Specialized Opioid Antagonist Formulations for Niche Environments
Legal Citation
Summary of the Inventive Concept
Adapting opioid antagonist formulations for specific, narrow markets or unique operational environments, such as high-security needs, disaster relief, or extreme weather conditions.
Background and Problem Solved
The original patent provides compositions and methods for opioid antagonist delivery, but these formulations may not be suitable for specialized environments. The present inventive concept addresses the limitations of the original patent by developing tailored formulations for high-security, disaster relief, and extreme weather conditions.
Detailed Description of the Inventive Concept
The inventive concept comprises opioid antagonist formulations with specialized excipients, cryoprotectants, or other adaptations to ensure stability and potency in extreme temperatures, tropical environments, or low-light conditions. These formulations can be administered via rapid-dissolve tablets, wearable injector devices, or portable kits with auto-injector devices. The compositions are designed to provide effective opioid overdose rescue in unique operational environments.
Novelty and Inventive Step
The new claims introduce novel adaptations for opioid antagonist formulations, such as specialized excipients for extreme temperatures, cryoprotectants for freeze-dried compositions, and wearable injector devices for remote areas. These adaptations are non-obvious and provide a significant improvement over the original patent's formulations.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include opioid antagonist formulations adapted for use in high-altitude environments, underwater rescue scenarios, or for specific age groups or medical conditions. Variations could also include different routes of administration, such as nasal sprays or transdermal patches.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in industries such as pharmaceuticals, emergency medical services, disaster relief, and high-security operations. The targeted markets include government agencies, emergency responders, and organizations operating in extreme environments.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulations, specifically opioid antagonist delivery systems and emergency medical interventions, requiring expertise in pharmacology, drug delivery technologies, and emergency medical preparedness
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist or clinical pharmacologist with advanced degree, experience in drug formulation, knowledge of parenteral drug delivery, understanding of excipient technologies, and familiarity with emergency medical interventions
Obviousness Rationale
A PHOSITA would recognize that the PTD's variations represent predictable extensions of the source patent's core technology, applying known pharmaceutical formulation techniques to adapt opioid antagonist delivery for specialized environments. The disclosed modifications represent routine engineering adaptations using standard pharmaceutical design principles. The variations demonstrate incremental improvements that would be apparent to a skilled practitioner seeking to optimize drug delivery in challenging contexts.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,547 |
|---|---|
| Title | Compositions and methods for opioid antagonist delivery |
| Assignee(s) | Purdue Pharma L.P. |