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Claims for Patent: 7,420,069

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Claims for Patent: 7,420,069

Title:Crystalline composition containing escitalopram
Abstract:Crystalline particles of escitalopram oxalate with a particle size of at least 40 .mu.m is disclosed. Method for the manufacture of said crystalline particles and pharmaceutical compositions comprising said crystalline particles are also disclosed.
Inventor(s): Christensen; Troels Volsgaard (Holb.ae butted.k, DK), Liljegren; Ken (V.ae butted.rlose, DK), Elema; Michiel Onne (Kobnhavn O, DK), Andresen; Lene (Rodovre, DK), Mahashabde; Shashank (Kendall Park, NJ), Assenza; Sebastian P. (Fort Salonga, NY)
Assignee: H. Lundbeck A/S (Copenhagen-Valby, DK)
Application Number:11/053,641
Patent Claims: 1. A tablet prepared from a mixture of crystalline particles of escitalopram oxalate having a median particle size of 40-200 .mu.m and pharmaceutically acceptable excipients.

2. The tablet of claim 1, wherein the median particle size of the crystalline particles is from 50-200 .mu.m.

3. The tablet of claim 1, wherein the pharmaceutically acceptable excipients comprising a disintegrant, lubricant, colorant, or sweetener.

4. A tablet prepared by directed compression of a mixture of crystalline particles of escitalopram oxalate having a median particle size of 40-200 .mu.m and pharmaceutically acceptable excipients.

5. The tablet of claim 4, wherein the median particle size of the crystalline particles is from 50-200 .mu.m.

6. The tablet of claim 4, wherein the tablet is coated.

7. The tablet of claim 4, wherein the tablet does not contain a binder.

8. The tablet of claim 4, wherein the tablet comprises 1-30% w/w active ingredient calculated as escitalopram base.

9. The tablet of claim 4, wherein the tablet comprises 4-20% w/w active ingredient calculated as escitalopram base.

10. The tablet of claim 4, wherein the tablet is substantially free of lactose.

11. A tablet prepared from crystalline particles of escitalopram oxalate having a median particle size of 40-200 .mu.m.

12. The tablet of claim 11, wherein the median particle size of the crystalline particles is from 50-200 .mu.m.

13. A method for preparing an escitalopram oxalate tablet comprising the steps of: (a) preparing crystalline particles of escitalopram oxalate having a median particle size of 40-200 .mu.m; and (b) preparing a tablet from the crystalline particles.

14. The method of claim 13, wherein the median particle size of the crystalline particles is from 50-200 .mu.m.

15. The method of claim 13, wherein the crystalline particles of escitalopram oxalate are prepared by: (a) dissolving escitalopram oxalate in a solvent at a first temperature between about 50.degree. C. and the refluxing temperature of the solvent to form a solution of escitalopram oxalate; (b) gradually cooling the solution of escitalopram oxalate to a second temperature between about 0.degree. C. and 20.degree. C. while maintaining a controlled cooling rate; (c) adding crystals of escitalopram oxalate during the cooling of step (b); (d) holding the solution at the second temperature; and (e) isolating crystalline particles of escitalopram oxalate from the solution.

16. The method of claim 15, wherein the solvent contains at least one alcohol and optionally water.

17. The method of claim 16, wherein the solvent comprises ethanol.

18. The method of claim 15, wherein the solute:solvent weight ratio is between about 0.05:1 and 0.6:1.

19. The method of claim 15, wherein the solute:solvent weight ratio is between about 0.1:1 and 0.5:1.

20. The method of claim 15, wherein the solute:solvent weight ratio is between about 0.2:1 and 0.4:1.

21. The method of claim 15, wherein the first temperature is between about 60.degree. C. and the refluxing temperature of the solvent system.

22. The method of claim 15, wherein the first temperature is between about 70.degree. C. and the refluxing temperature of the solvent system.

23. The method of claim 15, wherein the second temperature is between about 0.degree. C. and 15.degree. C.

24. The method of claim 15, wherein the second temperature is between about 7.degree. C. and 15.degree. C.

25. The method of claim 15, wherein the controlled cooling rate comprises an initial cooling period during which the cooling rate does not exceed 0.6.degree. C. per minute.

26. The method of claim 25, wherein the initial cooling period comprises the time between the start of the cooling period and the time at which the temperature is below 60.degree. C.

27. The method of claim 25, wherein the initial cooling period comprises the time between the start of the cooling period and the time at which the temperature is below 50.degree. C.

28. The method of claim 25, wherein the initial cooling period comprises the time between the start of the cooling period and the time at which the temperature is below 40.degree. C.

29. The method of claim 25, wherein the cooling rate is from 0.2 to 0.4.degree. C. per minute.

30. The method of claim 15, which comprises adding crystals of escitalopram oxalate at least two times during the cooling of step (b).

31. The method of claim 15, which comprises holding the solution at the predetermined temperature for at least one hour.

32. The method of claim 15, which comprises holding the solution at the predetermined temperature for 4 to 24 hours.

33. The method of claim 15, which comprises holding the solution at the predetermined temperature for 6 to 12 hours.

34. The method of claim 15, wherein step (e) comprises isolating the crystalline particles of escitalopram oxalate by solid/liquid separation techniques.

35. The method of claim 15, wherein the solid/liquid separation techniques comprise filtration.
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