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Claims for Patent: 6,328,994

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Claims for Patent: 6,328,994

Title: Orally disintegrable tablets
Abstract:An orally disintegrable tablet, of the present invention, which comprises (i) fine granules having an average particle diameter of 400 .mu.m or less, which fine granules comprise a composition coated by an enteric coating layer, said composition having 10 weight % or more of an acid-labile physiologically active substance and (ii) an additive, has superior disintegrability or dissolution in the oral cavity so that it can be used for treatment or prevention of various diseases, as an orally disintegrable tablet capable of being administered to the aged or children and easily administered without water. Also, because the tablet of the present invention contains fine granules having the average particle diameter such that it will not impart roughness in mouth, it can be administered easily without discomfort at the administration.
Inventor(s): Shimizu; Toshihiro (Itami, JP), Morimoto; Shuji (Suita, JP), Tabata; Tetsuro (Suita, JP)
Assignee: Takeda Chemical Industries, Ltd. (Osaka, JP)
Application Number:09/355,781
Patent Claims: 1. An orally disintegrable tablet which comprises

(i) fine granules having an average particle diameter of 400 .mu.m or less, which fine granules comprise a composition coated by an enteric coating layer comprising a first component which is an enteric coating agent and a second component which is a sustained-release agent, said composition having 10 weight % or more of an acid-labile physiologically active substrate that is lansoprazole and (ii) an additive wherein said tablet having a hardness strength of about 1 to about 20 kg, is orally disintegrable.

2. An orally disintegrable tablet of claim 1, wherein the average particle diameter of the fine granule is 300 to 400 .mu.m.

3. An orally disintegrable tablet of claim 1, wherein the fine granules further comprise a basic inorganic salt.

4. An orally disintegrable tablet of claim 1, wherein the additive comprises a water-soluble sugar alcohol.

5. An orally disintegrable tablet of claim 1, wherein the composition coated by an enteric coating layer is further coated by a coating layer which comprises a water-soluble sugar alcohol.

6. An orally disintegrable tablet of claim 4, wherein the additive comprises (1) crystalline cellulose and/or (ii) low-substituted hydroxypropyl cellulose.

7. An orally disintegrable tablet of claim 1, wherein the particle diameter of the fine granules is practically 425 .mu.m or less.

8. An orally disintegrable tablet of claim 1, wherein the particle diameter of the fine granules is practically 400 .mu.m or less.

9. An orally disintegrable tablet of claim 3, wherein the basic inorganic salt is a salt of magnesium and/or a salt of calcium.

10. An orally disintegrable tablet of claim 1, wherein the composition comprises a core being coated by a benzimidazole compound and a basic inorganic salt, said core comprising crystalline cellulose and lactose.

11. An orally disintegrable tablet of claim 10, wherein the core comprises 50 weight % or more of lactose.

12. An orally disintegrable tablet of claim 10, wherein the core comprises 40 to 50 weight % of crystalline cellulose and 50 to 60 weight % of lactose.

13. An orally disintegrable tablet of claim 1, wherein the composition comprises 20 weight % or more of an acid-labile physiologically active substance.

14. An orally disintegrable tablet of claim 1, wherein the composition comprises 20 to 50 weight % of an acid-labile physiologically active substance.

15. An orally disintegrable tablet of claim 1, wherein the fine granules are produced by fluidized-bed granulation method.

16. An orally disintegrable tablet of claim 1, wherein the enteric coating layer comprises an aqueous enteric polymer agent.

17. An orally disintegrable tablet of claim 16, wherein the aqueous enteric polymer agent is a methacrylate copolymer.

18. An orally disintegrable tablet of claim 1, wherein the sustained-release agent is a methacrylate copolymer.

19. An orally disintegrable tablet of claim 16, wherein the sustained-release agent is in an amount of 5 15 weight % relative to 100 weight % of the aqueous enteric polymer agent.

20. An orally disintegrable tablet of claim 4, wherein the water-soluble sugar alcohol is erythritol.

21. An orally disintegrable tablet of claim 4, wherein the water-soluble sugar alcohol si mannitol.

22. An orally disintegrable tablet of claim 5, wherein the water-soluble sugar alcohol is in an amount of 5 to 97 weight % relative to 100 weight % of the orally disintegrable tablet apart from the fine granules.

23. An orally disintegrable tablet of claim 4, wherein the crystalline cellulose is in an amount of 3 to 50 weight % relative to 100 weight % of the tablet apart from the fine granule.

24. An orally disentegrable tablet of claim 6, wherein the content of hydroxypropoxyl group in the low-substituted hydroxypropyl cellulose is 7.0 to 9.9 weight %.

25. An orally disintegrable tablet of claim 6, wherein the content of hydroxypropoxyl group in the low-substituted hydroxypropoxyl cellulose is 5.0 7.0 weight %.

26. An orally disintegrable tablet of claim 1, which further comprises crosprovidone.

27. An orally disintegrable tablet of claim 1, wherein the oral disintegration time is one minute or less.

28. An orally disintegrable tablet of claim 1, which comprises no lubricant inside the tablet.

29. Fine granules having an average particle diameter of 400 .mu.m or less, which comprise a composition coated by an enteric coating layer comprising a first component which is an enteric coating agent and a second component which is a sustained-release agent, said composition having (i) 25 weight % or more of an acid-liable physiologically active substance that is lansoprazole and (ii) a basic inorganic salt.

30. Fine granules of claim 28, wherein the average particle diameter of the fine granules is 300 to 400 .mu.m.

31. Fine granules of claim 28, wherein the particle diameter of the fine granules is practically 425 .mu.m or less.

32. Fine granules of claim 28, wherein the particle diameter of the fine granules is practically 400 .mu.m or less.

33. Fine granules of claim 28, wherein the basic inorganic salt is a salt of magnesium and/or a salt of calcium.

34. Fine granules of claim 28, wherein the composition comprises a core being coated by a benzimidazole compound and a basic inorganic salt, said core comprising crystalline cellulose and lactose.

35. Fine granules of claim 34, wherein the core comprises 50 weight % or more of lactose.

36. Fine granules of claim 28, wherein the composition comprises 25 to 40 weight % of an acid-labile physiologically active substance.

37. Fine granules of claim 28, which are produced by fluidized-bed granulation method.

38. Fine granules of claim 28, wherein the enteric coating layer comprises an aqueous enteric polymer agent.

39. Fine granules of claim 38, wherein the aqueous enteric polymer agent is a methacrylate copolymer.

40. Fine granules of claim 28, wherien the sustained-release agent is a methacrylate copolymer.

41. Fine granules of claim 28, wherein the sustained-release agent is in an amount of 5 to 15 weight % relative to 100 weight % of the aqueous enteric polymer agent.

42. Fine granules of claim 28, wherein the enteric coating layer is in an amount of 50 to 70 weight % relative to 100 weight % of the fine granules.

43. A tablet, granule, fine granule, capsule, effervescent or suspension preparation which comprises the fine granules of claim 28.

44. An orally disintegrable tablet of claim 16, wherein the sustained-release agent is in an amount of 5 to 30 weight % relative to 100 weight % of the aqueous enteric polymer agent.

45. Fine granules of claim 38, wherein the sustained-release agent is in an amount of 5 to 30% relative to 100 weight % of the aqueous enteric polymer agent.
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