Lipid-based solubilization technology via hot melt extrusion: promises and challenges

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Biopharmaceutics

Background:

• Self-emulsifying drug delivery systems (SEDDS) improve oral bioavailability of poorly water-soluble drugs (PWSD).
• Traditional SEDDS face challenges with low drug loading and formulation instability.
• Polymeric precipitation inhibitors and solidification strategies address these limitations.

Purpose of the Study:

• To explore hot melt extrusion (HME) as a manufacturing technology for supersaturable solid-SEDDS.
• To evaluate HME's potential for lean and continuous production of enhanced SEDDS.
• To highlight opportunities and challenges of HME for lipid-based excipient processing in SEDDS.

Main Methods:

• Review of literature on SEDDS, lipid-based delivery systems (LBDS), and hot melt extrusion (HME).
• Analysis of HME as a solidification technology for supersaturable SEDDS.
• Identification of critical formulation and process parameters for HME-based SEDDS preparation.

Main Results:

• Hot melt extrusion (HME) is identified as a viable, continuous, solvent-free technology for manufacturing solid supersaturable SEDDS.
• HME offers a cost-effective and scalable alternative for producing enhanced SEDDS.
• Key formulation and process parameters for successful HME-based SEDDS production are identified.

Conclusions:

• HME presents a promising manufacturing approach for supersaturable solid-SEDDS, overcoming limitations of traditional methods.
• This technology facilitates lean and continuous manufacturing, improving drug loading and stability for PWSD.
• Further investigation into HME for lipid-based excipient processing in SEDDS is warranted.