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Claims for Patent: 8,071,130

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Claims for Patent: 8,071,130

Title:Solid preparation
Abstract: The present invention intends to provide a solid preparation which contains an insulin sensitizer and an active ingredient other than an insulin sensitizer, and exhibits dissolution behavior of an insulin sensitizer similar to that of an insulin sensitizer from "a solid preparation containing only an insulin sensitizer as an active ingredient". The solid preparation comprises "a part containing coated particles in which the particles containing an insulin sensitizer are coated with lactose or a sugar alcohol" and "a part containing an active ingredient other than an insulin sensitizer".
Inventor(s): Kiyoshima; Kenichiro (Osaka, JP), Nakamura; Kenji (Osaka, JP), Kawano; Tetsuya (Osaka, JP), Misaki; Masafumi (Osaka, JP)
Assignee: Takeda Pharmaceutical Company Limited (Osaka, JP)
Application Number:12/086,700
Patent Claims: 1. A solid preparation comprising the following part (1) and part (2): (1) a part containing coated particles in which particles containing pioglitazone or a salt thereof are coated with lactose; and (2) a part containing glimepiride, wherein part (1) the coated particles are a granulated material obtained by granulating pioglitazone or a salt thereof, an excipient and a disintegrant with a dispersion of a binder and lactose in a solvent, and the amount of lactose coating the particle containing pioglitazone or a salt thereof is 5 to 50 parts by weight based on 100 parts by weight of the particle; wherein part (2) is a composition comprising a granulated material obtained by granulating an excipient with a dispersion of glimepiride, a surfactant, a coloring agent and a binder in a solvent, said composition also comprising an excipient, a disintegrant and a lubricant; and said solid preparation is a multilayer tablet obtained by tabletting the part (1) and the part (2) in the form of a laminate.

2. The solid preparation according to claim 1, wherein the part (2) is a part containing glimepiride and a surfactant.

3. The solid preparation according to claim 2, wherein the surfactant is Polysorbate 80.

4. The solid preparation according to claim 1, wherein the tableting pressure for either part (1) or part (2) tableted first is 60% or less of the tableting pressure for part (2) or part (1) tableted next.

5. The solid preparation according to claim 1, wherein the "coated particles in which particles containing pioglitazone or a salt thereof are coated with lactose"are a granulated material obtained by granulating pioglitazone or a salt thereof, an excipient and a disintegrant sequentially with a dispersion of a binder in a solvent, and a dispersion of a binder and lactose in a solvent.

6. The solid preparation according to claim 1, wherein the excipient is lactose or crystalline cellulose.

7. The solid preparation according to claim 1, wherein the surfactant is Polysorbate 80.

8. The solid preparation according to claim 1, wherein the binder is hydroxypropylcellulose.

9. The solid preparation according to claim 1, wherein the solvent is water.
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