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Claims for Patent: 7,815,942

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Claims for Patent: 7,815,942

Title:Rasagiline formulations of improved content uniformity
Abstract:Disclosed are pharmaceutical preparations of R(+)-N-propargyl-1-aminoindan salts having enhanced content uniformity, processes for preparation of the compositions, and their uses.
Inventor(s): Peskin; Tirtza Berger (Raanana, IL)
Assignee: Teva Pharmaceutical Industries, Ltd. (Petach Tikva, IL)
Application Number:11/359,324
Patent Claims: 1. A mixture of particles of a pharmaceutically acceptable salt of R(+)-N-propargyl-1-aminoindan, wherein more than 90% of the total amount by volume of R(+)-N-propargyl-1-aminoindan salt particles have a size of greater than 6 microns and less than 250 microns.

2. The mixture of claim 1, wherein more than 90% of the total amount by volume of the R(+)-N-propargyl-1-aminoindan salt particles have a size of greater than 6 microns and less than 220 microns.

3. The mixture of claim 2, wherein more than 90% of the total amount by volume of the R(+)-N-propargyl-1-aminoindan salt particles have a size of greater than 6 microns and less than 200 microns.

4. The mixture of claim 1, wherein the pharmaceutically acceptable salt is tartrate, esylate, mesylate, or sulfate salt.

5. The mixture of claim 4 wherein the pharmaceutically acceptable salt is mesylate salt.

6. A solid composition comprising an amount of the mixture of particles of claim 1 and a carrier.

7. The solid composition of claim 6, comprising a therapeutically effective amount of the mixture of particles and a pharmaceutically acceptable carrier.

8. The solid composition of claim 6, wherein the mixture of particles and the carrier constitute a granulate.

9. The composition of claim 8, in a solid dosage form.

10. The composition of claim 9, in oral dosage form.

11. The composition of claim 10, wherein the oral dosage form is a tablet.

12. The composition of claim 9, wherein the relative standard deviation (RSD) of R(+)-N-propargyl-1-aminoindan salt content among the solid dosage forms is less than 4%.

13. The composition of claim 12, wherein the relative standard deviation (RSD) of R(+)-N-propargyl-1-aminoindan salt content is less than 3%.

14. The composition of claim 13, wherein the relative standard deviation (RSD) of R(+)-N-propargyl-1aminoindan salt content is less than 2%.

15. The composition of claim 9, wherein the content uniformity is between 95% and 105%.

16. A method of treating a subject afflicted with Parkinson's disease comprising administering to the subject a solid composition comprising a carrier, and a therapeutically effective amount of a mixture of particles of a pharmaceutically acceptable salt of R(+)-N-propargyl-1-aminoindan, wherein more than 90% of the total amount by volume of R(+)-N-propargyl-1-aminoindan salt particles have a size of greater than 6 microns and less than 250 microns.

17. A process for preparing a composition which comprises reducing the particle size of a pharmaceutically acceptable salt of R(+)-N-propargyl-1-aminoindan to a particle size of greater than 6 microns and less than 250 microns.

18. The process of claim 17, wherein the particle size is less than 200 microns.

19. The process of claim 17, wherein the reducing step comprises comminution of the particles of the pharmaceutically acceptable salt of R(+)-N-propargyl-1-aminoindan.

20. The process of claim 17, further comprising admixing the particles of R(+)-N-propargyl-1-aminoindan with a carrier to form a granulate.

21. The process of claim 20, wherein the blend uniformity of the granulate is between 90% and 110% and the relative standard deviation (RSD) of the blend uniformity is less than 2%.

22. The process of claim 21, wherein the blend uniformity is between 95% and 105% and the relative standard deviation of the blend uniformity is less than 2%.

23. The process of any claim 20, further comprising compressing the granulate comprising the particles of a pharmaceutically acceptable salt of R(+)-N-propargyl-1-aminoindan having a particle size of less than 250 microns into a solid dosage form.

24. The process of claim 23, wherein the solid dosage form is a tablet.

25. A process for preparing a solid composition comprising: a) subjecting a batch of particles of a pharmaceutically acceptable salt of R(+)-N-propargyl-1-aminoindan to comminution; b) admixing the product of step a) with a carrier to form a granulate; c) determining the blend uniformity of the granulate; and d) forming the composition from the granulate only if the blend uniformity of the granulate satisfies a predetermined criteria, so as to prepare the composition.

26. The composition of claim 6, wherein the pharmaceutically acceptable salt is tartrate, esylate, mesylate, or sulfate salt.

27. The composition of claim 26, wherein the pharmaceutically acceptable salt is mesylate salt.

28. The composition of claim 11, wherein the pharmaceutically acceptable salt is tartrate, esylate, mesylate, or sulfate salt.

29. The composition of claim 28, wherein the pharmaceutically acceptable salt is mesylate salt.

30. The composition of claim 12, wherein the pharmaceutically acceptable salt is tartrate, esylate, mesylate, or sulfate salt.

31. The composition of claim 30, wherein the pharmaceutically acceptable salt is mesylate salt.

32. The composition of claim 15, wherein the pharmaceutically acceptable salt is tartrate, esylate, mesylate, or sulfate salt.

33. The composition of claim 32, wherein the pharmaceutically acceptable salt is mesylate salt.

34. The method of claim 16, wherein the pharmaceutically acceptable salt is tartrate, esylate, mesylate, or sulfate salt.

35. The method of claim 34, wherein the pharmaceutically acceptable salt is mesylate salt.

36. The process of claim 24, wherein the pharmaceutically acceptable salt is tartrate, esylate, mesylate, or sulfate salt.

37. The process of claim 36, wherein the pharmaceutically acceptable salt is mesylate salt.
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