One of the challenges in designing nanomaterials that are efficacious for clinical use is the nanoparticles themselves. Historically, it has been difficult to design nanoparticles in which multiple substances are distributed uniformly throughout the particle and then to produce those nanoparticles with a consistent size and shape.
Singapore-based NanoMaterials Technology has overcome that with high gravity controlled precipitation (HGCP). “We can control the size, the shape, and even the crystallinity,” claimed Jimmy Yun, Ph.D., CEO. “We are talking about particle design,” not merely manufacturing nanoparticles. This method ensures the uniform mixing of two solutions, so nucleation can be controlled.
NanoMaterials’ particles are of uniform quality, size, distribution, particle shape, and morphology. Therefore, Dr. Yun explained, their contents behave more predictably than when carried by particles in which the solutions mixed unevenly, which is inherent in manual mixing methods.
In comparing dissolution rates of gravity-controlled precipitation particles with those of spray-dried active ingredients, Dr. Yun said that 80% of the HGCP particles dissolved within 10 minutes, compared to only 20% of the spray-dried particles.
Aerosol performance tests comparing NanoMaterials’ spherical nanoparticles to microsized APIs showed that the total fine-particle fraction for the nanoparticles was nearly 85%, compared to 35% for the microparticles. Additional applications include using these nanoparticles as a controlled-release technology for therapeutics and to induce hyperthermia for tumors (which do not dissipate heat as readily as normal cells).
The company is working at the industrial scale, designing particles as small as 10 nm. The first pharmaceutical pilot plant using HGCP technology can produce 40 tons of antibiotics per year, according to Dr. Yun, and the first commercial production facility can produce 10,000 tons per year.
NanoMaterials just signed a deal to develop particles for a product destined for the FDA-approval process and also has signed a license agreement with a Chinese pharmaceutical firm to develop the particles for State Food and Drug Administration approval.