Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl—1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid

1. A pharmaceutical composition comprising a Form α crystal of 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid.

2. The pharmaceutical composition of claim 1 , wherein said Form α crystal is characterized by a powder X-ray diffraction pattern having powder X-ray diffraction peaks at about 14.0, 14.3, and 14.7 degrees 2-theta.

3. The pharmaceutical composition of claim 1 , wherein said Form α crystal is characterized by a powder X-ray diffraction pattern having powder X-ray diffraction peaks at about 10.2, 11.3, 14.0, 14.3, and 14.7 degrees 2-theta.

4. The pharmaceutical composition of claim 1 , wherein said Form α crystal is characterized by a powder X-ray diffraction pattern having powder X-ray diffraction peaks at about 10.2, 11.3, 11.8, 14.0, 14.3, 14.7, 16.1, and 18.3 degrees 2-theta.

5. The pharmaceutical composition of claim 1 , wherein said Form α crystal is characterized by a powder X-ray diffraction pattern having powder X-ray diffraction peaks substantially as shown in Table 1.

6. The pharmaceutical composition of claim 1 , wherein said Form α crystal is characterized by a powder X-ray diffraction pattern having powder X-ray diffraction peaks substantially similar to the powder X ray diffraction peaks of FIG. 1 .

7. The pharmaceutical composition of claim 1 , wherein said Form α crystal is characterized by a thermal gravimetric analysis (TGA) substantially similar to the TGA in FIG. 2 .

8. The pharmaceutical composition of claim 1 , wherein said Form α crystal is characterized by a differential scanning calorimetry (DSC) measurement substantially similar to the DSC in FIG. 3 .

9. The pharmaceutical composition of claim 1 , in a dosage form suitable for oral administration.

10. The pharmaceutical composition of claim 9 , wherein the dosage form is a solid.

11. The pharmaceutical composition of claim 9 , wherein the dosage form is selected from the group consisting of a tablet, a caplet, a hard gelatin capsule, a starch capsule, a hydroxypropyl methylcellulose (HPMC) capsule, and a soft elastic gelatin capsule.

12. The pharmaceutical composition of claim 9 , wherein the dosage form as administered is a liquid.

13. The pharmaceutical composition of claim 9 , wherein the dosage form as administered is selected from the group consisting of a suspension, a solution, a syrup, and an emulsion.

14. The pharmaceutical composition of claim 9 , wherein the dosage form is a tablet.

15. A method of treating a disease in a mammal, wherein the disease is an opioid receptor disorder, comprising administering to said mammal an effective amount of a pharmaceutical composition comprising a Form α crystal of 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid.

16. The method of claim 15 , wherein the opioid receptor disorder is selected from the group consisting of irritable bowel syndrome, pain and a combination of both.

17. The method of claim 15 , wherein the opioid receptor disorder is irritable bowel syndrome.

18. The method of claim 15 , wherein the opioid receptor disorder is pain.

19. The method of claim 15 , wherein the pharmaceutical composition is administered in a dosage form suitable for oral administration.

20. The method of claim 19 , wherein the pharmaceutical composition is administered in a solid dosage form.

21. The method of claim 19 , wherein the dosage form is selected from the group consisting of a tablet, a caplet, a hard gelatin capsule, a starch capsule, a hydroxypropyl methylcellulose (HPMC) capsule, and a soft elastic gelatin capsule.

22. The method of claim 19 , wherein the dosage form is a tablet.

23. The method of claim 15 , wherein the mammal is a human.

24. A pharmaceutical composition comprising a Form β crystal of 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid.

25. A method of treating a disease in a mammal, wherein the disease is an opioid receptor disorder, comprising administering to said mammal an effective amount of a pharmaceutical composition comprising a Form β crystal of 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid.

26. The pharmaceutical composition of claim 24 , wherein said Form β crystal is characterized by a powder X-ray diffraction pattern having powder X-ray diffraction peaks at about 11.0, 12.4, and 15.2 degrees 2-theta.

27. The pharmaceutical composition of claim 24 , wherein said Form β crystal is characterized by a powder X-ray diffraction pattern having powder X-ray diffraction peaks at about 11.0, 12.4, 14.9, 15.2, and 22.1 degrees 2-theta.

28. The pharmaceutical composition of claim 24 , wherein said Form β crystal is characterized by a powder X-ray diffraction pattern having powder X-ray diffraction peaks at about 11.0, 12.4, 14.9, 15.2, 22.1, 25.6, 27.4, and 30.4 degrees 2-theta.

29. The pharmaceutical composition of claim 24 , wherein said Form β crystal is characterized by a powder X-ray diffraction pattern having powder X-ray diffraction peaks substantially as shown in Table 2.

30. The pharmaceutical composition of claim 24 , wherein said Form β crystal is characterized by a powder X-ray diffraction pattern having powder X-ray diffraction peaks substantially similar to the powder X ray diffraction peaks of FIG. 1 .

31. The pharmaceutical composition of claim 24 , wherein said Form β crystal is characterized by a thermal gravimetric analysis (TGA) substantially similar to the TGA in FIG. 4 .

32. The pharmaceutical composition of claim 24 , wherein said Form β crystal is characterized by a differential scanning calorimetry (DSC) measurement substantially similar to the DSC in FIG. 5 .

33. The pharmaceutical composition of claim 24 , in a dosage form suitable for oral administration.

34. The pharmaceutical composition of claim 33 , wherein the dosage form is a solid.

35. The pharmaceutical composition of claim 33 , wherein the dosage form is selected from the group consisting of a tablet, a caplet, a hard gelatin capsule, a starch capsule, a hydroxypropyl methylcellulose (HPMC) capsule, and a soft elastic gelatin capsule.

36. The pharmaceutical composition of claim 33 , wherein the dosage form as administered is a liquid.

37. The pharmaceutical composition of claim 33 , wherein the dosage form as administered is selected from the group consisting of a suspension, a solution, a syrup, and an emulsion.

38. The pharmaceutical composition of claim 33 , wherein the dosage form is a tablet.

39. The method of claim 25 , wherein the opioid receptor disorder is selected from the group consisting of irritable bowel syndrome, pain and a combination of both.

40. The method of claim 25 , wherein the opioid receptor disorder is irritable bowel syndrome.

41. The method of claim 25 , wherein the opioid receptor disorder is pain.

42. The method of claim 25 , wherein the pharmaceutical composition is administered in a dosage form suitable for oral administration.

43. The method of claim 42 , wherein the pharmaceutical composition is administered in a solid dosage form.

44. The method of claim 42 , wherein the dosage form is selected from the group consisting of a tablet, a caplet, a hard gelatin capsule, a starch capsule, a hydroxypropyl methylcellulose (HPMC) capsule, and a soft elastic gelatin capsule.

45. The method of claim 42 , wherein the dosage form is a tablet.

46. The method of claim 25 , wherein the mammal is a human.