Olopatadine formulations for topical nasal administration

  • US 7,977,376 B2
  • Filed: 02/07/2007
  • Issued: 07/12/2011
  • Est. Priority Date: 06/27/2001
  • Status: Active Grant
First Claim
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1. A topically administrable, aqueous, nasal spray solution composition consisting ofa) 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.

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