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Patent landscape, scope, and claims: |
United States Patent 5,190,765: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,190,765, though not directly provided in the sources, can be analyzed within the context of similar patents and the broader patent landscape related to controlled drug delivery systems. This analysis will focus on the general principles and components often found in such patents, drawing parallels from similar inventions.
Background of Controlled Drug Delivery Systems
Controlled drug delivery systems are designed to release active agents at a predetermined rate, ensuring optimal therapeutic effects while minimizing side effects. These systems have become crucial in modern pharmacology, allowing for sustained release, targeted delivery, and improved patient compliance[2].
Scope of the Patent
General Scope
Patents in the realm of controlled drug delivery typically cover innovative methods, devices, and formulations that enhance the delivery of pharmaceuticals. The scope often includes the composition of the delivery system, the mechanism of action, and the manufacturing process.
Specific Components
- Dosage Forms: These patents often describe specific dosage forms such as capsules, tablets, or other delivery vehicles that contain the active agent.
- Layers and Coatings: Multiple layers, including barrier layers, expandable layers, and semipermeable layers, are common. These layers control the rate of drug release[1].
- Mechanisms of Action: The patent may detail how the drug is released, such as through osmotic pressure, hydro-activation, or erosion of the delivery vehicle[1].
Claims of Similar Patents
Composition Claims
- Claims often include the specific composition of the dosage form, such as a gelatin capsule filled with a liquid drug formulation surrounded by various layers (barrier, expandable, semipermeable)[1].
- The materials used for these layers, such as hydrophilic polymers or osmotic agents, are also specified.
Structural Claims
- The structural integrity of the dosage form, including the formation of an exit orifice, is a critical claim. This orifice allows the controlled release of the active agent[1].
Functional Claims
- Claims related to the functionality of the delivery system, such as sustained release over a specified period, are essential. For example, patents may claim release rates over 11 hours, 12 hours, or 24 hours[2].
Manufacturing Process Claims
- The steps involved in manufacturing the dosage form are also claimed. This includes coating the gelatin capsule with various layers, forming the exit orifice, and ensuring the integrity of the barrier layer[1].
Patent Landscape
Related Patents
- Patents like U.S. Patent 5,324,280 and U.S. Patent 6,245,357 describe similar controlled drug delivery systems. These patents cover various aspects such as osmotic layers, bilayer tablets, and sustained release formulations[1][2].
Trends in Controlled Drug Delivery
- There is a growing trend towards developing more sophisticated delivery systems that combine sustained release with immediate release components. This ensures both rapid onset of action and prolonged therapeutic effect[2].
International Patent Landscape
- The European Patent Office (EPO) and other international patent offices have seen numerous filings in this area. Tools like esp@cenet and PATENTSCOPE provide access to a global database of patents, highlighting the international scope of this technology[4].
Challenges and Opportunities
Regulatory Challenges
- Patents in this field must navigate complex regulatory environments. Opposition to granted patents, as seen in the European Patent Convention, can be a significant challenge[1].
Technological Advancements
- Advances in materials science and pharmaceutical technology continue to open new opportunities for innovative drug delivery systems. For instance, the use of hydro-activated layers and semipermeable membranes has significantly improved the precision of drug release[1].
Key Takeaways
- Controlled drug delivery systems are a critical area of innovation in pharmacology.
- Patents in this field cover a wide range of components, including dosage forms, layers, and mechanisms of action.
- The manufacturing process and structural integrity of the delivery system are key aspects of these patents.
- The patent landscape is global, with significant contributions from various international patent offices.
FAQs
What are the main components of a controlled drug delivery system?
The main components typically include a dosage form (e.g., gelatin capsule), a barrier layer, an expandable layer, a semipermeable layer, and an exit orifice.
How do osmotic layers work in drug delivery systems?
Osmotic layers work by using osmotic pressure to push the drug out of the delivery system at a controlled rate, often through an exit orifice.
What is the significance of the exit orifice in controlled drug delivery?
The exit orifice is crucial as it allows the controlled release of the active agent from the delivery system into the environment of use.
How do regulatory challenges impact patents in controlled drug delivery?
Regulatory challenges, such as opposition to granted patents, can delay or even invalidate patents. It is essential to navigate these challenges carefully to ensure the patent remains valid.
What are some recent trends in controlled drug delivery systems?
Recent trends include the development of systems that combine sustained release with immediate release components, ensuring both rapid onset and prolonged therapeutic effect.
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