# US 2024/0189348 A1 · Non-infective nasal symptom management compositions and methods

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- Number: US 2024/0189348 A1
- Document ID: US20240189348A1
- Status: Published application
- Kind: A1
- Application number: 18/583,611
- Filed: 2024-02-21
- Published: 2024-06-13
- Earliest claimed: 2018-10-22
- Assignees: CMPD Licensing, LLC
- Applicants: CMPD Licensing, LLC
- Inventors: Jay Richard Ray, II
- Web page: https://patentgrep.com/patent/US20240189348A1

## CPC

- A61K 33/30: Zinc; Compounds thereof
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/0043: {Nose}
- A61K 9/4858: {Organic compounds}
- A61K 9/4866: {Organic macromolecular compounds}
- A61K 31/194: having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
- 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 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
- A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- A61K 35/742: Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
- A61K 35/744: Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K 35/745: Bifidobacteria
- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61K 36/064: Saccharomycetales, e.g. baker's yeast
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 9/0078: {for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions}
- 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

A method of managing non-infective nasal symptoms may include formulating a topical composition for nasal administration. The formulation may include zinc, acetylcysteine, azelastine, one or more probiotics, or a combination thereof. The formulation may also include additional ingredients such as a steroid, poloxamers, or xylitol. Ingredients of the topical composition may be provided in a dry powder format within a capsule for combining with an aqueous diluent at the time of administration. The topical composition may be administered nasally.

## Claims

### Claim 1

A method of managing non-infective nasal symptoms, the method comprising:
topically administering to a nasal cavity of a human a unit dose of a topical nasal composition to manage a non-infective nasal symptom, the topical nasal composition comprising active agents in an aqueous diluent, wherein the active agents include zinc or pharmaceutical salt thereof and a probiotic component, and wherein each unit dose in the topical nasal composition includes between about 1 mg and about 30 mg zinc.

### Claim 2 (depends on 1)

The method of claim 1, wherein administering comprises combining the active agents with the aqueous diluent at time of the topical administration to the nasal cavity.

### Claim 3 (depends on 2)

The method of claim 2, wherein the aqueous diluent comprises water, distilled water, sterile water, water for irrigation, water for injection, or sodium chloride solution.

### Claim 4 (depends on 1)

The method of claim 1, wherein the aqueous diluent comprises water, distilled water, sterile water, water for irrigation, water for injection, or sodium chloride solution.

### Claim 5 (depends on 1)

The method of claim 1, wherein the probiotic component comprises one or more probiotics selected from the genus Bacillus, Bifidobacteria, Enterococcus, Escherichia, Lactobacillus, Saccharomyces, or Streptococcus.

### Claim 6 (depends on 1)

The method of claim 1, wherein the active agents further include acetylcysteine and azelastine, and wherein each unit dose of the topical nasal composition includes between about 50 mg and about 300 mg acetylcysteine and between about 100 mcg and about 1,000 mcg azelastine.

### Claim 7 (depends on 6)

The method of claim 6, wherein the probiotic component comprises one or more probiotics selected from the genus Bacillus, Bifidobacteria, Enterococcus, Escherichia, Lactobacillus, Saccharomyces, or Streptococcus.

### Claim 8 (depends on 7)

The method of claim 7, wherein the aqueous diluent comprises water, distilled water, sterile water, water for irrigation, water for injection, or sodium chloride solution.

### Claim 9 (depends on 8)

The method of claim 8, wherein each unit dose of the topical nasal composition comprises the probiotic component in an amount between 1 billion CFU and 80 billion CFU.

### Claim 10 (depends on 9)

The method of claim 9, wherein administering comprises combining the active agents with the aqueous diluent at time of the topical administration to the nasal cavity.

### Claim 11 (depends on 10)

The method of claim 10, wherein the probiotic component comprises one or more probiotics selected from the genus Bacillus, Enterococcus, or Escherichia.