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Claims for Patent: 7,361,676

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Claims for Patent: 7,361,676

Title:Solid preparation containing single crystal form
Abstract:There are provided a solid preparation containing a single crystal of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid, an excipient and a disintegrating agent, and a method for producing the same.
Inventor(s): Iwai; Michio (Osaka, JP), Nakamura; Kazuhiro (Yamaguchi, JP), Dohi; Masahiko (Tokyo, JP), Mochizuki; Hiroko (Yamaguchi, JP), Mochizuki; Seiji (Yamaguchi, JP)
Assignee: Teijin Limited (Osaka, JP)
Application Number:10/503,391
Patent Claims: 1. A tablet comprising crystal A of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid with an X-ray powder diffraction pattern having specific peaks at a reflection angle 2.theta., of 6.62.degree., 7.18.degree., 12.80.degree., 13.26.degree., 16.48.degree., 19.58.degree., 21.92.degree., 22.68.degree., 25.84.degree., 26.70.degree., 29.16.degree. and 36.70.degree., an excipient, and a disintegrating agent, wherein the average particle diameter of the crystal A is from 12.9 .mu.m to 26.2 .mu.m.

2. The tablet according to claim 1, wherein the tablet is prepared by a wet granulating method.

3. The tablet according to claim 1 or 2, wherein said excipient is one or more selected from the group consisting of lactose and partly pregelatinized starch.

4. The tablet according to claim 1 or 2, further comprising hydroxypropyl cellulose as a binder.

5. The tablet according to claim 1 or 2, wherein the tablet is coated with polyethylene glycol.

6. A method for producing the tablet according to claim 2 comprising combining said crystal A of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid with an X-ray powder diffraction pattern having specific peaks at a reflection angle 2.theta., of 6.62.degree., 7.18.degree., 12.80.degree., 13.26.degree., 16.48.degree., 19.58.degree., 21.92.degree., 22.68.degree., 25.84.degree., 26.70.degree., 29.16.degree. and 36.70.degree., an excipient, and a disintegrating agent, wherein the average particle diameter of the crystal A is from 12.9 .mu.m to 26.2 .mu.m.

7. The method for producing a tablet according to claim 6, comprising a step of wet granulating.

8. The method for producing a tablet according to claim 6 or 7, wherein said excipient is one or more selected from the group consisting of lactose and partly pregelatinized starch.

9. The method for producing a tablet according to claim 6 or 7, wherein hydroxypropyl cellulose is added as a binder.

10. The method for producing a tablet according to claim 6 or 7, comprising a step of coating the tablet with polyethylene glycol.
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