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Last Updated: January 2, 2025

Details for Patent: 4,863,743


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Summary for Patent: 4,863,743
Title: Controlled release potassium chloride
Abstract:A controlled release potassium chloride tablet is disclosed which is comprised of potassium chloride crystals having a mesh size of about 30 to about 50 mesh which are coated with a coating material comprised of ethylcellulose and hydroxypropylcellulose. The coated crystals form micro pellets which then can be compressed into tablets. The tablets disintegrate rapidly in an aqueous environment thus assuring a more uniform dissolution of the active component as compared with other types of controlled release potassium chloride dosage formulations. The distribution of the potassium chloride micro pellets over a wide surface area in the gastrointestinal mucosa aids in reducing the risk of gastrointestinal lesions. The formation of the coated micro pellets which disperse quickly upon contact with aqueous environment allow for the repeated chronic oral administration of a relatively large dose of potassium chloride (20 mEq).
Inventor(s): Hsiao; Charles (Cooper City, FL), Chou; Chi T. (Monsey, NY)
Assignee: Key Pharmaceuticals, Inc. (Kenilworth, NJ)
Application Number:06/830,981
Patent Claim Types:
see list of patent claims
Dosage form; Use;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 4,863,743: A Comprehensive Guide

Introduction

United States Patent 4,863,743, issued on October 5, 1989, to inventor Hsiao, pertains to a controlled release potassium chloride tablet. This patent is significant in the field of pharmaceuticals, particularly for oral therapeutic potassium supplements. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Patent

The patent addresses the need for an improved oral therapeutic potassium supplement. Prior to this invention, existing potassium supplements had several drawbacks, including rapid release of potassium, which could lead to gastrointestinal irritation and other adverse effects[4].

Scope of the Patent

The scope of the patent revolves around a controlled release potassium chloride tablet designed to mitigate the issues associated with traditional potassium supplements. Here are the key aspects:

Controlled Release Mechanism

The patent describes a tablet formulation that ensures the slow and controlled release of potassium chloride. This mechanism is crucial for minimizing gastrointestinal side effects and maintaining therapeutic efficacy over an extended period[4].

Composition

The tablet is composed of potassium chloride crystals with a specific mesh size, typically between 30 to 50. This size range is critical for achieving the desired release profile[4].

Manufacturing Process

The patent outlines a method for manufacturing these tablets, which involves mixing the potassium chloride crystals with other excipients and then compressing the mixture into a tablet form. The process ensures uniform distribution of the active ingredient and maintains the controlled release characteristics[4].

Claims of the Patent

The claims section of the patent is pivotal as it defines the legal boundaries of the invention. Here are the main claims:

Independent Claims

  • Claim 1 describes the controlled release potassium chloride tablet, specifying the mesh size of the potassium chloride crystals and the composition of the tablet.
  • Claim 2 details the method of manufacturing the tablet, including the steps of mixing and compressing the ingredients[4].

Dependent Claims

  • These claims further elaborate on the independent claims, providing additional details such as the specific excipients used, the ratio of potassium chloride to other ingredients, and the release profile characteristics[4].

Patent Landscape

Understanding the patent landscape is essential for grasping the broader context and potential implications of this patent.

Prior Art

The patent references prior art related to oral therapeutic potassium supplements, highlighting the limitations and problems associated with earlier formulations. For instance, U.S. Patent #4,863,743 discusses how previous supplements caused rapid release of potassium, leading to adverse effects[4].

Related Patents

Other patents in the same domain, such as EP0804172A1, also deal with controlled release formulations for therapeutic agents. These patents collectively contribute to the advancement of controlled release technology in pharmaceuticals[2].

International Patent Offices

The global patent landscape includes similar inventions filed in other countries. For example, the European Patent Office (EPO) and the Japan Patent Office (JPO) have databases that include patents related to controlled release formulations, which can be accessed through platforms like esp@cenet and PATENTSCOPE[1].

Impact on the Pharmaceutical Industry

The invention described in U.S. Patent 4,863,743 has had a significant impact on the pharmaceutical industry:

Improved Therapeutic Efficacy

The controlled release mechanism ensures that the potassium chloride is released slowly, maintaining therapeutic levels over a longer period and reducing side effects[4].

Market Competition

This patent has influenced the development of subsequent controlled release formulations, driving innovation and competition in the market. Companies have had to either license the technology or develop their own alternatives to stay competitive.

Regulatory Compliance

The patent's focus on safety and efficacy has set a standard for regulatory compliance. Regulatory bodies now expect similar formulations to meet or exceed these standards, ensuring better patient outcomes.

Search and Analysis Tools

For researchers and inventors, several tools are available to search and analyze patents like U.S. Patent 4,863,743:

USPTO Patent Public Search

The USPTO's Patent Public Search tool provides enhanced access to prior art, allowing users to search and analyze patents more efficiently[1].

Global Dossier

The Global Dossier service offers access to file histories of related applications from participating IP Offices, facilitating a more comprehensive analysis of patent families[1].

Common Citation Document (CCD)

The CCD application consolidates citation data from multiple offices, enabling users to visualize search results for the same invention on a single page[1].

Conclusion

U.S. Patent 4,863,743 represents a significant advancement in the field of controlled release pharmaceuticals. The patent's scope and claims define a specific and innovative solution to the challenges of oral therapeutic potassium supplements. Understanding this patent and its place within the broader patent landscape is crucial for both researchers and industry professionals seeking to innovate and comply with regulatory standards.

Key Takeaways

  • Controlled Release Mechanism: The patent introduces a controlled release mechanism for potassium chloride tablets to minimize gastrointestinal side effects.
  • Composition and Manufacturing: The tablet is composed of potassium chloride crystals with a specific mesh size, and the manufacturing process ensures uniform distribution and controlled release.
  • Claims: The patent includes independent and dependent claims that define the invention and its manufacturing process.
  • Patent Landscape: The patent is part of a broader landscape that includes related patents and international filings.
  • Impact on Industry: The invention has improved therapeutic efficacy, driven market competition, and set standards for regulatory compliance.
  • Search and Analysis Tools: Various tools like USPTO Patent Public Search, Global Dossier, and CCD facilitate the search and analysis of patents.

FAQs

What is the main innovation of U.S. Patent 4,863,743?

The main innovation is the controlled release mechanism for potassium chloride tablets, designed to reduce gastrointestinal side effects.

How does the controlled release mechanism work?

The mechanism involves using potassium chloride crystals of a specific mesh size (30 to 50) to ensure slow and controlled release of the active ingredient.

What are the key claims of the patent?

The key claims include the description of the controlled release tablet and the method of manufacturing it.

How has this patent impacted the pharmaceutical industry?

It has improved therapeutic efficacy, driven innovation and competition, and set regulatory standards for similar formulations.

What tools are available for searching and analyzing patents like U.S. Patent 4,863,743?

Tools include the USPTO Patent Public Search, Global Dossier, and the Common Citation Document (CCD) application.

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. Google Patents - EP0804172A1: https://patents.google.com/patent/EP0804172A1/en
  3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. Google Patents - US4863743A: https://patents.google.com/patent/US4863743A/en

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Drugs Protected by US Patent 4,863,743

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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