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

Abstract

In pediatric wards, bisoprolol, betaxolol, or nadolol can be administered orally at nonlicensed dosages. To provide pediatric patients with the appropriate treatment, batches of beta-blocker oral suspensions must be compounded, involving 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 2-8oC, for 1 month after opening at 2-8oC, and for 15 days stored at 25oC/60% RH. Bisoprolol hemifumarate 0.5 mg.mL-1 was stable for 2 months when stored at 2-8oC, for 1 month after opening at 2-8oC, and for 15 days stored at 25oC/60% RH. Nadolol 10 mg.mL-1 was stable for 3 months when stored at 2-8oC, for 1 month after opening at 2-8oC, and for 15 days stored at 25oC/60% RH. Hospital pharmacies can compound batches of beta-blocker liquid oral suspensions and store them for secured dispensation and administration.