110 Development and stability of 40 mg/mL amiodarone oral suspension

5 October 2022

M. Cavelier, H. Gondé, D. Costa, F. Lamoureux, T. Pereira, R. Varin, C. Hervouët
CHU de Rouen, France

Amiodarone is used to treat supraventricular tachycardia in pediatrics. No commercial oral drug is suitable for this population. The compounding of capsules requires iterative manufacturing in order to adapt the dose to the body surface area and to the dosage (loading or maintenance dose). The objective is to develop an oral form of amiodarone and to evaluate its stability.

The excipients were selected to be appropriate for pediatric use. A stability-indicating method by UPLC-PDA was developed and validated.
The suspension was packaged in brown glass vials, stored at room temperature (25°C±2°C) and refrigerated (5°C±3°C). The stability study was performed on vials before opening, and after opening with daily sampling of the suspension.
Amiodarone concentration, pH and osmolality were evaluated at D0, D1, D3, D7, D15, D22 and D30 and microbiological stability (bacterial and fungal enumeration and specific E. Coli test) at D0 and D30.

Amiodarone 40 mg/mL oral suspension included thickener, antimicrobial preservative, buffer, sweetener and strawberry flavor. The efficacy of antimicrobial preservation was in accordance with the European Pharmacopoeia. The concentration of amiodarone was within 95 – 105 % of the initial concentration for 30 days and no degradation products were detected. pH and osmolality remained constant during the study. Microbiological results were in accordance with pharmacopoeia specifications at the different analysis times. In the “after opening” vials stored at room temperature, crystals appeared on the edges of the walls.

We have developed an oral formulation of amiodarone, adapted to pediatrics, which avoids the problems associated with the compounding of capsules. This suspension was stable for 30 days at 4°C before and after opening, the latter condition mimicking real-life conditions of use.

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