Methods and compositions for alleviating respiratory dysfunction
Inventors
Assignees
Publication Number
US-11844811-B2
Publication Date
2023-12-19
Expiration Date
2039-05-20
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Abstract
Compositions, methods of manufacturing compositions, methods of protecting against respiratory problems including coronavirus and coronavirus-associated severe acute respiratory syndrome (SARS) in humans and animals, are provided. Compositions comprising inorganic nitrate used for improving nitric oxide levels, improving health and/or reducing symptoms of SARS are provided. The compositions and methods are applicable for subjects experiencing SARS, and for protecting non-infected subjects against SARS. Compositions and methods for improving nitric oxide levels in a subject disclosed herein comprise administration of compositions comprising inorganic nitrate such as potassium nitrate or sodium nitrate optionally combined with ascorbate.
Core Innovation
The invention provides methods and compositions comprising inorganic nitrate, such as potassium nitrate or sodium nitrate optionally combined with ascorbate, for treating, preventing, alleviating, and managing respiratory dysfunction including symptoms related to Severe Acute Respiratory Syndrome (SARS), acute respiratory distress syndrome (ARDS), and nitric oxide deficiencies in humans and animals. These methods improve nitric oxide bioavailability which is critical in restoring endothelial function, preventing thrombotic events, and increasing antiviral activity. The compositions are effective for subjects experiencing SARS or ARDS and for protecting non-infected subjects exposed to SARS.
The invention addresses the problem that prior art fails to provide convenient and effective measures to elevate physiological levels of nitrogen oxides to combat infection, cancer, or alleviate respiratory distress. Existing approaches involving nitrite or acidified nitrite either escape before use or require injection and health care support, limiting their utility. Furthermore, there is a need for low-cost, oral, self-administrable prophylactics that enable simple monitoring of antiviral nitric oxide levels, which this invention fulfills by providing nitrate-based compositions and monitoring methods using non-invasive saliva testing.
The invention overcomes limitations of prior art by enabling natural generation and prolonged efficacy of protective nitric oxide doses from a single oral dose with optional intermittent dosing based on salivary nitrite monitoring. It discloses defined nitrate or nitrate-ascorbate formulations administered in water, lozenge, chewable, or capsule forms for treating, preventing, and managing nitric oxide deficiencies associated with SARS, ARDS, infections, and cancer. The methods maintain elevated nitric oxide levels to alleviate respiratory dysfunction symptoms such as difficulty breathing, low oxygenation, thrombotic events, sore throat, or fever.
Claims Coverage
The patent presents two independent claims focused on methods of enhancing nitric oxide bioavailability in subjects with detectable nitric oxide deficiencies and symptoms of respiratory distress, such as ARDS or SARS, with symptom-reducing doses of potassium nitrate in combination with ascorbate.
Method for enhancing nitric oxide bioavailability using potassium nitrate and ascorbate
A method comprising oral administration of a water-soluble composition containing potassium nitrate and ascorbate in a weight ratio of 1 to 2, in forms such as capsules, tablets, lozenges, or chewables, to a subject with nitric oxide deficiency associated with ARDS or SARS from metastatic lung cancer or viral infections.
Monitoring and intermittent dosing based on salivary nitrite levels
The method includes increasing salivary nitrite within 90 minutes after administration, monitoring nitrite or nitrite/nitrate levels with dry-based Griess reagent test strips, and administering intermittent second doses if salivary nitrite drops below 200 uM to sustain above 300 uM, with two to three doses daily spaced 4-10 hours apart to maintain elevated nitric oxide bioavailability.
These claims cover methods of administering potassium nitrate with ascorbate to treat nitric oxide deficiencies associated with respiratory distress, employing salivary monitoring to optimize dosing schedules for sustained therapeutic nitric oxide levels.
Stated Advantages
Provides a low-cost, orally self-administrable prophylactic that enables easy self-monitoring of antiviral protective nitric oxide levels.
Naturally generates and prolongs protective nitric oxide efficacy with single oral dosing and allows intermittent dosing guided by non-invasive saliva testing.
Improves endothelial function, prevents thrombotic events, and increases direct antiviral activity, thereby aiding subjects with respiratory dysfunction, SARS, ARDS, infections, and cancer.
Documented Applications
Treating, preventing, and managing respiratory dysfunction related to SARS, ARDS, and nitric oxide deficiency-related complications in humans and animals.
Safeguarding front-line health workers and individuals exposed to infectious diseases such as coronavirus and influenza by enhancing nitric oxide bioavailability.
Reducing oral bacterial carriage, specifically Streptococcus mutans, to lower caries risk via plasma activated water.
Inhibiting tumor growth and preventing metastasis in various cancers, including lung metastases, using nitrate-based compositions.
Use in subjects experiencing respiratory distress associated with influenza, coronavirus infections (e.g., SARS-CoV-1 and SARS-CoV-2), bacterial, fungal infections, and metastatic lung cancer.
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