GRAS Material Nanoparticles for Encapsulation and Delivery of Active Pharmaceutical Ingredients

Princeton University Technology Overview
Researchers in the Department of Chemical and Biological Engineering at Princeton University have developed a new nano-encapsulation process using generally recognized as safe (GRAS) material. Through this novel synthesis process, components of the core and coating are kinetically assembled in a continuous, low-energy, self-contained micromixing system. The process uses amphiphilic, water-insoluble protein-based polymers such as the prolamine zein that kinetically assemble around a hydrophobic core material such as alpha-Tocopharol acetate using Flash Nanoprecipitation (FNP). FNP is currently a Princeton patented technology to prepare nanoparticle composites with amphiphilic copolymers. FNP is effective in encapsulating active ingredients at high particle loadings which has not been achieved by other processes.
These composite nanoparticles can be used as proteinaceous size standards and as encapsulation and delivery vehicles for pharmaceuticals, nutraceuticals, cosmetics, biomedical therapeutics, and diagnostic applications. This approach represents a major advance over previous methods because it uses a less expensive polymer that is bio-sourced, biodegradable, and classified as a GRAS substance by the FDA.
The entire process uses GRAS substances only and the ethanol solvent is recycled by evaporation/condensation which makes the process self-contained. The new fabrication methodologies are both scalable to industrial production levels and allow for reliable production of nanometer-sized particles, two critical aspects of the production process that have thus far not been achieved using the same fabrication process. This fine control over size and particle distribution also allows these nanoparticles to be used for protein size standard applications. Finally, in proof of concept experiments with zein, these nanoparticles have the ability to encapsulate both hydrophobic and hydrophilic molecules such as DNA, RNA and proteins for effective drug delivery.
Stage of Development
Proof of concept studies have been completed and are available under confidentiality.

Produces protein nanoparticles with a defined size and narrow size distribution
Proof of concept performed with zein, which is bio-sourced, inexpensive, and classified as GRAS
FNP is scalable and amenable to GMP process needs


Protein size standards
Encapsulation and excipient delivery vehicle of active pharmaceutical, nutraceutical, cosmetic, and biomedical therapeutic ingredients including both hydrophobic and hydrophilic drugs

Princeton is seeking to identify appropriate partners for the further development and commercialization of this technology.

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