Technology

Nanoform’s platform technology can give failed drug molecules a second chance. The patented technology is based on supercritical CO2. The drug solution is expanded through a controlled process to produce pure drug nanoparticles. The process is more controlled than conventional supercritical technologies, and it produces smaller and more uniformly sized particles. Besides the particle size, also the polymorphism can be controlled. Several active pharmaceutical ingredients have been successfully nanonized using our technology. We have produced particles ranging from 10 nm to 2 µm from both test molecules as well as proprietary APIs.

The reduction of particle size increases the active surface area of API and thus also the dissolution rate and bioavailability of the drug – a feature evident especially with APIs from BCS classes II and IV. The technology is suitable for both chemical and protein-based APIs. Favorable effects in preclinical studies have been shown.

Before and after process

Before nanonization

After nanonization

Reproducible

Nanoform - Scematics

Our nanoparticle production process is robust and reproducible. We can produce stable, pure drug nanoparticles.

Comparison to traditional RESS

Piroxicam microparticles produced with RESS-technology

Piroxicam nanoparticles produced with Nanoform's technology

Stability of Nanonized Particles

The chemical and XRD analysis both show that there is no indication of degradation of any of the processed molecules. The polymorphic purity tests showed that only pure known polymorphs were produced. Moreover, we have tested the stability of nanonized particles using the 10 months' non-accelerated tests and demonstrated that the nanonized particles are stable.

The Dissolution Rates

The dissolution rates of the bulk piroxicam and the nanoparticles in phosphate buffer at pH 6.8 up to 30 min.

Compared to standard drug

Fitted mean plasma concentration–time profile of Piroxicam in female Sprague-Dawley (SD) rats.

Bioavailability of nanonized Piroxicam (Group 1) is better compared to standard drug (Group 3) and bulk raw material (Group 2).

Animal tests confirm the results of our in vitro tests carried out with instrumentation developed and patented by Nanoform.