Stable ascorbic acid compositions and methods of using same
Inventors
Copeland, Dan • DURHAM, Carolyn
Assignees
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Publication Number
US-12350307-B2
Publication Date
2025-07-08
Expiration Date
Abstract
The application is directed a composition comprising organic acid (e.g., ascorbic acid), glutathione, a glutathione derivative, a glutathione conjugate, a pharmaceutically-acceptable salt thereof, or any combination thereof, and methods of using the same. In certain aspects the application is directed to glutathione, a glutathione derivative, a glutathione conjugate, a pharmaceutically-acceptable salt thereof; and an organic acid; wherein the molar ratio is about 0.5-1:1. The composition can further comprises a bicarbonate salt, wherein the molar ratio is about 0.1-0.5:0.5-1:1.
Core Innovation
The disclosed invention relates to methods of treating asthma, inflammation and/or infection associated with lung transplantation, acute or chronic lung rejection and/or lung dysfunction, chronic obstructive pulmonary disease (COPD), bronchitis, or any combination thereof. The methods administer to a subject’s airway a therapeutically effective amount of a composition comprising glutathione, or a glutathione derivative, glutathione conjugate, or pharmaceutically-acceptable salt, ascorbic acid, and bicarbonate. The composition is characterized by a molar ratio of (a):(b):(c) of about 0.1-0.5:0.5-1:1.
In the asthma treatment context, the invention uses the same composition components, namely glutathione or its derivative, conjugate, or salt, ascorbic acid, and bicarbonate, while maintaining the defined molar ratio constraint. In the lung transplantation context, the invention addresses inflammation and/or infection associated with lung transplantation, and also covers acute or chronic lung rejection and/or lung dysfunction. The administration is directed to the subject’s airway, emphasizing targeted delivery to the respiratory system.
For COPD and bronchitis, the invention applies a therapeutically effective composition comprising glutathione or a related form or salt, ascorbic acid, and bicarbonate at the specified molar ratio. The COPD and bronchitis methods include treating a subject in need thereof, including embodiments specifying COPD together with bronchitis, and further characterizing the bronchitis as eosinophilic bronchitis.
Claims Coverage
The claim coverage is unified by the requirement to administer a therapeutically effective glutathione/ascorbic acid/bicarbonate airway composition with a defined molar ratio of (a):(b):(c) about 0.1-0.5:0.5-1:1, while independently specifying disease context for asthma; lung transplantation-associated inflammation/infection including rejection and dysfunction; COPD; and bronchitis.
Glutathione-ascorbic acid-bicarbonate airway treatment composition for broad lung conditions
A method of treating asthma, inflammation and/or infection associated with lung transplantation, acute or chronic lung rejection and/or lung dysfunction, COPD, bronchitis, or any combination thereof by administering to the subject’s airway a therapeutically effective amount of a composition comprising glutathione, or a glutathione derivative, glutathione conjugate, or pharmaceutically-acceptable salt, an ascorbic acid, and a bicarbonate, wherein the molar ratio of (a):(b):(c) is about 0.1-0.5:0.5-1:1.
Asthma treatment using glutathione-ascorbic acid-bicarbonate composition
A method of treating asthma in a subject in need thereof by administering a therapeutically effective amount of a composition comprising glutathione, or a glutathione derivative, glutathione conjugate, or pharmaceutically-acceptable salt, an ascorbic acid, and a bicarbonate, wherein the molar ratio of (a):(b):(c) is about 0.1-0.5:0.5-1:1.
Lung transplantation-associated inflammation/infection treatment and prevention using glutathione-ascorbic acid-bicarbonate composition
A method of treating or preventing inflammation and/or infection associated with lung transplantation, acute or chronic lung rejection and/or lung dysfunction, or any combination thereof in a subject in need thereof by administering to the subject’s airway a therapeutically effective amount of a composition comprising glutathione, or a glutathione derivative, glutathione conjugate, or pharmaceutically-acceptable salt, an ascorbic acid, and a bicarbonate, wherein the molar ratio of (a):(b):(c) is about 0.1-0.5:0.5-1:1.
COPD and/or bronchitis treatment using glutathione-ascorbic acid-bicarbonate composition
A method of treating chronic obstructive pulmonary disease (COPD) and/or bronchitis in a subject in need thereof by administering to the subject a therapeutically effective amount of a composition comprising glutathione, or a glutathione derivative, glutathione conjugate, or pharmaceutically-acceptable salt, an ascorbic acid, and a bicarbonate, wherein the molar ratio of (a):(b):(c) is about 0.1-0.5:0.5-1:1.
The claim coverage is unified by the requirement to administer a therapeutically effective glutathione/ascorbic acid/bicarbonate airway composition with a defined molar ratio of (a):(b):(c) about 0.1-0.5:0.5-1:1, while independently specifying disease context for asthma; lung transplantation-associated inflammation/infection including rejection and dysfunction; COPD; and bronchitis.
Stated Advantages
Maintaining high reduced forms during storage (low oxidized glutathione and low oxidized ascorbic acid).
Minimizing oxidation-mediated complications.
Antibacterial and biofilm inhibition of clinical isolates.
Upregulation of mucociliary clearance.
Anti-inflammatory effects including reduced NET formation, decreased nitric oxide/FeNO, and downregulation of TNF-α, IL-6, and IL-8.
Documented Applications
Treating asthma by administering an airway composition comprising glutathione or derivative/conjugate/salt, ascorbic acid, and bicarbonate at the recited molar ratio.
Treating or preventing inflammation and/or infection associated with lung transplantation, acute or chronic lung rejection and/or lung dysfunction by administering the recited airway composition.
Treating COPD and/or bronchitis, including eosinophilic bronchitis, by administering the recited composition.
In vitro and limited in vivo testing in support of the disclosed composition, including stability data; MIC against clinical isolates; mucociliary transport improvements; NET/NO/cytokine reductions in neutrophil assays; and FeNO reduction in a lung transplant patient.
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