We can produce SCPs in both an oral and parenteral form, and alternate routes of delivery including topical and/or patch may be provided. In general concerning the oral route, SCPs are stable and do not aggregate at extremes of pH such as in the stomach. A key features of SCP technology is that it significantly increases the solubility of hydrophobic compounds (by an average of 10-fold.
The gastrointestinal uptake of micro- and nanoparticles has been the subject of our exertions in developing operational carriers that enhance the oral uptake of drugs and large molecules such as vaccines. Facilitation of the oral delivery of large molecular medicationis a core competency of our organization in association with our strong track record in formulation. This includes easy transportationof these large molecules through the gastrointestinal tract (GIT), validation of their absorption pathway, andmaintenance oftheir integrity in the GIT through particle conjugation modification. Our scientists have developed large molecular oral and nasal formulationsincluding vaccines and insulin, building upon lessons learned from known products in the field such as Exuberate®.
Issues to be addressed in formulating medication for oral deliveryinclude the potential for instability and aggregation at low pH, enzymatic breakdown, and low permeability in the GIT. We have utilized a number of approaches to overcome these obstacles including absorption enhancers, enzyme inhibitors, muco-adhesive polymers, and the formulation of vehicles (emulsions, liposomes, microspheres, and nanoparticles). In doing so, we have addressed several issues including the increased possibility for passage of unwanted molecules into the serum that may be caused by absorption enhancers, and the potential for disturbance of the normal metabolism of other proteins caused by protease inhibitors. We have undertaken a detailed evaluation of the toxicity of polymers we have used as vehicles.
We have a clear picture of the pathway for absorption of our conjugated particles, which increase the diffusion coefficient of both small and larger molecules (such as Insulin). We elucidated this pathway through animal studies by using correlative instrumental neutron activation analysis and electron microscopy. We have quantitatively and qualitatively analyzed and appreciated the GIT uptake and subsequent tissue/organ distribution of SCP- medications/vaccines of up to 60 nm in diameter in humans. We understand how to modulate the transfer rate/absorption rate through the GIT.
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