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Claims for Patent: 9,265,762

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Claims for Patent: 9,265,762

Title:Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Abstract: The invention relates to stable pharmaceutical compositions comprising the compound of the below formula, or pharmaceutically acceptable salts, solvates, hydrates or morphological forms thereof. ##STR00001##
Inventor(s): Adesuyi; Charles Tokunbo (Swindon, GB), Lithgow; Bruce Hamilton (Bath, GB), Lambert; Olivier (Spechbach-le-Haut, FR), Holman; Lovelace (Arlesheim, CH)
Assignee: ACTELION PHARMACEUTICALS LTD. (Allschwil, CH)
Application Number:13/736,699
Patent 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 3% 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. The pharmaceutical composition according to claim 1, which is in the form of a tablet.

8. A method of treating pulmonary arterial hypertension comprising the administration to a patient in need thereof a pharmaceutical composition according to claim 1.

9. 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 3% 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.

10. The pharmaceutical composition according to claim 9, wherein the polysorbate is polysorbate 80.

11. The pharmaceutical composition according to claim 9, wherein the disintegrant is consisting of a combination of sodium starch glycolate and polyvinylpyrrolidone.

12. The pharmaceutical composition according to claim 11, 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.

13. The pharmaceutical composition according to claim 9, 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.

14. The pharmaceutical composition according to claim 9, which is in the form of a capsule.

15. The pharmaceutical composition according to claim 9, which is in the form of a tablet.

16. A method of treating pulmonary arterial hypertension comprising the administration to a patient in need thereof a pharmaceutical composition according to claim 9.
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