Claims for Patent: 11,311,515

Summary for Patent: 11,311,515

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:	17/461,052
Patent Claims:	1. A child-resistant packaging having a single use container enclosed therein, wherein the single use container comprises an aqueous ophthalmic, sterile, preservative-free formulation comprising: a) about 0.1 wt % oxymetazoline or a pharmaceutically acceptable salt thereof; b) sodium chloride, potassium chloride, calcium chloride, and magnesium chloride; c) about 0.5 wt % hypromellose; d) sodium acetate and sodium citrate; e) hydrochloric acid; and f) water, wherein the formulation has a pH range from about 5.8 to about 6.8; wherein the container delivers about 0.035 mg of oxymetazoline or a pharmaceutically acceptable salt thereof per drop; and wherein the formulation has a viscosity of about 15 cPs to about 35 cPs. 2. The child-resistant packaging of claim 1, wherein the packaging is a foil pouch. 3. The child-resistant packaging of claim 2, wherein the foil pouch is a foil laminate pouch. 4. The child-resistant packaging of claim 1, wherein the formulation has an osmolality of from about 290 to about 365 mOsm/kg. 5. The child-resistant packaging of claim 1, wherein the container is formed by a blow/fill/seal process. 6. The child-resistant packaging of claim 1, wherein the container is a low density polyethylene container. 7. The child-resistant packaging of claim 1, wherein the pharmaceutically acceptable salt is oxymetazoline hydrochloride. 8. The child-resistant packaging of claim 1, wherein the formulation 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. 9. The child-resistant packaging of claim 8, wherein the calcium chloride is calcium chloride dihydrate and the magnesium chloride is magnesium chloride hexahydrate. 10. The child-resistant packaging of claim 1, wherein the sodium acetate is sodium acetate trihydrate and the sodium citrate is sodium citrate dihydrate. 11. The child-resistant packaging of claim 1, wherein the formulation comprises about 0.39 wt % sodium acetate and about 0.17 wt % sodium citrate. 12. The child-resistant packaging of claim 1, wherein the formulation has a pH range from about 6.3 to about 6.5. 13. The child-resistant packaging 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 6 months. 14. The child-resistant packaging of claim 1, wherein the formulation is aseptically prepared. 15. A child-resistant foil pouch having a single use low density polyethylene container enclosed therein, wherein the single use container comprises an aqueous ophthalmic, sterile, preservative-free formulation comprising: a) about 0.1 wt % oxymetazoline hydrochloride; b) sodium chloride, potassium chloride, calcium chloride, and magnesium chloride; c) about 0.5 wt % hypromellose; d) sodium acetate and sodium citrate; e) hydrochloric acid; and f) 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, wherein the formulation has an osmolality of from about 290 to about 365 mOsm/kg, and wherein the container delivers about 0.035 mg of oxymetazoline or a pharmaceutically acceptable salt thereof per drop. 16. The child-resistant foil pouch of claim 15, wherein the foil pouch is a foil laminate pouch. 17. The child-resistant foil pouch of claim 15, wherein the fill of the container is about 0.3 mL. 18. The child-resistant foil pouch of claim 15, wherein volume of the container is about 0.5 mL. 19. The child-resistant foil pouch of claim 15, wherein the container is formed by a blow/fill/seal process. 20. The child-resistant foil pouch of claim 15, wherein the formulation comprises about 0.64 wt % of sodium chloride, about 0.075 wt % of potassium chloride, about 0.048 wt % of calcium chloride or calcium chloride dihydrate, and about 0.03 wt % of magnesium chloride or magnesium chloride hexahydrate. 21. The child-resistant foil pouch of claim 15, wherein the sodium acetate is sodium acetate trihydrate and the sodium citrate is sodium citrate dihydrate. 22. The child-resistant foil pouch of claim 15, wherein the formulation comprises about 0.39 wt % sodium acetate and about 0.17 wt % sodium citrate. 23. The child-resistant foil pouch of claim 15, 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 6 months. 24. The child-resistant packaging of claim 13, wherein the formulation maintains the pH range, the viscosity range and the osmolality range for a period of 12 months. 25. The child-resistant packaging of claim 13, wherein the formulation maintains the pH range, the viscosity range and the osmolality range for a period of 18 months. 26. The child-resistant packaging of claim 13, wherein the formulation maintains the pH range, the viscosity range and the osmolality range at a temperature of about 25.degree. C. and about 60% relative humidity. 27. The child-resistant foil pouch of claim 23, wherein the formulation maintains the pH range, the viscosity range and the osmolality range for a period of 12 months. 28. The child-resistant foil pouch of claim 23, wherein the formulation maintains the pH range, the viscosity range and the osmolality range for a period of 18 months. 29. The child-resistant foil pouch of claim 23, wherein the formulation maintains the pH range, the viscosity range and the osmolality range at a temperature of about 25.degree. C. and about 60% relative humidity.