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Claims for Patent: 7,858,594

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Claims for Patent: 7,858,594

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 (Kent, GB)
Assignee: Novartis Pharma AG (Basel, CH)
Application Number:12/505,839
Patent Claims: 1. A non-solvated crystalline form of beta-L-2'-deoxythymidine devoid of waters of association, having less than 0.1% weight loss at 5% relative humidity, 1.1% weight gain at 95% relative humidity and 1.1% weight loss from 95%-5% relative humidity.

2. A non-solvated crystalline form of beta-L-2'-deoxythymidine devoid of waters of association and having the X-ray powder diffraction pattern shown in FIG. 1.

3. The beta-L-2'-deoxythymidine of claim 1 or 2 prepared by crystallizing beta-L-2'-deoxythymidine from solution, optionally filtering said crystallized belta-L-2'-deoxythymidine, and drying said beta-L-2'-deoxythymidine in an environment comprising less than about 40% relative humidity.

4. A pharmaceutical formulation comprising the non-solvated crystalline form of beta-L-2'-deoxythymidine according to claim 1 or 2.

5. The pharmaceutical formulation according to claim 4 in an oral solid form.

6. The oral solid formulation of claim 5 further comprising at least one of an inert diluent, an edible carrier, excipient, a compatible binding agent, glidant, lubricant or adjuvant material.

7. The oral solid formulation of claim 6 wherein the binding agent is microcrystalline cellulose, the excipient is starch, the glidant is colloidal silicon dioxide, and the lubricant is magnesium stearale.

8. The oral solid formulation of claim 6 in the form of a tablet, troche or capsule.

9. The oral solid formulation of claim 8 having a dosage unit of 50-1000 mg.

10. The oral solid formulation of claim 8 in the form of a tablet having a dosage unit of 50-1000 mg.

11. The tablet of claim 10 comprising a coating of sugar, shellac or other enteric agent.

12. A method of treating hepatitis B in a human subject comprising administering the oral solid formulation of claim 9.

13. A method of treating hepatitis B in a human subject comprising administering the oral solid formulation of claim 10.

14. A method of treating hepatitis B virus comprising administering to a human afflicted with Hepatitis B virus the oral solid formulation of claim 9.

15. A method of treating hepatitis B virus comprising administering to a human afflicted with Hepatitis B virus the oral solid formulation of claim 10.
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