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Last Updated: September 21, 2021

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Claims for Patent: 9,901,546


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Summary for Patent: 9,901,546
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:14/287,740
Patent Claims: 1. An orally disintegrable tablet, which comprises: (i) fine granules comprising a composition coated with an enteric coating layer, said composition comprising: 10 weight % or more of lansoprazole or a salt thereof relative to the composition; and a basic inorganic salt selected from the group consisting of a salt of magnesium and a salt of calcium; and (ii) an additive comprising crospovidone and a water-soluble sugar alcohol, wherein the water-soluble sugar alcohol is comprised in the tablet separately from the fine granules, the enteric coating layer is about 30-70 weight % relative to the fine granule, the enteric coating layer comprises a methacrylic acid copolymer as an aqueous enteric polymer agent, the orally disintegrable tablet is administerable without water, an oral disintegration time of the orally disintegrable tablet is one minute or less, the orally disintegrable tablet is not an effervescent, and the composition does not comprise alkaline metal carbonate.

2. The 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.

3. The orally disintegrable tablet of claim 1, wherein the additive further comprises at least one material selected from the group consisting of (i) crystalline cellulose and (ii) low-substituted hydroxypropyl cellulose.

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

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

6. The orally disintegrable tablet of claim 1, wherein the composition comprises a core being coated with the lansoprazole or the salt thereof and the basic inorganic salt, said core comprising crystalline cellulose and lactose.

7. The orally disintegrable tablet of claim 6, wherein the core comprises lactose in an amount of 50 weight % or more.

8. The orally disintegrable tablet of claim 6, wherein the core comprises crystalline cellulose in an amount from 40 to 50 weight % and the lactose in an amount from 50 to 60 weight %.

9. The orally disintegrable tablet of claim 1, wherein the composition comprises the lansoprazole or the salt thereof in an amount of 20 weight % or more.

10. The orally disintegrable tablet of claim 1, wherein the composition comprises the lansoprazole or the salt thereof in an amount from 20 to 50 weight %.

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

12. The orally disintegrable tablet of claim 1, wherein the enteric coating layer further comprises a sustained-release agent.

13. The orally disintegrable tablet of claim 12, wherein the sustained-release agent is a methacrylate copolymer.

14. The orally disintegrable tablet of claim 12, wherein the sustained-release agent is contained in an amount from 5 to 15 weight % relative to 100 weight % of the aqueous enteric polymer agent.

15. The orally disintegrable tablet of claim 1, wherein the water-soluble sugar alcohol is erythritol.

16. The orally disintegrable tablet of claim 1, wherein the water-soluble sugar alcohol is mannitol.

17. The orally disintegrable tablet of claim 12, wherein the water-soluble sugar alcohol is contained in an amount from 5 to 97 weight % relative to 100 weight % of the orally disintegrable tablet apart from the fine granules.

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

19. The orally disintegrable tablet of claim 1, wherein the tablet comprises no lubricant inside the tablet.

20. The orally disintegrable tablet of claim 1, wherein the enteric coating layer has a thickness from 20 to 70 .mu.m.

21. The orally disintegrable tablet of claim 1, wherein the oral disintegration time of the tablet is about 40 seconds or less.

22. The orally disintegrable tablet of claim 1, wherein the orally disintegrable tablet has a tablet hardness in a range from about 1 kg to about 20 kg.

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