SBIR Phase II: Improved drug delivery platforms for localized and sustained drug deposition for traumatic injuries

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the development of the safe and efficacious treatment for orthopedic and trauma surgery complications. This treatment includes localized and sustained drug delivery platform that will address the unmet medical needs for orthopedic patients. The successful commercialization of this technology is also expected to spur more nanomedicine and nanofabrication research for the medical field. The goal of the proposed project is to create a medication delivery system for soft tissue trauma consequences using sustained, biodegradable nanoparticles. The state of sustained-release technology will be greatly advanced, and the rehabilitation care provided to trauma patients will be substantially improved with this technology. The treatment to be developed will decrease the number of complications. New pharmacoeconomic research shows that cost/revenue over the long term is positively affected by fewer complications. Currently, there are major industry initiatives underway to create localized drug delivery systems for ophthalmic and cancer treatments. However, there are currently no approved or in-development treatments for this unmet medical need in orthopedic surgery. Support from the NSF will function as a spark to significantly increase the commercial effect of this first orthopedic nanomedicine project. This Small Business Innovation Research (SBIR) Phase II project will address an innovative approach by utilizing anti-inflammatory nanoparticles embedded with potent Hedgehog pathway antagonist-Arsenic trioxide (NP102nano). This innovative and distinctive approach for developing a sustained-release, biodegradable drug delivery that delivers post-traumatic medication locally within the injured tissue is based on the desire to obviate unnecessary systemic drug applications and create a safe and effective off-the-shelf therapy. Such a product has the potential to improve outcomes for patients with post-traumatic injuries and reduce societal costs associated with additional surgeries and rehabilitation among trauma surgery patients. Current orthopedic treatments utilize systemic, untargeted administration of medications that result in unintended side effects, implant failure, and/or lack of intended efficacy. Moreover, the lack of an efficient delivery vehicle requires drug application at supraphysiological doses to reach clinical efficacy. The application at supraphysiological doses significantly increases the risk of side effects. It, therefore, is desirable to provide formulations and methods that target the delivery of medications only to the tissues needing treatment. This platform under development offers exactly this benefit. The goal of this project is to produce sufficient data for the pre-Investigational New Drug meeting with the regulatory authorities (such as Food and Drug Administration). This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.