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|Title:||Crystalline and amorphous forms of beta-L-2'-deoxythymidine|
|Abstract:||Physical forms of beta-L-2'-deoxythymidine are disclosed that can be characterized by physical appearance, purity levels, Infra-Red and Raman spectroscopy, X-ray powder diffraction patterns, thermal properties, and methods of manufacture. These forms of beta-L-2'-deoxythymidine can be used in the manufacture of other forms of beta-L-2'-deoxythymidine, or in pharmaceutical compositions. Particularly preferred uses are in the treatment of hepatitis B.|
|Inventor(s):||Jonaitis; David (West Lafayette, IN), Storer; Richard (Folkestone, GB)|
|Assignee:||Idenix Pharmaceuticals, Inc. (Cambridge, MA)|
|Filing Date:||Aug 06, 2003|
|Claims:||1. Amorphous beta-L-2'-deoxythymidine. |
2. Amorphous beta-L-2'-deoxythymidine in substantially pure form.
3. A substantially pure amorphous phase of beta-L-2'-deoxythymidine prepared by quench cooling the melted beta-L-2'-deoxythymidine.
4. A process of preparing substantially pure amorphous beta-L-2'-deoxythymidine comprising: a) melting a beta-L-2'-deoxythymidine, and b) quench cooling the melt to avoid recrystallization.
5. The process of claim 4 further comprising cooling the beta-L-2'-deoxythymidine to below about 50.degree. C.
6. The process of claim 4 further comprising storing the amorphous beta-L-2'-deoxythymidine at a relative humidity below about 20%.
7. A pharmaceutical composition comprising the compound or composition of any one of claims 1 3, and a pharmaceutically acceptable carrier.
8. A method of treating hepatitis B virus comprising administering to a patient afflicted with the disease a treatment effective amount of the compound of any one of claims 1 3.
9. The amorphous beta-L-2'-deoxythymidine of claim 2, wherein the amorphous beta-L-2'-deoxythymidine does not contain more than about 5% of crystalline beta-L-2'-deoxythymidine.
10. The amorphous beta-L-2'-deoxythymidine of claim 2, wherein the amorphous beta-L-2'-deoxythymidine does not contain more than about 4% of crystalline beta-L-2'-deoxythymidine.
11. The amorphous beta-L-2'-deoxythymidine of claim 2, wherein the amorphous beta-L-2'-deoxythymidine does not contain more than about 3% of crystalline beta-L-2'-deoxythymidine.
12. The amorphous beta-L-2'-deoxythymidine of claim 2, wherein the amorphous beta-L-2'-deoxythymidine does not contain more than about 1% of crystalline beta-L-2'-deoxythymidine.
13. The method of claim 8, wherein the compound is administered in a pharmaceutically acceptable carrier.
14. The method of claim 13, wherein the carrier is suitable for oral delivery.
15. The method of claim 8, wherein the compound is administered in the form of a tablet, pill or capsule.
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