.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 7,431,942

« Back to Dashboard

Claims for Patent: 7,431,942

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:10/017,755
Patent Claims: 1. An orally disintegrable tablet which comprises (i) fine granules having an average particle diameter of 300 to 400 .mu.m, which 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 comprising a first component that is an enteric coating agent and a second component that is a sustained-release agent, and (c) a coating layer comprising mannitol outside the enteric coating layer; and (ii) a water-soluble sugar alcohol, wherein said water-soluble sugar alcohol is comprised in the tablet separately from said fine granules (i) in said tablet and wherein the water-soluble sugar alcohol separate from said fine granules is in an amount of 5 to 97 weight % relative to 100 weight % of the orally disintegrable tablet apart from the fine granules; wherein said tablet having a hardness strength of about 1 to about 20 kg is orally disintegrable; and wherein the oral disintegration time for complete disintegration of said tablet is one minute or less.

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

3. An orally disintegrable tablet of claim 1, wherein the particle diameter of the fine granules is practically 300 to 425 .mu.m.

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

5. An orally disintegrable tablet of claim 2, wherein the basic inorganic salt is a salt of magnesium and/or a salt of calcium.

6. 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.

7. An orally disintegrable tablet of claim 6, wherein the core comprises 50 weight % or more of lactose.

8. An orally disintegrable tablet of claim 6, wherein the core comprises 40 to 50 weight % of crystalline cellulose and 50 to 60 weight % of lactose.

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

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

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

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

13. An orally disintegrable tablet of claim 12, wherein the aqueous enteric polymer agent is a methacrylate copolymer.

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

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

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

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

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

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

20. An orally disintegrable tablet of claim 1, wherein an additive selected from crystalline cellulose, low substituted hydroxypropyl cellulose or a combination thereof is further comprised in combination with said water-soluble sugar alcohol in (ii).

21. An orally disintegrable tablet of claim 20, 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.

22. An orally disintegrable tablet of claim 4, wherein the benzimidazole compound is lansoprazole.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc