High molecular iodine concentration compositions, pharmaceutical formulations, preparation and uses
Inventors
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Assignees
Member
I2PureI2Pure specializes in molecular iodine-based technologies for broad-spectrum infection prevention and biosafety across healthcare, consumer, and industrial markets. Its mission is to prevent pathogenic threats globally by developing, optimizing, and licensing stable, non-toxic molecular iodine solutions. The company focuses on formulation, clinical validation, manufacturing, and regulatory compliance related to antiseptic and antimicrobial products, supported by ongoing research into iodine chemistry, bioavailability, and delivery at biological interfaces.
I2Pure specializes in molecular iodine-based technologies for broad-spectrum infection prevention and biosafety across healthcare, consumer, and industrial markets. Its mission is to prevent pathogenic threats globally by developing, optimizing, and licensing stable, non-toxic molecular iodine solutions. The company focuses on formulation, clinical validation, manufacturing, and regulatory compliance related to antiseptic and antimicrobial products, supported by ongoing research into iodine chemistry, bioavailability, and delivery at biological interfaces.
Publication Number
US-12485141-B2
Publication Date
2025-12-02
Expiration Date
Abstract
Embodiments of high molecular iodine concentration composition and pharmaceutical formulation are disclosed, which may be biostatic persistent, biocidal persistent, and have prolonged biocidal activities against microorganisms for hours after administration of the composition or pharmaceutical formulation. Articles comprising high molecular iodine concentration composition and pharmaceutical formulation, as well as preparation and use of same are also disclosed.
Core Innovation
The invention relates to a non-aqueous high molecular iodine concentration solution comprising molecular iodine, glycerin, and ethanol, in which molecular iodine has a concentration of about 1,500 ppm by wt/v, glycerin has a concentration of about 99% wt of the total weight of the solution, and ethanol has a concentration of about 0.1% to about 1% of the total weight of the solution. The solution remains stable after 480 days at room temperature. The solution is complexed iodine free and the molecular iodine is at least 99% of all iodine species in the solution.
The invention further relates to a high molecular iodine concentration composition comprising molecular iodine at about 1,400 ppm to about 150,000 ppm by wt/v, an organic carrier at no less than about 93.5% wt of the total weight of the high molecular iodine concentration composition, and ethanol at about 0.1% to about 1% of the total weight of the solution. The organic carrier is selected from glycerin, propylene glycol, and combinations thereof. The composition remains stable after 480 days at room temperature and is characterized as biostatic persistent or biocidal persistent.
The invention also relates to methods of use in which a therapeutically or prophylactically effective amount of the non-aqueous high molecular iodine concentration solution or the high molecular iodine concentration composition is administered to a subject to kill or inhibit the growth of a parasite and/or a microorganism. This includes administration for therapeutic or prophylactic purposes with respect to parasites and microorganisms in or on a subject.
Claims Coverage
The document identifies two independent claims. One covers a specific non-aqueous solution formulation, and the other covers a broader high molecular iodine concentration composition. Both require low ethanol and stability after 480 days at room temperature, and both are associated with high-wt organic carrier formulations and molecular iodine concentration limitations.
Non-aqueous high molecular iodine concentration solution with specified glycerin and ethanol and 480-day stability
A non-aqueous high molecular iodine concentration solution comprising molecular iodine at about 1,500 ppm by wt/v, glycerin at about 99% wt of the total weight of the solution, and ethanol at about 0.1% to about 1% of the total weight of the solution, wherein the non-aqueous high molecular iodine concentration solution remains stable after 480 days at room temperature.
High molecular iodine concentration composition with defined iodine range, high-wt organic carrier selection, low ethanol, and 480-day stability
A high molecular iodine concentration composition comprising molecular iodine at about 1,400 ppm to about 150,000 ppm by wt/v; an organic carrier having a concentration of no less than about 93.5% wt of the total weight of the high molecular iodine concentration composition; the organic carrier being selected from glycerin, propylene glycol, and combinations thereof; and ethanol having a concentration of about 0.1% to about 1% of the total weight of the solution, wherein the high molecular iodine concentration composition remains stable after 480 days at room temperature.
Across the independent claims, the core claim coverage centers on non-aqueous or composition-form iodine delivery using a high-wt organic carrier with low ethanol, while specifying molecular iodine concentration ranges and requiring stability after 480 days at room temperature. Additional claim coverage includes complexed iodine free, molecular iodine at least 99% of all iodine species, biostatic persistent or biocidal persistent, and administration to kill or inhibit the growth of a parasite and/or a microorganism in or on a subject.
Stated Advantages
Stability after 480 days at room temperature.
Complexed iodine free.
Molecular iodine constitutes at least 99% of all iodine species in the solution.
Biostatic persistent.
Biocidal persistent.
Killing or inhibiting growth of a parasite and/or a microorganism in or on a subject.
Documented Applications
Treating a subject by administering a therapeutically or prophylactically effective amount of the non-aqueous high molecular iodine concentration solution to kill or inhibit growth of a parasite and/or a microorganism.
Treating a subject by administering a therapeutically or prophylactically effective amount of the high molecular iodine concentration composition to kill or inhibit growth of a parasite and/or a microorganism.
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