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Details for Patent: 7,531,528

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Details for Patent: 7,531,528

Title:Formulation containing anti-inflammatory androstane derivatives
Abstract: There is provided according to the invention a pharmaceutical formulation comprising an aqueous carrier liquid having dissolved therein (a) an ester of fluticasone or a solvate thereof as medicament and (b) a solubilizing agent for assisting the solubilization of the medicament in the aqueous carrier liquid.
Inventor(s): Biggadike; Keith (Stevenage, GB), Sayani; Amyn (Mississauga, CA), Buxton; Ian (Mississauga, CA), Reed; Kenton (Mississauga, CA)
Assignee: Glaxo Group Limited (Greenford, Middlesex, GB)
Filing Date:Aug 13, 2004
Application Number:10/918,770
Claims:1. A pharmaceutical formulation comprising an aqueous carrier liquid having dissolved therein (a) a glucocorticoid of formula (I) ##STR00008## wherein R represents a 5 membered heterocyclic aromatic ring containing 1 to 3 heteroatoms selected from O, N and S, or a solvate thereof, as a medicament; and (b) a solubilising agent for assisting the solubilisation of the medicament in the aqueous carrier liquid.

2. A pharmaceutical formulation according to claim 1 wherein the solubilising agent is a surfactant.

3. A pharmaceutical formulation according to claim 2 wherein the surfactant is selected from the group consisting of a .alpha.-[4-(1,1,3,3-tetramethylbutyl)phenyl]-.omega.-hydroxypoly (oxy-1,2-ethanediyl) polymer and a 4-(1,1,3,3-Tetramethylbutyl) phenol polymer with formaldehyde and oxirane.

4. A pharmaceutical formulation according to claim 3 wherein the surfactant is a 4-(1,1,3,3-Tetramethylbutyl)phenol polymer with formaldehyde and oxirane.

5. A pharmaceutical formulation according to claim 2 which further has dissolved therein a hydroxy containing organic co-solvating agent or phosphatidyl choline.

6. A pharmaceutical formulation according to claim 5 wherein the hydroxy containing organic co-solvating agent is dextrose.

7. A pharmaceutical formulation according to claim 1 wherein the formulation further comprises chloride as an isotonic agent.

8. A pharmaceutical formulation according to claim 1 which comprises another therapeutically active agent.

9. A pharmaceutical formulation according to claim 8 wherein the other therapeutically active agent is an anti-histamine or an anti-allergic.

10. A container containing a pharmaceutical formulation according to claim 1, fitted with a metering valve.

11. A device adapted for intranasal delivery of a pharmaceutical formulation comprising a container according to claim 10.

12. A method of treatment of inflammatory and/or allergic conditions of the nasal passages which comprises administering to the nose a pharmaceutical formulation according to claim 1.

13. The method according to claim 12 wherein the administration is once-per-day.

14. A process for preparing a pharmaceutical formulation which comprises: (a) providing: (i) a glucocorticoid of formula (I) ##STR00009## wherein R represents a 5 membered heterocyclic aromatic ring containing 1 to 3 heteroatoms selected from O, N and S, optionally substituted by one or more methyl or halogen atoms or a solvate thereof, as a medicament; (ii) water and (iii) a solubilizing agent for assisting the solubilization of the medicament in the aqueous carrier liquid, wherein said solubilizing agent is a surfactant; (b) dissolving the glucocorticoid of formula (I) in the undiluted surfactant at a temperature of at least 60.degree. C., to form a mixture of glucocorticoid and surfactant; (c) heating said water to a temperature of at least 60.degree. C., and combining said heated water to said mixture of glucocorticoid and surfactant to achieve the desired concentration of active ingredient; (d) optionally modifying the pH of the final solution; (e) filtering the hot solution comprising of water, surfactant and medicament to remove any residual particulate matter.
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