United States Patent 10,765,749: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,765,749, titled "Non-aqueous patch," is a significant innovation in the field of transdermal drug delivery, particularly for relieving muscle pain. This patent, granted to ITOCHU CHEMICAL FRONTIER Corporation, introduces a novel formulation and design for non-aqueous patches containing lidocaine.
Technical Field
The patent falls under the technical field of pharmaceutical formulations, specifically transdermal drug delivery systems. It addresses the challenges associated with traditional aqueous patches, such as poor skin permeability and limited efficacy[2].
Background of the Invention
Traditional non-aqueous patches containing lidocaine often suffer from poor permeability through the skin due to the crystalline state of lidocaine. This limitation hampers the effective delivery of the drug, reducing its therapeutic efficacy. The inventors aimed to overcome this issue by developing a new formulation that enhances skin permeability and improves drug delivery.
Summary of the Invention
The patented non-aqueous patch includes lidocaine and/or its reactant, along with a dissolving agent. This combination ensures that lidocaine is not in a crystalline state, thereby improving its permeability through the skin. The patch is designed to be effective in relieving muscle pain without the need for aqueous components[1][2].
Detailed Description of the Invention
Components of the Patch
- Lidocaine: The primary active ingredient, which is a well-known local anesthetic and pain reliever.
- Dissolving Agent: This component is crucial as it prevents lidocaine from being in a crystalline state, enhancing its skin permeability.
- Other Materials: The patch may include additional materials such as resins, polyisobutene, elastomers, and natural products like rosin and abietic acid, which contribute to its structural integrity and drug delivery properties[1].
Formulation
The formulation of the patch involves a careful balance of the active ingredient and the dissolving agent. This balance is critical to ensure that the lidocaine is in a state that allows for optimal skin penetration. The patent describes various methods for preparing the patch, including the use of specific solvents and manufacturing processes[2].
Manufacturing Process
The manufacturing process involves several steps, including the preparation of the lidocaine and dissolving agent mixture, the application of this mixture onto a backing material, and the drying process to form the final patch. The patent provides detailed descriptions of these steps to ensure reproducibility and consistency in the product[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Claim 1: A non-aqueous patch comprising lidocaine and a dissolving agent, where the lidocaine is not in a crystalline state.
- Claim 2: The patch of claim 1, further comprising a resin and/or an elastomer.
- Claim 3: The patch of claim 1, where the dissolving agent is selected from a group of specific compounds.
- Claim 4: A method for preparing the non-aqueous patch, including the steps of mixing lidocaine with a dissolving agent and applying the mixture to a backing material[2].
Patent Landscape
Related Patents
The patent is part of a series of related applications and patents, including U.S. Pat. No. 9,931,403, U.S. Pat. No. 9,925,264, and U.S. Pat. No. 9,283,174. These patents collectively contribute to the development of advanced transdermal drug delivery systems[2].
International Patent Filings
The invention has been filed in various international jurisdictions, reflecting its global significance. The use of the Patent Cooperation Treaty (PCT) and national stage filings ensures broad protection across different countries[2].
Prior Art
The patent distinguishes itself from prior art by addressing the specific issue of lidocaine's poor skin permeability in non-aqueous patches. The introduction of a dissolving agent to prevent the crystallization of lidocaine is a novel approach that sets this invention apart from existing solutions[1].
Economic and Market Impact
Market Demand
The demand for effective transdermal pain relief solutions is high, driven by the need for non-invasive and convenient treatments. This patent fills a critical gap in the market by providing a more effective alternative to traditional patches.
Competitive Advantage
The unique formulation and design of the non-aqueous patch give ITOCHU CHEMICAL FRONTIER Corporation a competitive advantage in the pharmaceutical market. This innovation can lead to increased market share and revenue.
Legal and Regulatory Aspects
Patent Protection
The patent provides legal protection for the invention, preventing others from making, using, or selling the non-aqueous patch without permission. This protection is crucial for maintaining the company's competitive edge.
Regulatory Compliance
The development and commercialization of the patch must comply with regulatory requirements, including those set by the FDA. The patent does not address regulatory aspects directly but implies that the invention is designed to meet such standards.
Future Developments and Applications
Potential Applications
The technology behind this patent can be extended to other transdermal drug delivery systems, potentially treating a range of conditions beyond muscle pain.
Research and Development
Further research can focus on optimizing the formulation and exploring new dissolving agents to enhance the efficacy of the patch. This could lead to new patents and innovations in the field.
Key Takeaways
- The United States Patent 10,765,749 introduces a novel non-aqueous patch for muscle pain relief using lidocaine.
- The patch's unique formulation includes a dissolving agent to prevent lidocaine crystallization, enhancing skin permeability.
- The patent is part of a broader series of related patents and international filings.
- It addresses a significant market need for effective transdermal pain relief solutions.
- The invention has the potential for future developments and applications in various therapeutic areas.
FAQs
Q: What is the main innovation of the United States Patent 10,765,749?
A: The main innovation is the use of a dissolving agent to prevent lidocaine from being in a crystalline state, thereby improving its skin permeability.
Q: What are the key components of the non-aqueous patch?
A: The key components include lidocaine, a dissolving agent, and other materials such as resins and elastomers.
Q: How does the manufacturing process of the patch ensure its efficacy?
A: The manufacturing process involves careful preparation of the lidocaine and dissolving agent mixture, application onto a backing material, and a controlled drying process.
Q: What is the significance of the patent in the market?
A: The patent fills a critical gap in the market for effective transdermal pain relief solutions, giving ITOCHU CHEMICAL FRONTIER Corporation a competitive advantage.
Q: Are there potential future applications of this technology?
A: Yes, the technology can be extended to other transdermal drug delivery systems for treating various conditions beyond muscle pain.
Sources
- US10765749B2 - Non-aqueous patch - Google Patents
- US Patent for Non-aqueous patch Patent (Patent # 10,765,749) - Justia Patents
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- Ex Parte Kucinski et al | 10765749 | P.T.A.B. | Judgment | Law - CaseMine