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Claims for Patent: 6,096,341

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Claims for Patent: 6,096,341

Title: Delayed release tablet of bupropion hydrochloride
Abstract:The invention provides a controlled release tablet, free of stabilizer and free of pore-forming agent comprising: (i) a core consisting essentially of bupropion hydrochloride, a binder and a lubricant; and (ii) a coating consisting essentially of a water-insoluble, water-permeable film-forming polymer, a plasticizer and a water-soluble polymer.
Inventor(s): Seth; Pawan (Irvine, CA)
Assignee: Pharma Pass LLC (Irvine, CA)
Application Number:09/184,091
Patent Claims: 1. A delayed release tablet comprising:

(i) a core comprising bupropion hydrochloride and conventional excipients, free of stabilizer; and

(ii) a coating consisting essentially of a water-insoluble, water-permeable film-forming polymer, a plasticizer and a water-soluble polymer, where the proportion of water-insoluble, water-permeable film-forming polymer varies between 25 and 90% of the coating dry weight, the proportion of plasticizer varies between 5 and 30% of the coating dry weight, and the proportion of water-soluble polymer varies between 10 and 75% of the coating dry weight,

exhibiting a dissolution profile such that after 1 hour, from 0 up to 30% of the bupropion hydrochloride is released, after 4 hours, from 10 to 60% of the bupropion hydrochloride is released, after 6 hours, from 20 to 70% of the bupropion hydrochloride is released, after 8 hours, more than 40% of the bupropion hydrochloride is released.

2. The tablet of claim 1, where the water-insoluble, water-permeable film-forming polymer is ethylcellulose.

3. The tablet of claim 1, where the water-soluble polymer is polyvinylpyrrolidone.

4. The tablet of claim 1, where the plasticizer is polyethyleneglycol.

5. The tablet of claim 1, where the water-insoluble, water-permeable film-forming polymer is ethylcellulose, the water-soluble polymer is polyvinylpyrrolidone and the plasticizer is polyethyleneglycol.

6. The tablet of claim 1, where the core comprises a lubricant.

7. The tablet of claim 5, where the core comprises a lubricant.

8. The tablet of claim 6, where the core further comprises a binder.

9. The tablet of claim 7, where the core further comprises a binder.

10. The tablet of claim 6, where the core further comprises a filler.

11. The tablet of claim 7, where the core further comprises a filler.

12. The tablet of claim 6, where the lubricant is selected from the group consisting of stearic acid, glyceryl behenate and mixtures thereof.

13. The tablet of claim 7, where the lubricant is selected from the group consisting of stearic acid, glyceryl behenate and mixtures thereof.

14. The tablet of claim 8, where the binder is polyvinylpyrrolidone.

15. The tablet of claim 9, where the binder is polyvinylpyrrolidone.

16. The tablet of claim 10, where the filler is microcristalline cellulose.

17. The tablet of claim 11, where the filler is microcristalline cellulose.

18. The tablet of claim 1, comprising from 50 to 400 mg bupropion hydrochloride.

19. The tablet of claim 5, comprising from 50 to 400 mg bupropion hydrochloride.

20. The tablet of claim 6, comprising from 50 to 400 mg bupropion hydrochloride.

21. The tablet of claim 7, comprising from 50 to 400 mg bupropion hydrochloride.

22. The tablet of claim 8, comprising from 50 to 400 mg bupropion hydrochloride.

23. The tablet of claim 9, comprising from 50 to 400 mg bupropion hydrochloride.

24. The tablet of claim 10, comprising from 50 to 400 mg bupropion hydrochloride.

25. The tablet of claim 11, comprising from 50 to 400 mg bupropion hydrochloride.

26. A delayed release tablet comprising:

(i) a core consisting essentially of bupropion hydrochloride, polyvinylpyrrolidone and stearic acid; and

(ii) a coating consisting essentially of ethylcellulose, polyvinylpyrrolidone and polyethyleneglycol, where the proportion of ethylcellulose varies between 25 and 90% of the coating dry weight, the proportion of polyethyleneglycol varies between 5 and 30% of the coating dry weight, and the proportion of polyvinylpyrrolidone varies between 10 and 75% of the coating dry weight,

exhibiting a dissolution profile such that after 1 hour, from 0 up to 30% of the bupropion hydrochloride is released, after 4 hours, from 10 to 60% of the bupropion hydrochloride is released, after 6 hours, from 20 to 70% of the bupropion hydrochloride is released, after 8 hours, more than 40% of the bupropion hydrochloride is released.

27. The tablet of claim 26, comprising from 50 to 400 mg bupropion hydrochloride.

28. A delayed release tablet comprising:

(i) a core consisting essentially of bupropion hydrochloride, microcristalline cellulose and a lubricant selected from the group consisting of stearic acid, glyceryl behenate and mixtures thereof; and

(ii) a coating consisting essentially of ethylcellulose, polyvinylpyrrolidone and polyethyleneglycol, where the proportion of ethylcellulose varies between 25 and 90% of the coating dry weight, the proportion of polyethyleneglycol varies between 5 and 30% of the coating dry weight, and the proportion of polyvinylpyrrolidone varies between 10 and 75% of the coating dry weight,

exhibiting a dissolution profile such that after 1 hour, from 0 up to 30% of the bupropion hydrochloride is released, after 4 hours, from 10 to 60% of the bupropion hydrochloride is released, after 6 hours, from 20 to 70% of the bupropion hydrochloride is released, after 8 hours, more than 40% of the bupropion hydrochloride is released.

29. The tablet of claim 28, comprising from 50 to 400 mg bupropion hydrochloride.

30. A bupropion hydrochloride delayed release tablet free of stabilizer and free of pore-forming agent, exhibiting a dissolution profile such that after 1 hour, from 0 up to 30% of the bupropion hydrochloride is released, after 4 hours, from 10 to 60% of the bupropion hydrochloride is released, after 6 hours, from 20 to 70% of the bupropion hydrochloride is released, after 8 hours, more than 40% of the bupropion hydrochloride is released.

31. The tablet of claim 30, comprising from 50 to 400 mg bupropion hydrochloride.

32. A tablet comprising the delayed release tablet of claim 1, coated with a bupropion hydrochloride immediate release coating.

33. A tablet comprising the delayed release tablet of claim 26, coated with a bupropion hydrochloride immediate release coating.

34. A tablet comprising the delayed release tablet of claim 28, coated with a bupropion hydrochloride immediate release coating.

35. A tablet comprising the delayed release tablet of claim 30, coated with a bupropion hydrochloride immediate release coating.
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