Enhanced Preservative-Free Intranasal Composition for Pain Relief

Publication ID: 24-11857520_0006_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Preservative-Free Intranasal Composition for Pain Relief,” Published Technical Disclosure No. 24-11857520_0006_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857520_0006_PTD
This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,520.

Summary of the Inventive Concept

An improved preservative-free intranasal composition for treating various pain conditions, featuring optimized concentrations, pH ranges, and spray device configurations to enhance efficacy and user experience.

Background and Problem Solved

The original patent disclosed a preservative-free intranasal composition for pain relief, but it had limitations in terms of dosage, pH, and spray device design. The new inventive concept addresses these limitations by introducing metered dose spray devices, optimized pH ranges, and improved droplet size distributions, providing a more efficient and effective treatment option.

Detailed Description of the Inventive Concept

The new inventive concept comprises a preservative-free intranasal composition containing a locally active sodium channel blocker, such as lidocaine, in a concentration range of 2% to 12%. The composition is designed to be administered via a metered dose spray device, which provides a precise volume of 0.01 ml to 0.2 ml per spray. The pH range of the composition is optimized to be between 4.5 and 6.5, ensuring maximum efficacy and comfort for the user. The spray device is designed to produce a droplet size distribution of 10 microns to 200 microns, allowing for efficient absorption and minimizing irritation. The composition can be used to treat various pain conditions, including tri-geminal neuralgia, facial neuropathic pain, migraine pain, and cluster headache pain.

Novelty and Inventive Step

The new inventive concept introduces a novel combination of optimized concentration, pH range, and spray device configuration, which provides a significant improvement over the original patent. The use of metered dose spray devices and optimized droplet size distributions are key innovations that enhance the efficacy and user experience of the preservative-free intranasal composition.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include different concentrations of the locally active sodium channel blocker, varying pH ranges, and different spray device designs. For example, a bi-dose spray device could be used for cluster headache pain, or a unit dose spray device could be used for facial neuropathic pain. Additionally, the composition could be modified to include other locally active sodium channel blockers or other pain-relieving agents.

Potential Commercial Applications and Market

The enhanced preservative-free intranasal composition has significant commercial potential in the pain relief market, particularly in the treatment of tri-geminal neuralgia, facial neuropathic pain, migraine pain, and cluster headache pain. The optimized composition and spray device design could provide a competitive advantage in the market, and the potential for partnerships with pharmaceutical companies or licensing agreements could be explored.

CPC Classifications

SectionClassGroup
A A61 A61K31/167
A A61 A61K9/0043
A A61 A61M11/00
A A61 A61M2210/0618

Field of Art

Pharmaceutical formulations, specifically intranasal drug delivery systems for pain management, involving expertise in pharmacology, drug formulation, and medical device design

Person of Ordinary Skill (PHOSITA) Profile

A pharmaceutical scientist or formulation engineer with advanced degree, experience in nasal spray design, understanding of drug delivery mechanisms, sodium channel blockers, and formulation optimization techniques

Obviousness Rationale

A PHOSITA would recognize that the PTD represents predictable variations of the source patent's core invention by systematically exploring known design parameters for intranasal drug delivery. The modifications to concentration ranges, pH, and spray device configurations represent routine optimization techniques well within the ordinary skill of pharmaceutical formulation experts. These variations demonstrate standard engineering approaches to improving drug delivery systems while maintaining the fundamental therapeutic approach of the original patent.

Obvious Combinations & Variations

Source Patent Element
Preservative-free intranasal composition for treating neuropathic pain using lidocaine
PTD Variation
Expanding lidocaine concentration range from original patent to 2-12%, with refined pH optimization between 4.5-6.5
Obviousness Reasoning
Concentration and pH adjustments are predictable design choices for improving drug stability and absorption, representing routine pharmaceutical engineering optimization
Source Patent Element
Multi-dose nasal spray pump device providing 0.04-0.2 ml volume
PTD Variation
Introducing metered dose spray with 0.01-0.2 ml volume and specific droplet size distribution of 10-200 microns
Obviousness Reasoning
Modifying spray device parameters is a known technique for improving drug delivery efficiency, representing a predictable variation within standard pharmaceutical device design
Source Patent Element
Treatment of specific pain conditions like trigeminal neuralgia and migraine
PTD Variation
Adding alternative spray device configurations (bi-dose, unit-dose) tailored to specific pain conditions
Obviousness Reasoning
Adapting delivery mechanisms for specific therapeutic contexts represents a standard approach to personalized medical treatment design
Source Patent Element
Locally active sodium channel blocker as primary therapeutic agent
PTD Variation
Introducing complexing agents to inhibit sodium channel blocker precipitation
Obviousness Reasoning
Adding stabilization techniques is a known pharmaceutical formulation strategy for improving drug performance, representing a predictable solution to potential chemical interaction issues
Source Patent Element
Preservative-free intranasal composition for pain management
PTD Variation
Expanding potential sodium channel blockers beyond lidocaine and exploring alternative buffer systems
Obviousness Reasoning
Exploring alternative chemical compositions within a known therapeutic approach represents routine scientific investigation and design variation
35 U.S.C. § 103 Summary: Based on a comprehensive analysis of US Patent 11857520 and the corresponding Published Technical Disclosure, a Person Having Ordinary Skill In The Art would find the disclosed variations obvious and anticipated. The systematic exploration of concentration ranges, delivery mechanisms, and formulation parameters represents predictable extensions of the original patent's core invention, thereby rendering potential derivative claims obvious under 35 U.S.C. Section 103.

Original Patent Information

Patent NumberUS 11,857,520
TitleTherapeutic composition of intranasal lidocaine
Assignee(s)Nortic Holdings Inc.