Claims for Patent: 12,605,363

Summary for Patent: 12,605,363

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:	Revitalid Inc , RVL Pharmaceuticals Inc
Application Number:	US18/146,127
Patent Claims:	1. An aqueous ophthalmic, sterile, preservative-free formulation for treating ptosis 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 maintains the pH range from about 5.8 to about 6.8 for a period of 24 months, and wherein the formulation delivers about 0.035 mg of oxymetazoline hydrochloride per drop. 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 has a viscosity from about 15 cPs to about 35 cPs. 8. The formulation of claim 1, wherein the formulation has an osmolality from about 290 mOsm/kg to about 365 mOsm/kg. 9. 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 mOsm/kg to about 365 mOsm/kg for a period of 24 months. 10. 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 mOsm/kg to about 330 mOsm/kg for a period of 6 months. 11. An aqueous ophthalmic, sterile, preservative-free stable formulation for treating ptosis 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) about 0.5 wt % of a viscosity modifier; i) hydrochloric acid; and j) water; wherein the formulation has a viscosity from about 15 cPs to about 35 cPs, wherein the formulation maintains the viscosity from about 15 cPs to about 35 cPs for a period of 24 months, and wherein the formulation delivers about 0.035 mg of oxymetazoline hydrochloride per drop. 12. The formulation of claim 11, wherein the viscosity modifier comprises hypromellose. 13. The formulation of claim 12, wherein the viscosity modifier comprises about 0.5 wt % hypromellose. 14. The formulation of claim 11, wherein the sodium acetate is sodium acetate trihydrate and the sodium citrate is sodium citrate dihydrate. 15. The formulation of claim 11, wherein the calcium chloride is calcium chloride dihydrate and the magnesium chloride is magnesium chloride hexahydrate. 16. The formulation of claim 11, wherein the formulation has a pH range from about 5.8 to about 6.8. 17. The formulation of claim 11, wherein the formulation has a pH range from about 6.3 to about 6.5. 18. The formulation of claim 11, wherein the formulation has an osmolality from about 290 mOsm/kg to about 365 mOsm/kg. 19. The formulation of claim 11, 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 mOsm/kg to about 365 mOsm/kg for a period of 24 months. 20. The formulation of claim 11, wherein the formulation maintains a pH range from about 5.8 to about 6.8 and an osmolality from about 290 mOsm/kg to about 330 mOsm/kg for a period of 6 months.