Stability of intravesical epirubicin infusion: a sequential temperature study

Area of Science:

• Oncology
• Pharmaceutical Sciences
• Urology

Background:

• Bladder instillation is a common chemotherapy delivery method.
• Epirubicin is an anthracycline chemotherapy agent used for bladder cancer.
• Assessing the stability of pharmaceutical preparations is crucial for patient safety and treatment efficacy.

Purpose of the Study:

• To evaluate the chemical and physical stability of epirubicin bladder instillation.
• To determine stability under conditions simulating refrigerated storage, transportation, and clinical use.
• To investigate if different epirubicin formulations impact the stability of the final instillation product.

Main Methods:

• A sequential study design was employed.
• Epirubicin instillations (1 mg/mL) in polypropylene syringes were incubated.
• Incubation involved 84 days at 8°C, followed by 2 hours at 25°C, and 1 hour at 37°C.

Main Results:

• Epirubicin bladder instillation demonstrated both chemical and physical stability.
• Stability was maintained throughout the simulated storage, transport, and intravesical use conditions.
• The specific epirubicin formulation used did not influence the stability of the prepared instillations.

Conclusions:

• Epirubicin bladder instillation is a stable pharmaceutical preparation.
• The stability is unaffected by storage, transport, or clinical use conditions.
• Formulation choice does not compromise the stability of epirubicin for intravesical therapy.