Self-dispersible eutectic mixtures with fenofibrate and ibuprofen: Processability and API particle size.

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Poorly water-soluble drugs often exhibit low dissolution rates, limiting their bioavailability.
• Eutectic mixtures offer a method to reduce drug particle size without mechanical processing.

Purpose of the Study:

• To investigate eutectic mixtures of polyethylene glycol stearates/stearyl ethers with model drugs.
• To evaluate the impact of self-dispersible excipients on eutectic properties and drug dissolution.

Main Methods:

• Phase diagrams were established for various eutectic mixtures.
• Processability, disintegration, and drug particle size were analyzed.

Main Results:

• Eutectic properties (concentration, fusion temperature) correlated with excipient melting points.
• Eutectics with self-dispersing excipients showed faster disintegration.
• Smaller drug particle sizes were achieved with higher recrystallization tendency and near eutectic concentrations.

Conclusions:

• Self-dispersible excipients enhance the performance of drug-loaded eutectics.
• Eutectic formation is a viable strategy for improving dissolution of poorly soluble drugs.