Crystalline and amorphous forms of 17-alpha-hydroxyprogesterone caproate
The disclosure is in part directed to crystalline forms of 17-α-hydroxyprogesterone caproate and variants thereof.
1. A crystalline form of 17-α-hydroxyprogesterone caproate characterized by a powder X-ray diffraction pattern having a characteristic peak in degrees 2θ at about 9.6, 12.2, and 18.3 and a differential scanning calorimetry endothermic peak at about 100-105° C.
2. The crystalline form of claim 1 , characterized by a powder X-ray diffraction pattern having characteristic peaks in degrees 2θ at about 9.6, 12.2, 13.9, 14.8, 15.4, 18.3, and 19.2.
3. The crystalline form of claim 1 , characterized by a powder X-ray diffraction pattern having characteristic peaks in degrees 2θ at 9.6, 12.2, 13.0, 13.9, 14.8, 15.4, 18.3, and 19.2.
4. The crystalline form of claim 1 , having the powder X-ray diffraction pattern shown in FIG. 4 .
5. The crystalline form of claim 1 , wherein the powder X-ray diffraction pattern was obtained using Cu Kα radiation.
6. A pharmaceutical composition comprising the crystalline form of claim 1 , and a pharmaceutically acceptable excipient.
7. The pharmaceutical composition of claim 6 , wherein the composition is a formulation for subcutaneous or intramuscular injections.
8. The pharmaceutical composition of claim 6 , wherein the composition is a formulation for oral administration.
9. The pharmaceutical composition of claim 6 , wherein the composition is a formulation for topical administration.
10. The pharmaceutical composition of claim 6 , wherein the composition is a formulation for rectal or vaginal administration.
11. The pharmaceutical composition of claim 6 , wherein the composition is a suspension of the crystalline form.
12. A drug substance comprising at least a detectable amount of the crystalline form of claim 1 .
13. A drug substance comprising substantially pure crystalline form of claim 1 .
14. The drug substance of claim 12 , further comprising a crystalline form of 17-α-hydroxyprogesterone caproate characterized by a powder X-ray diffraction pattern having a characteristic peak in degrees 2θ at about 7.3.
15. A crystalline form of 17-α-hydroxyprogesterone caproate characterized by a powder X-ray diffraction pattern having a characteristic peak in degrees 2θ at about 9.6, 12.2, 13.9, 14.8, 15.4, 18.3, and 19.2.
16. A pharmaceutical composition comprising the crystalline form of claim 15 , and a pharmaceutically acceptable excipient.
17. The pharmaceutical composition of claim 16 , wherein the composition is a formulation for subcutaneous or intramuscular injections.
18. The pharmaceutical composition of claim 16 , wherein the composition is a formulation for oral administration.
19. The pharmaceutical composition of claim 16 , wherein the composition is a formulation for topical, rectal or vaginal administration.
20. The pharmaceutical composition of claim 16 , wherein the composition is a suspension of the crystalline form.
21. A drug substance comprising at least a detectable amount of the crystalline form of claim 15 .
22. A drug substance comprising substantially pure crystalline form of claim 15 .