United States Patent 11,173,141: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,173,141, titled "Enalapril formulations," is a significant patent that addresses the formulation and administration of enalapril, a widely used ACE inhibitor for treating hypertension and other cardiovascular disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background on Enalapril
Enalapril, an angiotensin-converting enzyme (ACE) inhibitor, is crucial in managing hypertension and heart failure. Traditional formulations often come in tablet form, but there has been a growing need for more convenient and stable oral liquid formulations, especially for patients who have difficulty swallowing tablets[1][4].
Scope of the Patent
The patent focuses on the development of stable enalapril oral liquid formulations. Here are the key aspects of its scope:
Stable Oral Liquid Formulations
The patent describes stable enalapril oral liquid formulations that do not require additional steps or manipulation before administration. These formulations are designed to be safe and effective for the treatment of hypertension and other disorders[1].
Components of the Formulation
The enalapril liquid formulations include:
- Enalapril or its pharmaceutically acceptable salts
- A preservative
- A sweetening agent (such as sucralose or xylitol)
- A buffer
- Water
Notably, these formulations do not require mannitol or colloidal silicon dioxide for stability and dissolution, which is an improvement over previous formulations[1].
Types of Oral Liquids
The patent encompasses various types of oral liquids, including solutions (both aqueous and nonaqueous), suspensions, emulsions, syrups, slurries, juices, elixirs, and dispersions[1].
Claims of the Patent
The claims of the patent are detailed and specific, ensuring broad protection for the invention while also providing clarity on what is covered:
Claim 1
The first claim describes a stable oral liquid formulation comprising enalapril or its pharmaceutically acceptable salt in a concentration of about 0.6 to about 1.2 mg/ml, along with the aforementioned components (preservative, sweetening agent, buffer, and water)[5].
Subsequent Claims
Subsequent claims further specify the types of preservatives, sweetening agents, and buffers that can be used, as well as the pH range of the formulation. These claims also cover the method of preparation and the use of these formulations for treating hypertension and other cardiovascular conditions[5].
Patent Landscape
The patent landscape surrounding enalapril formulations is complex and involves several related patents and technologies.
Related Patents
Other patents, such as US8568747B1 and US9855214B2, also deal with enalapril compositions but differ in their approaches. For example, US8568747B1 describes powder compositions for reconstitution as oral liquids, which require mannitol and colloidal silicon dioxide for stability and dissolution. In contrast, the current patent (US11173141B2) offers a more streamlined and stable formulation without these additives[2][4].
Competitive Landscape
The competitive landscape includes other ACE inhibitors and their formulations. The patent mentions other ACE inhibitors like quinapril, indolapril, ramipril, and lisinopril, indicating a broad field of competition in cardiovascular treatments[1].
Intellectual Property Strategy
To navigate this landscape effectively, companies must employ robust intellectual property strategies. This includes using patent analytics tools to track patents by claims and scope concepts, identifying gaps in coverage, and determining the value of their patent claims[3].
Advantages and Innovations
The patent offers several advantages over previous formulations:
Stability and Convenience
The stable oral liquid formulations do not require any extra steps or manipulation before administration, making them more convenient for patients. This stability also ensures consistent efficacy and safety[1].
Safety
The formulations avoid the use of mannitol and colloidal silicon dioxide, which can be problematic in some patients. Additionally, they eliminate the risk of contamination associated with crushing tablets[1].
Industry Impact
The impact of this patent on the pharmaceutical industry is significant:
Patient Compliance
The convenience and stability of these formulations can improve patient compliance, especially for those who struggle with swallowing tablets.
Market Competition
The unique formulation and lack of need for additional additives give the patent holder a competitive edge in the market for ACE inhibitors.
Future Developments
The patent's focus on stable oral liquid formulations opens up avenues for further research and development in similar areas, such as other cardiovascular medications.
Key Takeaways
- Stable Oral Liquid Formulations: The patent describes stable enalapril oral liquid formulations without the need for mannitol or colloidal silicon dioxide.
- Components: The formulations include enalapril, a preservative, a sweetening agent, a buffer, and water.
- Claims: Specific claims cover the concentration of enalapril, types of preservatives and sweetening agents, and the method of preparation.
- Patent Landscape: The patent is part of a broader landscape involving related patents and competitive ACE inhibitors.
- Advantages: The formulations offer convenience, stability, and safety improvements over previous methods.
FAQs
Q: What is the primary advantage of the enalapril oral liquid formulations described in US11173141B2?
A: The primary advantage is the stability and convenience of the formulations, which do not require any extra steps or manipulation before administration.
Q: What components are included in the enalapril oral liquid formulations?
A: The components include enalapril or its pharmaceutically acceptable salts, a preservative, a sweetening agent (such as sucralose or xylitol), a buffer, and water.
Q: How do these formulations differ from previous enalapril powder compositions?
A: These formulations do not require mannitol or colloidal silicon dioxide for stability and dissolution, unlike previous powder compositions.
Q: What is the significance of avoiding mannitol and colloidal silicon dioxide in these formulations?
A: Avoiding these additives eliminates potential safety issues and contamination risks associated with crushing tablets or using previous powder compositions.
Q: How does this patent impact the pharmaceutical industry?
A: The patent improves patient compliance, offers a competitive edge in the market for ACE inhibitors, and opens up avenues for further research in similar areas.
Sources
- US11173141B2 - Enalapril formulations - Google Patents
- US8568747B1 - Enalapril compositions - Google Patents
- Patent Analytics | Intellectual Property Law - SLWIP
- US9855214B2 - Enalapril compositions - Google Patents
- Claims for Patent: 11173141 - DrugPatentWatch
