Olopatadine formulations for topical nasal administration
View Patent ↗Topical formulations of olopatadine for treatment of allergic or inflammatory disorders of the nose are disclosed. The aqueous formulations contain approximately 0.6% (w/v) of olopatadine.
1. A method of treating allergic rhinitis comprising topically administering to a patient's nasal cavity an aqueous, nasal spray solution composition formed from ingredients consisting of
a) 0.665% (w/v) olopatadine hydrochloride;
b) a phosphate salt in an amount equivalent to 0.4-0.6% (w/v) dibasic sodium phosphate, wherein the phosphate salt selected from the group consisting of monobasic sodium phosphate; dibasic sodium phosphate; tribasic sodium phosphate; monobasic potassium phosphate; dibasic potassium phosphate; and tribasic potassium phosphate;
c) 0.35-0.45% (w/v) NaCl;
d) one or more pH-adjusting agents in an amount sufficient to cause the composition to have a pH of 3.6-3.8, wherein the pH-adjusting agents are selected from the group consisting of HCl and NaOH;
e) 0.005-0.015% (w/v) benzalkonium chloride;
f) 0.005-0.015% (w/v) edetate disodium; and
g) water;
wherein the composition has an osmolality of 260-330 mOsm/kg.
2. A method of treating allergic rhinitis comprising topically administering to a patient's nasal cavity an aqueous, nasal spray solution composition formed from ingredients consisting of
a) 0.665% (w/v) olopatadine hydrochloride;
b) 0.4-0.6% (w/v) dibasic sodium phosphate;
c) 0.35-0.45% (w/v) NaCl;
d) one or more pH-adjusting agents in an amount sufficient to cause the composition to have a pH of 3.6-3.8, wherein the pH-adjusting agents are selected from the group consisting of HCl and NaOH;
e) 0.01% (w/v) benzalkonium chloride;
f) 0.01% (w/v) edetate disodium; and
g) water;
wherein the composition has an osmolality of 260-330 mOsm/kg.