Physicochemical and microbiological stability of 40 mg/mL amiodarone hydrochloride oral suspension.

This article focuses on the development and stability evaluation of a pediatric oral suspension of amiodarone hydrochloride, an antiarrhythmic drug used to treat supraventricular tachycardia (SVT) in children. Due to the lack of commercially available pediatric formulations and the need for dose flexibility, the study formulated a 40 mg/mL amiodarone hydrochloride suspension using pharmaceutical-grade excipients tailored for children, including hydroxypropylmethylcellulose as a thickener and potassium sorbate as a preservative. Stability testing demonstrated that the suspension maintained at least 95% of its initial concentration, along with stable physicochemical and microbiological properties, when stored refrigerated (5 °C) for 60 days unopened and for 1 month after opening; however, storage at room temperature led to physical changes such as crystal formation. This formulation offers a child-appropriate, flexible dosing option suitable for hospital and community pharmacy compounding to support pediatric SVT treatment.