United States Patent 11,123,321: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 11,123,321, titled "Aqueous iron carbohydrate complexes, their production and medicaments containing them," pertains to the development and application of water-soluble iron-carbohydrate complexes. These complexes are designed for medical use, particularly for treating iron deficiencies.
Scope of the Patent
Medical Applications
The patent focuses on aqueous iron-carbohydrate complexes that are highly soluble and suitable for various medical applications, including parenteral (intravenous or intramuscular), oral, and topical use[1][4].
Production Method
The complexes are produced by combining an aqueous solution of an iron(III) salt with an aqueous solution of the oxidation product of one or more carbohydrates. This process results in stable, water-soluble complexes that can be easily formulated into different types of medicaments[1][4].
Claims of the Patent
Key Claims
- Composition: The patent claims the aqueous iron-carbohydrate complexes themselves, emphasizing their water solubility and stability. These complexes have a weight average molecular weight ranging from 80 kDa to 400 kDa, with a preference for up to 300 kDa[1][4].
- Production Process: The method of producing these complexes involves the reaction between iron(III) salts and the oxidation products of carbohydrates, such as polysaccharides or starch derivatives[1][4].
- Medical Formulations: The patent includes claims for various formulations of these complexes, including solutions for parenteral application, oral preparations, and topical applications. These solutions can be sterilized at high temperatures without the need for preservatives[1][4].
Specific Formulations
- Parenteral Solutions: The patent highlights the suitability of these complexes for parenteral administration, including intravenous and intramuscular injections. These solutions can be filled into ampoules or phials and sterilized at temperatures of 121°C or higher for short periods[1][4].
- Oral and Topical Preparations: The complexes can also be formulated with common excipients and additives for oral or topical use, offering versatile treatment options[1][4].
Patent Landscape
Classification
The patent is classified under the International Patent Classification (IPC) system as follows:
- A61K31/70: Carbohydrates; Sugars; Derivatives thereof
- A61K31/715: Polysaccharides, i.e., having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof
- A61K33/24: Heavy metals; Compounds thereof, specifically iron and its compounds[1][4].
Prior Art and Innovations
The patent builds upon prior art by introducing a novel method of producing stable, water-soluble iron-carbohydrate complexes that do not require preservatives. This innovation addresses previous limitations where known preparations had to be sterilely filtered and mixed with preservatives like benzyl alcohol or phenol[1][4].
Competitive Landscape
The development of these aqueous iron-carbohydrate complexes positions them as a competitive alternative to existing iron-based medicaments. For instance, products like INJECTAFER, which are also used for treating iron deficiency, may face competition from these newly patented complexes due to their enhanced stability and ease of administration[2].
Legal and Regulatory Aspects
Patent Status
The patent has been granted and is currently in force, although the legal status is subject to change based on future legal analyses and potential challenges.
Regulatory Compliance
The patent complies with regulatory requirements for medical preparations, including the ability to be sterilized at high temperatures and formulated with standard excipients and additives. This ensures that the medicaments containing these complexes can meet the stringent standards for medical use[1][4].
Technical Details
Molecular Weight
The weight average molecular weight of the obtained complexes is a critical parameter, ranging from 80 kDa to 400 kDa, with a preference for up to 300 kDa. This range ensures the stability and solubility of the complexes[1][4].
Sterilization
The solutions of these complexes can be sterilized at high temperatures (e.g., 121°C) for short periods, which is a significant advantage over previous formulations that required sterile filtration and preservatives[1][4].
Industry Impact
Treatment of Iron Deficiencies
The aqueous iron-carbohydrate complexes patented here offer a new and improved method for treating iron deficiencies. This is particularly significant given the prevalence of iron deficiency anemia and the need for effective, safe, and convenient treatment options.
Pharmaceutical Industry
The introduction of these complexes could influence the pharmaceutical industry by providing a more stable and user-friendly alternative to existing iron-based treatments. This could lead to changes in market dynamics and potentially impact the sales and usage of other iron deficiency treatments.
Key Takeaways
- Water-Soluble Complexes: The patent introduces stable, water-soluble iron-carbohydrate complexes suitable for various medical applications.
- Production Method: The complexes are produced through a novel reaction between iron(III) salts and the oxidation products of carbohydrates.
- Medical Formulations: The patent includes claims for parenteral, oral, and topical formulations, all of which can be sterilized at high temperatures without preservatives.
- Regulatory Compliance: The medicaments comply with stringent medical standards, ensuring safety and efficacy.
- Industry Impact: The patented complexes could significantly impact the treatment of iron deficiencies and influence the pharmaceutical market.
FAQs
What are the main components of the aqueous iron-carbohydrate complexes patented in US 11,123,321?
The main components are iron(III) salts and the oxidation products of one or more carbohydrates, such as polysaccharides or starch derivatives.
How are the aqueous iron-carbohydrate complexes produced?
The production involves reacting an aqueous solution of an iron(III) salt with an aqueous solution of the oxidation product of one or more carbohydrates.
What are the medical applications of these complexes?
The complexes are suitable for parenteral (intravenous or intramuscular), oral, and topical applications.
Why are these complexes advantageous over previous formulations?
They are stable, water-soluble, and can be sterilized at high temperatures without the need for preservatives.
How do these complexes impact the treatment of iron deficiencies?
They offer a new, stable, and convenient treatment option for iron deficiencies, potentially improving patient outcomes and compliance.
Sources
- US11123321B2 - Aqueous iron carbohydrate complexes, their production and medicaments containing them - Google Patents
- Claims Appeals - DSI Access Central
- Patent Claims and Patent Scope - Hoover Institution
- US9376505B2 - Aqueous iron carbohydrate complexes, their production and medicaments containing them - Google Patents
- Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes - PubChem
