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Stability of dobutamine in continuous ambulatory delivery devices
F Al Madfai1, B Valah1, S T R Zaidi1
1Division of Pharmacy, School of Medicine, University of Tasmania, Hobart, TAS, Australia.
Insights
Dobutamine is chemically stable in continuous ambulatory delivery devices (CADDs) for at least 168 hours at 4°C, plus additional time at higher temperatures. This stability supports weekly CADD supplies for home infusions in heart failure patients.
Area of Science:
- Pharmacology
- Pharmaceutical Science
- Clinical Pharmacy
Background:
- Continuous dobutamine infusion is vital for end-stage heart failure management.
- Home infusion via CADDs improves patient care and reduces hospitalization.
- The stability of dobutamine in CADDs was previously unknown.
Purpose of the Study:
- To investigate the physicochemical stability of dobutamine in CADDs.
- To assess dobutamine stability at various temperatures and time points.
- To inform home infusion protocols for heart failure patients.
Main Methods:
- Prepared CADDs with dobutamine in 0.9% sodium chloride or 5% glucose.
- Stored CADDs at 4°C, 35°C, and 25°C for specified durations.
- Analyzed dobutamine concentration, pH, color, and particle content using HPLC.
Main Results:
- No changes in particle formation, color, or pH were observed.
- Dobutamine demonstrated chemical stability for at least 168 hours at 4°C.
- Stability was maintained for an additional 12 hours at 35°C and 12 hours at 25°C.
Conclusions:
- Dobutamine is chemically stable in CADDs under the tested conditions.
- Findings support weekly dispensing of dobutamine CADDs for home use.
- This can reduce CADD exchanges and lower infection risk in heart failure patients.
What Is Known And Objective:
Continuous infusion of dobutamine plays an important role in the management of patients with end-stage heart failure. Home infusion of dobutamine using a continuous ambulatory delivery device (CADD) facilitates the management of patients in their home, avoiding complications associated with long-term hospitalization. However, the stability of dobutamine in CADD is currently unknown. Therefore, this study investigated the physicochemical stability of dobutamine in CADDs at three different temperatures over various time points.
Methods:
Six CADDs (three containing dobutamine 10 mg/mL in 0.9% sodium chloride and three containing dobutamine 10 mg/mL in 5% glucose) were prepared and stored at 4°C for 7 days, followed by 12 hours at 35°C and then for another 12 hours at 25°C. An aliquot (n = 3) was withdrawn aseptically at 0, 24, 48, 72, 96, 120, 144 and 168 hours when stored at 4°C, and at 0, 6 and 12 hours when stored at the other two temperatures. Each sample was analysed for dobutamine concentration using a stability-indicating high-performance liquid chromatography. All the samples were also evaluated for change in pH, colour and for particle content.
Results And Discussion:
No evidence of particle formation, colour or pH change was observed throughout the study period. Dobutamine, when admixed with 0.9% sodium chloride or 5% glucose, was found to be chemically stable for at least 168 hours at 4°C and for another 12 hours at 35°C and for another 12 hours at 25°C.
What Is New And Conclusions:
Our findings will allow health professionals to provide a weekly supply of dobutamine-containing CADDs to patients for home infusions. Continuous infusion over a 24-hour period using one CADD per day will also decrease the number of exchanges required and thus reduce the risk of catheter-related bloodstream infections.
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