Compositions containing solid ibuprofen concentrates and methods of making solid ibuprofen concentrates

1. A composition comprising a solid ibuprofen concentrate, wherein the solid ibuprofen concentrate comprises (a) a solid ibuprofen free acid and (b) a solid ibuprofen alkali salt, and wherein at least 90% of the weight of the solid ibuprofen concentrate is ibuprofen free acid and ibuprofen alkali salt.

2. The composition of claim 1 , wherein at least 92% of the weight of the solid ibuprofen concentrate is ibuprofen free acid and ibuprofen alkali salt.

3. The composition of claim 1 , wherein at least 95% of the weight of the solid ibuprofen concentrate is ibuprofen free acid and ibuprofen alkali salt.

4. The composition of claim 1 , wherein at least 97% of the weight of the solid ibuprofen concentrate is ibuprofen free acid and ibuprofen alkali salt.

5. The composition of claim 1 , wherein the solid ibuprofen concentrate has a bulk density of at least 0.3 g/mL.

6. The composition of claim 1 , wherein the solid ibuprofen concentrate is soluble in polyethylene glycol.

7. The composition of claim 1 , wherein the composition is a hard shell capsule, soft gelatin capsule, liquid suspension, liquid solution, or tablet.

8. The composition of claim 7 , wherein the composition is a tablet.

9. The composition of claim 8 , equivalent to about 200 to about 800 mg ibuprofen per tablet.

10. The composition of claim 7 , wherein the composition is a solution.

11. The composition of claim 10 , equivalent to about 10 mg to about 50 mg ibuprofen per mL.

12. The composition of claim 7 , wherein the composition is a soft gelatin capsule.

13. The composition of claim 12 , equivalent to about 200 mg to about 400 mg ibuprofen per capsule.

14. The composition of claim 7 , wherein the composition is a hard shell capsule.

15. The composition of claim 14 , equivalent to about 200 mg to about 400 mg ibuprofen per capsule.

16. The composition of claim 1 , wherein at least 85% of the solid ibuprofen concentrate dissolves within in 30 minutes.

17. The composition of claim 16 , wherein at least 85% of the solid ibuprofen concentrate dissolves within in 20 minutes.

18. The composition of claim 1 , wherein the solid ibuprofen alkali salt is an ibuprofen potassium salt, ibuprofen sodium salt, or ibuprofen ammonium salt or a mixture thereof.

19. The composition of claim 18 , wherein the solid ibuprofen alkali salt is an ibuprofen potassium salt.

20. A method of manufacturing a solid ibuprofen concentrate, wherein at least 90% of the weight of the ibuprofen concentrate is ibuprofen free acid and ibuprofen alkali salt, comprising:

(a) mixing an ibuprofen free acid with a first alkaline substance to form a first composition,

(b) mixing the first composition with a second alkaline substance to form a second composition, and

(c) drying the second composition to produce a solid ibuprofen concentrate.

21. The method of claim 20 , further comprising sieving the second composition prior to drying.

22. The method of claim 20 , wherein the first alkaline substance is selected from the group consisting of a carbonate species, a bicarbonate species, and mixtures thereof.

23. The method of claim 22 , wherein the first alkaline substance is a carbonate species selected from the group consisting of ammonium carbonate, ammonium bicarbonate, potassium carbonate, potassium bicarbonate, sodium carbonate, and sodium bicarbonate.

24. The method of claim 23 , wherein the first alkaline substance is potassium carbonate.

25. The method of claim 20 , wherein the second alkaline substance comprises a hydroxide species.

26. The method of claim 25 , wherein the hydroxide species is selected from the group consisting of ammonium hydroxide, potassium hydroxide, and sodium hydroxide.

27. The method of claim 26 , wherein the hydroxide species is potassium hydroxide.

28. The method of claim 22 , wherein the ibuprofen alkali salt is ibuprofen potassium salt.

29. The method of claim 20 , further comprising filling the solid ibuprofen concentrate in hard shell capsules.

30. A solid ibuprofen concentrate obtained by the method of claim 20 .

31. A method of formulating the composition of claim 1 into a soft gelatin capsule comprising:

(a) dissolving the ibuprofen concentrate in a soft capsule vehicle to form a soft gelatin fill, and

(b) encapsulating the soft gelatin fill in a soft gelatin capsule.

32. The method of claim 31 , wherein the soft capsule vehicle is polyethylene glycol.

33. The method of claim 31 , wherein the soft capsule vehicle is selected from the group consisting of polyethylene glycol or a polyethylene glycol-water mixture.

34. The method of claim 31 , wherein the amount of ibuprofen-esters formed is less than about 0.2%.

35. A composition comprising a solid ibuprofen concentrate, wherein the solid ibuprofen concentrate comprises (a) a solid ibuprofen free acid and (b) a solid ibuprofen alkali salt, and wherein at least 90% of the weight of the solid ibuprofen concentrate is ibuprofen free acid and ibuprofen alkali salt, wherein the ibuprofen alkali salt is produced from a solid ibuprofen free acid using at least two alkaline substances.

36. The composition of claim 35 , wherein at least 95% of the weight of the solid ibuprofen concentrate is ibuprofen free acid and ibuprofen alkali salt.

37. The composition of claim 35 , wherein the composition is a hard shell capsule, soft gelatin capsule, liquid suspension, liquid solution, or tablet.

38. The composition of claim 37 , wherein the solid ibuprofen alkali salt is an ibuprofen potassium salt.