United States Patent 11,400,019: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,400,019, titled "Sustained release drug delivery systems with reduced impurities and related methods," is a significant innovation in the field of pharmaceuticals. This patent addresses the development of sustained release drug delivery systems, focusing on reducing impurities and enhancing the efficacy of these systems.
Background and Context
Sustained release drug delivery systems are designed to release the active pharmaceutical ingredient over an extended period, providing consistent therapeutic effects and improving patient compliance. The reduction of impurities in these systems is crucial for ensuring the safety and effectiveness of the drugs[1].
Scope of the Patent
Composition and Components
The patent describes a composition that includes an active pharmaceutical agent, along with various excipients and carriers. Key components mentioned include sucrose acetate isobutyrate, benzyl alcohol, and benzyl acetate. These components are selected to minimize impurities and optimize the sustained release profile[1].
Methods of Preparation
The patent outlines specific methods for preparing the sustained release drug delivery systems. These methods involve the use of coating techniques, sterilization, and degradation reactions to ensure the purity and stability of the final product[1].
Claims of the Patent
Primary Claims
The primary claims of the patent revolve around the composition and the method of preparation. These include:
- The composition comprising an active pharmaceutical agent and specific excipients.
- The method of preparing the composition, including steps to reduce impurities.
- The sustained-release form of the composition, which ensures a controlled release of the active agent over time[1].
Dependent Claims
Dependent claims further detail the specifics of the composition and the preparation method. These include:
- The use of particular solvents and carriers to enhance the sustained release profile.
- The application of coating methods to ensure uniform drug distribution.
- The sterilization and disinfection processes to maintain the purity of the final product[1].
Patent Landscape
Related Patents and Technologies
Other patents in the field, such as US8182835B2, focus on sustained-release liposomal anesthetic compositions. These patents highlight the broader landscape of drug delivery systems, including the use of liposomes for encapsulating local anesthetics like bupivacaine[2].
Competitive Analysis
The patent landscape indicates a competitive environment with multiple players developing sustained release drug delivery systems. Companies are investing in research to improve the efficacy, safety, and purity of these systems. The use of advanced materials and methods, such as those described in US11400019B2, is a key differentiator in this market[1][3].
Intellectual Property Protection
Claim Coverage and Scope Concepts
To effectively protect the intellectual property related to this patent, companies use tools like Claim Coverage Matrix and ClaimScape® software. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and future design opportunities[3].
Patent Analytics
Patent analytics play a crucial role in managing the patent portfolio. By tracking patents by claims and scope concepts, companies can ensure that their intellectual property is well-protected and aligned with their technological advancements[3].
Technical and Scientific Aspects
Pharmaceutical Excipients and Carriers
The patent emphasizes the importance of selecting appropriate pharmaceutical excipients and carriers. For example, sucrose acetate isobutyrate is used due to its ability to form a stable matrix that controls the release of the active agent[1].
Impurity Reduction
The methods described in the patent focus on reducing impurities to levels below 100 ppm, which is critical for ensuring the safety and efficacy of the drug delivery system. This involves careful selection of raw materials and rigorous quality control during the manufacturing process[1].
Regulatory and Safety Considerations
Sterilization and Disinfection
The patent highlights the importance of sterilization and disinfection methods to maintain the purity of the final product. These processes are essential for complying with regulatory standards and ensuring patient safety[1].
Toxicity and Side Effects
The use of certain components, such as benzyl alcohol, must be carefully managed to avoid toxicity. For instance, bupivacaine, a local anesthetic, can have serious side effects if not used properly, including cardiac conduction depression and central nervous system stimulation[4].
Market and Commercial Implications
Patient Compliance and Efficacy
Sustained release drug delivery systems improve patient compliance by reducing the frequency of dosing. This can lead to better therapeutic outcomes and enhanced patient satisfaction[1].
Competitive Advantage
Companies that develop and patent innovative sustained release drug delivery systems can gain a significant competitive advantage. This innovation can lead to market dominance and increased revenue through improved product offerings[3].
Future Directions and Opportunities
Advanced Materials and Technologies
The future of sustained release drug delivery systems lies in the development of advanced materials and technologies. This includes the use of nanotechnology, biodegradable polymers, and other innovative carriers to enhance the efficacy and safety of these systems[1].
Personalized Medicine
There is a growing trend towards personalized medicine, where drug delivery systems are tailored to individual patient needs. This patent sets the stage for further research in this area by providing a foundation for developing customized sustained release systems[1].
Key Takeaways
- The patent US11400019B2 focuses on sustained release drug delivery systems with reduced impurities.
- The composition includes specific excipients and carriers to optimize the release profile.
- The method of preparation involves coating, sterilization, and degradation reactions.
- The patent landscape is competitive, with multiple players developing similar technologies.
- Intellectual property protection is crucial and can be managed through patent analytics and claim coverage tools.
- Regulatory and safety considerations are paramount, including sterilization and the management of potential toxicity.
Frequently Asked Questions (FAQs)
What is the main focus of the United States Patent 11,400,019?
The main focus of the patent is on sustained release drug delivery systems with reduced impurities and the related methods of preparation.
What are the key components mentioned in the patent?
The key components include an active pharmaceutical agent, sucrose acetate isobutyrate, benzyl alcohol, and benzyl acetate.
How does the patent ensure the purity of the drug delivery system?
The patent ensures purity through careful selection of raw materials, coating methods, sterilization, and degradation reactions to minimize impurities.
What are the potential benefits of sustained release drug delivery systems?
The benefits include improved patient compliance, consistent therapeutic effects, and enhanced safety due to reduced impurities.
How does this patent fit into the broader patent landscape?
This patent is part of a competitive landscape where multiple companies are developing innovative drug delivery systems, including sustained-release liposomal anesthetic compositions.
Cited Sources:
- US11400019B2 - Sustained release drug delivery systems with reduced impurities and related methods - Google Patents
- US8182835B2 - Sustained-release liposomal anesthetic compositions - Google Patents
- Patent Analytics | Intellectual Property Law - SLWIP
- Bupivacaine: Uses, Interactions, Mechanism of Action - DrugBank
