Physicochemical stability of 20 mg/mL amiodarone hydrochloride oral suspension in SyrSpend® SF PH4 (liquid)

Amiodarone hydrochloride is a class III antiarrhythmic drug indicated for the treatment of ventricular and supraventricular tachycardias. Oral amiodarone is only available in a tablet dosage form, which is not suitable for pediatric use. The stability of amiodarone hydrochloride suspension at 5 mg/m...

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Bibliographic Details
Main Authors: Adoum Anissa (Author), Le Pho Viet Anh Diane (Author), Faisant Sophie (Author), Legendre Pauline (Author), Lester Marie-Antoinette (Author), Boivin Pierre-Nicolas (Author)
Format: Book
Published: De Gruyter, 2022-06-01T00:00:00Z.
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Summary:Amiodarone hydrochloride is a class III antiarrhythmic drug indicated for the treatment of ventricular and supraventricular tachycardias. Oral amiodarone is only available in a tablet dosage form, which is not suitable for pediatric use. The stability of amiodarone hydrochloride suspension at 5 mg/mL was assessed in SyrSpend® SF PH4 (liquid) but oral amiodarone is typically given as a loading dose of 10-15 mg/kg/day for 4-10 days and then reduced to a maintenance dose of 5 mg/kg/day, making the 20 mg/mL concentration a better option. A hospital preparation of 20 mg/mL amiodarone hydrochloride oral suspension was developed. The purpose of this study was to determine the physicochemical stability of a 20 mg/mL amiodarone hydrochloride oral multidose suspension in a commercial compounding excipient, SyrSpend® SF PH4 (liquid) at ambient temperature and under dark conditions.
Item Description:2365-2411
2365-242X
10.1515/pthp-2022-0005