This Small Business Innovation Research (SBIR) project focuses of novel method for sustained pulmonary release of protein based antitoxins for counter bioterrorism applications. There is a significant need of therapeutic treatments against bioterrorism agents such as anthrax, cholera, tetanus, diphtheria, ricin, etc. These biotoxin agents are lethal in very small amount ranging from 0.001 microg / kg to 0.1 microg / kg. Typically antibiotics are only effective in neutralizing the bioterrorism agent (e.g. bacterium) and not the released protein toxin. Significant challenges currently exist in the development of therapeutic methods that can neutralize the protein biotoxin during and after it has been released in the human environment . The overall goal of this exploratory project is to develop and demonstrate the effectiveness of completely nano-encapsulated hydrophilic proteins (such as antibodies, enzymes or protein based cell receptor) that can be delivered via the pulmonary route. Such particles will be synthesized using a novel semiconductor film deposition technique, which has until recently not been explored for pharmaceutical applications.
Sustained Pulmonary release of proteins can not only neutralize biotoxin agents but also deliver other drugs. The development of solvent-free drug encapsulation systems has the potential to be used not only in pulmonary-based applications but also in injectable and oral delivery of peptide, traditional non-peptide and gene-therapy based drugs. Efficient delivery of proteins and peptides is required for a number of diseases such as diabetes, cystic fibrosis, and genetic protein deficiency disorders. Thus this project could lead to development of a platform technology for delivery of macromolecules for several diseases.
