Oxymetazoline compositions
The present disclosure is directed to compositions comprising oxymetazoline and methods of stabilizing oxymetazoline compositions for long term storage.
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.