PLxGuardTM Drug Delivery Platform
Some active pharmaceutical ingredients (APIs) can cause injury to the stomach lining.
The innovative PLxGuard drug delivery platform employs a pH-dependent release mechanism that relies on chemical association of lipidic excipients with APIs to selectively release them to targeted portions of the GI tract.
Utilizing this chemical association of lipidic excipients to our advantage is what makes PLxGuard unique. The preassociation of PLxGuard’s own pharmaceutical lipid means that the API won’t interact with similar naturally occurring phospholipids in the stomach lining, helping to prevent gastric injury.
This preassociation makes it less likely that APIs will come in direct contact with the stomach.
This complex remains stable in the low pH of the stomach, limiting direct contact of the API with the gastric mucosa.
Once the complex arrives in the duodenum, it dissociates in the higher-pH environment and the API is free to be absorbed.
Even if reflux occurs and the API and lipidic excipients return to the stomach, they reassemble into the complex, limiting direct stomach contact, helping to reduce GI injury.
This drug delivery platform is intended to reliably release APIs in the duodenum and decrease exposure to the stomach, which is the most susceptible part of the GI tract to NSAID-induced acute gastric injury.
PLxGuardTM may have the potential to:
- Enhance delivery of active pharmaceutical ingredients
- Optimize drug absorption and reduce acute GI injury
- Provide new or extended patent protection for an already approved or development-stage drug
- Utilize the 505(b)(2) NDA regulatory path that often provides a faster and lower-cost FDA approval when used with already approved drugs
GI: gastrointestinal, NDA: new drug application, NSAID: nonsteroidal anti-inflammatory drug