmedetomidine admixtures of 200 mcg/50 mL were stable in both polyvinyl chloride bags and non-polyvinyl chloride bags for 14 days under refrigeration and 48 hours at room temperature. This represents the longest time allowable under United States Pharmacopeia Chapter <797> without the need for sterility testing.

Related Keywords: Kathleen Marquis, PharmD, PhD, Benjamin Hohlfelder, PharmD, BCPS, Paul M. Szumita, PharmD, FCCM, BCCCP, BCPS, dexmedetomidine, selective alpha adrenergic receptor agonist, sedation, sedative, intensive care, drug admixtures, physical stability, packaging, compounded sterile preparations, chemical stability, polyvinyl chloride, PVC bags

Related Categories: PACKAGING, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, STERILE PREPARATIONS, NEUROLOGY

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Stability of Dexmedetomidine in 0.9% Sodium Chloride in Two Types of Intravenous Infusion Bags
Marquis Kathleen
, Hohlfelder Benjamin, Szumita Paul M
Sep/Oct 2017
Pg. 436-439

Y-site Physical Compatibility of Beta-blocker Infusions with Intensive Care Unit Admixtures
Foushee Jaime A
, Meredith Pmichaele, Fox Laura M, Grace EdwardE
Jul/Aug 2016
Pg. 328-332

Long-term Physicochemical Stability of Concentrated Solutions of Noradrenaline Bitartrate in Polypropylene Syringes for Administration in the Intensive Care Unit
Lardinois Benjamin
, Pector Johan, Delcave Charlotte, Soumoy Laura, Jamart Jacques, Bihin B, Hecq Jean-Daniel, Galanti Laurence M
Jul/Aug 2018
Pg. 335-339

Physical Compatibility of Medications Used in Critically Ill Patients with Balanced Fluid Solutions
Wilder Alyson G
, Foushee Jaime A, Fox Laura M, Navalle Jordan, Wright Adrienne M, Greer Megan A
May/Jun 2020
Pg. 238-241

Stability of Dexmedetomidine in Polyvinyl Chloride Bags Containing 0.9% Sodium Chloride Intended for Subcutaneous Infusions
Wolfe Amanda
, Zhang Jeremy, Lapenskie Julie, Downar James, Kanji Salmaan
Jul/Aug 2021
Pg. 330-335

Evaluation of the Physicochemical Stability of Amiodarone Hydrochloride in Syringes for the Intensive Care Unit
Lardinois Benjamin
, Dimitriou Alexandre, Delcave Charlotte, Jamart Jacques, Bihin Benoît, Soumoy Laura, Hecq Jean-Daniel, Galanti Laurence M
Mar/Apr 2019
Pg. 163-166

Long-term Physiochemical Stability of Concentrated Solutions of Salbutamol (Albuterol) in Polypropylene Syringes for Use in the Intensive Care Unit and in Obstetrics
Lardinois Benjamin
, Baltzis Alexandre, Delcave Charlotte, Soumoy Laura, Jamart Jacques, Bihin Benoît, Hecq Jean-Daniel, Galanti Laurence
Sep/Oct 2019
Pg. 434-437

Long-term Physicochemical Stability of Concentrated Solutions of Sodium Valproate in Polypropylene Syringes for Administration in the Intensive Care Unit
Lardinois Benjamin
, Baltzis Alexandre, Braibant Maximilien, Soumoy Laura, Jamart Jacques, Bihin Benoît, Hecq Jean-Daniel, Galanti Laurence
Jul/Aug 2019
Pg. 320-323

Compounding for Diabetic Patients:An Interview with Paul Lofholm, PharmD
Allen Loyd V Jr
Nov/Dec 1997
Pg. 381-385

Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula
Hossain Mohammad Faisal
, Levesque Dan, Frye John, Rashid Mamoon
Jul/Aug 2020
Pg. 322-326

Particle Measuring Systems - USP <797> Environmental Monitoring Solutions