PLxGuardTM Drug Delivery Platform
The unique complex remains stable in low pH, limiting direct contact of the API within the GI tract.
The complex employs a pH-dependent release mechanism that selectively releases the API in higher pH environments within the GI tract. The API is quickly and completely absorbed, delivering predictable drug effects.
Even if reflux occurs and the API and lipidic excipients return to the stomach, they reassemble into the complex, limiting direct stomach contact.
PLxGuardTM may have the potential to:
- Enhance delivery of active pharmaceutical ingredients
- Optimize drug absorption and reduce local 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