United States Patent 4,957,745: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,957,745, titled "Pharmaceutical Preparation," is a significant patent in the field of pharmaceuticals, particularly focusing on 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, granted to an unspecified assignee, describes a pharmaceutical preparation designed for controlled release, particularly advantageous in the treatment of cardiovascular disorders. The preparation involves beads containing a salt of metoprolol, a commonly used beta-blocker, as the main soluble component[2].
Scope of the Invention
The scope of this patent is centered around the development of a controlled release pharmaceutical preparation. Here are the key aspects:
Controlled Release Mechanism
The preparation utilizes beads that release the active ingredient, metoprolol, in a controlled manner. This is achieved through a specific coating and core composition that ensures a steady release of the drug over time[1].
Application in Cardiovascular Disorders
The patent highlights the particular advantage of this preparation in treating cardiovascular disorders. The controlled release mechanism ensures a consistent therapeutic effect, which is crucial for managing conditions such as hypertension and heart failure[1].
Composition and Formulation
The beads are composed of a soluble material, such as lactose, covered by the active compound. The coating layer can include various materials like cellulose derivatives, polysaccharides, or other organic macromolecular compounds[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1: Controlled Release Beads
The first claim describes the beads comprising a salt of metoprolol as the main soluble component, along with a coating layer that controls the release of the drug[2].
Claim 2: Method of Production
This claim outlines the method for producing these controlled release beads, including the steps of forming the core, applying the coating, and ensuring the desired release profile[2].
Claim 3: Pharmaceutical Preparation
This claim encompasses the final pharmaceutical preparation, which includes the controlled release beads in a suitable dosage form, such as tablets or capsules[2].
Patent Landscape
Prior Art and Related Patents
The patent landscape in pharmaceutical preparations, especially those involving controlled release mechanisms, is extensive. Prior art includes depot preparations and other controlled release systems, such as those described in EP 13263, which involve multiple smaller units for drug release[1].
Classification and Categories
The patent is classified under various categories, including A61K9/50 for microcapsules and solid microparticles with distinct coating layers, and A61K31/13 for medicinal preparations containing organic active ingredients like amines with aromatic rings[1].
International Patent Context
The global patent landscape for controlled release pharmaceuticals is highly competitive. Similar inventions can be found in databases of other international intellectual property offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[4].
Impact and Significance
Therapeutic Benefits
The controlled release mechanism described in this patent provides significant therapeutic benefits, including improved patient compliance and reduced side effects due to the consistent release of the active ingredient[1].
Market and Commercial Implications
The invention has commercial implications in the pharmaceutical industry, particularly in the market for cardiovascular medications. The controlled release formulation can offer a competitive edge over immediate-release formulations by providing a more stable and consistent therapeutic effect.
Legal Status and Expiration
The patent has expired, as indicated by its legal status. This means that the technology described is now in the public domain and can be freely used and improved upon by other entities[1].
Conclusion
United States Patent 4,957,745 represents a significant advancement in controlled release pharmaceutical preparations, particularly for cardiovascular disorders. The patent's scope, claims, and the broader patent landscape highlight its importance and the competitive environment in which it was developed.
Key Takeaways
- The patent describes a controlled release pharmaceutical preparation using beads containing metoprolol.
- The preparation is particularly advantageous for treating cardiovascular disorders.
- The claims include the composition, method of production, and the final pharmaceutical preparation.
- The patent is classified under specific categories related to microcapsules and medicinal preparations.
- The invention has significant therapeutic and commercial implications.
- The patent has expired, making the technology publicly available.
FAQs
Q1: What is the main active ingredient in the pharmaceutical preparation described in US Patent 4,957,745?
The main active ingredient is metoprolol, a beta-blocker used in treating cardiovascular disorders.
Q2: How does the controlled release mechanism work in this patent?
The mechanism involves beads with a soluble core covered by a coating layer that controls the release of metoprolol over time.
Q3: What are the therapeutic benefits of this controlled release formulation?
The benefits include improved patient compliance and reduced side effects due to the consistent release of the active ingredient.
Q4: Is the technology described in this patent still under patent protection?
No, the patent has expired, making the technology publicly available.
Q5: Where can similar patents and prior art be found?
Similar patents and prior art can be found in databases of international intellectual property offices such as the EPO, JPO, and WIPO.
Sources
- US4957745A - Pharmaceutical preparation - Google Patents
- US-4957745-A - Pharmaceutical Preparation - Unified Patents
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
