Details for Patent: 6,787,532

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 solubilising agent for assisting the solubilisation of the medicament in the aqueous carrier liquid.
Inventor(s):	Biggadike; Keith (Stevenage, GB), Sayani; Amyn P. (Mississauga, CA), Buxton; Ian (Mississauga, CA), Reed; Kenton (Mississauga, CA)
Assignee:	SmithKline Beecham Corporation (Philadelphia, PA)
Filing Date:	Feb 04, 2002
Application Number:	10/066,951
Claims:	1. A pharmaceutical formulation comprising an aqueous carrier liquid having dissolved therein (a) an ester of fluticasone or a solvate thereof as medicament, wherein the ester of fluticasone is a compound of formula (I) ##STR8## wherein R represents furan-2-yl 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 selected from the group consisting of a .alpha.-[4-(1,1,3,3-tetramehylbutyl)phenyl]-.omega.-hydroxypoly(oxy-1,2-et hanediyl) polymer (also known as a octylphenoxypolyethanol) and a 4-(1,1,3,3-Tetramethylbutyl)phenol polymer with formaldehyde and oxirane. 3. A pharmaceutical formulation according to claim 2 which further has dissolved therein a hydroxy containing organic co-solvating agent or phosphatidyl choline. 4. A pharmaceutical formulation according to claim 3 wherein the hydroxy containing organic co-solvating agent is dextrose. 5. A container containing a pharmaceutical formulation according to claim 1 fitted with a metering valve. 6. A device adapted for intranasal delivery of a pharmaceutical formulation comprising a container according to claim 5. 7. A method of treatment of inflammatory and/or allergic conditions of the nasal passages which comprises administering to the nose a pharnaceutical formulation according to claim 1. 8. The pharmaceutical composition according to claim 1, which further comprises at least one additional therapeutically active agent. 9. The pharmaceutical composition according to claim 8, wherein said at least one additional therapeutically active agent is a .beta..sub.2 -adrenoreceptor agonist. 10. The pharmaceutical composition according to claim 8, wherein said at least one additional therapeutically active agent is a PDE4 inhibitor. 11. The pharmaceutical composition according to claim 9, wherein said .beta..sub.2 -adrenoreceptor agonist is at least one selected from the group consisting of salmeterol, salbutamol, formoterol, fenoterol and terbutaline and salts thereof. 12. The pharmaceutical composition according to claim 8, wherein said at least one additional therapeutically active agent is an anti-histamine, anti-inflammatory agent or antiinfective agent. 13. The pharmaceutical composition according to claim 12, wherein said anti-histamine is methapyrilene or loratadine, said anti-inflammatory agent is an NSAID and said antiinfective agent is an antibiotic or antiviral. 14. The pharmaceutical composition according to claim 1, wherein the solubilising agent for assisting the solubilisation of the medicament in the aqueous carrier liquid is selected from the group consisting of Triton X-100, Tyloxapol and Triton X-305. 15. The pharmaceutical composition according to claim 3, wherein the hydroxyl containing organic co-solvating agent is PEG 200, propylene glycol or dextrose. 16. A method for the treatment of at least one condition selected from the group consisting of rhinitis, dermatitis, asthma and chronic obstructive pulmonary disease (COPD) in a human or animal subject, which comprises administering an effective amount of the composition as defined in claim 1 to said human or animal subject in need thereof for the treatment of said at least one condition. 17. The method of treatment as recited in claim 16, wherein said composition is administered by inhalation or by nebulisation. 18. An inhaler comprising the composition as defined in claim 1.