Solid self-emulsifying drug delivery system (S-SEDDS) for improved dissolution rate of fenofibrate

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Nanotechnology

Background:

• Fenofibrate (FF) is a poorly water-soluble drug with limited oral bioavailability.
• Enhancing FF dissolution is crucial for improving its therapeutic efficacy.

Purpose of the Study:

• To develop and characterize self-emulsifying drug delivery systems (S-SEDDS) for fenofibrate.
• To enhance the dissolution rate of fenofibrate through formulation design.

Main Methods:

• S-SEDDS pre-concentrates were prepared using Labrafac WL1349, Cremophor EL, and Gelucire 44/14, then solidified with PEG 6000.
• Alternative formulations utilized TPGS as a surfactant and solidifier.
• Formulations were characterized for nanoemulsion formation, particle size, and drug dissolution.

Main Results:

• S-SEDDS formulations successfully formed nanoemulsions with particle sizes of 150-200 nm upon dispersion.
• Fenofibrate remained in a crystalline state within the S-SEDDS formulations.
• Formulations with 10% w/w FF exhibited 90-100% dissolution within 60 minutes, a significant increase from 2-4% for untreated FF.

Conclusions:

• A novel S-SEDDS was successfully developed for fenofibrate using Cremophor/PEG and TPGS excipients.
• The developed S-SEDDS demonstrated a substantial enhancement in fenofibrate dissolution, approximately 20-fold, particularly in simulated gastric fluid (SGF) at pH 1.2.