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Claims for Patent: 7,465,800

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Claims for Patent: 7,465,800

Title:Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
Abstract:Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione are disclosed. Compositions comprising the polymorphic forms, methods of making the polymorphic forms and methods of their use are also disclosed.
Inventor(s): Jaworsky; Markian S. (Hopewell, NJ), Chen; Roger Shen-Chu (Edison, NJ), Muller; George W. (Bridgewater, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Application Number:10/934,863
Patent Claims: 1. Crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate.

2. The hemihydrate of claim 1 having an X-ray powder diffraction pattern comprising peaks at approximately 16, 22 and 27 degrees 2.theta..

3. The hemihydrate of claim 2 wherein the pattern further comprises a peak at approximately 18 degrees 2.theta..

4. The hemihydrate of claim 1 having an X-ray powder diffraction pattern comprising peaks at 15.8, 22.2 and 26.7 degrees 2.theta..

5. The hemihydrate of claim 4 wherein the pattern further comprises a peak at 18.2 degrees 2.theta..

6. The hemihydrate of claim 1 having an X-ray powder diffraction pattern corresponding to the representative X-ray powder diffraction patterns depicted in FIG. 6, FIG. 32, FIG. 33 and FIG. 34.

7. The hemihydrate of claim 1 having a differential scanning calorimetry thermogram comprising an endotherm with a maximum at about 268.degree. C.

8. The hemihydrate of claim 7 wherein the thermogram further comprises an endotherm corresponding to dehydration.

9. The hemihydrate of claim 1 having a differential scanning calorimetry thermogram corresponding to the representative differential scanning calorimetry thermograms depicted in FIG. 9, FIG. 42, FIG. 43 and FIG. 44.

10. The hemihydrate of claim 1 having between approximately 0.46 and approximately 0.59 moles of water per mole of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione.

11. The hemihydrate of claim 1 having a thermogravimetric analysis thermogram comprising a weight loss of between about 3.1% and about 4.0% when heated from about 30.degree. C. to about 175.degree. C.

12. The hemihydrate of claim 1 having an infrared spectrum comprising peaks at approximately 3513 and 1960 cm.sup.-1.

13. The hemihydrate of claim 1 having an infrared spectrum corresponding to the representative infrared spectrum depicted in FIG. 7.

14. The hemihydrate of claim 1 having a Raman spectrum corresponding to the representative Raman spectrum depicted in FIG. 8.
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