Claims for Patent: 10,898,573

Summary for Patent: 10,898,573

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):	deVries; Tina (Bridgewater, NJ), Jacobs; David (Bernardsville, NJ)
Assignee:	RVL Pharmaceuticals, Inc. (Bridgewater, NJ)
Application Number:	17/064,915
Patent Claims:	1. An aqueous ophthalmic, sterile, preservative-free formulation comprising: a) about 0.1 wt % oxymetazoline hydrochloride; b) about 0.64 wt % sodium chloride; c) about 0.075 wt % potassium chloride; d) about 0.048 wt % calcium chloride; e) about 0.03 wt % magnesium chloride; f) about 0.39 wt % sodium acetate and about 0.17 wt % sodium citrate; g) about 0.5 wt % hypromellose; and wherein the aqueous ophthalmic formulation has a pH range from about 5.8 to about 6.8, and wherein the aqueous ophthalmic formulation has a viscosity of from about 15 cPs to about 35 cPs. 2. The ophthalmic formulation of claim 1, wherein the 0.1 wt % oxymetazoline hydrochloride is equivalent to about 0.09 wt % of oxymetazoline free base. 3. The ophthalmic formulation of claim 1, wherein the sodium acetate is sodium acetate trihydrate and the sodium citrate is sodium citrate dihydrate. 4. The ophthalmic formulation of claim 1, wherein the formulation further comprises a pH adjuster. 5. The ophthalmic formulation of claim 4, wherein the pH adjuster is hydrochloric acid. 6. The ophthalmic formulation of claim 1, wherein the formulation has a pH range from about 6.3 to about 6.5. 7. The ophthalmic formulation of claim 1, wherein the formulation further comprises water QS. 8. The ophthalmic formulation of claim 1, wherein the formulation is aseptically prepared. 9. The ophthalmic formulation of claim 1, wherein the formulation is stable at a temperature of from about 20.degree. C. to about 30.degree. C. and about 40% or 60% relative humidity for a period of at least 24 months. 10. The ophthalmic formulation of claim 1, wherein the formulation has a viscosity of about 26 cPs. 11. The ophthalmic formulation of claim 1, wherein the formulation is an eye drop. 12. The ophthalmic formulation of claim 1, wherein the formulation is for topical application to the eye. 13. The ophthalmic formulation of claim 1, wherein the calcium chloride is calcium chloride dihydrate and the magnesium chloride is magnesium chloride hexahydrate. 14. A single use container comprising the ophthalmic formulation of claim 1. 15. A single use container comprising an aqueous ophthalmic, sterile, preservative-free formulation comprising: a) about 0.1 wt % oxymetazoline hydrochloride; b) about 0.64 wt % sodium chloride; c) about 0.075 wt % potassium chloride; d) about 0.048 wt % calcium chloride; e) about 0.03 wt % magnesium chloride; f) about 0.39 wt % sodium acetate and about 0.17 wt % sodium citrate; g) about 0.5 wt % hypromellose; h) a pH adjuster; and i) water QS; wherein the aqueous ophthalmic formulation has a pH range from about 5.8 to about 6.8, and wherein the aqueous ophthalmic formulation has a viscosity of from about 15 cPs to about 35 cPs. 16. The single use container of claim 15, wherein the 0.1 wt % oxymetazoline hydrochloride is equivalent to about 0.09 wt % of oxymetazoline free base. 17. The single use container of claim 15, wherein the sodium acetate is sodium acetate trihydrate and the sodium citrate is sodium citrate dihydrate. 18. The single use container of claim 15, wherein the pH adjuster is hydrochloric acid. 19. The single use container of claim 15, wherein the formulation has a pH range from about 6.3 to about 6.5. 20. The single use container of claim 15, wherein the formulation is aseptically prepared. 21. The single use container of claim 15, wherein the formulation is stable at a temperature of from about 20.degree. C. to about 30.degree. C. and about 40% or 60% relative humidity for a period of at least 24 months. 22. The single use container of claim 15, wherein the formulation has a viscosity of about 26 cPs. 23. The single use container of claim 15, wherein volume of the container is about 0.5 mL. 24. The single use container of claim 15, wherein the fill of the container is about 0.3 mL. 25. The single use container of claim 15, wherein the container is a low density polyethylene container. 26. The single use container of claim 15, wherein the container is in a foil pouch. 27. The single use container of claim 15, wherein the container is in child resistant packaging. 28. The single use container of claim 15, wherein the container delivers about 0.035 mg of oxymetazoline hydrochloride per drop. 29. The single use container of claim 15, wherein the calcium chloride is calcium chloride dihydrate and the magnesium chloride is magnesium chloride hexahydrate. 30. An aqueous ophthalmic, sterile, preservative-free formulation consisting of: a) about 0.1 wt % oxymetazoline hydrochloride; b) about 0.64 wt % sodium chloride; c) about 0.075 wt % potassium chloride; d) about 0.048 wt % calcium chloride; e) about 0.03 wt % magnesium chloride; f) about 0.39 wt % sodium acetate and about 0.17 wt % sodium citrate; g) about 0.5 wt % hypromellose; h) a pH adjuster; and i) 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 about 15 cPs to about 35 cPs and wherein the formulation is stable at a temperature of about 25.degree. C. for 24 months.