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Last Updated: April 15, 2026

Claims for Patent: 11,541,036

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Summary for Patent: 11,541,036

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:	US17/728,860
Patent Claims:	1. An aqueous ophthalmic, sterile, preservative-free formulation comprising 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 0.05 wt % to about 1.0 wt % one or more suitable buffers; g) about 0.5 wt % hypromellose; h) hydrochloric acid; and i) water; wherein the formulation has a pH range from about 5.8 to about 6.8, wherein the formulation has a viscosity of from about 15 cPs to about 35 cPs, and wherein the formulation has an osmolality of from about 290 to about 365 mOsm/kg. 2. The formulation of claim 1, wherein the one or more suitable buffers comprise sodium acetate and sodium citrate. 3. The formulation of claim 2, wherein the one or more suitable buffers comprise about 0.39 wt % sodium acetate and about 0.17 wt % sodium citrate. 4. The formulation of claim 3, wherein the sodium acetate is sodium acetate trihydrate and the sodium citrate is sodium citrate dihydrate. 5. The formulation of claim 1, wherein the calcium chloride is calcium chloride dihydrate and the magnesium chloride is magnesium chloride hexahydrate. 6. The formulation of claim 1, wherein the formulation has a pH range from about 6.3 to about 6.5. 7. The formulation of claim 1, wherein the formulation maintains a pH range from about 5.8 to about 6.8, a viscosity from about 15 cPs to about 35 cPs, and an osmolality from about 290 to about 365 mOsm/kg for a period of 24 months. 8. The formulation of claim 1, wherein the formulation maintains a pH range from about 5.8 to about 6.8 and an osmolality from about 290 to about 330 mOsm/kg for a period of 6 months. 9. 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; g) about 0.17 wt % sodium citrate; h) a viscosity modifier; i) hydrochloric acid; and j) water; wherein the formulation has a pH range from about 5.8 to about 6.8, wherein the formulation has a viscosity of from about 15 cPs to about 35 cPs, and wherein the formulation has an osmolality of from about 290 to about 365 mOsm/kg. 10. The formulation of claim 9, wherein the viscosity modifier comprises hypromellose. 11. The formulation of claim 10, wherein the formulation comprises about 5 wt % hypromellose. 12. The formulation of claim 9, wherein the sodium acetate is sodium acetate trihydrate and the sodium citrate is sodium citrate dihydrate. 13. The formulation of claim 9, wherein the calcium chloride is calcium chloride dihydrate and the magnesium chloride is magnesium chloride hexahydrate. 14. The formulation of claim 9, wherein the formulation has a pH range from about 6.3 to about 6.5. 15. The formulation of claim 9, wherein the formulation maintains a pH range from about 5.8 to about 6.8, a viscosity from about 15 cPs to about 35 cPs, and an osmolality from about 290 to about 365 mOsm/kg for a period of 24 months. 16. The formulation of claim 9, wherein the formulation maintains a pH range from about 5.8 to about 6.8 and an osmolality from about 290 to about 330 mOsm/kg for a period of 6 months.

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