Polyoxylglycerides and glycerides: effects of manufacturing parameters on API stability, excipient functionality and...

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Materials Science

Background:

• Lipid-based formulations address challenges in oral bioavailability and sustained drug release.
• Glycerides and polyoxylglycerides are key lipid excipients used across various administration routes.
• Limited understanding exists regarding manufacturing's impact on API chemical stability within lipid excipients.

Purpose of the Study:

• To review critical parameters for formulating with lipid-based excipients.
• To anticipate potential impacts on drug stability and excipient functionality.
• To provide insights into the chemical stability of APIs in lipid-based drug products.

Main Methods:

• Review of lipid chemistry, fatty acid properties, and extraction/refinement processes.
• Analysis of manufacturing parameters influencing lipid-based excipient quality.
• Discussion of excipient characteristics, functionality, and API interactions.

Main Results:

• Key parameters influencing lipid-based excipient quality during manufacturing are identified.
• Critical characteristics of excipients are linked to their functionality and API interactions.
• The review highlights the importance of understanding manufacturing effects on drug stability.

Conclusions:

• Formulating with lipid-based excipients requires careful consideration of manufacturing processes.
• Anticipating API stability and excipient functionality is vital for successful drug product development.
• This review provides a framework for evaluating lipid-based excipient behavior in pharmaceutical formulations.