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

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.