United States Patent 5,607,697: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,607,697, titled "Taste masking microparticles for oral dosage forms," was issued on March 4, 1997. This patent is significant in the pharmaceutical industry, particularly in the development of oral dosage forms that mask unpleasant tastes of active pharmaceutical ingredients. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Motivation
The invention addresses a common issue in pharmaceuticals: the unpleasant taste of many active ingredients, which can lead to poor patient compliance. The patent aims to provide a solution by developing taste-masking microparticles that can be incorporated into solid oral dosage forms.
Scope of the Invention
Overview
The patent describes a solid pharmaceutical dosage form designed for direct oral administration. This form includes microparticles with a core containing at least one pharmaceutical ingredient and a compound that is sweet in taste and has a negative heat of solution, such as mannitol, sorbitol, or xylitol[4].
Key Components
- Core: The core of each microparticle contains the active pharmaceutical ingredient along with a sweet-tasting compound and possibly a binder or other excipient.
- Coating: The core is surrounded by a coating material that retards the dissolution of the pharmaceutical ingredient in the mouth, thereby masking its taste.
- Dosage Form: The microparticles are sized, shaped, and compressed into a form suitable for oral administration. The dosage form is designed to disintegrate in the mouth, releasing the microparticles[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the solid pharmaceutical dosage form comprising microparticles with a core and a coating material.
- Claim 2 specifies the composition of the core, including the active ingredient and the sweet-tasting compound.
- Claim 3 details the coating material and its function in retarding dissolution[4].
Dependent Claims
- These claims further specify the characteristics of the microparticles, such as their size (generally not longer than 1,000 microns), the amount of coating material (no more than about 75% of the microparticle's weight), and the preferred range of active ingredient (between about 0.1 and 2,000 milligrams)[4].
Patent Landscape
Prior Art
The invention builds upon earlier technologies, such as those described in the Redding et al. patent, but advances them by providing a more effective taste-masking solution. The prior art keywords include "dosage form," "microparticles," and "taste masking," indicating the focus on improving existing methods[4].
Classification
The patent is classified under various categories in the International Patent Classification (IPC) system, including A61K9/00 (Medicinal preparations characterized by special physical form) and A61K9/50 (Microcapsules having a gas, liquid, or semi-solid filling)[4].
International Context
While this patent is specific to the United States, similar innovations are being developed globally. For instance, databases like those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) offer access to international patent applications and granted patents in the pharmaceutical field[1].
Impact and Applications
Pharmaceutical Industry
This patent has significant implications for the pharmaceutical industry, particularly in the development of pediatric and geriatric medications where taste is a critical factor. The technology can improve patient compliance by masking unpleasant tastes, thereby enhancing the efficacy of treatments.
Market and Competition
The patent landscape in the pharmaceutical sector is highly competitive, with numerous patents and applications related to taste-masking technologies. Companies and researchers continuously innovate to improve these technologies, ensuring a dynamic and evolving market.
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 other companies or researchers can use and build upon this invention without infringing on the original patent[4].
Research and Development
For those interested in further research or development in this area, datasets like the Patent Claims Research Dataset provided by the USPTO can be invaluable. This dataset contains detailed information on claims from US patents and applications, which can help in understanding trends and advancements in patent scope and claims[3].
Conclusion
United States Patent 5,607,697 represents a significant advancement in the field of pharmaceuticals, particularly in the development of taste-masking technologies for oral dosage forms. Understanding the scope, claims, and broader patent landscape of this invention is crucial for researchers, pharmaceutical companies, and anyone interested in innovating within this field.
Key Takeaways
- The patent describes a solid pharmaceutical dosage form with taste-masking microparticles.
- The core of each microparticle contains an active ingredient and a sweet-tasting compound.
- The coating material retards dissolution in the mouth, masking the taste.
- The patent has expired, making the technology public domain.
- The invention has significant implications for improving patient compliance in pharmaceutical treatments.
FAQs
Q: What is the main purpose of United States Patent 5,607,697?
A: The main purpose is to provide a taste-masking solution for oral pharmaceutical dosage forms, improving patient compliance by masking unpleasant tastes.
Q: What are the key components of the microparticles described in the patent?
A: The key components include a core with an active pharmaceutical ingredient and a sweet-tasting compound, and a coating material that retards dissolution.
Q: How does the coating material function in the microparticles?
A: The coating material surrounds the core and retards the dissolution of the pharmaceutical ingredient in the mouth, thereby masking its taste.
Q: What is the current legal status of the patent?
A: The patent has expired, making the technology available in the public domain.
Q: Where can one find more detailed information on similar patents and applications?
A: Databases such as those provided by the USPTO, EPO, JPO, and WIPO offer access to patent applications and granted patents in the pharmaceutical field.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Casetext - Ex Parte 6024981 et al: https://casetext.com/admin-law/ex-parte-6024981-et-al-1
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US5607697A: https://patents.google.com/patent/US5607697A/en
- Google APIs - Reissued Patent: https://patentimages.storage.googleapis.com/f4/28/56/98eb4707373cf1/USRE41108.pdf