NASAL SPRAY FORMULATION WITH MOISTURIZING BENEFITS
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.
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.