Our PLxGuard delivery system uses surface acting lipids, such as phospholipids and free fatty acids, to modify the physiochemical properties of various drugs to selectively release these drugs to targeted portions of the GI tract. Unlike tablet or capsule polymer coating technologies (e.g., enteric coating), which rely solely on drug release based on pH differences in the GI tract, the PLxGuard system uses the differential in pH and bile acid contents between the stomach and duodenum to target Vazalore’s release. This approach is intended to more reliably release active pharmaceutical ingredients in the duodenum and decrease their exposure to the stomach, which is more susceptible to NSAID-induced bleeding and ulceration. The PLxGuard system is a platform technology that we believe may be useful in improving the absorption of many acid labile, corrosive, and insoluble or impermeable drugs.
We believe our PLxGuard delivery system has the potential to improve many already-approved drugs and drugs in development, because it may:
- enhance the efficacy of the drug using our technology;
- improve the GI safety of the drug;
- provide new or extended patent protection for an already approved or development-stage drug; and
- utilize the 505(b)(2) New Drug Application (NDA) regulatory path that often provides a faster and lower cost FDA approval when used with already-approved drugs.
The PLxGuard delivery system has clinically proven these benefits with our novel formulations using aspirin and ibuprofen and has preclinical evidence supporting the potential for a GI safer oral diclofenac and intravenous indomethacin products. Other existing or new drugs in development that may benefit from the PLxGuard delivery system will be evaluated either by us or through collaboration agreements with other companies.