Optimization of Microfluidizer-Produced PLGA Nano-Micelles for Enhanced Stability and Antioxidant Efficacy: A Quality...

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Nanotechnology

Background:

• Poly(lactic-co-glycolic acid) nano-micelles (PLGANM) are crucial for parenteral delivery of poorly water-soluble drugs.
• Conventional methods often result in PLGANM with poor physical stability, limiting their clinical utility.
• Enhancing PLGANM stability is vital for long-term storage and successful clinical translation.

Purpose of the Study:

• To optimize the microfluidizer-based preparation of poly(lactic-co-glycolic acid) nano-micelles (PLGANM).
• To enhance the physical stability and ensure robust, scalable manufacturing of PLGANM.
• To investigate the influence of key microfluidization parameters on PLGANM attributes.

Main Methods:

• Utilized a Central Composite Design (CCD) to systematically tune microfluidization parameters.
• Analyzed the impact of PLGA amount, Tween 80 concentration, homogenization pressure, and number of passes on PLGANM size and polydispersity.
• Compared microfluidizer-produced nano-micelles (PMFZ) with those from traditional oil-in-water (POW) methods over 60 days.

Main Results:

• Optimized microfluidization parameters (82.96 mg PLGA, 6.78 mL 5% T80, 11,000 psi, 1 pass) yielded stable PLGANM.
• Microfluidization demonstrated superior control over particle size and polydispersity compared to traditional methods.
• Analyzed stability of PLGANM over a 60-day period.

Conclusions:

• Microfluidization, guided by a Quality by Design (QbD) framework, provides precise control over PLGANM attributes.
• This optimized method enables reproducible production of physically stable PLGANM.
• The findings support the clinical translation and long-term storage of PLGANM for drug delivery applications.