Stability study of oral pediatric idebenone suspensions

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery
• Formulation Development

Background:

• Limited availability of adapted oral liquid formulations for pediatric idebenone administration.
• Idebenone is a synthetic antioxidant with potential therapeutic applications.

Purpose of the Study:

• To develop and evaluate oral liquid formulations of idebenone suitable for infant administration.
• To assess the stability of idebenone in various pharmaceutical vehicles over 90 days.

Main Methods:

• Preparation of idebenone suspensions in Ora-Plus, Ora-Sweet, Ora-Sweet SF, Ora-Blend, Ora-Blend SF, and Inorpha.
• Storage of formulations in amber glass bottles at 5°C and 25°C for 90 days.
• Quantification of idebenone content using a stability-indicating high-performance liquid chromatography (HPLC) method; pH, color, odor, and microbial assessments.

Main Results:

• Idebenone remained stable for at least 90 days in the Inorpha vehicle at both tested temperatures.
• Stability in Ora-Blend was estimated at 14 days, and in other suspensions at 20 days.
• Minimal pH changes were observed across formulations, with no significant alterations in color, odor, or visual microbiology.

Conclusions:

• The Inorpha vehicle is recommended for formulating stable oral liquid idebenone for infants.
• Idebenone in Inorpha demonstrates adequate stability for at least 90 days under recommended storage conditions (25°C).
• Further research may explore long-term stability and clinical efficacy of this formulation.