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Claims for Patent: 7,977,376

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Claims for Patent: 7,977,376

Title:Olopatadine formulations for topical nasal administration
Abstract: 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.
Inventor(s): Singh; Onkar N. (Arlington, TX), Wall; G. Michael (Fort Worth, TX), Jani; Rajni (Fort Worth, TX), Chowhan; Masood A. (Arlington, TX), Han; Wesley Wehsin (Arlington, TX)
Assignee: Novartis AG (Basal, CH)
Application Number:11/703,373
Patent Claims: 1. A topically administrable, aqueous, nasal spray solution composition 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 topically administrable, aqueous, nasal spray solution composition 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.
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