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Claims for Patent: 8,168,624

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Claims for Patent: 8,168,624

Title:Crystalline forms of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride
Abstract: The present invention is directed to crystalline forms of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine, compositions containing the same, preparations, and uses thereof.
Inventor(s): Agarwal; Rajesh K. (San Diego, CA), Betts, III; William L. (San Diego, CA), Henshilwood; James A. (Carlsbad, CA), Kiang; Yuan-Hon (Newbury Park, CA), Post; Noah (San Diego, CA)
Assignee: Arena Pharmaceuticals, Inc. (San Diego, CA)
Application Number:11/793,473
Patent Claims: 1. A compound which is (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride hemihydrate, having an X-ray powder diffraction pattern comprising peaks, in terms of 2.theta., at about 13.7.degree. and about 14.9.degree., and having a differential scanning calorimetry trace comprising an endotherm between about 90 and about 110.degree. C. and an endotherm at about 200.degree. C.

2. The hemihydrate of claim 1 having an X-ray powder diffraction pattern comprising peaks, in terms of 2.theta., at about 13.7.degree., about 14.9.degree., about 15.4.degree., about 15.8.degree., about 16.7.degree., about 20.1.degree., and about 21.4.degree..

3. The hemihydrate of claim 1 having an X-ray powder diffraction pattern substantially as shown in FIG. 11.

4. The hemihydrate of claim 1 having a differential scanning calorimetry trace substantially as shown in FIG. 10.

5. The hemihydrate of claim 1 having a dynamic vapor sorption profile substantially as shown in FIG. 12.

6. The hemihydrate of claim 1 having a thermogravimetric analysis profile showing about 3.7% weight loss below about 150.degree. C.

7. The hemihydrate of claim 1 having a thermogravimetric analysis profile substantially as shown in FIG. 9.

8. A composition comprising the hemihydrate of claim 1.

9. The composition of claim 8 wherein said hemihydrate constitutes at least about 50% by weight of said composition.

10. The composition of claim 8 wherein said hemihydrate constitutes at least about 90% by weight of said composition.

11. The composition of claim 8 wherein said hemihydrate constitutes at least about 99% by weight of said composition.

12. A composition comprising the hemihydrate of claim 1 and a pharmaceutically acceptable carrier.

13. The hemihydrate of claim 1, wherein said hemihydrate gains less than about 1.0% weight after undergoing a dynamic vapor sorption cycle from about 10% RH to about 90% RH.

14. The hemihydrate of claim 1 having an X-ray powder diffraction pattern comprising peaks, in terms of 2.theta., at about 13.7.degree., about 14.9.degree., about 15.4.degree., about 15.8.degree., about 16.7.degree., about 20.1.degree., and about 21.4.degree. and having a differential scanning calorimetry trace comprising an endotherm between about 90 and about 110.degree. C. and an endotherm at about 200.degree. C.

15. A composition comprising the hemihydrate of claim 14 and a pharmaceutically acceptable carrier.

16. The hemihydrate of claim 1 having: a) an X-ray powder diffraction pattern comprising peaks, in terms of 2.theta., at about 13.7.degree., about 14.9.degree., about 15.4.degree., about 15.8.degree., about 16.7.degree., about 20.1.degree., and about 21.4.degree.; b) a differential scanning calorimetry trace comprising an endotherm between about 90 and about 110.degree. C. and an endotherm at about 200.degree. C.; c) a dynamic vapor sorption profile substantially as shown in FIG. 12; and d) a thermogravimetric analysis profile substantially as shown in FIG. 9.

17. A composition comprising the hemihydrate of claim 16 and a pharmaceutically acceptable carrier.
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