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Details for Patent: 8,058,443

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Details for Patent: 8,058,443

Title:Processes for preparing 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): Saindane; Manohar T. (Monmouth Junction, NJ), Cameron; Louise M. (East Windsor, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Filing Date:Dec 15, 2008
Application Number:12/335,262
Claims:1. A process for preparing crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate comprising the steps: a. slurrying 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione in water at a temperature from about 60.degree. C. to about 80.degree. C.; b. filtering 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate; and c. drying 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate under vacuum.

2. The process of claim 1, wherein the slurrying is performed with about 10 volumes of water.

3. The process of claim 1, wherein the slurrying is performed at a temperature of about 60.degree. C.

4. The process of claim 1, wherein the slurrying is performed at a temperature from about 70.degree. C. to about 80.degree. C.

5. The process of claim 1, wherein the slurrying is performed at a temperature from about 70.degree. C. to about 75.degree. C.

6. The process of claim 1, wherein the filtering is performed at a temperature from about 60.degree. C. to about 65.degree. C.

7. The process of claim 1, wherein the filtering is performed at a temperature from about 65.degree. C. to about 75.degree. C.

8. The process of claim 1, wherein the drying is performed at a temperature from about 30.degree. C. to about 70.degree. C.

9. The process of claim 1, wherein the drying is performed at a temperature from about 35.degree. C. to about 40.degree. C.

10. The process of claim 1, wherein the drying is performed at a temperature from about 60.degree. C. to about 70.degree. C.

11. The process of claim 1, wherein the drying is performed at a vacuum from about 125 mm Hg to about 152 mm Hg.

12. The process of claim 1, wherein the drying is performed at a vacuum of about 152 mm Hg.

13. The process of any one of claims 1-12, wherein the crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate is substantially pure.

14. A process for preparing crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione dihydrate comprising the steps: a. slurrying 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione in water at about room temperature; b. filtering 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione; and c. drying 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione at about room temperature.

15. The process of claim 14, wherein the slurrying is performed with about 20 volumes of water.

16. The process of claim 14, wherein the slurrying is performed at a temperature from about 23.degree. C. to about 25.degree. C.

17. The process of claim 14, wherein the drying is performed at a temperature from about 23.degree. C. to about 25.degree. C.

18. The process of any one of claims 14-17, wherein the crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione dihydrate is substantially pure.
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