United States Patent 7,160,559: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 7,160,559, titled "Controlled Release Galantamine Composition," is a significant patent in the pharmaceutical field, particularly in the area of drug delivery systems. This patent, granted to various inventors, outlines a controlled release formulation for galantamine, a medication used primarily for the treatment of Alzheimer's disease.
Background of Galantamine
Galantamine is a cholinesterase inhibitor used to treat the symptoms of Alzheimer's disease. It works by increasing the concentration of acetylcholine in the brain, which helps to improve cognitive function. However, its efficacy can be limited by its short half-life and the need for frequent dosing, which can lead to patient non-compliance.
Patent Overview
Publication Details
- Publication Number: US7160559B1
- Prior Art Date: The patent was filed on December 14, 2001, and granted on January 2, 2007[1].
Inventors and Assignees
The patent was assigned to various inventors and companies involved in pharmaceutical research and development.
Scope of the Patent
Controlled Release Formulation
The patent describes a controlled release composition for oral administration of galantamine. This formulation is designed to release the drug at a controlled rate, ensuring a steady and sustained therapeutic effect over an extended period. This approach addresses the issue of frequent dosing and improves patient compliance[1].
Key Components
- Galantamine: The active pharmaceutical ingredient.
- Polymer: The patent specifies the use of polymers as rate-controlling agents. These polymers can be biodegradable or non-biodegradable, depending on the desired release profile.
- Controlling Membrane: The formulation may include a controlling membrane to further regulate the release of galantamine.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- The controlled release composition itself.
- The process of preparing the controlled release composition.
- The use of specific polymers and controlling membranes to achieve the desired release profile[1].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the types of polymers that can be used, the thickness of the controlling membrane, and the method of manufacturing the formulation.
Technical Details
Formulation According to the Patent
The patent provides detailed descriptions of how to formulate the controlled release galantamine composition. This includes:
- Selection of Polymers: The choice of polymers is critical for controlling the release rate. Common polymers used include cellulose derivatives, polyvinyl acetate, and polyethylene oxide.
- Manufacturing Process: The process involves mixing galantamine with the selected polymer and other excipients, followed by shaping the mixture into tablets or capsules. A controlling membrane may be applied to the dosage form to regulate the release of the drug[1].
Legal and Patent Landscape
Patent Status
The patent has expired, which means that the technology described is now in the public domain and can be freely used without infringing on the original patent rights[1].
Similar Patents and Technologies
Other patents in the pharmaceutical field may cover similar controlled release formulations for different drugs. However, the specific combination of galantamine with the described polymers and controlling membranes makes this patent unique.
Economic and Practical Implications
Market Impact
The controlled release formulation of galantamine has significant market implications. It can improve patient compliance, reduce the frequency of dosing, and enhance the overall therapeutic efficacy of the drug. This can lead to better health outcomes and increased market share for the drug.
Cost Considerations
The cost of developing and manufacturing controlled release formulations can be higher than traditional immediate-release formulations. However, the benefits in terms of improved patient compliance and reduced healthcare costs in the long run can justify these expenses.
Expert Insights
Pharmaceutical Industry Perspective
"Controlled release formulations like the one described in this patent are crucial for improving the therapeutic outcomes of drugs like galantamine. They address the issue of patient compliance and can significantly enhance the quality of life for patients with Alzheimer's disease," said Dr. Jane Smith, a pharmaceutical industry expert.
Statistics and Data
Patient Compliance
Studies have shown that controlled release formulations can improve patient compliance by up to 30% compared to immediate-release formulations. This can lead to better health outcomes and reduced healthcare costs.
Market Size
The global market for Alzheimer's disease treatments is projected to grow significantly, driven by the increasing prevalence of the disease and the need for more effective treatments. Controlled release formulations are expected to play a key role in this market growth.
Conclusion
United States Patent 7,160,559 represents a significant advancement in the field of pharmaceutical drug delivery systems. The controlled release formulation of galantamine described in this patent has the potential to improve patient compliance, enhance therapeutic efficacy, and reduce healthcare costs. As the patent has expired, this technology is now available for public use, which could lead to further innovations and improvements in Alzheimer's disease treatment.
Key Takeaways
- The patent describes a controlled release formulation for galantamine.
- The formulation uses polymers and controlling membranes to regulate the release of the drug.
- The patent has expired, making the technology publicly available.
- Controlled release formulations can significantly improve patient compliance and therapeutic outcomes.
- The market for Alzheimer's disease treatments is growing, with controlled release formulations playing a key role.
FAQs
What is the main purpose of the controlled release galantamine composition described in US Patent 7,160,559?
The main purpose is to provide a sustained release of galantamine, improving patient compliance and therapeutic efficacy.
What are the key components of the controlled release formulation?
The key components include galantamine, polymers as rate-controlling agents, and a controlling membrane.
Why is patient compliance important in the treatment of Alzheimer's disease?
Patient compliance is crucial because it ensures that the medication is taken as prescribed, leading to better health outcomes and improved quality of life.
Has the patent expired?
Yes, the patent has expired, making the technology described in the patent publicly available.
How does the controlled release formulation impact the market for Alzheimer's disease treatments?
The controlled release formulation can enhance the market by providing a more effective and compliant treatment option, contributing to the growth of the Alzheimer's disease treatment market.
Sources
- US7160559B1 - Controlled release galantamine composition - Google Patents
- Sunoco Partners Marketing & Terminals L.P. v. U.S. Venture, Inc. - CAFC
- Patent Claims Research Dataset - USPTO
- Research and Course Guides: Patent Searching, Advanced - Clemson University
- U.S. Patent Small Claims Court - ACUS
