The Processing Technology
Lena Nanoceutics processing technology is scalable from lab based R&D to full production level. Shown opposite are a lab scale mill (left) capable of processing up to 250 ml at a time and a larger rig that is capable of handling several litres. A second larger rig has been installed at R5’s GMP facilities in Nottingham.
The purpose of nano-processing of pharmaceutical actives in this way is to improve the dissolution profile of pharmaceutical actives in order to enhance their potential bioavailability.
Lena’s technology is covered by two patents that have been granted, the second of which went into National filings in 2009.
- A “Rotating chamber mill”-provides a multi-functional grinding process in which grinding power is different in each zone as the concentration of beads increases from low to high.
- The higher the level of the zone the more beads contained in the cavities creating an increasing grinding power. This ensures maximum grinding effect on the smallest particles.
- In each zone the beads oscillate in the rotating cavities creating the grinding effect, enabling attrition via particles being rolled between vibrating/oscillating beads unlike a simple peg mill, this is not a hammering effect.
- This is “Energy Impact Control” which provides a gentler and more efficient attrition process leading to faster rates, lower residence times and the advantages this brings in terms of better stability and crystallinity and energy and excipient usage.
Key Features and benefits
- Ability to process a range materials
- Ability to process coarse starting materials (>100 µm)
- Ability to process high solids contents (up to 40% w/v)
- Consistent and rapid nano-particle processing
- Physically and chemically stable product
- Products with crystallinity maintained
- Small scale mill for feasibility (<1g)
- Scalable process-Lena mill installed at R5 GMP facility
- Powder form through spray drying and freeze drying
- Rapid aqueous dissolution
- Improved bioavailability and speed of onset