Stability of midazolam and noradrenaline stored in cyclic olefin copolymer AT-Closed Vials® and polypropylene syringes during 365 days
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Frédéric Feutry
,
Stéphanie Genay
Introduction
Midazolam (MDZ) and noradrenaline (NA) are drugs commonly used in intensive care units to control sedation and hemodynamic status of patients. They require a dilution step by the nurse several times a day. To decrease preparation risks they could be compounded by the pharmacy, provided that stability is sufficient.
Methods
50mL cyclic olefin copolymer AT-Closed Vials® (Aseptic Technologies) and polypropylene syringes (Plastipak®, Becton Dickinson) were filled with MDZ or NA (Mylan) diluted in saline at respectively 1 mg/mL and 0.2 mg/mL. The study was performed according to the SFPC/GERPAC guidelines during 365 days at 2 temperature conditions: –20 °C, 5 °C. Concentrations were determined by an HPLC/UV stability indicating method, expressed as mean±standard deviation and considered stable if the concentration stayed over 90 % of the initial concentration value. Particulate contamination, pH evolution and sterility were followed.
Results
Solutions were stable during 365 days in AT-Closed Vial® at –20 °C (MDZ 99.01±0.90 %, NA 98.91±0.54 %) and 5 °C (MDZ 97.98±0.96 %, NA 99.52±0.36 %) and in syringes at –20 °C (MDZ 99.29±0.85 %, NA 98.92±0.98 %) and 5 °C (MDZ 97.89±0.51 %, NA 99.42± 0.51 %). There was no modification of pH. Sterility and particle tests were in accordance with European Pharmacopeia after 365 days whatever the storage conditions.
Discussion-conclusion
MDZ and NA are stable during 365 days at 5 °C and –20 °C. Storage at 5 °C should be preferred to exclude freezing-thawing issues. AT-Closed Vial® could be chosen for their automated aseptic filling process and for logistic considerations particularly considering the space gains.
© 2017 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- graphical-abstract
- Editorial
- A special issue dedicated to the GERPAC 2016 meeting
- Conference Reports
- Quality Management Workshop: Feedback on ISO Certification in a Pharmaceutical Technology Unit
- Subcontracting Workshop – GERPAC 2016
- Short Communications
- Stability of 25 mg/mL Azacitidine Suspensions Kept in Fridge after Freezing
- Permeability and Release of Decontaminating Agent Used in Cytotoxic Reconstitution Units: Diffusion of Hydrogen Peroxide in IV Bags
- Innovation in the Transport of Cytotoxic Drugs by a Pneumatic Transport System
- Opinion Paper
- Centrally Prepared Cytotoxic Drugs: What Is the Purpose of Their Quality Control?
- Conference Abstracts
- Stability of midazolam and noradrenaline stored in cyclic olefin copolymer AT-Closed Vials® and polypropylene syringes during 365 days
- Implementation of a remote oncology-monitoring program for cancer patients in outpatient care unit
- Analysis of notified adverse events: a tool for improving risk mapping related to the automatic repackaging and preparation of individual doses
