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Last Updated: April 29, 2024

Claims for Patent: RE48923

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Summary for Patent: RE48923

Title:	Crystal forms
Abstract:	The present invention features crystalline forms of Compound I. In one embodiment, a crystalline form of Compound I has characteristic peaks in the PXRD pattern as shown in one of FIGS. 1-10.
Inventor(s):	Califano; Jean-Christophe (Whitefish Bay, WI), Fickes; Michael G. (Lake Bluff, IL), Nordstroem; Lars Fredrik (Evanston, IL)
Assignee:	AbbVie Inc. (North Chicago, IL)
Application Number:	15/830,544
Patent Claims:	1. A process for making a pharmaceutical composition comprising Compound I ##STR00002## comprising .[.dissolving.]. .Iadd.combining .Iaddend.a crystalline form of Compound I .[.in a solvent.]. .Iadd.with a hydrophilic polymer.Iaddend., .[.wherein said crystalline form has characteristic peaks in PXRD pattern as described in one of Tables 1-10 when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG..]. .Iadd.wherein the crystalline form has a powder X-ray diffraction pattern comprising a two theta (.degree. 2.theta.) peak at about 17.62.+-.0.2.degree. 2.theta. when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG..Iaddend.. 2. The process of claim 1, wherein .[.said solvent is a volatile solvent, and said.]. .Iadd.the .Iaddend.process further comprises .Iadd.dissolving Compound I and the polymer in a solvent, and .Iaddend.spray drying the .[.dissolved Compound I.]. .Iadd.resulting solution .Iaddend.to remove the solvent, thereby creating a solid dispersion comprising amorphous Compound I .Iadd.and the polymer.Iaddend.. 3. The process of claim 1, wherein .[.said solvent.]. .Iadd.the polymer .Iaddend.is a molten or rubbery polymer .Iadd.in which the crystalline form of Compound I dissolves.Iaddend., and .[.said.]. .Iadd.the .Iaddend.process further comprises cooling and solidifying the dissolved Compound I, thereby creating a solid dispersion comprising amorphous Compound I and .[.said polymer.]. .Iadd.the polymer.Iaddend.. .[.4. The process of claim 1, wherein said characteristic peaks in PXRD pattern are as described in Table 9..]. .[.5. The process of claim 2, wherein said characteristic peaks in PXRD pattern are as described in Table 9..]. .[.6. The process of claim 3, wherein said characteristic peaks in PXRD pattern are as described in Table 9..]. .[.7. A process for making a pharmaceutical composition comprising Compound I, ##STR00003## comprising dissolving a crystalline form of Compound I in a solvent, wherein said crystalline form has characteristic peaks in PXRD pattern as described in one of FIGS. 1-10 when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG...]. .[.8. The process of claim 7, wherein said solvent is a volatile solvent, and said process further comprises spray drying the dissolved Compound I to remove the solvent, thereby creating a solid dispersion comprising amorphous Compound I..]. .[.9. The process of claim 7, wherein said solvent is a molten or rubbery polymer, and said process further comprises cooling and solidifying the dissolved Compound I, thereby creating a solid dispersion comprising amorphous Compound I and said polymer..]. .[.10. The process of claim 7, wherein said characteristic peaks in PXRD pattern are as described in FIG. 9..]. .[.11. The process of claim 8, wherein said characteristic peaks in PXRD pattern are as described in FIG. 9..]. .[.12. The process of claim 9, wherein said characteristic peaks in PXRD pattern are as described in FIG. 9..]. .[.13. A process for making a pharmaceutical composition comprising Compound I, ##STR00004## comprising dissolving a crystalline form of Compound I in a solvent, wherein said crystalline form has characteristic peaks in PXRD pattern at values of two theta (.degree. 2.theta.) of 5.31, 11.11, 12.60, 13.75, 15.29, 15.96, 17.62, 19.71, 21.30, and 22.88 when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG...]. .[.14. The process of claim 13, wherein said solvent is a volatile solvent, and said process further comprises spray drying the dissolved Compound I to remove the solvent, thereby creating a solid dispersion comprising amorphous Compound I..]. .[.15. The process of claim 13, wherein said solvent is a molten or rubbery polymer, and said process further comprises cooling and solidifying the dissolved Compound I, thereby creating a solid dispersion comprising amorphous Compound I and said polymer..]. .[.16. A process for making a pharmaceutical composition comprising Compound I, ##STR00005## comprising dissolving a crystalline form of Compound I in a solvent, wherein said crystalline form has characteristic peaks in PXRD pattern at values of two theta (.degree. 2.theta.) of 5.31, 10.16, 10.62, 11.11, 12.60, 13.75, 15.29, 15.96, 17.62, 18.19, 19.16, 19.71, 20.58, 21.30, 22.40, 22.88, 23.66, 26.40, 26.74, and 33.46 when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG...]. .[.17. The process of claim 16, wherein said solvent is a volatile solvent, and said process further comprises spray drying the dissolved Compound I to remove the solvent, thereby creating a solid dispersion comprising amorphous Compound I..]. .[.18. The process of claim 16, wherein said solvent is a molten or rubbery polymer, and said process further comprises cooling and solidifying the dissolved Compound I, thereby creating a solid dispersion comprising amorphous Compound I and said polymer..]. .[.19. A process for making a pharmaceutical composition comprising Compound I, ##STR00006## comprising dissolving a crystalline form of Compound I in a solvent, wherein said crystalline form has characteristic peaks in PXRD pattern at values of two theta (.degree. 2.theta.) of 5.31, 10.16, 10.62, 11.11, 12.60, 13.75, 15.29, 15.96, 17.62, 18.19, 19.16, 19.71, 20.58, 21.30, 22.40, 22.88, 23.66, 26.40, 26.74, 28.12, 31.62, and 33.46 when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG...]. .[.20. The process of claim 19, wherein said solvent is a volatile solvent, and said process further comprises spray drying the dissolved Compound I to remove the solvent, thereby creating a solid dispersion comprising amorphous Compound I..]. .[.21. The process of claim 19, wherein said solvent is a molten or rubbery polymer, and said process further comprises cooling and solidifying the dissolved Compound I, thereby creating a solid dispersion comprising amorphous Compound I and said polymer..]. .Iadd.22. The process of claim 1, wherein the crystalline form has a powder X-ray diffraction pattern further comprising a two theta (.degree. 2.theta.) peak at about 13.75.+-.0.2.degree. 2.theta. when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG.. .Iaddend. .Iadd.23. The process of claim 22 wherein the crystalline form has a powder X-ray diffraction pattern further comprising a two theta (.degree. 2.theta.) peak at about 11.11.+-.0.2.degree. 2.theta. when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG.. .Iaddend. .Iadd.24. A process for making a pharmaceutical composition comprising Compound I ##STR00007## comprising combining a crystalline form of Compound I with a hydrophilic polymer wherein the crystalline form has a powder X-ray diffraction pattern comprising a two theta (.degree. 2.theta.) peak at about 10.16.+-.0.2.degree. 2.theta. when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG., wherein the crystalline form is anhydrous. .Iaddend. .Iadd.25. The process of claim 24 wherein the process further comprises dissolving Compound I and the polymer in a solvent, and spray drying the resulting solution to remove the solvent, thereby creating a solid dispersion comprising amorphous Compound I and the polymer. .Iaddend. .Iadd.26. The process of claim 24, wherein the polymer is a molten or rubbery polymer in which the crystalline form of Compound I dissolves, and the process further comprises cooling and solidifying the dissolved Compound I, thereby creating a solid dispersion comprising amorphous Compound I and the polymer. .Iaddend. .Iadd.27. The process of claim 24, wherein the crystalline form is anhydrous. .Iaddend. .Iadd.28. The process of claim 24, wherein the crystalline form has a powder X-ray diffraction pattern further comprising a two theta (.degree. 2.theta.) peak at about 21.30.+-.0.2.degree. 2.theta. and about 23.66.+-.0.2.degree. 2.theta. when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG.. .Iaddend. .Iadd.29. The process of claim 24, wherein the crystalline form has a powder X-ray diffraction pattern further comprising a two theta (.degree. 2.theta.) peak at about 5.31.+-.0.2.degree. 2.theta., 11.11.+-.0.2.degree. 2.theta., 12.60.+-.0.2.degree. 2.theta., 13.75.+-.0.2.degree. 2.theta., 15.29.+-.0.2.degree. 2.theta., 15.96.+-.0.2.degree. 2.theta., 19.71.+-.0.2.degree. 2.theta., 21.30.+-.0.2.degree. 2.theta., and 22.88.+-.0.2.degree. 2.theta. when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG.. .Iaddend. .Iadd.30. The process of claim 24, wherein the crystalline form has a powder X-ray diffraction pattern further comprising a two theta (.degree. 2.theta.) peak at about 5.31.+-.0.2.degree. 2.theta., 10.62.+-.0.2.degree. 2.theta., 11.11.+-.0.2.degree. 2.theta., 12.60.+-.0.2.degree. 2.theta., 13.75.+-.0.2.degree. 2.theta., 15.29.+-.0.2.degree. 2.theta., 15.96.+-.0.2.degree. 2.theta., 17.62.+-.0.2.degree. 2.theta., 18.19.+-.0.2.degree. 2.theta., 19.16.+-.0.2.degree. 2.theta., 19.71.+-.0.2.degree. 2.theta., 20.58.+-.0.2.degree.2.theta., 21.30.+-.0.2.degree. 2.theta., 22.40.+-.0.2.degree. 2.theta., 22.88.+-.0.2.degree. 2.theta., 23.66.+-.0.2.degree. 2.theta., 26.40.+-.0.2.degree. 2.theta., 26.74.+-.0.2.degree. 2.theta. and 33.46.+-.0.2.degree. 2.theta., when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG.. .Iaddend. .Iadd.31. The process of claim 24, wherein the crystalline form has a powder X-ray diffraction pattern of Pattern G. .Iaddend. .Iadd.32. A crystalline form of Compound I, ##STR00008## wherein the crystalline form has a powder X-ray diffraction pattern comprising a two theta (.degree. 2.theta.) peak at about 17.62.+-.0.2.degree. 2.theta. when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG.. .Iaddend. .Iadd.33. The crystalline form of claim 32, wherein the crystalline form has a powder X-ray diffraction pattern further comprising a two theta (.degree. 2.theta.) peak at about 13.75.+-.0.2.degree. 2.theta.. .Iaddend. .Iadd.34. The crystalline form of claim 33, wherein the crystalline form has a powder X-ray diffraction pattern further comprising a two theta (.degree. 2.theta.) peak at about 11.11.+-.0.2.degree. 2.theta.. .Iaddend. .Iadd.35. A crystalline form of Compound I, ##STR00009## wherein the crystalline form has a powder X-ray diffraction pattern comprising a two theta (.degree. 2.theta.) peak at about 10.16.+-.0.2.degree. 2.theta. when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG.. .Iaddend. .Iadd.36. The process of claim 35, wherein the crystalline form is anhydrous. .Iaddend. .Iadd.37. The crystalline form of claim 35, wherein the crystalline form has a powder X-ray diffraction pattern further comprising a two theta (.degree. 2.theta.) peak at about 21.30.+-.0.2.degree. 2.theta. and about 23.66.+-.0.2.degree. 2.theta. when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG.. .Iaddend. .Iadd.38. The crystalline form of claim 35, wherein the crystalline form has a powder X-ray diffraction pattern further comprising a two theta (.degree. 2.theta.) peak at about 5.31.+-.0.2.degree. 2.theta., 11.11.+-.0.2.degree. 2.theta., 12.60.+-.0.2.degree. 2.theta., 13.75.+-.0.2.degree. 2.theta., 15.29.+-.0.2.degree. 2.theta., 15.96.+-.0.2.degree. 2.theta., 19.71.+-.0.2.degree. 2.theta., 21.30.+-.0.2.degree. 2.theta., and 22.88.+-.0.2.degree. 2.theta. when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG.. .Iaddend. .Iadd.39. The crystalline form of claim 35, wherein the crystalline form has a powder X-ray diffraction pattern further comprising a two theta (.degree. 2.theta.) peak at about 5.31.+-.0.2.degree. 2.theta., 10.62.+-.0.2.degree. 2.theta., 11.11.+-.0.2.degree. 2.theta., 12.60.+-.0.2.degree. 2.theta., 13.75.+-.0.2.degree. 2.theta., 15.29.+-.0.2.degree. 2.theta., 15.96.+-.0.2.degree. 2.theta., 17.62.+-.0.2.degree. 2.theta., 18.19.+-.0.2.degree. 2.theta., 19.16.+-.0.2.degree. 2.theta., 19.71.+-.0.2.degree. 2.theta., 20.58.+-.0.2.degree. 2.theta., 21.30.+-.0.2.degree. 2.theta., 22.40.+-.0.2.degree. 2.theta., 22.88.+-.0.2.degree. 2.theta., 23.66.+-.0.2.degree. 2.theta., 26.40.+-.0.2.degree. 2.theta., 26.74.+-.0.2.degree. 2.theta. and 33.46.+-.0.2.degree. 2.theta., when tested using a diffractometer that is operated with a copper anode tube at 40 kV and 30 mA and a germanium monochromator to provide monochromatic Cu-K.sub..alpha. radiation with a wavelength of 1.54178 .ANG.. .Iaddend. .Iadd.40. The crystalline form of claim 35, wherein the crystalline form has a powder X-ray diffraction pattern of Pattern G. .Iaddend.

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