United States Patent 10,888,534: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,888,534, titled "Storage Stable Ready-to-use Norepinephrine Aqueous Solutions in Flexible Plastic Bags," is a significant patent in the field of pharmaceutical formulations, particularly for norepinephrine solutions. This patent, assigned to Inforlife SA, addresses critical issues related to the stability and packaging of norepinephrine solutions, which are crucial for medical use.
Background on Norepinephrine
Norepinephrine is a sympathomimetic agent used primarily to manage hypotensive states such as septic shock and neurogenic shock. It is also used as an adjunct treatment during cardiac arrest and for managing severe hypotension[1].
Patent Overview
Title and Assignees
The patent titled "Storage Stable Ready-to-use Norepinephrine Aqueous Solutions in Flexible Plastic Bags" is assigned to Inforlife SA. The priority date for this patent is April 26, 2019[5].
Claims and Scope
Main Claims
The patent primarily focuses on the development of a sterile, antioxidant-free aqueous norepinephrine solution packaged in a flexible plastic container. Here are the key claims:
- Formulation: The solution contains norepinephrine as the free base, with a concentration of between about 0.010 and 0.2 mg/ml. It includes a tonicity adjusting agent to provide an osmolality of from 260 to 320 mOsm/kg, and sufficient acid and optionally a base to maintain a pH between about 3.6 and 3.8[4].
- Packaging: The solution is packaged in a flexible plastic container within a sealed over-wrap pouch containing an oxygen absorber. This design ensures the stability of the norepinephrine solution by minimizing exposure to oxygen[4].
Innovative Aspects
- Stability: The formulation is designed to be stable for an extended period, with stability tests indicating that the solution remains stable for at least 9 to 36 months at room temperature or refrigerated conditions[4].
- Antioxidant-Free: Unlike many other formulations, this solution is substantially free of metal ion chelators and antioxidants, which are commonly used to stabilize liquid pharmaceuticals. This innovation avoids the need for these additives, making the solution safer and more efficient[4].
Patent Landscape
Related Patents
Several other patents and patent applications relate to norepinephrine formulations and their stability:
- U.S. Pat. No. 10,251,848: This patent describes an injectable noradrenaline solution with a pH range of 3.3 to 3.6 and without preservatives or anti-oxidizing agents[4].
- U.S. Patent Application Publication No. 2021/0038539: This application discloses a ready-to-use aqueous dosage form of norepinephrine with sulfite antioxidants and an ion chelator, which contrasts with the antioxidant-free approach of U.S. Patent 10,888,534[4].
Competitive Advantage
The unique packaging and formulation described in U.S. Patent 10,888,534 offer several competitive advantages:
- Extended Shelf Life: The stability of the solution over an extended period reduces the need for frequent replacements and ensures that the product remains effective.
- Simplified Storage: The use of flexible plastic containers and oxygen absorbers simplifies storage and transportation, making it more convenient for medical facilities.
- Enhanced Safety: The absence of antioxidants and metal ion chelators reduces the risk of adverse reactions and makes the solution safer for patients[4].
Technical and Practical Implications
Clinical Use
The stable and ready-to-use norepinephrine solution is particularly beneficial in critical care settings where rapid and reliable administration of the drug is crucial. This formulation ensures that healthcare providers have a consistent and reliable source of norepinephrine, which is vital for managing severe hypotension and shock states[1].
Manufacturing and Quality Control
The patent's focus on stability and packaging also has significant implications for manufacturing and quality control processes. The use of flexible plastic containers and oxygen absorbers requires precise manufacturing techniques to ensure the integrity of the solution. Quality control measures must be stringent to maintain the stability and efficacy of the product[4].
Regulatory and Intellectual Property Considerations
Patent Scope and Claims
The scope of the patent is defined by the specific claims related to the formulation and packaging of the norepinephrine solution. The patent's claims are narrow and focused, which can help in defending against potential infringement but may also limit the scope of protection[3].
Regulatory Compliance
The patent complies with regulatory requirements for pharmaceutical formulations, including stability tests and packaging standards. Ensuring compliance with these regulations is crucial for obtaining and maintaining approval for the product[4].
Future Developments and Trends
Advancements in Formulation Technology
The development of stable and ready-to-use norepinephrine solutions is part of a broader trend in pharmaceutical formulation technology. Future developments may focus on further enhancing stability, reducing the need for additives, and improving packaging designs[4].
Market Impact
The impact of this patent on the market could be significant, particularly in critical care settings where reliable and stable norepinephrine solutions are essential. The competitive advantages offered by this formulation could lead to increased market share and adoption by healthcare providers[4].
Key Takeaways
- Stable Formulation: The patent describes a stable, antioxidant-free aqueous norepinephrine solution.
- Innovative Packaging: The use of flexible plastic containers and oxygen absorbers ensures extended shelf life and simplified storage.
- Clinical Benefits: The formulation is crucial for managing severe hypotension and shock states in critical care settings.
- Regulatory Compliance: The patent complies with regulatory standards for pharmaceutical formulations.
- Market Impact: The competitive advantages of this formulation could lead to increased market adoption.
Frequently Asked Questions (FAQs)
What is the primary use of norepinephrine in medical settings?
Norepinephrine is primarily used to manage hypotensive states such as septic shock and neurogenic shock, and as an adjunct treatment during cardiac arrest[1].
What are the key components of the norepinephrine solution described in U.S. Patent 10,888,534?
The solution contains norepinephrine as the free base, a tonicity adjusting agent, and sufficient acid and optionally a base to maintain a pH between about 3.6 and 3.8[4].
Why is the absence of antioxidants and metal ion chelators significant in this patent?
The absence of these additives makes the solution safer and more efficient, avoiding potential adverse reactions and the need for additional components[4].
How does the packaging described in the patent contribute to the stability of the norepinephrine solution?
The use of flexible plastic containers and oxygen absorbers within a sealed over-wrap pouch minimizes exposure to oxygen, ensuring the stability of the solution over an extended period[4].
What are the potential market implications of this patent?
The competitive advantages offered by this stable and ready-to-use norepinephrine solution could lead to increased market share and adoption by healthcare providers, particularly in critical care settings[4].
Cited Sources:
- DrugBank: Norepinephrine: Uses, Interactions, Mechanism of Action.
- Google Patents: Norepinephrine compositions and methods therefor.
- Hoover Institution: Patent Claims and Patent Scope.
- Justia Patents: U.S. Patent Application for NOREPINEPHRINE LIQUID FORMULATION.
- Unified Patents Portal: US-20190133973-A1 - Storage Stable Ready-to-use Norepinephrine Aqueous Solutions in Flexible Plastic Bags.
