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

Area of Science:

• Pharmacology
• Pharmaceutical Science
• Neonatal Care

Background:

• Clonidine hydrochloride is used off-label for neonatal abstinence syndrome in neonates born to opioid-addicted mothers.
• Current oral administration uses diluted injectable forms, posing risks to safe and accurate dosing.
• A need exists for a stable, specifically formulated oral clonidine hydrochloride solution for pediatric use.

Purpose of the Study:

• To design a 10 µg/mL oral solution of clonidine hydrochloride using Inorpha®.
• To evaluate the chemical, physicochemical, and microbiological stability of the compounded oral solution.
• To establish a basis for safe and accurate individualized clonidine administration in pediatric populations.

Main Methods:

• Development of a 10 µg/mL clonidine hydrochloride oral solution in Inorpha®.
• Validation of a stability-indicating liquid chromatography (LC) method for analysis.
• Assessment of formulation stability under refrigerated (5±3°C) and room temperature (25±2°C) conditions for 60 days.

Main Results:

• The LC method was specific, linear, accurate, and precise.
• Clonidine and potassium sorbate concentrations remained within 90.0-110.0% of initial values under refrigerated storage (2-8°C).
• The pH remained stable between 4.4 and 4.7, with no microbial growth observed during the study period.

Conclusions:

• The developed clonidine hydrochloride oral solution in Inorpha® is chemically, physically, and microbiologically stable.
• This formulation supports individualized, safe, and accurate administration of clonidine to neonates.
• The study provides a foundation for improved neonatal abstinence syndrome management.