IP Library › Patent Application 15033171
Patent Application
App. No. 15/033,171

FORMULATION OF OLOPATADINE

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Quick Facts
Patent No.
US None
App. No.
15/033,171
Abstract

Stable formulations of Olopatadine, methods of making such formulations and methods of treatment using such formulations are provided.

Claims (20)

1 . A pharmaceutical composition comprising an aqueous solution of 11-(3 dimethylaminopropylidene)-6,11-dihydrodibenz(b,e) oxepin-2-acetic acid or a pharmaceutically acceptable salt thereof, and polyvinyl alcohol at a concentration of greater than 0.50% w/w and less than 1.75% w/w, wherein the pH is between 5.0 and 8.0, and the osmolality is between 260 and 340 mOsm/kg.

2 . The pharmaceutical composition of claim 1 , wherein the 11-(3 dimethylamino)propylidene]-6-11-dihydrodibenz[b,e]oxepin-2-acetic acid is 11-([Z]-3 dimethylaminopropylidene)-6- 11 dihydrodibenz(b,e) oxepin-2-acetic acid.

3 . The pharmaceutical composition of claim 1 , wherein the 11-(3 dimethylaminopropylidene)-6,11-dihydrodibenz(b,e) oxepin-2-acetic acid is present in an amount between 0.5 mg/mL and 3.0 mg/mL.

4 . The pharmaceutical composition of claim 1 , wherein the 11-(3 dimethylaminopropylidene)-6,11-dihydrodibenz(b,e) oxepin-2-acetic acid is present in an amount between 1.5 mg/mL and 2.5 mg/mL.

5 . The pharmaceutical composition of claim 1 , further comprising a chelating agent.

6 . The pharmaceutical composition of claim 1 , further comprising a buffer.

7 . The pharmaceutical composition of claim 6 , further wherein the buffer is disodium phosphate and sodium chloride.

8 . The pharmaceutical composition of claim 1 , wherein the formulation is free of benzalkonium chloride.

9 . The pharmaceutical composition of claim 1 , wherein the formulation is free of polymeric quaternary ammonium compounds.

10 . The pharmaceutical composition of claim 1 , wherein the formulation is free of any preservative.

11 . The pharmaceutical composition of claim 1 , wherein the formulation is free of povidone.

12 . The pharmaceutical composition of claim 1 , wherein the formulation is free of benzalkonium chloride and free of povidone.

13 . The pharmaceutical composition of claim 1 , wherein the polyvinyl alcohol is at a concentration of between 0.60 and 1.50% w/w.

14 . The pharmaceutical composition of claim 1 , wherein the polyvinyl alcohol is at a concentration of between 0.75 and 1.35% w/w.

15 . A pharmaceutical composition comprising an aqueous solution containing 11-[(Z)-3-(Dimethylamino)propylidene]-6-11-dihydrodibenz[b,e]oxepin-2-acetic acid present in an amount between 1.5 mg/mL and 2.5 mg/mL, polyvinyl alcohol at a concentration of between 0.50 and 1.75% w/w, disodium phosphate, sodium chloride, and EDTA, and wherein the pH of the composition is between 5.0 and 8.0, and the osmolality is between 260 and 340 mOsm/kg.

16 . The pharmaceutical composition of claim 15 , wherein the pharmaceutical composition is free of benzalkonium chloride and free of povidone.

17 . The pharmaceutical composition of claim 16 , wherein the pharmaceutical composition is free of any preservative.

18 . A method of treating an allergic condition comprising administering topically to the eye a pharmaceutical composition of claim 1 .

19 . The pharmaceutical composition of claim 1 , wherein the pH is between 6.8 and 7.2.

20 . The pharmaceutical composition of claim 15 , wherein the pH is between 6.8 and 7.2.