Detailed Analysis of the Scope and Claims of United States Patent 11,110,093
Introduction
The United States Patent 11,110,093, titled "Sustained release small molecule drug formulation," presents a significant innovation in the field of pharmaceuticals, particularly in the area of drug delivery systems. This patent describes an injectable depot formulation designed for the controlled release of small molecule drugs over an extended period.
Overview of the Patent
The patent focuses on a novel formulation that includes a biocompatible polymer, an organic solvent, and a small molecule drug incorporated into a viscous gel. This formulation is intended for various administration routes, including subcutaneous, intramuscular, and intratumoral injections, among others[1].
Key Components of the Formulation
Biocompatible Polymer
The formulation utilizes biocompatible polymers that are non-irritating and do not cause necrosis in the environment of use. These polymers can be bioerodible, meaning they gradually decompose, dissolve, hydrolyze, or erode in situ[1].
Organic Solvent
The organic solvent is combined with the biocompatible polymer to form a viscous gel. The choice of solvent can significantly influence the in vivo release profile of the drug, as demonstrated in the patent's figures[1].
Small Molecule Drug
The small molecule drug is incorporated into the viscous gel, ensuring a controlled release profile. The patent highlights various small molecule drug formulations with specific release characteristics, such as a C max to C min ratio less than 200 and a lag time less than 0.2[1].
Release Profile and Pharmacokinetics
C max and C min
The patent defines C max as the maximum drug concentration in plasma or serum and C min as the minimum drug concentration. The formulation is designed to maintain a C max to C min ratio less than 200, ensuring stable and effective drug levels[1].
Lag Time (T lag)
The lag time, or T lag, is the time before the drug starts to release significantly. The patent specifies that T lag should be less than 0.2, indicating a rapid onset of action[1].
Total Release Duration (T total)
The total release duration, or T total, can extend over periods of one week, one month, or more, depending on the formulation and the therapeutic needs of the patient[1].
Administration and Therapeutic Use
Routes of Administration
The formulation can be administered via various routes, including subcutaneous, intramuscular, intratumoral, and other body cavities. This versatility allows for tailored treatment strategies based on the specific condition being treated[1].
Multiple Injections
The patent notes that multiple or repeated injections may be necessary to maintain therapeutic drug levels over time. This is particularly relevant when the therapeutic effect of the drug subsides or when further administration is required[1].
Patent Claims and Scope
Claim Structure
The claims of the patent are structured to define the matter for which protection is sought clearly and concisely. They must be fully supported by the description provided in the patent, adhering to the guidelines set forth by the USPTO[5].
Independent and Dependent Claims
The patent likely includes both independent and dependent claims. Independent claims define the invention broadly, while dependent claims narrow down the scope by adding specific features or limitations[5].
Patent Scope Metrics
While the patent itself does not delve into metrics for measuring patent scope, research in this area suggests that metrics such as independent claim length and independent claim count can be used to assess the breadth and clarity of patent claims[3].
Patent Landscape and Related Innovations
Biocompatible Polymers
The use of biocompatible polymers in drug delivery systems is a growing area of research. Patents like US11,110,093 contribute to this landscape by providing innovative formulations that enhance the efficacy and safety of drug delivery[1].
Controlled Release Systems
Controlled release drug delivery systems are increasingly important in pharmaceuticals. This patent aligns with broader trends in developing formulations that offer sustained release profiles, improving patient compliance and therapeutic outcomes[1].
Industry Impact and Future Directions
Therapeutic Applications
The sustained release formulation described in the patent has significant potential for various therapeutic applications, including chronic diseases that require long-term drug administration. This could lead to improved patient outcomes and reduced healthcare costs[1].
Regulatory Considerations
The development and approval of such formulations must adhere to stringent regulatory requirements. The clarity and conciseness of the patent claims, as well as the full support from the description, are crucial for navigating the regulatory landscape[5].
Conclusion
United States Patent 11,110,093 represents a substantial advancement in the field of pharmaceutical drug delivery. The detailed analysis of its scope and claims highlights the innovative use of biocompatible polymers, organic solvents, and small molecule drugs in a controlled release formulation. This technology has the potential to transform the way drugs are administered, offering improved therapeutic efficacy and patient compliance.
Key Takeaways
- Innovative Formulation: The patent describes an injectable depot formulation using biocompatible polymers and organic solvents for controlled release of small molecule drugs.
- Controlled Release Profile: The formulation ensures a stable release profile with a C max to C min ratio less than 200 and a lag time less than 0.2.
- Versatile Administration: The formulation can be administered via various routes, including subcutaneous, intramuscular, and intratumoral injections.
- Therapeutic Applications: The technology has significant potential for treating chronic diseases and improving patient outcomes.
- Regulatory Compliance: The patent claims must be clear, concise, and fully supported by the description to adhere to regulatory guidelines.
FAQs
Q: What is the primary innovation of United States Patent 11,110,093?
A: The primary innovation is an injectable depot formulation for the controlled release of small molecule drugs using biocompatible polymers and organic solvents.
Q: What are the key components of the formulation described in the patent?
A: The key components include a biocompatible polymer, an organic solvent, and a small molecule drug incorporated into a viscous gel.
Q: How does the patent define the release profile of the drug?
A: The release profile is defined by metrics such as C max (maximum drug concentration), C min (minimum drug concentration), and T lag (lag time), with a C max to C min ratio less than 200 and T lag less than 0.2.
Q: What are the potential therapeutic applications of this formulation?
A: The formulation has potential applications in treating chronic diseases that require long-term drug administration, improving patient compliance and therapeutic outcomes.
Q: What regulatory guidelines must the patent claims adhere to?
A: The patent claims must be clear, concise, and fully supported by the description, adhering to guidelines set forth by the USPTO.
Sources
- US11110093B2 - Sustained release small molecule drug formulation. Google Patents.
- Patent Claims Research Dataset - USPTO. USPTO.
- Patent Claims and Patent Scope - Search eLibrary :: SSRN. SSRN.
- US6750341B2 - Preparation of risperidone - Google Patents. Google Patents.
- 1824-The Claims - USPTO. USPTO.
