Stability study of a compounded oral solution of nicardipine for the treatment of hypertension in children.

Nicardipine is an antihypertensive drug that may be used off-label by oral route to treat hypertension in children. Currently commercially available tablets are inappropriate for oral use in children and manufactured hard capsules are not suitable for easy dose individualization to achieve target blood pressure. We aimed to fulfill this lack of appropriate dose forms by developing an oral liquid formulation of nicardipine. We compounded an extemporaneous 2 mg/mL nicardipine solution in InOrpha® vehicle for oral use with 1% polysorbate 80. A HPLC-MS/MS stability-indicating method was developed and validated. The stability was assessed under room temperature and refrigerated storage conditions. Nicardipine concentration remained above 95% of the initial concentration for 90 days in both storage conditions, without apparition of degradation products. Organoleptic parameters, pH, osmolality, viscosity and density were assessed and remained stable throughout storage. A uniformity of content was maintained before and after agitation of the packaging bottles. Mass uniformity of delivered doses was also ensured. Finally, the formulation met the Pharmacopoeia specifications for microbiological contaminations. In this study we report a compounded formulation of nicardipine for oral use in pediatrics. This solution, which could be easily manufactured, is being used in our hospital. Pharmacological and clinical parameters including bioavailability, pharmacokinetics, efficacy and tolerance remain to be assessed.