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Claims for Patent: 7,875,292

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Claims for Patent: 7,875,292

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 Pharmaceutical Company Limited (Osaka, JP)
Application Number:12/151,572
Patent Claims: 1. An orally disintegrable tablet which comprises (i) fine granules having an average particle diameter of 400 .mu.m or less, wherein the fine granules comprise: (a) a core composition comprising excipient and 10 weight % or more of an acid-labile physiologically active substance, (b) an enteric coating layer for the core composition, and (c) a coating layer comprising a water-soluble sugar alcohol outside the enteric coating layer; and (ii) wherein the additive in (ii) is comprised in the tablet separately from said fine granules in (i) in said tablet and said additive comprises water-soluble sugar alcohol, and wherein oral disintegration time for complete disintegration of the tablet is one minute or less.

2. An orally disintegrable tablet of claim 1, wherein the average particle diameter of the fine granules 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 further comprises crystalline cellulose, low-substituted hydroxypropyl cellulose or a combination thereof.

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

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

7. An orally disintegrable tablet of claim 1, wherein the acid-labile physiologically active substance is a benzimidazole compound or a salt thereof.

8. An orally disintegrable tablet of claim 3, wherein the basic inorganic salt is at least one selected from the group consisting a salt of magnesium and a salt of calcium.

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

10. An orally disintegrable tablet of claim 9, wherein the core comprises 50 weight % or more of lactose.

11. An orally disintegrable tablet of claim 9, wherein the core comprises 40 to 50 weight % of crystalline cellulose and 50 to 60 weight % of lactose.

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

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

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

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

16. An orally disintegrable tablet of claim 15, wherein the aqueous enteric polymer agent is a methacrylate copolymer.

17. An orally disintegrable tablet of claim 15, wherein the enteric coating layer further comprises a sustained-release agent.

18. An orally disintegrable tablet of claim 17, wherein the sustained-release agent is a methacrylate copolymer.

19. An orally disintegrable tablet of claim 17, wherein the sustained-release agent is in an amount of 5 to 15 weight % relative to 100 weight % of the aqueous enteric polymer agent.

20. An orally disintegrable tablet of claim 1, wherein the water-soluble sugar alcohol in (ii) is erythritol.

21. An orally disintegrable tablet of claim 1, wherein the water-soluble sugar alcohol in (ii) is mannitol.

22. An orally disintegrable tablet of claim 1, wherein the water-soluble sugar alcohol in (ii) 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 disintegrable tablet of claim 4, 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 4, wherein the content of hydroxypropoxyl group in the low-substituted hydroxypropyl cellulose is 5.0 to 7.0 weight %.

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

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

28. An orally disintegrable table of claim 17, wherein the sustained-release agent is in an amount of 5 to 30 weight % relative to 100 weight % of the aqueous enteric polymer agent.

29. An orally disintegrable tablet of claim 1, wherein the enteric coating layer comprises a first component that is an enteric coating agent and a second component that is a sustained-release agent.

30. An orally disintegrable tablet of claim 1, wherein said tablet has a hardness strength of about 1 to about 20 kg.
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