Claims for Patent: 11,103,482

Summary for Patent: 11,103,482

Title:	Oxymetazoline compositions
Abstract:	The present disclosure is directed to compositions comprising oxymetazoline and methods of stabilizing oxymetazoline compositions for long term storage.
Inventor(s):	Tina deVries, David Jacobs
Assignee:	RVL Pharmaceuticals Inc
Application Number:	US17/154,676
Patent Claims:	1. A single use container comprising an aqueous ophthalmic, sterile, preservative-free formulation consisting of: a) about 0.1 wt % oxymetazoline hydrochloride; b) tonicity modifiers comprising sodium chloride, potassium chloride, calcium chloride, and magnesium chloride; c) about 0.5 wt % to about 1.0 wt % of hypromellose or sodium carboxymethyl cellulose; d) sodium acetate and sodium citrate; e) hydrochloric acid; and f) water QS, wherein the aqueous ophthalmic formulation has a pH range from about 5.8 to about 6.8, wherein the aqueous ophthalmic formulation has a viscosity of from 15 cPs to 35 cPs, and wherein the aqueous ophthalmic formulation has an osmolality of from about 290 to about 365 mOsm/kg. 2. The single use container of claim 1, wherein the tonicity modifier comprises about 0.64 wt % of sodium chloride, about 0.075 wt % of potassium chloride, about 0.048 wt % of calcium chloride, and about 0.03 wt % of magnesium chloride. 3. The single use container of claim 1, wherein the calcium chloride is calcium chloride dihydrate and the magnesium chloride is magnesium chloride hexahydrate. 4. The single use container of claim 1, wherein the sodium acetate is sodium acetate trihydrate and the sodium citrate is sodium citrate dihydrate. 5. The single use container of claim 1 comprising about 0.39 wt % sodium acetate and about 0.17 wt % sodium citrate. 6. The single use container of claim 1 comprising about 0.5 wt % hypromellose. 7. The single use container of claim 1 comprising about 1.0 wt % sodium carboxymethyl cellulose. 8. The single use container of claim 1, wherein the formulation has a pH range from about 6.3 to about 6.5. 9. The single use container of claim 1, wherein the aqueous ophthalmic formulation has an osmolality of from about 290 to about 330 mOsm/kg. 10. The single use container of claim 1, wherein the formulation is stable at a temperature of about 25° C. and about 40% or 60% relative humidity for a period of 24 months. 11. The single use container of claim 1, wherein the formulation has a viscosity of about 26 cPs. 12. The single use container of claim 1, wherein the fill of the container is about 0.3 mL. 13. The single use container of claim 1, wherein the container is a low density polyethylene container. 14. The single use container of claim 1, wherein the container delivers about 0.035 mg of oxymetazoline hydrochloride per drop. 15. The single use container of claim 1, wherein the 0.1 wt % oxymetazoline hydrochloride is equivalent to about 0.09 wt % of oxymetazoline free base. 16. The single use container of claim 1, wherein the formulation is aseptically prepared. 17. The single use container of claim 1, wherein volume of the container is about 0.5 mL. 18. The single use container of claim 1, wherein the container is in a foil pouch. 19. The single use container of claim 1, wherein the container is in child resistant packaging. 20. The single use container of claim 1, wherein the container is formed by a blow/fill/seal process.