Method of treating a person afflicted with COVID-19 and pharmaceutical formulation including dapsone
Inventors
Sekhavat, Houfar • Asotra, Satish
Assignees
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Publication Number
US-11826323-B2
Publication Date
2023-11-28
Expiration Date
Abstract
A method for treating patients with COVID-19 and/or other respiratory conditions includes administering eighty-five milligrams of dapsone twice daily for twenty-one days. A variety of dapsone formulations and delivery devices are disclosed, including an inhaler, nasal spray, nasal gel, otic formulation, intravenous formulation, oral solution, oral suspension, patch and suppository.
Core Innovation
The invention relates to a method of suppressing an autoimmune reaction to COVID-19 in a person afflicted with COVID-19 by administering an effective dosage of dapsone together with a macrolide selected from the group consisting of doxycycline and azithromycin. The disclosed material also associates dapsone-based treatment with anti-inflammatory and neutrophil/cytokine storm pathways, including IL-8 and reactive oxygen species (ROS) related pathways, and the myeloperoxidase/HOCl pathway.
The documented rationale is presented in terms of suppressing an autoimmune reaction and inflammatory signaling in the context of COVID-19. The disclosure further presents extensive pharmaceutical formulation and delivery routes for dapsone, including inhaler delivery, nasal solution/suspension/spray/gel/drops into a nasal cavity, and multiple other dosage forms.
Claims Coverage
The independent claim is clm-00001, which specifies an autoimmune-reaction suppression method for COVID-19 using dapsone combined with a macrolide (doxycycline or azithromycin). Dependent claims refine the dosing and delivery/formulation, including a specific dapsone amount and twice-daily schedule, nasal spray formulations, and intranasal dry powder via an inhaler apparatus.
Suppressing autoimmune reaction to COVID-19 with dapsone and doxycycline or azithromycin
A method of suppressing an autoimmune reaction to COVID-19 in a person afflicted with COVID-19 comprising administering to the person an effective dosage of dapsone with a macrolide selected from the group consisting of doxycycline and azithromycin.
Specific dapsone twice-daily dosing of 85 milligrams
The method includes administering to a person 85 milligrams of dapsone twice daily.
Nasal spray liquid solution dose range for dapsone
The method specifies administering a dapsone nasal-spray dosage made from a liquid solution containing 5–200 milligrams of dapsone in about fifty milliliters of liquid, dispensed into a person's nasal cavity.
Nasal spray with dapsone and defined nasal excipients
The method uses a dapsone dosage delivered as a nasal spray containing dapsone, glycerin, and lauroyl polyoxyl-6 glycerides, dispensed into a person's nasal cavity.
Micronized dry powder intranasal delivery via an inhaler apparatus
The claim covers a method that provides a dapsone dosage in a dry powder formulation with micronized dapsone particles, supplies an inhaler apparatus configured to dispense it, and administers the formulation intranasally to a person via the inhaler apparatus.
Micronized dapsone particle size distribution for the dry powder
The method uses micronized dapsone particles having a diameter of 1 to 5 micrometers, with 80% of the particles between 2 and 4 micrometers.
Overall, the claim coverage centers on suppressing an autoimmune reaction to COVID-19 using dapsone in combination with doxycycline or azithromycin, with dependent refinements specifying an 85 milligram twice-daily dosing example, and nasal/intranasal delivery embodiments that include a defined nasal spray liquid dose range, nasal excipients, and an inhaler-dispensed dry powder with a specified micronized particle size distribution.
Stated Advantages
Rapid lung delivery.
Avoiding first-pass metabolism.
Documented pharmacokinetics (PK).
Generic affordability.
Documented Applications
Treatment of COVID-19/ARDS in a person afflicted with COVID-19 using dapsone in combination with a macrolide selected from doxycycline and azithromycin.
Dapsone nasal-spray and inhaler-based intranasal delivery embodiments are documented for administering a dapsone dosage to a person.
Formulation/delivery routes for dapsone are documented across multiple dosage forms, including intravenous, oral, otic, transdermal patches, suppositories, and enema.
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