BioLegacy Evaluative Group Inc., a subsidiary of Branded Legacy, Inc. (OTC: BLEG), has filed a provisional patent application with the United States Patent and Trademark Office for a groundbreaking intranasal drug delivery platform. The technology, titled "Air-Driven Unitary Intranasal Drug Delivery Device for Stable and Reconstitutable Medicaments," represents a significant advancement in nasal drug administration, particularly for emergency and self-administered pharmaceuticals.
Revolutionary Delivery Technology
The air-powered device addresses critical challenges in intranasal drug delivery through several key innovations. A compressible air chamber drives medication through a precision atomizer, ensuring complete and consistent dosing with minimal residual volume. The platform's dual-function architecture accommodates both pre-formed stable solutions, such as naloxone for opioid overdose reversal, and lyophilized or unstable drugs that require on-demand reconstitution.
The device features unitary blow-fill-seal construction, manufactured as a single, sterile component that minimizes contamination risk, assembly steps, and production costs. Sequential frangible membranes with engineered rupture zones enable user-activated mixing and delivery through a simple one- or two-step squeeze mechanism.
Clinical Applications and Design
The patent application describes two key embodiments: one supporting reconstitutable medicaments such as lyophilized biologics or peptides requiring immediate mixing before use, and another optimized for stable solutions. Both versions deliver medication intranasally as a fine, uniform mist, ensuring rapid absorption and systemic effect.
The ergonomic, portable design creates a thumb-sized, single-use format that ensures easy handling for untrained users in emergency scenarios. This accessibility is particularly crucial for overdose-reversal therapies, where rapid administration by non-medical personnel can be life-saving.
Strategic Manufacturing and Development
"This filing represents a pivotal milestone for BioLegacy. Our air-driven intranasal device offers a scalable, globally manufacturable solution that overcomes cost, complexity, and stability barriers in emergency and routine drug delivery. It also directly supports our goal of democratizing access to affordable overdose-reversal therapies," said Amin Janmohamed, CEO.
The patent aligns with BioLegacy's recent acquisition of a GMP-compliant manufacturing facility featuring ISO Class 7 & 8 cleanrooms and high-containment capabilities. This facility will accelerate prototype testing, validation, and regulatory submissions to Health Canada and the FDA.
Academic Partnerships and Pipeline Development
BioLegacy's R&D collaborations with McMaster University and Stanford University will continue to advance formulation, testing, and translational development of the inhaled naloxone program and other pipeline candidates leveraging this proprietary delivery system. These partnerships position the company to deliver scalable, cost-effective solutions in areas of high unmet medical need.
The technology targets the multi-billion-dollar global therapeutics market, with particular focus on emergency medications and treatments requiring precise, reliable delivery in critical situations. The platform's versatility in handling both stable and reconstitutable formulations expands its potential applications across various therapeutic areas.
