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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
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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

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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

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