Authors: T.P. Castor
Affilation: Aphios Corporation, United States
Pages: 172 - 175
Keywords: protein, nanoparticles, drug delivery, supercritical fluids
Protein nanoparticles can be utilized for the pulmonary delivery of protein therapeutics or can be incorporated into biodegradable polymer microspheres/nanospheres for controlled release depot or oral delivery. With proteinaceous therapeutics, the generation of nanoparticles is particularly problematic. Existing practices have difficulty achieving the desired particle size distribution, expose the protein to denaturing conditions such as heat, organic solvents or air and often require stabilizing excipients or leave residual product contamination that necessitates further processing. We have developed a protein nanoparticles technology platform that avoids most of the aforementioned difficulties. Our process utilizes supercritical, critical or near-critical fluids with or without polar entrainers (SuperFluids). These fluids encompass gases such as carbon dioxide which, when compressed, exhibit enhanced thermodynamic properties of penetration, solvation, selection and expansion. The process exploits the ability of SuperFluids to penetrate the protein aggregates and then utilizes the expansive energy of SuperFluids to disaggregate protein crystals into monodisperse nanoparticles. The SuperFluidsÔ PNP technology is not constrained by limited solubility in benign solvents such as ethanol that may be used with other supercritical fluid techniques, and the utilization of large volumes of liquids that limits other techniques such as spray drying.