Stability of micafungin sodium solutions at different concentrations in glass bottles and syringes

Briot, Thomas; Vrignaud, Sandy; Lagarce, Frédéric

doi:10.1016/j.ijpharm.2015.07.019

Cited by 7 publications

(4 citation statements)

References 20 publications

(22 reference statements)

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“…Zhu et al 10 reported a loss of 25.1% of a 2.5 mg/mL solution of micafungin in a 0.1 M NaOH solution (pH = 13) at room temperature after 1 hour. Briot et al 11 measured a 27% chemical degradation of a 2 mg/mL solution of micafungin also in a 0.1 M NaOH solution (pH = 13) after 30 minutes at room temperature. While both of these studies report significant chemical instability of micafungin in an alkaline solution, it should be noted that the pH was much higher (13 vs 8.4) and the time the micafungin is mixed with alkaline solution was much longer than what would occur in a clinical setting.…”

Section: Resultsmentioning

confidence: 99%

Physical Compatibility of Micafungin With Sodium Bicarbonate Hydration Fluids Commonly Used With High-Dose Methotrexate Chemotherapy

et al. 2017

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The purpose of this study was to determine the physical compatibility of micafungin with commonly used concentrations of sodium bicarbonate hydration fluids administered via a Y-site connected to a central venous catheter (Y-site/CVC). Micafungin sodium (evaluated concentration of 1.5 mg/mL) was combined in a 3:1 (vehicle:drug) ratio with the following commonly used hydration vehicles: 40 mEq/L sodium bicarbonate in 5% dextrose in water with ¼ normal saline (40SB-D5W-1/4NS), 75 mEq/L sodium bicarbonate in D5W (75SB-D5W), and 154 mEq/L sodium bicarbonate in D5W (154SB-D5W). A 3:1 ratio was used based on the flow rates (typically 125 mL/m/h for bicarbonate-containing vehicles and 50 mL/h for micafungin) of the corresponding solutions in a clinical setting. Visual observations recorded to determine physical compatibility included visual inspection against different backgrounds (unaided, black, and white). Other physical observations were as follows: odor, evolution of gas, pH, and turbidity immediately recorded after mixing and at specified time points up to 2 hours. Evaluations at each time point were compared against baseline observation values at Time 0. All combinations tested were found to be compatible up to 2 hours. Time points beyond 2 hours cannot be safely verified as compatible. Micafungin may be administered safely using a Y-site/CVC delivery system with all the vehicles tested in this study.

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Section: Resultsmentioning

confidence: 99%

Physical Compatibility of Micafungin With Sodium Bicarbonate Hydration Fluids Commonly Used With High-Dose Methotrexate Chemotherapy

et al. 2017

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“…Micafungin stability has been reported in a polyvinyl chloride (PVC) infusion bag and is stable for seven days if refrigerated, protected from light, and at a concentration of 0.125–1 mg/mL in sodium chloride 0.9% 12 . When compounded in a polypropylene syringe, micafungin stability is reported for 15 days at room temperature, protected from light, and at a concentration of 0.5–1 mg/mL in sodium chloride 0.9% 13 . However, products compounded by the pharmacy APU stored at room temperature have an expiry date capped at four days.…”

Section: Introductionmentioning

confidence: 99%

“…12 When compounded in a polypropylene syringe, micafungin stability is reported for 15 days at room temperature, protected from light, and at a concentration of 0.5-1 mg/mL in sodium chloride 0.9%. 13 However, products compounded by the pharmacy APU stored at room temperature have an expiry date capped at four days. This is based on the beyond use date recommendations in the United States Pharmacopoeia Pharmaceutical Compounding Sterile Preparations Chapter 797.…”

Section: Introductionmentioning

confidence: 99%

What is the most cost‐beneficial way to prepare micafungin for paediatric oncology patients?

Li,

Smith

2023

Pharmacy Practice and Res

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BackgroundA recent change in local paediatric antifungal guidelines resulted in an increase in micafungin use. Micafungin is an expensive medicine costing AUD $80 per vial. The pharmacy aseptic production unit (APU) has the ability to compound doses to share vials of micafungin to minimise wastage.AimTo determine whether aseptically compounded and individually prepared doses of micafungin would be more cost‐beneficial than nurses using whole vials prepared on the ward, and to determine which dose and numbers of doses would be most cost‐beneficial to compound.MethodA time and motion study of 20 patients determined how long it took for nurses and the pharmacy APU to prepare doses. An economic analysis of time, cost of labour, and consumables outlined the cost to make one to seven doses with doses ranging from 10 to 200 mg.ResultsOn average, it took the pharmacy APU 42 min and nurses 9 min to prepare a single dose. Aseptically compounding one dose, whole vials (doses of 50 mg increments), and doses near whole vials had no cost‐benefit. Aseptically compounding five doses or more had would result in a cost‐benefit.ConclusionDepending on the dose required, cost savings could be obtained when the pharmacy APU prepared multiple doses, with a maximum saving of $350.10 for a 7‐day course. Determining baseline costs of micafungin preparation is relevant if there are future requests to compound medicines as the data could be extrapolated and applied to the new request.

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“…For example, Briot et al demonstrated that centralised preparation of Mycamine ® in pharmacy generates 80,000.00 euros of product-related savings per year [22]. Funding initiatives for such costly products, for instance by Regional Health Agencies in France, do not encourage CIVAS because most costly products are refunded as part of hospital activity-based payment.…”

mentioning

confidence: 99%

Resolution CM/Res(2016)2 and Centralised Intra Venous Additive Services (CIVAS): Challenges and Opportunities

Vrignaud

2017

Pharmaceutical Technology in Hospital Pharmacy

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AbstractThe aim of the European Council’s Resolution CM/res(2016)2 on good reconstitution practices in health care establishments for medicinal products for parenteral use is to guide the health care establishment’s decision as to where reconstitution should take place: in the pharmacy or the clinical area. Injectable preparation in hospital pharmacy is performed in Centralised Intra Venous Additive Services (CIVAS). Nevertheless, challenges such as ensuring the sterility of the preparation, the physicochemical stability of the product, and process validation for instance should be taken into account. This opinion paper examines the challenges, impacts, and responsibilities for pharmacists, nurses, and hospital management related to implementing the resolution, regarding the experience of countries where CIVAS are already implemented. It also discusses the opportunities of implementing CIVAS with regard to patient care safety and potential financial savings.

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Stability of micafungin sodium solutions at different concentrations in glass bottles and syringes

Cited by 7 publications

References 20 publications

Physical Compatibility of Micafungin With Sodium Bicarbonate Hydration Fluids Commonly Used With High-Dose Methotrexate Chemotherapy

Physical Compatibility of Micafungin With Sodium Bicarbonate Hydration Fluids Commonly Used With High-Dose Methotrexate Chemotherapy

What is the most cost‐beneficial way to prepare micafungin for paediatric oncology patients?

Resolution CM/Res(2016)2 and Centralised Intra Venous Additive Services (CIVAS): Challenges and Opportunities

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