Stability study of a clonidine oral solution in a novel vehicle designed for pediatric patients.

Clonidine hydrochloride is administered to opioid-addicted mothers' neonates to reduce neonatal abstinence syndrome. It is prescribed off-label to neonates at 0.5-1 µg/kg/6 h, alone or in combination. The commercially injectable form of clonidine-Catapressan® 0.15 mg/mL-is being orally given after an appropriate dilution in water. However, this practice is not suitable for a perfectly safe and accurate administration. The objectives were to design a 10 µg/mL oral solution of clonidine hydrochloride in Inorpha® and to study the stability of this solution by a validated stability-indicating liquid chromatography (LC) method. The chemical, physicochemical and microbiological stability of the compounded formulation stored at 5 ± 3 °C and 25 ± 2 °C was tested over 60 days. The LC method used is specific, linear, accurate and precise. Upon storage between 2 and 8 °C according to classical and 'in use' schedules, the concentrations of clonidine and potassium sorbate (preservative) were found to be between 90.0 and 110.0% of the initial concentration, the pH between 4.4 and 4.7 and no microbial growth was noted. The stability of clonidine hydrochloride oral solution in Inorpha® sets the basis for individualized, easy and safe administration of clonidine in pediatric populations.