# US 12,594,254 B2 · Intranasal administration of n-acetylcysteine and uses thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,594,254 B2 - Document ID: US12594254B2 - Status: Granted - Kind: B2 - Application number: 18/855,563 - Filed: 2023-02-07 - Published: 2025-07-10 - Granted: 2026-04-07 - Earliest claimed: 2022-02-07 - Assignees: Neuronasal, Inc. - Applicants: Neuronasal, Inc. - Inventors: Douglas A. Greene; Thomas I. Bradshaw - Web page: https://patentgrep.com/patent/US12594254B2 ## CPC - A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00) - A61K 9/0043: {Nose} - A61K 31/045: Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates - A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} - A61K 38/063: {Glutathione} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract The present disclosure describes methods comprising administering N-acetylcysteine (NAC) or a pharmaceutically-acceptable salt or congener thereof. The disclosed methods can be used to treat a brain disorder. ## Claims ### Claim 1 A method comprising administering to a subject in need thereof: a) a dose of a compound, wherein the compound is N-acetylcysteine (NAC) or a pharmaceutically-acceptable salt thereof or glutathione (GSH); and b) a therapeutically-effective amount of a therapeutic agent, wherein the administering delivers the therapeutic agent to a brain tissue of the subject in an amount that is at least about 20% greater than an amount of the therapeutic agent delivered to the brain tissue of the subject when administered without the dose of the compound. ### Claim 2 (depends on 1) The method of claim 1, wherein the administering of the compound is intranasal. ### Claim 3 (depends on 1) The method of claim 1, wherein the subject is human. ### Claim 4 (depends on 1) The method of claim 1, wherein substantially all of the dose of the compound enters the brain without crossing a blood brain barrier of the subject. ### Claim 5 (depends on 1) The method of claim 1, wherein the dose of the compound is a therapeutically-effective amount. ### Claim 6 (depends on 1) The method of claim 1, wherein the dose of the compound is from about 1 mg/kg to about 10 mg/kg. ### Claim 7 (depends on 1) The method of claim 1, wherein the dose of the compound is from about 100 mg to about 400 mg. ### Claim 8 (depends on 1) The method of claim 1, wherein the dose of the compound is administered using a nasal pump. ### Claim 9 (depends on 1) The method of claim 1, wherein the dose of the compound is administered using an atomizer. ### Claim 10 (depends on 1) The method of claim 1, wherein the dose of the compound is administered using a nebulizer. ### Claim 11 (depends on 1) The method of claim 1, wherein substantially all of the dose of the compound enters the nasal cavity of the subject. ### Claim 12 (depends on 1) The method of claim 1, wherein the compound and the therapeutic agent are in a unit dose form. ### Claim 13 (depends on 1) The method of claim 1, wherein the therapeutic agent is an antibiotic. ### Claim 14 (depends on 1) The method of claim 1, wherein the therapeutic agent is a betalactam. ### Claim 15 (depends on 1) The method of claim 1, wherein the therapeutic agent is an aminoglycosi de. ### Claim 16 (depends on 1) The method of claim 1, wherein the therapeutic agent is ambroxol. ### Claim 17 (depends on 1) The method of claim 1, wherein the therapeutic agent is an antibody. ### Claim 18 (depends on 1) The method of claim 1, wherein the therapeutic agent is aducanumab. ### Claim 19 (depends on 1) The method of claim 1, wherein the therapeutic agent is farnesol. ### Claim 20 (depends on 1) The method of claim 1, wherein the administering delivers the therapeutically-effective amount of the therapeutic agent to the brain tissue of the subject in an amount that is at least about 30% greater than an amount of the therapeutic agent delivered to the brain tissue of the subject when administered without the dose of the compound. ### Claim 21 (depends on 1) The method of claim 1, wherein the administering delivers the therapeutically-effective amount of the therapeutic agent to the brain tissue of the subject in an amount that is at least about 50% greater than an amount of the therapeutic agent delivered to the brain tissue of the subject when administered without the dose of the compound. ### Claim 22 A method of treating a brain disorder in a subject in need thereof, the method comprising intranasally administering to a nose of the subject: a) a dose of a compound, wherein the compound is N-acetylcysteine (NAC) or a pharmaceutically-acceptable salt thereof or glutathione (GSH); and b) a therapeutically-effective amount of a therapeutic agent, wherein the brain disorder is any of a traumatic brain injury, a mild traumatic brain injury, a concussion, post-concussion syndrome, a stroke, a neurodegenerative disease, dementia, Parkinson's disease, or an age-related disorder. ### Claim 23 (depends on 22) The method of claim 22, wherein the dose of the compound is a therapeutically-effective amount. ### Claim 24 (depends on 22) The method of claim 22, wherein the brain disorder is a concussion. ### Claim 25 (depends on 22) The method of claim 22, wherein the brain disorder is a mild traumatic brain injury. ### Claim 26 (depends on 22) The method of claim 22, wherein the brain disorder is a traumatic brain injury. ### Claim 27 (depends on 22) The method of claim 22, wherein the brain disorder is associated with athletic activity. ### Claim 28 (depends on 22) The method of claim 22, wherein the brain disorder is a neurodegenerative disease. ### Claim 29 (depends on 22) The method of claim 22, wherein the brain disorder is dementia. ### Claim 30 (depends on 22) The method of claim 22, wherein the brain disorder is age-related. ### Claim 31 (depends on 22) The method of claim 22, wherein the brain disorder is a stroke. ### Claim 32 (depends on 22) The method of claim 22, wherein substantially all of the dose of the compound enters the brain without crossing a blood brain barrier of the subject. ### Claim 33 (depends on 22) The method of claim 22, wherein the therapeutically-effective amount of the compound is about 1 mg/kg to about 10 mg/kg. ### Claim 34 (depends on 22) The method of claim 22, wherein the therapeutically-effective amount of the compound is from about 100 mg to about 400 mg. ### Claim 35 (depends on 22) The method of claim 22, wherein the dose of the compound is administered using a nasal pump. ### Claim 36 (depends on 22) The method of claim 22, wherein the dose of the compound is administered using an atomizer. ### Claim 37 (depends on 22) The method of claim 22, wherein the dose of the compound is administered using a nebulizer. ### Claim 38 (depends on 22) The method of claim 22, wherein substantially all of the dose of the compound enters a nasal cavity of the subject. ### Claim 39 (depends on 22) The method of claim 22, wherein the compound and the therapeutic agent are in a unit dose form. ### Claim 40 (depends on 22) The method of claim 22, wherein the administering delivers the therapeutically-effective amount of the therapeutic agent to a brain tissue of the subject in an amount that is at least about 20% greater than an amount of the therapeutic agent delivered to the brain tissue when administered without the dose of the compound. ### Claim 41 (depends on 22) The method of claim 22, wherein the administering delivers the therapeutically-effective amount of the therapeutic agent to a brain tissue of the subject in an amount that is at least about 30% greater than an amount of the therapeutic agent delivered to the brain tissue of the subject when administered without the dose of the compound. ### Claim 42 (depends on 22) The method of claim 22, wherein the administering delivers the therapeutically-effective amount of the therapeutic agent to a brain tissue of the subject in an amount that is at least about 50% greater than an amount of the therapeutic agent delivered to the brain tissue of the subject when administered without the dose of the compound. ### Claim 43 (depends on 22) The method of claim 22, wherein the brain disorder is Parkinson's disease.