AUTHOR=Dubois Laura , Bouguergour Cyrielle , Paoli-Lombardo Romain , Castera-Ducros Caroline , Jean Christophe , Fuchs Mélanie , Vanelle Patrice , Rathelot Pascal , Terme Thierry , Curti Christophe 

TITLE=Compounding and stability studies of liquid oral formulations of beta-blockers (bisoprolol, betaxolol, and nadolol) for paediatric patients

JOURNAL=Journal of Pharmacy & Pharmaceutical Sciences

VOLUME=Volume 28 - 2025

YEAR=2025

URL=https://www.frontierspartnerships.org/journals/journal-of-pharmacy-pharmaceutical-sciences/articles/10.3389/jpps.2025.15387

DOI=10.3389/jpps.2025.15387

ISSN=1482-1826

ABSTRACT=In paediatric wards, bisoprolol, betaxolol, or nadolol can be administered orally at non-licensed dosages. To provide paediatric patients with appropriate treatment, batches of beta-blocker oral suspensions must be compounded, which involves subsequent stability studies. A stability-indicating HPLC-UV method and microbiological analyses were validated. Experimental batches were compounded (betaxolol hydrochloride 1 mg.mL−1, bisoprolol hemifumarate 0.5 mg.mL−1 and nadolol 10 mg.mL−1). Bisoprolol hemifumarate 0.5 mg.mL−1 and nadolol 10 mg.mL−1 needed the addition of citric acid (3 mg.mL−1) and potassium sorbate (3 mg.mL−1) to ensure preservative efficacy. Betaxolol hydrochloride 1 mg.mL−1 was stable for 2 months when stored at 2–8  °C, for 1 month after opening at 2–8 °C, and for 15 days when stored at 25 °C/60% RH. Bisoprolol hemifumarate 0.5 mg.mL−1 was stable for 2 months when stored at 2–8 °C, for 1 month after opening at 2–8 °C, and for 15 days when stored at 25 °C/60% RH. Nadolol 10 mg.mL−1 was stable for 3 months when stored at 2–8 °C, for 1 month after opening at 2–8 °C, and for 15 days when stored at 25 °C/60% RH. Hospital pharmacies can compound batches of beta-blocker liquid oral suspensions and store them for secure dispensing and administration.