United States Patent 5,869,100: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 5,869,100, titled "Extended release clonidine formulation (tablet)," is a significant patent in the pharmaceutical field, particularly in the development of extended-release formulations. This patent, granted to a pharmaceutical company, outlines a method and composition for an extended-release clonidine tablet, which is used in the treatment of various clinical disorders.
Background of Clonidine
Clonidine is an alpha-2 adrenergic agonist that has been effective in treating a wide range of clinical disorders, including hypertension, prophylaxis of common migraine headaches, and subduing motor tics associated with Tourette's Syndrome[1].
Patent Overview
Publication and Legal Status
The patent was published on February 9, 1999, and has since expired. The legal status indicates that the patent is no longer in force, but its contents remain relevant for understanding the development of extended-release formulations.
Prior Art and Related Patents
The patent builds upon prior art related to extended-release formulations, particularly those involving cellulose derivatives. It references various substances and methods used in sustained drug release technologies[1].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims focus on the composition and method of preparing the extended-release clonidine tablet. Key claims include:
- Composition Claims: The patent claims a pharmaceutical composition comprising clonidine and a sustained-release matrix, typically made from cellulose derivatives such as ethyl cellulose, hydroxyethyl cellulose, or hydroxypropyl cellulose[1].
- Method Claims: The method claims describe the process of preparing the extended-release tablets, including the steps of mixing clonidine with the sustained-release matrix and forming the tablets through compression or other suitable methods[1].
Dependent Claims
Dependent claims further specify the details of the composition and method, such as the weight ratio of clonidine to the sustained-release matrix, the use of additional excipients, and the physical characteristics of the tablets.
Technical Details
Sustained Release Mechanism
The patent describes a sustained-release mechanism that ensures the gradual release of clonidine over an extended period. This is achieved by using a matrix that slowly dissolves or erodes, releasing the active ingredient in a controlled manner[1].
Excipients and Formulation
The formulation includes various excipients such as cellulose derivatives, which are crucial for the sustained-release properties. Other excipients like dextrose and glucose may also be included to enhance the formulation's stability and release characteristics[1].
Clinical Applications
Hypertension
Clonidine is widely used in the treatment of hypertension. The extended-release formulation ensures that the drug is released consistently over time, maintaining therapeutic levels and reducing the need for frequent dosing[1].
Migraine Prophylaxis
The patent also mentions the use of clonidine for prophylaxis of common migraine headaches. The extended-release formulation helps in maintaining a steady level of the drug in the body, which is beneficial for preventive treatment[1].
Tourette's Syndrome
Clonidine is used to subdue motor tics associated with Tourette's Syndrome. The extended-release formulation provides a stable and consistent release of the drug, which is essential for managing this condition effectively[1].
Patent Landscape
Related Patents
Other patents in the same field include compositions that combine alpha-2 adrenergic agonists with other therapeutic agents. For example, a patent combining an alpha-2 adrenergic agonist with a calcium channel blocker highlights the versatility of these agents in various therapeutic applications[4].
Patent Scope and Quality
The scope of this patent is well-defined, with clear claims that specify the composition and method of preparation. This clarity is crucial for patent quality, as it helps in avoiding disputes and ensuring that the patent is enforceable. Research on patent scope and quality emphasizes the importance of clear and narrow claims, which this patent exemplifies[3].
Impact and Significance
Innovation in Drug Delivery
The extended-release clonidine formulation represents a significant innovation in drug delivery technology. It improves patient compliance by reducing the frequency of dosing and maintains therapeutic drug levels over an extended period.
Clinical Benefits
The consistent release of clonidine provides stable therapeutic effects, which is particularly beneficial for chronic conditions like hypertension and Tourette's Syndrome. This formulation also helps in reducing side effects associated with peak and trough levels of the drug.
Key Takeaways
- Extended-Release Formulation: The patent describes an extended-release clonidine tablet using cellulose derivatives.
- Clinical Applications: The formulation is used for treating hypertension, migraine prophylaxis, and managing Tourette's Syndrome.
- Patent Scope: The patent has clear and specific claims defining the composition and method of preparation.
- Impact: The innovation improves patient compliance and maintains stable therapeutic drug levels.
FAQs
What is the primary use of the extended-release clonidine formulation described in US Patent 5,869,100?
The primary use is for treating hypertension, prophylaxis of common migraine headaches, and subduing motor tics associated with Tourette's Syndrome.
What are the key components of the sustained-release matrix in this patent?
The sustained-release matrix is typically made from cellulose derivatives such as ethyl cellulose, hydroxyethyl cellulose, or hydroxypropyl cellulose.
How does the extended-release mechanism work?
The mechanism involves the gradual release of clonidine over an extended period through the slow dissolution or erosion of the sustained-release matrix.
What are the benefits of using an extended-release formulation of clonidine?
The benefits include improved patient compliance due to reduced dosing frequency and stable therapeutic drug levels, which help in managing chronic conditions effectively.
Is the patent still in force?
No, the patent has expired, but its contents remain relevant for understanding the development of extended-release formulations.
Sources
- US5869100A - Extended release clonidine formulation (tablet)
- US20140309271A1 - Treatment of autistic ... - Google Patents
- Patent Claims and Patent Scope - Hoover Institution
- Alpha2-adrenergic agonist a calcium channel blocker composition
- US-9132119-B2 - Unified Patents Portal
