Enhanced Opioid Antagonist Delivery Systems
Legal Citation
Summary of the Inventive Concept
The present invention relates to improved compositions and methods for opioid antagonist delivery, providing enhanced efficacy, safety, and accessibility in rescuing subjects from opioid overdose.
Background and Problem Solved
The original patent disclosed parenteral formulations for opioid overdose rescue, but had limitations in terms of targeted delivery, sustained release, and accessibility. The present invention addresses these limitations by introducing nanocarriers, sustained release formulations, and easy-to-use devices, providing improved efficacy and reduced side effects.
Detailed Description of the Inventive Concept
The inventive concept comprises a system for opioid overdose rescue, featuring a parenteral formulation with an aqueous solution containing about 1.5 mg of nalmefene free base and a nanocarrier for targeted delivery to the brain. The formulation can be designed to release nalmefene in a sustained manner over a period of at least 2 hours, providing prolonged protection against opioid overdose. Additionally, the composition can be combined with a peripheral opioid receptor antagonist to reduce the risk of opioid-induced constipation. The inventive concept also includes a device for opioid overdose rescue, comprising a pre-filled syringe containing the parenteral formulation, designed for easy and safe administration by a non-medical person.
Novelty and Inventive Step
The new claims introduce the use of nanocarriers for targeted delivery, sustained release formulations, and easy-to-use devices, which are not disclosed in the original patent. These features provide improved efficacy, safety, and accessibility in rescuing subjects from opioid overdose, thereby representing a non-obvious improvement over the prior art.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include the use of different nanocarriers, sustained release mechanisms, or devices for administration. Variations of the composition could include different opioid antagonists or peripheral opioid receptor antagonists, or different ratios of these components.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the pharmaceutical industry, particularly in the area of opioid overdose rescue. The improved efficacy, safety, and accessibility of the inventive concept could lead to increased adoption and market share, with potential applications in emergency medical services, hospitals, and community-based settings.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulations, specifically opioid antagonist delivery systems, with expertise in parenteral drug delivery, pharmacokinetics, and medical device design
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist or pharmacological engineer with advanced degree, experience in drug formulation, knowledge of nanocarrier technologies, and understanding of controlled drug delivery mechanisms
Obviousness Rationale
A PHOSITA would recognize that the PTD's variations represent predictable extensions of the source patent's core technology by applying known pharmaceutical engineering techniques to enhance nalmefene delivery. The proposed nanocarrier targeting, sustained release mechanism, and combination with peripheral antagonists are logical incremental improvements that leverage existing knowledge in drug delivery systems. These modifications would be considered routine optimization within the pharmaceutical field, utilizing standard techniques to improve drug efficacy and patient accessibility.
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. |