IP Library Patent Application 17918790
Patent Application
App. No. 17/918,790

NASAL SPRAY FORMULATION WITH MOISTURIZING BENEFITS

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Quick Facts
Patent No.
US None
App. No.
17/918,790
Abstract

Aspects of the present invention are directed to a nasal spray formulation comprising: at least one active pharmaceutical ingredient, glycerin, polyethylene glycol, and dextrose. Formulations of the present invention provide moisturizing benefits and retain at least about 3% water when exposed to about 80% relative humidity at a temperature of about 23° C. for about 750 minutes in a Dynamic Vapor Sorption (DVS) test.

Claims (33)

1 . A nasal spray formulation comprising:

at least one active pharmaceutical ingredient;

glycerin;

polyethylene glycol; and

dextrose, and

water

wherein the formulation retains at least about 3% water when exposed to about 80% relative humidity at a temperature of about 23° C. for about 750 minutes in a Dynamic Vapor Sorption (DVS) test.

2 . The nasal spray formulation of claim 1 , wherein the formulation has a pH between about 5 and about 7.

3 . The nasal spray formulation of claim 1 , wherein the formulation has an osmolarity between about 100 mOsmoles and about 800 mOsmoles.

4 . The nasal spray formulation of claim 1 , wherein the active pharmaceutical ingredient is present in an amount between about 0.005% w/w and about 0.2% w/w.

5 . The nasal spray formulation of claim 1 , wherein the active pharmaceutical ingredient is fluticasone propionate, fluticasone furoate, azelastine, oxymetazoline, xylometazoline, beclomethasone, mometasone, budesonide, salts and esters thereof, or a combination thereof.

6 . The nasal spray formulation of claim 5 , wherein the active pharmaceutical ingredient is fluticasone propionate.

7 . The nasal spray formulation of claim 1 , wherein the formulation is isotonic.

8 . The nasal spray formulation of claim 7 , wherein the formulation comprises an isotonicity adjusting agent being sodium chloride, dextrose, potassium chloride, or a combination thereof.

9 . The nasal spray formulation of claim 8 , wherein the isotonicity adjusting agent is sodium chloride.

10 . The nasal spray formulation of claim 1 , wherein glycerin is present in an amount between about 0.5% w/w and about 8% w/w.

11 . The nasal spray formulation of claim 1 , wherein polyethylene glycol is present in an amount between about 0.5% w/w and about 20% w/w.

12 . The nasal spray formulation of claim 1 , wherein the polyethylene glycol has an average molecular weight between about 200 and about 600.

13 . The nasal spray formulation of claim 12 , wherein the polyethylene glycol has an average molecular weight of about 400.

14 . The nasal spray formulation of claim 1 , wherein dextrose is present in an amount between about 0.3% w/w and about 7% w/w.

15 . The nasal spray formulation of claim 1 , wherein the formulation has a droplet size distribution of about 10% of droplets are less than about 18 μm, about 50% of droplets are between about 33 μm and about 51 μm, and about 90% of droplets are less than about 120 μm, at Tzero.

16 . The nasal spray formulation of claim 1 , wherein about 100% of the active pharmaceutical ingredient particles are less than about 10 μm at Tzero.

17 . A method for treating the symptoms of allergic rhinitis whereby the nasal cavity feels moisturized, comprising administering the nasal spray formulation according to claim 1 .

18 . A method for treating the symptoms of allergic rhinitis whereby a gently soothing sensation is provided in the nasal cavity, comprising administering the nasal spray formulation according to claim 1 .

19 . A method of treating the symptoms of allergic rhinitis whereby the nasal cavity feels comfortable, comprising administering the nasal spray formulation according to claim 1 .

20 . The nasal spray formulation of claim 1 , comprising:

the at least one active pharmaceutical ingredient in an amount between about 0.005% w/w and about 0.2% w/w,

glycerin in an amount between about 0.5% w/w and about 8% w/w,

polyethylene glycol having an average molecular weight of about 400 in an amount between about 0.5% w/w and about 20% w/w,

dextrose in an amount between about 0.3% w/w and about 7% w/w, and

water in an amount between about 80% w/w and about 99% w/w,

all weight percents being based on the total weight of the formulation.

21 . A nasal spray formulation according to claim 20 wherein the active pharmaceutical ingredient comprises fluticasone propionate or fluticasone furoate.

Assignments (2)
CHANGE OF NAME Recorded Jan 18, 2024
From: GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
To: HALEON US HOLDINGS LLC
Reel/Frame 066344/0609 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 13, 2022
From: AKUNURI, VENKATA VIJAY KUMAR; BULSARA, PALLAV ARVIND; PATEL, MANESHKUMAR P.
To: GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
Reel/Frame 061415/0532 →