United States Patent 4,140,756: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 4,140,756, titled "Solid, stable dosage forms with an elastic film coating," is a significant patent in the pharmaceutical field, particularly concerning controlled release formulations. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent, filed in 1981 and granted in 1983, describes solid, stable dosage forms consisting of a moisture- and temperature-sensitive core prepared from a medicament or a mixture of medicaments and excipients. The core is coated with an elastic film to achieve controlled release of the active ingredient over a prolonged period[2].
Scope of the Patent
The scope of the patent is focused on the design and formulation of solid dosage forms, specifically tablets, that are engineered for sustained release of water-soluble medicaments. The invention addresses the need for a stable and controlled release system that can maintain the integrity of the medicament and ensure consistent drug delivery.
Claims of the Patent
The patent includes several key claims that define the invention:
- Claim 1: The patent claims a solid dosage form comprising a core containing a medicament and excipients, coated with an elastic film that controls the release of the medicament.
- Claim 2: The core is described as being moisture- and temperature-sensitive.
- Claim 3: The elastic film coating is specified to be made from materials that do not dissolve in the gastrointestinal tract but allow for the controlled release of the medicament[2].
Key Components and Formulation
Core Composition
The core of the dosage form contains a water-soluble medicament, such as potassium chloride, and various excipients to facilitate the formulation and stability of the core.
Elastic Film Coating
The elastic film coating is crucial for the controlled release mechanism. This coating is designed to be insoluble in the gastrointestinal tract but permeable to allow the gradual release of the medicament over a specified period.
Patent Landscape Analysis
Defining Scope and Keywords
To analyze the patent landscape around US Patent 4,140,756, one must define the relevant technology field and keywords. Key terms include "controlled release," "sustained release," "elastic film coating," and "solid dosage forms."
Search and Organize Patents
Using patent databases, relevant patents can be identified and organized based on factors such as filing date, assignee, and technology subcategories. This helps in creating a comprehensive view of the patent landscape[3].
Identify Trends and Key Players
The analysis reveals trends in patent filings related to controlled release formulations. Key players in this field include pharmaceutical companies and research institutions that have been actively filing patents in this domain.
Analyze Citations and Evolution
Studying the citations and references within these patents provides insights into the evolution of the technology. For instance, US Patent 4,140,756 has been cited in numerous subsequent patents related to controlled release formulations, indicating its influence on the field[3].
Generate Insights for Decisions
The analysis translates into practical guidance for strategic decisions. For example, understanding the competitive landscape and potential legal vulnerabilities helps in navigating the intellectual property landscape.
Data Visualization and Analysis
Visualizations such as heat maps and citation networks are essential for revealing trends, geographical distribution, and interconnections among patents. This helps in identifying innovation hotspots and potential white spaces in the technology domain[3].
Insights from Patent Landscape Analysis
Technological Trends
The analysis shows a significant trend towards the development of advanced controlled release formulations. There is a focus on improving the stability, efficacy, and patient compliance of these dosage forms.
Key Players
Major pharmaceutical companies and research institutions are actively involved in this field, indicating a high level of competition and innovation.
Impact and Influence
US Patent 4,140,756 has had a substantial impact on the development of subsequent controlled release formulations. Its influence can be seen in the numerous citations and references in later patents.
Comparison with Other Patents
US20050084531A1
This patent, titled "Tablet with aqueous-based sustained release coating," describes a similar but distinct approach to sustained release formulations. It uses an aqueous-based coating system, which contrasts with the organic solvent-based coating of US Patent 4,140,756[4].
US4822619A
This patent focuses on controlled release products containing gastrointestinal irritant drugs. While it shares the broader goal of controlled release, it addresses specific challenges related to gastrointestinal irritants, which is not the primary focus of US Patent 4,140,756[5].
Conclusion
US Patent 4,140,756 is a pivotal invention in the field of controlled release pharmaceuticals. Its scope and claims define a significant advancement in the formulation of solid dosage forms with elastic film coatings. The patent landscape analysis reveals a dynamic and competitive field with ongoing innovations and a strong influence from this patent.
Key Takeaways
- Controlled Release Formulations: The patent focuses on the development of solid dosage forms with controlled release mechanisms.
- Elastic Film Coating: The use of an elastic film coating is a key innovation for achieving sustained release.
- Impact on the Field: The patent has been influential in subsequent developments in controlled release formulations.
- Competitive Landscape: The patent landscape is highly competitive, with major pharmaceutical companies and research institutions actively involved.
- Technological Trends: There is a continuous trend towards improving the stability, efficacy, and patient compliance of controlled release formulations.
FAQs
What is the main innovation of US Patent 4,140,756?
The main innovation is the use of an elastic film coating on a moisture- and temperature-sensitive core to achieve controlled release of medicaments.
How does this patent differ from other controlled release patents?
It differs primarily in its use of an elastic film coating and its focus on solid dosage forms, contrasting with other patents that may use aqueous-based coatings or address different specific challenges.
Who are the key players in this field?
Major pharmaceutical companies and research institutions are the key players, as they are actively filing patents and driving innovation in controlled release formulations.
What is the significance of the patent landscape analysis?
The analysis provides insights into technological trends, key players, and the competitive landscape, helping in making informed strategic decisions.
How has US Patent 4,140,756 influenced subsequent patents?
It has been cited in numerous subsequent patents, indicating its significant influence on the development of controlled release formulations.
