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Stability of fluconazole in injectable solutions
A K Hunt-Fugate1, C K Hennessey, C M Kazarian
1Department of Pharmacy Services, Sparrow Hospital, Lansing, MI 48912.
Insights
Fluconazole injection stability was assessed in common IV solutions. It remained stable for 72 hours in dextrose with potassium chloride or theophylline, but only 24 hours in others.
Area of Science:
- Pharmaceutical Sciences
- Clinical Pharmacy
- Drug Stability
Background:
- Intravenous fluconazole is widely used for fungal infections.
- Understanding its stability in various intravenous admixtures is crucial for safe administration.
- Limited data exists on fluconazole stability in complex injectable solutions.
Purpose of the Study:
- To evaluate the stability of fluconazole in several common injectable solutions at 25°C for up to 72 hours.
- To determine the compatibility of fluconazole with dextrose, lactated Ringer's, potassium chloride, heparin, theophylline, and morphine sulfate admixtures.
Main Methods:
- Fluconazole (2 mg/mL) was admixed with various injectable solutions in a 1:1 ratio.
- Samples were analyzed for fluconazole concentration using stability-indicating gas chromatography at specified time points (0-72 hours).
- The study focused solely on fluconazole stability, not the stability of other components.
Main Results:
- Fluconazole demonstrated stability for 72 hours in 5% dextrose injection with potassium chloride and with theophylline.
- Fluconazole exhibited stability for 24 hours in 5% dextrose injection, lactated Ringer's injection, and admixtures with heparin or morphine sulfate.
- The stability of other components in the admixtures was not assessed.
Conclusions:
- Fluconazole is stable in specific intravenous admixtures (potassium chloride/dextrose, theophylline/dextrose) for extended periods (72 hours).
- Compatibility is limited to 24 hours in other tested injectable solutions, necessitating careful preparation and administration protocols.
- Further studies are needed to assess the stability of other components in these admixtures.
Abstract:
The stability of fluconazole 1 mg/mL in several injectable solutions at 25 degrees C over 72 hours was studied. Fluconazole 2 mg/mL was mixed in a 1:1 ratio with 5% dextrose injection, lactated Ringer's injection, potassium chloride 20 meq/L in 5% dextrose injection, heparin sodium 100 units/mL in 5% dextrose injection, theophylline 0.8 mg/mL in 5% dextrose injection, and morphine sulfate 0.5 mg/mL in 5% dextrose injection. Three 1-mL samples were taken from each admixture at 0, 6, 12, 24, 36, 48, and 72 hours and analyzed for fluconazole concentration by stability-indicating gas chromatography. Fluconazole 2 mg/mL was stable in potassium chloride plus 5% dextrose injection and in theophylline plus 5% dextrose injection for 72 hours. Fluconazole was stable in the other injectable solutions for 24 hours. The stability of theophylline, heparin, or morphine sulfate in the presence of fluconazole was not studied. Fluconazole was stable in potassium chloride 20 meq/L plus 5% dextrose injection and in theophylline 0.8 mg/mL plus 5% dextrose injection for 72 hours and stable in the other injectable solutions for 24 hours.
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