Stability of midazolam hydrochloride injection 1-mg/ml solutions in polyvinyl chloride and polyolefin bags

Kelly Karlage, Zachary Earhart, Kelly Green-Boesen, Paul B Myrdal

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Purpose. The stability of midazolam hydrochloride injection 1-mg/mL solutions in polyvinyl chloride (PVC) and polyolefin bags under varying conditions was evaluated. Methods. Triplicate solutions of midazolam hydrochloride 1-mg/mL were prepared in polyolefin and PVC i.v. bags by diluting midazolam hydrochloride injection 5 mg/mL with 5% dextrose injection. Bags were then stored under refrigeration (3-4 &δεγ;C), exposed to light at room temperature (20-25 &δεγ;C), or protected from light in amber bags at room temperature. Samples were taken immediately after preparation (day 0) and on days 1, 2, 3, 6, 13, 20, and 27 for analysis with a stability-indicating high-performance liquid chromatography assay in order to determine solution concentration. Stability was defined as retention of at least 90% of the initial drug concentration. The pH of each solution was also measured weekly. Sterility of the i.v. bags was determined at the end of the study by microbiological testing with culture in growth media. Differences in concentrations under the various storageconditions and bags used were analyzed using analysis of variance. Results. All solutions retained over 98% of the initial midazolam hydrochloride concentration, with no statistically significant (p ≥ 0.05) change in concentration over the four-week period. Stability was not affected by temperature, exposure to light, or bag type. The pH of all solutions remained between 3.2 and 3.4 throughout the study. Sterility after 28 days was retained. Conclusion. Midazolam hydrochloride 1-mg/mL solutions diluted in 5% dextrose injection remained stable over 27 days in both polyolefin and PVC i.v. bags, regardless of storage condition.

Original languageEnglish (US)
Pages (from-to)1537-1540
Number of pages4
JournalAmerican Journal of Health-System Pharmacy
Volume68
Issue number16
DOIs
StatePublished - Aug 15 2011

Fingerprint

Midazolam
Polyvinyl Chloride
Injections
Light
Infertility
Temperature
Amber
Glucose
Refrigeration
PL 732
Analysis of Variance
High Pressure Liquid Chromatography
Growth
Pharmaceutical Preparations

Keywords

  • Anxiolytics, sedatives and hypnotics
  • Chromatography, liquid
  • Concentration
  • Containers
  • Contamination
  • Dextrose
  • Diluents
  • Hydrogen ion concentration
  • Injections
  • Midazolam hydrochloride
  • Polyolefin
  • Polyvinyl chloride
  • Refrigeration
  • Stability
  • Storage
  • Temperature

ASJC Scopus subject areas

  • Pharmacology
  • Health Policy

Cite this

Stability of midazolam hydrochloride injection 1-mg/ml solutions in polyvinyl chloride and polyolefin bags. / Karlage, Kelly; Earhart, Zachary; Green-Boesen, Kelly; Myrdal, Paul B.

In: American Journal of Health-System Pharmacy, Vol. 68, No. 16, 15.08.2011, p. 1537-1540.

Research output: Contribution to journalArticle

@article{c9ae521a50424d2db0f76cc88e5930f7,
title = "Stability of midazolam hydrochloride injection 1-mg/ml solutions in polyvinyl chloride and polyolefin bags",
abstract = "Purpose. The stability of midazolam hydrochloride injection 1-mg/mL solutions in polyvinyl chloride (PVC) and polyolefin bags under varying conditions was evaluated. Methods. Triplicate solutions of midazolam hydrochloride 1-mg/mL were prepared in polyolefin and PVC i.v. bags by diluting midazolam hydrochloride injection 5 mg/mL with 5{\%} dextrose injection. Bags were then stored under refrigeration (3-4 &δεγ;C), exposed to light at room temperature (20-25 &δεγ;C), or protected from light in amber bags at room temperature. Samples were taken immediately after preparation (day 0) and on days 1, 2, 3, 6, 13, 20, and 27 for analysis with a stability-indicating high-performance liquid chromatography assay in order to determine solution concentration. Stability was defined as retention of at least 90{\%} of the initial drug concentration. The pH of each solution was also measured weekly. Sterility of the i.v. bags was determined at the end of the study by microbiological testing with culture in growth media. Differences in concentrations under the various storageconditions and bags used were analyzed using analysis of variance. Results. All solutions retained over 98{\%} of the initial midazolam hydrochloride concentration, with no statistically significant (p ≥ 0.05) change in concentration over the four-week period. Stability was not affected by temperature, exposure to light, or bag type. The pH of all solutions remained between 3.2 and 3.4 throughout the study. Sterility after 28 days was retained. Conclusion. Midazolam hydrochloride 1-mg/mL solutions diluted in 5{\%} dextrose injection remained stable over 27 days in both polyolefin and PVC i.v. bags, regardless of storage condition.",
keywords = "Anxiolytics, sedatives and hypnotics, Chromatography, liquid, Concentration, Containers, Contamination, Dextrose, Diluents, Hydrogen ion concentration, Injections, Midazolam hydrochloride, Polyolefin, Polyvinyl chloride, Refrigeration, Stability, Storage, Temperature",
author = "Kelly Karlage and Zachary Earhart and Kelly Green-Boesen and Myrdal, {Paul B}",
year = "2011",
month = "8",
day = "15",
doi = "10.2146/ajhp100413",
language = "English (US)",
volume = "68",
pages = "1537--1540",
journal = "American Journal of Health-System Pharmacy",
issn = "1079-2082",
publisher = "American Society of Health-Systems Pharmacy",
number = "16",

}

TY - JOUR

T1 - Stability of midazolam hydrochloride injection 1-mg/ml solutions in polyvinyl chloride and polyolefin bags

AU - Karlage, Kelly

AU - Earhart, Zachary

AU - Green-Boesen, Kelly

AU - Myrdal, Paul B

PY - 2011/8/15

Y1 - 2011/8/15

N2 - Purpose. The stability of midazolam hydrochloride injection 1-mg/mL solutions in polyvinyl chloride (PVC) and polyolefin bags under varying conditions was evaluated. Methods. Triplicate solutions of midazolam hydrochloride 1-mg/mL were prepared in polyolefin and PVC i.v. bags by diluting midazolam hydrochloride injection 5 mg/mL with 5% dextrose injection. Bags were then stored under refrigeration (3-4 &δεγ;C), exposed to light at room temperature (20-25 &δεγ;C), or protected from light in amber bags at room temperature. Samples were taken immediately after preparation (day 0) and on days 1, 2, 3, 6, 13, 20, and 27 for analysis with a stability-indicating high-performance liquid chromatography assay in order to determine solution concentration. Stability was defined as retention of at least 90% of the initial drug concentration. The pH of each solution was also measured weekly. Sterility of the i.v. bags was determined at the end of the study by microbiological testing with culture in growth media. Differences in concentrations under the various storageconditions and bags used were analyzed using analysis of variance. Results. All solutions retained over 98% of the initial midazolam hydrochloride concentration, with no statistically significant (p ≥ 0.05) change in concentration over the four-week period. Stability was not affected by temperature, exposure to light, or bag type. The pH of all solutions remained between 3.2 and 3.4 throughout the study. Sterility after 28 days was retained. Conclusion. Midazolam hydrochloride 1-mg/mL solutions diluted in 5% dextrose injection remained stable over 27 days in both polyolefin and PVC i.v. bags, regardless of storage condition.

AB - Purpose. The stability of midazolam hydrochloride injection 1-mg/mL solutions in polyvinyl chloride (PVC) and polyolefin bags under varying conditions was evaluated. Methods. Triplicate solutions of midazolam hydrochloride 1-mg/mL were prepared in polyolefin and PVC i.v. bags by diluting midazolam hydrochloride injection 5 mg/mL with 5% dextrose injection. Bags were then stored under refrigeration (3-4 &δεγ;C), exposed to light at room temperature (20-25 &δεγ;C), or protected from light in amber bags at room temperature. Samples were taken immediately after preparation (day 0) and on days 1, 2, 3, 6, 13, 20, and 27 for analysis with a stability-indicating high-performance liquid chromatography assay in order to determine solution concentration. Stability was defined as retention of at least 90% of the initial drug concentration. The pH of each solution was also measured weekly. Sterility of the i.v. bags was determined at the end of the study by microbiological testing with culture in growth media. Differences in concentrations under the various storageconditions and bags used were analyzed using analysis of variance. Results. All solutions retained over 98% of the initial midazolam hydrochloride concentration, with no statistically significant (p ≥ 0.05) change in concentration over the four-week period. Stability was not affected by temperature, exposure to light, or bag type. The pH of all solutions remained between 3.2 and 3.4 throughout the study. Sterility after 28 days was retained. Conclusion. Midazolam hydrochloride 1-mg/mL solutions diluted in 5% dextrose injection remained stable over 27 days in both polyolefin and PVC i.v. bags, regardless of storage condition.

KW - Anxiolytics, sedatives and hypnotics

KW - Chromatography, liquid

KW - Concentration

KW - Containers

KW - Contamination

KW - Dextrose

KW - Diluents

KW - Hydrogen ion concentration

KW - Injections

KW - Midazolam hydrochloride

KW - Polyolefin

KW - Polyvinyl chloride

KW - Refrigeration

KW - Stability

KW - Storage

KW - Temperature

UR - http://www.scopus.com/inward/record.url?scp=80051909118&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80051909118&partnerID=8YFLogxK

U2 - 10.2146/ajhp100413

DO - 10.2146/ajhp100413

M3 - Article

C2 - 21817086

AN - SCOPUS:80051909118

VL - 68

SP - 1537

EP - 1540

JO - American Journal of Health-System Pharmacy

JF - American Journal of Health-System Pharmacy

SN - 1079-2082

IS - 16

ER -