University of Pittsburgh researchers have developed TEMPS (Thermogel, Extended-release Microsphere-based Delivery to the Paranasal Sinuses), a novel local drug delivery system designed to improve patient outcomes following functional endoscopic sinus surgery for chronic rhinosinusitis. TEMPS combines a thermo-responsive acrylamide-based hydrogel with extended-release poly(lactic-co-glycolic acid) (PLGA) microspheres encapsulating the corticosteroid mometasone furoate. This system ensures a sustained, four-week release of medication directly to the sinus cavities, reducing inflammation and promoting recovery while minimizing the need for repeated treatments.
Description
TEMPS features a unique combination of a thermogel and PLGA microspheres for targeted drug delivery to the sinuses. The thermogel remains a flowable liquid at room temperature, allowing easy application via a trans-nasal catheter. Once in contact with body temperature, the gel solidifies, conforming to the unique anatomy of the sinuses for localized, long-acting treatment. The system provides sustained drug release over four weeks, and its phase can be reversed with saline irrigation, allowing for easy removal and reapplication. The encapsulated corticosteroid, mometasone furoate, is released steadily, reducing sinonasal inflammation and avoiding adverse effects commonly associated with other delivery methods, such as drug-eluting stents.
Applications
• Postoperative care following functional endoscopic sinus surgery
• Long-term treatment of chronic rhinosinusitis
• Localized, sustained delivery of corticosteroids and other therapeutics to the sinuses
Advantages
TEMPS offers several advantages over existing sinus drug delivery methods. Unlike nasal sprays and irrigations that require daily dosing, or drug-eluting stents that may cause irritation and require customized designs, TEMPS provides sustained, localized drug release for up to four weeks, eliminating the need for frequent treatments. The thermogel's ability to conform to sinus anatomy and its reversible phase-change feature make it a flexible, patient-friendly solution that can be tailored to individual needs. Furthermore, the system avoids the degradation and inflammation issues associated with stents, improving patient comfort and outcomes.
Invention Readiness
The TEMPS system is currently at the in vivo data stage, with a pilot study in rabbits demonstrating excellent tolerability, retention for four weeks, and effectiveness in reducing sinonasal inflammation without increasing ocular pressure. Detailed characterization of drug loading, release kinetics, bioactivity, cytocompatibility, and reversible phase change has been completed. Further studies will focus on optimizing the formulation for different therapeutic agents and expanding its applications to other sinus conditions.
IP Status
https://patents.google.com/patent/US20230225963A1
