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Claims for Patent: 9,101,660

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Claims for Patent: 9,101,660

Title:Solid preparation
Abstract: The present invention provides a solid preparation containing an insulin sensitizer and an active ingredient (except insulin sensitizers), which is useful as a therapeutic drug for diabetes and the like, and which is superior in preparation characteristics such as content uniformity and dissolution property of the insulin sensitizer and the active ingredient (except insulin sensitizers), preparation hardness and the like.
Inventor(s): Koike; Masahiko (Osaka, JP), Koyama; Hiroyoshi (Osaka, JP), Hamaguchi; Naoru (Osaka, JP)
Assignee: Takeda Pharmaceutical Company (Osaka, JP)
Application Number:10/530,262
Patent Claims: 1. A solid preparation comprising a phase, said phase comprising particles of pioglitazone or a salt thereof and particles of metformin or a salt thereof, wherein the particles of the pioglitazone or the salt thereof and the particles of the metformin or the salt thereof are uniformly dispersed particles, wherein the ratio of the median size of the particles of the metformin or the salt thereof to the median size of the particles of the pioglitazone or the salt thereof is 1 to 15, wherein the particles of the pioglitazone or the salt thereof have a median size of 2-10 .mu.m, and the particles of the metformin or the salt thereof have a median size of 10-100 .mu.m, and wherein an amount of the pioglitazone or the salt thereof in the preparation is 15-60 mg/day.

2. The solid preparation of claim 1, which is film-coated.

3. The solid preparation of claim 1, wherein pioglitazone or the salt thereof is pioglitazone hydrochloride.

4. The solid preparation of claim 1, wherein the metformin or the salt thereof is metformin hydrochloride.

5. The solid preparation of claim 1, wherein the pioglitazone or the salt thereof is pioglitazone hydrochloride and the metformin or the salt thereof is metformin hydrochloride.

6. The solid preparation of claim 1, wherein the solid preparation has a coefficient of variation of the pioglitazone or the salt thereof content of not more than 6%.

7. The solid preparation of claim 1, wherein the solid preparation has a hardness of 100 N to 400 N.

8. The solid preparation of claim 1, which elutes out not less than 70% of the pioglitazone or a salt thereof at 30 minutes after in a dissolution test according to a Paddle Method using a hydrochloric acid-potassium chloride buffer having pH of 2.0 as a test solution at 37.degree. C., 50 rpm.

9. The solid preparation of claim 1, which is an agent for treatment of diabetes comprising an amount of the pioglitazone or salt thereof and an amount of the metformin or salt thereof effective for the treatment of diabetes.

10. The solid preparation of claim 1, wherein the amount of the pioglitazone or the salt thereof in the preparation is 15 mg/day.

11. The solid preparation of claim 1, wherein an amount of the metformin or the salt thereof in the preparation is 250-2550 mg/day.

12. The solid preparation of claim 1, wherein the pioglitazone or the salt thereof and the metformin or the salt thereof are sole active ingredients of the preparation.

13. A solid preparation comprising a phase, said phase comprising particles of pioglitazone or a salt thereof and particles of metformin or a salt thereof, wherein the particles of the pioglitazone or the salt thereof and the particles of the metformin or the salt thereof are uniformly dispersed, and wherein the ratio of the median size of the particles of the metformin or the salt thereof to the median size of the particles of the pioglitazone or the salt thereof is 1 to 15, and wherein (1) the particles of the pioglitazone or the salt thereof have a median size of 2-10 .mu.m, and the particles of the metformin or the salt thereof have a median size of 10-100 .mu.m, (2) the solid preparation has a coefficient of variation of the pioglitazone or the salt thereof content of not more than 6%, (3) the solid preparation has a hardness of 100 to 400N, and (4) the solid preparation elutes out not less than 70% of the pioglitazone or the salt thereof at 30 minutes after in a dissolution test according to a Paddle Method using a hydrochloric acid-potassium chloride buffer having a pH of 2.0 as a test solution at 37.degree. C., 50 rpm, and wherein an amount of the pioglitazone or the salt thereof in the preparation is 15-60 mg/day.

14. The solid preparation of claim 13, wherein the amount of the pioglitazone or the salt thereof in the preparation is 15 mg/day.

15. The solid preparation of claim 13, wherein an amount of the metformin or the salt thereof in the preparation is 250-2550 mg/day.

16. The solid preparation of claim 13, wherein the pioglitazone or the salt thereof and the metformin or the salt thereof are sole active ingredients of the preparation.
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