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Claims for Patent: 3,975,536

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Claims for Patent: 3,975,536

Title: Composition
Abstract:There is described a composition comprising a substantially clear, sterile aqueous solution containing as active ingredient a therapeutically useful proportion of 1,3-bis(2-carboxy-chromon-5-yloxy)-propan-2-ol, or a pharmaceutically acceptable (e.g. the di-sodium) salt thereof, or 5,5'-[[5,5'-(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-yl]]t etrazole, or a pharmaceutically acceptable (e.g. the di-sodium) salt thereof. The composition is indicated for the treatment of conditions of the eye and the nose.
Inventor(s): Stevenson; Neil Arthur (Loughborough, EN), Wardell; George (Loughborough, EN)
Assignee: Fisons Limited (London, EN)
Application Number:05/471,141
Patent Claims: 1. In a pharmaceutical composition which comprises a sterile aqueous solution containing 1,3-bis(2-carboxy-chromon-5-yloxy)-propan-2-ol or a pharmaceutically acceptable salt thereof as an active ingredient, the improvement according to which the said active ingredient is present in an amount of from 0.1 to 10% w/v, the said composition contains less than about 0.40 ppm of ions of metals in Groups IIa, Ib, IIb and IVb of the Periodic Table and of the transition metals, the said composition being a substantially clear, sterile aqueous solution.

2. A composition according to claim 1 which additionally contains from 0.001 to 0.10% w/v of a pharmaceutically acceptable preservative, said composition being made up by mixing an aqueous solution containing the 1,3-bis(2-carboxy-chromon-5-yloxy)-propan-2-ol or a pharmaceutically effective salt thereof with an aqueous solution containing the preservative and subjecting the thus obtained admixture to filtration.

3. A composition according to claim 2 containing from 0.001 to 0.5% w/v of sodium 2-(ethyl mercuriothio)benzoate.

4. A composition according to claim 2 wherein the preservative is a member selected from the group of compounds of the formula ##SPC2##

wherein R is alkyl C.sub.8 H.sub.17 to C.sub.18 H.sub.37, and a mixture of such compounds.

5. A composition according to claim 4 containing from 0.005 to 0.10% w/v of the preservative.

6. In a pharmaceutical composition which comprises a sterile aqueous solution containing 1,3-bis(2-carboxy-chromon-5-yloxy)-propan-2-ol or a pharmaceutically acceptable salt thereof as an active ingredient, the improvement according to which the said active ingredient is present in an amount of from 0.1 to 10% w/v, the composition contains less than about 20 ppm of ions of metals in Groups IIa, Ib, IIb and IVb of the Periodic Table and of the transition metals, the composition contains from about 0.05 to 0.1% w/v of a pharmaceutically acceptable chelating or sequestering agent, and the said composition being a substantially clear aqueous solution.

7. A composition according to claim 6 wherein the chelating or sequestering agent is ethylene diamine tetraacetic acid or a salt thereof.

8. A composition according to claim 6 which additionally contains from 0.001 to 0.10% w/v of a pharmaceutically acceptable preservative, said composition being made up by mixing an aqueous solution containing the 1,3-bis(2-carboxy-chromon-5-yloxy)-propan-2-ol or a pharmaceutically acceptable salt thereof and the chelating or sequestering agent with an aqueous solution containing the preservative and subjecting the thus obtained admixture to filtration.
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