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Claims for Patent: 7,893,101

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Claims for Patent: 7,893,101

Title:Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof
Abstract: Solid forms comprising (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions comprising the solid forms, methods of making the solid forms and methods of their use are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-.alpha. or the inhibition of PDE4.
Inventor(s): Muller; George W. (Bridgewater, NJ), Schafer; Peter H. (Somerset, NJ), Man; Hon-Wah (Princeton, NJ), Ge; Chuansheng (Belle Mead, NJ), Xu; Jean (Warren, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Application Number:12/079,615
Patent Claims: 1. A Form B crystal form of the compound of Formula (I): ##STR00002## which is enantiomerically pure, and which has an X-ray powder diffraction pattern comprising peaks at about 10.1, 13.5, 20.7, and 26.9 degrees 2.theta..

2. The crystal form of claim 1, which has an X-ray powder diffraction pattern further comprising peaks at about 12.4, 15.7, 18.1, and 24.7 degrees 2.theta..

3. The crystal form of claim 2, which has an X-ray powder diffraction pattern further comprising peaks at about 16.3, 22.5, 26.2, and 29.1 degrees 2.theta..

4. The crystal form of claim 1, which has an X-ray powder diffraction pattern matching the pattern depicted in FIG. 5.

5. The crystal form of claim 1, which has a differential scanning calorimetry plot comprising an endothermic event with an onset temperature of about 154.degree. C.

6. The crystal form of claim 1, which has a differential scanning calorimetry plot matching the plot depicted in FIG. 6.

7. The crystal form of claim 1, which has a thermal gravimetric analysis plot comprising a mass loss of less than about 1% when heated from about 25.degree. C. to about 140.degree. C.

8. The crystal form of claim 7, wherein the mass loss is about 0.25%.

9. The crystal form of claim 1, which has a thermal gravimetric analysis plot matching the plot depicted in FIG. 7.

10. The crystal form of claim 1, which exhibits a mass increase of less than about 1% when subjected to an increase in relative humidity from about 0% to about 95% relative humidity.

11. The crystal form of claim 10, wherein the mass increase is about 0.6%.

12. The crystal form of claim 1, which has a moisture sorption isotherm plot matching the plot depicted in FIG. 8.

13. The crystal form of claim 1, which is stable upon exposure to about 40.degree. C. and about 75% relative humidity for about 4 weeks.

14. The crystal form of any one of claims 1 and 2 to 13, which is substantially pure.

15. A solid pharmaceutical composition comprising the crystal form of any one of claims 1 and 2 to 13.
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