Manufacturing Safe Nanomedicines Presented at BIT World Congress
October 24, 2010

Woburn, MA— We use "green" SuperFluids™ (supercritical fluids, critical or near-critical fluids with and without polar cosolvents such as ethanol) which are nontoxic and environmentally benign in combination with generally regarded as safe (GRAS) biodegradable nanomaterials to manufacture safe nanomedicines.

SuperFluids™ [SFS] are utilized phospholipid nanosomes, which are small, uniform liposomes by our SFS-CFN process. Phospholipid nanosomes are nanometer-sized vesicles of phospholipid bilayers comprised of single or multiple lipid bilayers. As such, they are non-toxic, non-antigenic and biodegradable in character since they have the molecular characteristics of mammalian cell membranes. Hydrophilic compounds and therapeutics such as recombinant proteins and siRNA are encapsulated in the aqueous core while hydrophobic compounds and therapeutics such as anticancer and other water-insoluble drugs are trapped within the lipid bilayers. Encapsulation masks the hydrophobic (water-insoluble) nature of drugs, and permits aqueous, biocompatible formulations to be administered. Phospholipid nanosomes protect the encapsulated therapeutics prolonging their circulation and increasing half-life. For cancer chemotherapy, this increases the likelihood that the drug will reach and destroy cancer cells. Encapsulation also protects cells from the circulating therapeutics and reduces their toxicities.

SuperFluids™ are also utilized to manufacture polymer nanospheres comprising of hydrophobic biodegradable copolymers by our SFS-PNS process. These nanospheres can be used for the oral delivery of therapeutic proteins such as insulin, hydrophobic anticancer drugs and small molecules as well as the controlled release of viral (HIV and influenza) and bacterial (anthrax) antigens for vaccines.

SuperFluids™ are also utilized to make protein nanoparticles by our SFS-PNP process. Protein nanoparticles can be utilized for the pulmonary delivery of protein therapeutics or in 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. Our process uses SuperFluids™ to penetrate the protein aggregates and then its expansive energy to disaggregate protein crystals into monodisperse nanoparticles without loss of bioactivity and no residual contamination to make a safe nanomedicine.