Granted Patent B2

US 12,605,363 · App. 18/146,127 · Granted Apr 21, 2026

Inventors: Tina deVries (Bridgewater, NJ); David Jacobs (Bernardsville, NJ)

Assignee: RVL Pharmaceuticals, Inc.

A61K31/4164A61F9/0008A61K9/0048A61K47/02A61K47/12A61K47/38A61P27/02

Abstract

Claims (45)

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.

Assignments (3)

Continuity (8)

References Cited (111)