United States Patent 4,576,604: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,576,604, titled "Osmotic system with instant drug availability," is a significant innovation in the field of controlled drug delivery systems. This patent, granted to Guittard et al., is part of a broader landscape of osmotic devices designed to deliver active agents in a controlled and efficient manner.
Background and Context
Osmotic devices have been widely used for delivering various beneficial active agents, including medicines, nutrients, and other chemicals, over prolonged periods. These devices utilize osmotic pressure to release the active agents, ensuring a consistent and controlled delivery rate[1].
Patent Overview
Inventors and Assignees
The patent was invented by Guittard et al. and assigned to ALZA Corporation, a company known for its advancements in drug delivery systems.
Publication and Grant Dates
The patent was granted on March 18, 1986, after being filed on August 24, 1982.
Claims and Scope
Main Claims
The patent primarily claims an osmotic therapeutic system designed for the controlled delivery of drugs. The system consists of:
- A core containing the drug.
- A semipermeable membrane surrounding the core.
- An instant drug availability feature, which ensures that the drug is released immediately upon exposure to an aqueous environment[5].
Detailed Description of the System
The osmotic system includes a bi-layered core, where one layer contains the drug and the other layer is a push-layer that helps in the release of the drug. The semipermeable membrane has at least one hole or passageway through which the drug is released. The design ensures that the drug is delivered at a controlled rate over a prolonged period, with an initial burst release to provide immediate therapeutic effect[1][5].
Key Components
Semipermeable Membrane
The semipermeable membrane is crucial as it allows water to enter the core while preventing the drug from escaping until the appropriate time. The membrane can have one or more holes, depending on the design, to control the release rate of the drug[1].
Bi-Layered Core
The bi-layered core consists of a drug-containing layer and a push-layer. The push-layer, which does not contain any drug, helps to expel the drug from the core as water enters through the semipermeable membrane[1].
Advantages and Innovations
Controlled Release
The system provides a controlled release of the drug, ensuring that the therapeutic levels are maintained over a long period. This is particularly beneficial for medications that require consistent dosing to be effective[5].
Instant Drug Availability
The instant drug availability feature is a significant innovation, allowing for an immediate therapeutic effect. This is crucial for conditions where rapid onset of action is necessary[5].
Patent Landscape
Related Patents
Several other patents relate to osmotic devices, each with their own unique features and improvements. For example:
- U.S. Pat. No. 4,014,334 to Theeuwes et al. and U.S. Pat. No. 4,673,405 to Guittard et al. also describe osmotic devices with similar but distinct designs[1].
- U.S. Pat. No. 4,915,954 to Ayer et al. describes an osmotic device with a bi-layered core where each layer releases a different drug at different rates[1].
Competing Technologies
Other technologies, such as those described in U.S. Pat. No. 4,455,143 to Theeuwes et al., involve multiple compartments with separate release mechanisms. These designs offer alternative approaches to controlled drug delivery but differ in their specific mechanisms and applications[1].
Impact and Applications
Pharmaceutical Industry
The osmotic system described in this patent has significant implications for the pharmaceutical industry, particularly in the development of controlled release formulations. This technology can be applied to a wide range of medications, improving patient compliance and therapeutic outcomes[5].
Clinical Use
The immediate and controlled release features make this system suitable for various clinical applications, including the treatment of chronic conditions that require consistent drug levels.
Legal and Regulatory Aspects
Patent Validity and Scope
The patent's validity and scope are critical in determining its enforceability and the extent of protection it offers. The claims must be clear, specific, and not overly broad to avoid legal challenges[3].
Search and Examination Process
The USPTO's search and examination process ensures that patents are granted only for novel and non-obvious inventions. Tools like the Patent Public Search and Global Dossier help in assessing the prior art and the patent family landscape[4].
Conclusion and Future Directions
United States Patent 4,576,604 represents a milestone in the development of osmotic drug delivery systems. Its innovative design and immediate drug availability feature have set a standard for controlled release formulations.
Key Takeaways
- The patent describes an osmotic system with a bi-layered core and a semipermeable membrane for controlled drug release.
- The system includes an instant drug availability feature.
- It is part of a broader landscape of osmotic devices with various designs and applications.
- The technology has significant implications for the pharmaceutical industry and clinical use.
Frequently Asked Questions (FAQs)
What is the primary innovation of U.S. Patent 4,576,604?
The primary innovation is the instant drug availability feature combined with a controlled release mechanism.
How does the bi-layered core work in this osmotic system?
The bi-layered core consists of a drug-containing layer and a push-layer. Water enters through the semipermeable membrane, causing the push-layer to expand and expel the drug from the core.
What are the advantages of using an osmotic system for drug delivery?
The advantages include controlled release of the drug, improved patient compliance, and the potential for immediate therapeutic effect.
How does this patent fit into the broader patent landscape of osmotic devices?
This patent is part of a series of innovations in osmotic devices, each with unique features such as multiple compartments, different release mechanisms, and various applications.
What are the potential clinical applications of this osmotic system?
The system is suitable for treating chronic conditions that require consistent drug levels, such as hypertension, diabetes, and other long-term health issues.
Cited Sources:
- US20030185882A1 - Pharmaceutical ... - Google Patents
- US8241667B2 - Dual controlled release osmotic ... - Google Patents
- Patent Claims and Patent Scope - Search eLibrary :: SSRN
- Search for patents - USPTO
- US Patent for Osmotic system with instant drug availability Patent ...
