The trusted partner who provides solutions to solve your drug solubility issues with drug nanomilling feasibility solutions
Drug Nanomilling Feasibility Services For Water Insoluble APIs
As many as 90% of active pharmaceutical ingredients (APIs) in the discovery pipeline are poorly water-soluble, resulting in poor bioavailability or prohibiting injectable dosage form development.
If you have an insoluble API, nanomilling may be the solution.
A leader in nanomilling
Nanomilling is an efficient, reproducible, and scalable approach for improving the rate of dissolution and bioavailability of BCS Class II and IV compounds.
LLS Health has decades of experience developing nanoparticulate suspensions, both with commercial milling equipment and our own proprietary mills. We are the only CDMO capable of performing nanomilling under aseptic conditions. If you choose to move forward with your nanomilling project, we have the personnel, facilities, and equipment to produce clinical and commercial scale nanomilled formulations. If you have an insoluble API, contact us below to learn how nanomilling can help to solve your formulation challenges, and let us take your product from concept to commercial.
In just 8 weeks, our nanomilling feasibility program allows us to:
Develop a target product profile and screen your API for nanomilling with GRAS-approved excipients
Generate particle size distribution and short-term stability data for each formulation
Identify promising formulation(s) and provide material for animal PK studies
Why Choose Nanomilling?
Nanomilling is a proven, commercially validated process for formulating just about any poorly water-soluble API. Numerous BCS class II and IV APIs have benefited from this technology and 10+ nanomilled drug products have gained FDA approval since 2000, including both solid and liquid dosage forms. The key to nanomilling is particle size reduction, which increases the surface area of an API and improves dissolution rate. Compared to other solubilization approaches, nanomilling has key advantages, including:
- No harsh organic solvents or pH extremes: Most nanomilled suspensions are aqueous-based
- High API concentrations: 5 – 40+% API (w/w)
- Easy scale-up: Commercial nanomilling equipment utilizes a recirculation process that allows batch sizes to increase without changing process variables
- Reproducibility: Once a nanomilling process is optimized, there is minimal variation in particle size distribution from batch-to-batch