SOLID DISPERSIONS COMPRISING A SGC STIMULATOR

1 . A solid dispersion of amorphous 1,1,1,3,3,3-hexafluoro-2-(((5-fluoro-2-(1-(2-fluorobenzyl)-5-(isoxazol-3-yl)-1H-pyrazol-3-yl)pyrimidin-4-yl)amino)methyl)propan-2-ol (Compound I).

2 . The solid dispersion of claim 1 comprising Compound I and a polymer carrier.

3 . The solid dispersion of claim 1 or claim 2 , wherein the polymer carrier is selected from a cellulosic polymer.

4 . The solid dispersion of claim 2 wherein the polymer carrier is selected from hydroxypropylmethylcellulose acetate succinate (HPMCAS), hydroxypropylmethylcellulose phthalate (HPMCP), cellulose acetate phthalate (CAP), polyvinyl pyrrolidone (PVP), or a co-polymer of polyvinyl pyrrolidone.

5 . The solid dispersion of claim 4 , wherein the polymer carrier is selected from HPMCAS or CAP.

6 . The solid dispersion of claim 5 wherein the polymer carrier is HPMCAS.

7 . The solid dispersion of claim 4 wherein the polymer carrier is HPMCP.

8 . The solid dispersion of claim 5 wherein the polymer carrier is CAP.

9 . The solid dispersion of claim 4 wherein the polymer carrier is PVP.

10 . The solid dispersion of claim 4 wherein the polymer carrier is a co-polymer of PVP.

11 . The solid dispersion of any one of claims 2 to 10 , wherein the polymer is present in an amount of between about 40% and about 95% of the total weight of the solid dispersion

12 . The solid dispersion of claim 11 , wherein the polymer is present in an amount of between 50% and 90% of the total weight of the solid dispersion.

13 . The solid dispersion of claim 12 , wherein the polymer is present in an amount of between 60% and 90% of the total weight of the solid dispersion.

14 . The solid dispersion of claim 11 , wherein the polymer is present in an amount of between 60% and 95% of the total weight of the solid dispersion.

15 . The solid dispersion of any one of claims 11 to 14 , wherein the polymer is present in an amount of between about 70% and about 90% of the total weight of the solid dispersion.

16 . The solid dispersion of claim 15 , wherein the polymer is present in an amount of between about 75% and about 90% of the total weight of the solid dispersion.

17 . The solid dispersion of claim 14 , wherein the polymer is present in an amount of between about 80% and about 95% of the total weight of the solid dispersion.

18 . The solid dispersion of claim 17 , wherein the polymer is present in an amount of between about 90% and about 95% of the total weight of the solid dispersion.

19 . The solid dispersion of any one of claims 1 to 18 , wherein said solid dispersion is obtained by spray-drying.

20 . The solid dispersion of any one of claims 1 to 18 , wherein said solid dispersion is produced by hot-melt extrusion.

21 . The solid dispersion of any one of claims 1 to 20 , wherein Compound I is present in an amount of from about 5% by weight to about 50% by weight of the dispersion.

22 . The solid dispersion of claim 21 , wherein Compound I is present in an amount of from about 5% by weight to about 40% by weight.

23 . The solid dispersion of claim 22 , wherein Compound I is present in an amount of from about 10% by weight to about 30% by weight.

24 . The solid dispersion of claim 23 , wherein Compound I is present in an amount of from about 10% by weight to about 25% by weight.

25 . The solid dispersion of claim 22 , wherein Compound I is present in an amount of from about 15% by weight to about 40% by weight.

26 . The solid dispersion of claim 25 , wherein Compound I is present in an amount of from about 20% by weight to about 30% by weight.

27 . The solid dispersion of any one of claims 1 to 26 , wherein said solid dispersion of Compound I comprises less than 20% crystalline Compound I.

28 . The solid dispersion of claim 27 , wherein said solid dispersion of Compound I comprises less than 10% crystalline Compound I.

29 . The solid dispersion of claim 28 , wherein said solid dispersion of Compound I comprises less than 5% crystalline Compound I.

30 . The solid dispersion of any one of claims 1 to 29 , wherein said solid dispersion is a stable solid dispersion of Compound I.

31 . The solid dispersion of any one of claims 1 to 10 , wherein the weight to weight ratio of Compound I to polymer is between 10:90 and 50:50.

32 . The solid dispersion of claim 31 , wherein the weight to weight ratio of Compound I to polymer is between 20:80 and 40:60.

33 . The solid dispersion of claim 32 , wherein the weight to weight ratio of Compound I to polymer is 25:75.

34 . The solid dispersion of claim 31 , wherein the weight to weight ratio of Compound I to polymer is 50:50.

35 . A pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a solid dispersion according to any one of claims 1 to 34 .

36 . The pharmaceutical composition of claim 35 , wherein the at least one pharmaceutically acceptable excipient is selected from a filler, a glidant, a lubricant or a disintegrant.

37 . A dosage unit form, comprising a solid dispersion of any one of claims 1-34 or a pharmaceutical composition of any one of claims 35 to 36 .

38 . A dosage unit form according to claim 37 , wherein said dosage unit form is suitable for oral administration.

39 . A dosage unit form according to claim 38 , wherein said dosage unit form is selected from a capsule, a suspension, a powder or a tablet.

40 . A dosage unit form according to claim 39 , wherein said dosage unit form is a tablet.

41 . A method of treating a disease, health condition or disorder in a subject in need of treatment, comprising administering a therapeutically effective amount of an amorphous solid dispersion of any one of claims 1 to 34 , or a pharmaceutical composition of claim 35 or 36 , or a dosage unit form of any one of claims 38 to 40 , to the subject in need of treatment, wherein the disease, health condition or disorder is selected from: diabetic nephropathy, diabetic retinopathy, non-alcoholic steatohepatitis (NASH), hypertension, or heart failure.

42 . The method of claim 41 , wherein the disease is diabetic nephropathy.

43 . The method according to claim 41 , wherein the disease or disorder is diabetic retinopathy.

44 . The method according to claim 41 , wherein the disease or disorder is non-alcoholic steatohepatitis.

45 . The method according to claim 41 , wherein the disease or disorder is heart failure.

46 . The method according to claim 45 , wherein said heart failure is selected from heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF).

47 . The method of claim 46 , wherein said heart failure is HFpEF.

48 . The method of claim 46 , wherein said heart failure is HFrEF.

49 . A method according to claim 41 , wherein the disease or disorder is hypertension.

50 . A method according to claim 49 , wherein said hypertension is resistant hypertension.