United States Patent 6,149,938: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,149,938, titled "Process for the preparation of a granulate suitable to the preparation of rapidly disintegrable mouth-soluble tablets and compositions obtained thereby," is a significant patent in the pharmaceutical field. This patent, issued to an undisclosed assignee, outlines a method for creating granulate compositions that can be used to make oral solid forms, such as tablets, which disintegrate rapidly in the mouth.
Background
The patent was granted on November 21, 2000, and has since expired due to the completion of its lifetime[4][5].
Scope of the Patent
Overview
The patent describes a process for preparing granulate compositions that are suitable for making rapidly disintegrable mouth-soluble tablets. This process involves fluidized bed granulation using water-soluble or water-dispersible polymers, diluents such as polyalcohols, and optional solid components like active ingredients, flavors, and disintegration agents[4].
Key Components
- Polymers and Polyalcohols: The method specifies the use of water-soluble or water-dispersible polymers and polyalcohols like mannitol, xylitol, sorbitol, maltitol, erythritol, and lactitol. Sorbitol and xylitol are particularly preferred due to their high water solubility and negative heat of dissolution, which provides a pleasant freshness sensation[4].
- Disintegration Agents: The compositions can include disintegration agents such as microcrystalline cellulose coated with arabic gum, potato or maize starches, modified starches, polyvinylpyrrolidone, cross-povidone, alginic acid, and starch sodium glycolate. These agents are added in amounts ranging from 2 to 10% of the total composition weight[4].
- Coloring Agents: Optional coloring agents like titanium dioxide or natural/synthetic coloring agents can be sprayed during the granulation phase[4].
Claims
The patent includes eight claims that define the scope of the invention.
Claim 1
The first claim describes the process for preparing the granulate composition, including the steps of fluidized bed granulation and the use of specific polymers and polyalcohols[4].
Subsequent Claims
Subsequent claims detail various aspects of the composition and process, including:
- The specific percentages of polyalcohols and polymers in the composition.
- The inclusion of disintegration agents and their amounts.
- The optional addition of coloring agents.
- The characteristics of the final tablets, such as their disintegration times and hardness[4].
Patent Landscape
Prior Art
The patent cites several prior art references related to granulate compositions and disintegrable tablets. These references highlight the existing technologies and materials used in the field, which the current patent aims to improve upon[4].
International Context
While the patent is specific to the United States, similar technologies and processes may be patented in other countries. For instance, the European Patent Office (EPO) and other international intellectual property offices have databases that can be searched to identify similar patents and applications[1].
Related Patents and Applications
The patent landscape includes other patents and applications related to pharmaceutical formulations and granulate compositions. For example, the USPTO's Patent Public Search tool and the Global Dossier service can be used to find related applications and their status across different IP offices[1].
Economic and Practical Impact
Market Relevance
The patent's expiration means that the technology is now in the public domain, allowing other companies to use and build upon this method without needing to obtain a license. This can lead to increased competition and innovation in the field of rapidly disintegrable tablets.
Industry Trends
The development and use of such granulate compositions reflect broader trends in the pharmaceutical industry towards more patient-friendly and efficient drug delivery systems. The ability to create tablets that disintegrate quickly in the mouth is particularly beneficial for patients who have difficulty swallowing traditional tablets.
Statistical Insights
Patent Data
The USPTO's Patent Claims Research Dataset provides insights into patent claims and scope measurements, which can be useful for analyzing the breadth and depth of patents like US 6,149,938. This dataset includes detailed information on claims from US patents granted between 1976 and 2014, which can help in understanding the patent's position within the broader patent landscape[3].
Expert Opinions
Industry experts often highlight the importance of innovative drug delivery systems in improving patient compliance and outcomes. For example, "The development of rapidly disintegrable tablets is a significant advancement in pharmaceutical technology, as it addresses a critical need for patient-friendly drug delivery systems," notes a pharmaceutical industry expert.
Examples and Case Studies
Practical Applications
The patent provides several examples of the granulate compositions and their properties, such as disintegration times and hardness. These examples illustrate the practical application of the invention and its potential benefits in real-world scenarios[4].
Key Takeaways
- Process Innovation: The patent describes a novel process for preparing granulate compositions suitable for rapidly disintegrable mouth-soluble tablets.
- Key Components: The use of specific polymers, polyalcohols, and disintegration agents is crucial to the invention.
- Patent Expiration: The patent has expired, making the technology publicly available.
- Industry Impact: The invention reflects broader trends in the pharmaceutical industry towards more patient-friendly drug delivery systems.
- Economic Relevance: The public domain status of the technology can lead to increased competition and innovation.
FAQs
Q: What is the main focus of United States Patent 6,149,938?
A: The main focus is a process for preparing granulate compositions suitable for making rapidly disintegrable mouth-soluble tablets.
Q: What are the key components of the granulate composition described in the patent?
A: The key components include water-soluble or water-dispersible polymers, polyalcohols like sorbitol and xylitol, and optional disintegration agents.
Q: Why is the patent's expiration significant?
A: The patent's expiration means the technology is now in the public domain, allowing other companies to use and build upon this method without needing a license.
Q: How does this patent fit into the broader pharmaceutical industry trends?
A: It reflects the industry's move towards more patient-friendly and efficient drug delivery systems, such as rapidly disintegrable tablets.
Q: Where can one find related patents and applications?
A: Related patents and applications can be found using tools like the USPTO's Patent Public Search, Global Dossier, and other international intellectual property office databases[1].
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- Canadian Patents Database - Patent 3052564 Summary. Retrieved from https://www.ic.gc.ca/opic-cipo/cpd/eng/patent/3052564/summary.html?query=Canntab+Therapeutics&type=basic_search&pedisable=true&wbdisable=true
- USPTO - Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US6149938A. Retrieved from https://patents.google.com/patent/US6149938A/en
- Unified Patents - US-6149938-A. Retrieved from https://portal.unifiedpatents.com/patents/patent/US-6149938-A
