smartCrystal combination technology--scale up from lab to pilot scale and long term stability

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Chemical Engineering

Background:

• Apigenin, a flavonoid, holds potential for pharmaceutical, cosmetic, and nutraceutical applications.
• Scaling up nanocrystal production is essential for commercial viability.
• Characterization and stability assessment are critical for successful scale-up.

Purpose of the Study:

• To scale up apigenin nanocrystal production from laboratory to pilot scale (150-fold increase).
• To compare particle size characterization methods for assessing scale-up success.
• To evaluate the long-term physical stability of the produced nanocrystals.

Main Methods:

• Laboratory scale: High Pressure Homogenization (HPH).
• Pilot scale: smartCrystal Combination Technology (CT) - pearl milling followed by HPH.
• Particle size analysis: Photon Correlation Spectroscopy (PCS) and Laser Diffractometry (LD).
• Stability assessment: Zeta Potential (ZP) measurements and 6-month storage study at various temperatures.

Main Results:

• Scale-up from 20 g to 3 kg was achieved.
• Particle size assessment varied with characterization method (PCS vs. LD).
• Zeta potential values indicated stable dispersions, though differing between scales (lab: >30 mV, pilot: 5-7 mV).
• Nanosuspensions demonstrated physical stability for 6 months across different storage conditions.

Conclusions:

• Successful scale-up of apigenin nanocrystals is achievable using combined technologies.
• Method selection for particle size characterization significantly impacts scale-up evaluation.
• Despite differing ZP values, the nanocrystals exhibit excellent long-term physical stability, crucial for product development.