Understanding peroxide formation in Tween® 80 using RapidOxy®: Implications for pharmaceutical nanoemulsions

Area of Science:

• Pharmaceutical Science
• Materials Science
• Physical Chemistry

Background:

• Tween 80 is a common surfactant in pharmaceutical formulations.
• Oxidative degradation of surfactants can impact drug product stability.
• Nanoemulsions (NEs) are increasingly used for drug delivery.

Purpose of the Study:

• To assess the oxidation stability of Tween 80 under pharmaceutical conditions.
• To investigate the impact of oxidized Tween 80 on nanoemulsion stability.
• To develop a mathematical model for real-time shelf-life prediction of nanoemulsions.

Main Methods:

• Analysis of Tween 80 oxidation stability by measuring peroxide formation.
• Correlation of oxygen absorption with oxidation levels.
• Preparation and characterization of nanoemulsions using Tween 80 with varying oxidation levels.
• Assessment of nanoemulsion properties: droplet size, polydispersity index, zeta potential, and active pharmaceutical ingredient (API) degradation.

Main Results:

• A novel mathematical approach was proposed to estimate shelf life based on peroxide value.
• Nanoemulsions formulated with oxidized Tween 80 showed no significant changes in droplet size or PDI.
• A slight increase in zeta potential and partial API degradation were observed with oxidized Tween 80.

Conclusions:

• Oxidative degradation of Tween 80 can influence nanoemulsion properties and API stability.
• The developed mathematical model offers a tool for predicting nanoemulsion shelf life.
• Further long-term studies are needed to fully elucidate the implications of Tween 80 oxidation on pharmaceutical nanoemulsions.