United States Patent 8,192,722: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 8,192,722, titled "Abuse-proof dosage form," is a significant innovation in the field of pharmaceuticals, particularly in the design and manufacture of dosage forms that are resistant to abuse. This patent, granted to address the growing issue of drug abuse, introduces a novel dosage form that prevents the extraction and misuse of active ingredients.
Background
Drug abuse, especially the misuse of prescription medications, has become a critical public health issue. The need for abuse-deterrent formulations has driven innovation in pharmaceutical technology. This patent is part of the broader effort to develop dosage forms that are both effective and safe from abuse.
Patent Overview
Publication Details
- Publication Number: US8192722B2
- Prior Art Date: The patent builds upon existing technologies and methods in pharmaceutical formulation and manufacturing[1].
Inventive Concept
The patent describes an abuse-proof dosage form designed to prevent the extraction of active ingredients through various methods such as grinding, crushing, or dissolving. This is achieved through a unique combination of materials and manufacturing processes.
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
- Dosage Form Composition: The dosage form comprises at least one synthetic or natural polymer, an active ingredient, and optionally other components such as waxes, plasticizers, and fillers[1].
- Manufacturing Process: The dosage form is manufactured using a thermoforming process without causing discoloration. This process involves extrusion and heat treatment to form a stable matrix that encapsulates the active ingredient[1].
- Abuse-Deterrent Features: The dosage form is designed to resist tampering, such as grinding or crushing, and to prevent the extraction of the active ingredient through solvents or other means[1].
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims specify additional features or limitations that further define the invention. For example, independent claims might cover the basic composition and manufacturing process, while dependent claims could detail specific types of polymers or additional components used[3].
Key Components and Materials
Polymers
The dosage form uses a combination of synthetic and natural polymers, such as poly(ethylene oxide), carboxymethyl cellulose sodium, and pectin. These polymers form a matrix that encapsulates the active ingredient and provides the abuse-deterrent properties[1].
Active Ingredients
The patent does not specify particular active ingredients but mentions that the dosage form can be used with a wide range of pharmaceutical substances. The focus is on ensuring that these ingredients are released in a controlled manner and are not easily extractable[1].
Additional Components
Other components such as waxes, plasticizers, and fillers may be included to enhance the stability and functionality of the dosage form. These components help in maintaining the integrity of the matrix and ensuring the controlled release of the active ingredient[1].
Manufacturing Process
Thermoforming
The manufacturing process involves thermoforming, which includes extrusion and heat treatment. This process ensures that the dosage form is stable and does not discolor, maintaining its efficacy and appearance[1].
Extrusion
Extrusion is a critical step in the manufacturing process, where the mixture of polymers, active ingredients, and other components is formed into a consistent shape. This step is crucial for achieving the desired physical properties of the dosage form[1].
Abuse-Deterrent Mechanisms
Resistance to Grinding and Crushing
The dosage form is designed to resist grinding and crushing, making it difficult for individuals to extract the active ingredient through mechanical means[1].
Resistance to Solvent Extraction
The matrix formed by the polymers and other components prevents the extraction of the active ingredient using solvents, further deterring abuse[1].
Patent Landscape
Related Patents and Applications
The patent landscape in the field of abuse-deterrent dosage forms is extensive. Other patents and applications focus on different mechanisms to prevent drug abuse, such as using different polymers, coatings, or delivery systems. This patent contributes to the existing body of work by introducing a unique combination of materials and manufacturing processes[4].
Global Dossier and International Implications
The Global Dossier system, which provides access to file histories of related applications from participating IP Offices, can be useful in understanding the international implications and related patents in this field. This system helps in identifying similar inventions and prior art globally[4].
Legal and Regulatory Aspects
Patent Prosecution and Examination
The patent prosecution process for this invention would have involved a detailed examination by the USPTO to ensure that the claims are novel, nonobvious, and enabled. The process can take several years and may involve amendments and arguments to secure claim allowance[5].
Commercialization and Costs
Commercializing a patent like this can be costly, with estimates ranging from $8,000 to $20,000 for drafting and filing a non-provisional patent application in the U.S. International patents can be even more expensive. However, the potential benefits in terms of public health and market value can justify these costs[5].
Impact and Future Directions
Public Health Impact
The development of abuse-deterrent dosage forms has significant public health implications. By preventing the misuse of prescription medications, these formulations can help reduce the incidence of drug abuse and its associated health risks.
Future Innovations
The field of pharmaceutical technology is continuously evolving. Future innovations may focus on improving the efficacy, safety, and manufacturability of abuse-deterrent dosage forms. This could involve new materials, manufacturing techniques, or delivery systems.
Key Takeaways
- Abuse-Deterrent Design: The patent introduces a novel dosage form designed to prevent the extraction and misuse of active ingredients.
- Unique Materials and Manufacturing: The dosage form uses a combination of synthetic and natural polymers and a thermoforming process to create a stable matrix.
- Regulatory and Legal Considerations: The patent prosecution process is critical, and commercialization costs can be significant.
- Public Health Impact: The invention has substantial public health implications by reducing drug abuse.
FAQs
What is the main purpose of the United States Patent 8,192,722?
The main purpose of this patent is to introduce an abuse-proof dosage form that prevents the extraction and misuse of active ingredients in pharmaceuticals.
What materials are used in the dosage form described in the patent?
The dosage form uses a combination of synthetic and natural polymers, such as poly(ethylene oxide), carboxymethyl cellulose sodium, and pectin, along with other components like waxes, plasticizers, and fillers.
How is the dosage form manufactured?
The dosage form is manufactured using a thermoforming process that includes extrusion and heat treatment to form a stable matrix without causing discoloration.
What are the abuse-deterrent mechanisms of the dosage form?
The dosage form is designed to resist grinding and crushing and to prevent the extraction of the active ingredient using solvents.
What are the potential costs associated with commercializing this patent?
Commercializing this patent can be costly, with estimates ranging from $8,000 to $20,000 for drafting and filing a non-provisional patent application in the U.S., and even more for international patents.
Sources
- US8192722B2 - Abuse-proof dosage form - Google Patents
- U.S. Patent and Trademark Office (USPTO) | USAGov
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO
- Intellectual Property Protection - KU Office of Research
