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Claims for Patent: 8,697,125

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Claims for Patent: 8,697,125

Title:Tablet preparation without causing a tableting trouble
Abstract: The present invention provides a tablet without causing a tableting trouble, which is superior in the tablet formability, dissolution property of pharmaceutically active ingredient, and the like.
Inventor(s): Ono; Akihiko (Osaka, JP), Marunaka; Shigeyuki (Osaka, JP), Fukuta; Makoto (Osaka, JP)
Assignee: Takeda Pharmaceutical Company Limited (Osaka, JP)
Application Number:12/449,256
Patent Claims: 1. A tablet comprising the following (A) and (B): (A) a granule comprising 2-[[6-[(3R)-3-amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-p- yrimidinyl]methyl]-benzonitrile or a salt thereof as a sole pharmaceutically active ingredient in the tablet and microcrystalline cellulose; (B) a tableting aid comprising magnesium stearate and microcrystalline cellulose, wherein the granule of (A) further comprises mannitol.

2. The tablet of claim 1, wherein the content of the microcrystalline cellulose of (A) and the microcrystalline cellulose of (B) in the tablet is 5-40 wt % and 2-20 wt %, respectively.

3. The tablet of claim 1, wherein the hardness is 70-200 N.

4. The tablet of claim 1, wherein not less than 85% of the pharmaceutically active ingredient is dissolved out in 15 min when the tablet is subjected to a dissolution test according to the Paddle Method at 37.degree. C., 50 rpm using 0.01N hydrochloric acid or the Japanese Pharmacopoeia 2nd fluid (pH 6.8) as a test solution.

5. The tablet of claim 1, wherein the tablet further comprises a binding aid consisting of hydroxypropylcellulose.

6. The tablet of claim 1, wherein the tablet does not contain polyvinylpyrrolidone.

7. A method of producing a tablet, which comprises mixing (A) a granule comprising 2-[[6-[(3R)-3-amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-p- yrimidinyl]methyl]-benzonitrile or a salt thereof as a sole pharmaceutically active ingredient in the tablet and microcrystalline cellulose, and (B) a tableting aid comprising magnesium stearate and microcrystalline cellulose, and then punching the mixture, wherein the granule of (A) further comprises mannitol.

8. The method of claim 7, wherein the content of the microcrystalline cellulose of (A) and the microcrystalline cellulose of (B) in the tablet is 5-40 wt % and 2-20 wt %, respectively.

9. A tablet obtained by the method of claim 7.
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