Details for Patent: 8,367,685

Title:	Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Abstract:	Stable pharmaceutical compositions include the compound of the below formula, or pharmaceutically acceptable salts, solvates, hydrates or morphological forms thereof: ##STR00001##
Inventor(s):	Adesuyi; Charles Tokunbo (Swindon, GB), Holman; Lovelace (Arlesheim, CH), Lambert; Olivier (Spechbach-le-Haut, FR), Lithgow; Bruce Hamilton (Bath, GB)
Assignee:	Actelion Pharmaceuticals, Ltd. (Allschwil, CH)
Filing Date:	Feb 18, 2009
Application Number:	12/388,142
Claims:	1. A pharmaceutical composition comprising: a) the compound of the formula I as drawn below ##STR00004## or a pharmaceutically acceptable salt, solvate, hydrate or morphological form thereof, b) a filler, consisting of lactose monohydrate with microcrystalline cellulose, c) a disintegrant, consisting of sodium starch glycolate or a combination of sodium starch glycolate and polyvinylpyrrolidone, d) a surfactant, consisting of a polysorbate, in a total amount of 0.1 to 1% in weight based on the total weight of the pharmaceutical composition, and e) a lubricant, consisting of magnesium stearate. 2. The pharmaceutical composition according to claim 1, wherein the polysorbate is polysorbate 80. 3. The pharmaceutical composition according to claim 1, wherein the disintegrant is consisting of a combination of sodium starch glycolate and polyvinylpyrrolidone. 4. The pharmaceutical composition according to claim 3, wherein the combination of sodium starch glycolate and polyvinylpyrrolidone is present in a total amount of 2 to 10% in weight based on the total weight of the pharmaceutical composition. 5. The pharmaceutical composition according to claim 1, wherein the magnesium stearate is present in a total amount of between 0.1 to 1% in weight based on the total weight of the pharmaceutical composition. 6. The pharmaceutical composition according to claim 1, which is in the form of a capsule. 7. A pharmaceutical composition according to claim 1, which is in the form of a tablet. 8. The pharmaceutical composition according to claim 1, comprising: a) the compound of the formula I as drawn below ##STR00005## or a pharmaceutically acceptable salt, solvate, hydrate or morphological form thereof, in a total amount of up to 50% in weight based on the total weight of the pharmaceutical composition, b) a filler, consisting of lactose monohydrate with microcrystalline cellulose, in a total amount of 10 to 95% in weight based on the total weight of the pharmaceutical composition, c) a disintegrant, consisting of sodium starch glycolate or a combination of sodium starch glycolate and polyvinylpyrrolidone, in a total amount of 1 to 20% in weight based on the total weight of the pharmaceutical composition, d) a surfactant, consisting of a polysorbate, in a total amount of 0.1 to 1% in weight based on the total weight of the pharmaceutical composition, and e) a lubricant, consisting of magnesium stearate, in a total amount of 0.05 to 10% in weight based on the total weight of the pharmaceutical composition. 9. A pharmaceutical composition according to claim 8, wherein the polysorbate is polysorbate 80. 10. A pharmaceutical composition according to claim 8, wherein the disintegrant is consisting of a combination of sodium starch glycolate and polyvinylpyrrolidone. 11. A pharmaceutical composition according to claim 10, wherein the combination of sodium starch glycolate and polyvinylpyrrolidone is present in a total amount of 2 to 10% in weight based on the total weight of the pharmaceutical composition. 12. A pharmaceutical composition according to claim 8, wherein the magnesium stearate is present in a total amount of between 0.1 to 1% in weight based on the total weight of the pharmaceutical composition. 13. A pharmaceutical composition according to claim 8, which is in the form of a capsule. 14. A pharmaceutical composition according to claim 8, which is in the form of a tablet. 15. A method of treating pulmonary arterial hypertension comprising the administration to a patient in need thereof a pharmaceutical composition according to claim 1. 16. A method of treating pulmonary arterial hypertension comprising the administration to a patient in need thereof a pharmaceutical composition according to claim 8.