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Claims for Patent: 8,551,522

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Claims for Patent: 8,551,522

Title:Sustained-release formulation
Abstract: A sustained-release formulation is provided comprising a solid dispersion composition comprising a tricyclic compound or a pharmaceutically acceptable salt thereof in a mixture comprising a water-soluble polymer and a water-insoluble polymer, and an excipient.
Inventor(s): Yamashita; Kazunari (Kyota, JP), Hashimoto; Eiji (Wakayama, JP), Nomura; Yukihiro (Osaka, JP), Shimojo; Fumio (Hyogo, JP), Tamura; Shigeki (Osaka, JP), Hirose; Takeo (Kyoto, JP), Ueda; Satoshi (Hyogo, JP), Saitoh; Takashi (Osaka, JP), Ibuki; Rinta (Kyoto, JP), Ideno; Toshio (Osaka, JP)
Assignee: Astellas Pharma Inc. (Tokyo, JP)
Application Number:12/265,108
Patent Claims: 1. A sustained-release formulation comprising tacrolimus or its hydrate, wherein the time (T63.2%) required for 63.2% of the maximum amount of tacrolimus or its hydrate to be dissolved is 0.7 to 15 hours, as measured according to the Japanese Pharmacopoeia, the 13-th edition, Dissolution Test, No. 2 (Puddle method, 50 rpm) using a test solution which is an aqueous 0.005% hydroxypropyl cellulose solution adjusted to pH 4.5, wherein, (1) the formulation comprises a solid dispersion composition wherein the tacrolimus or its hydrate is present as an amorphous state in a water-soluble polymer selected from the group consisting of hydroxypropylmethyl cellulose, methyl cellulose, polyvinylpyrrollidone, hydroxypropyl cellulose and polyethylene glycol, in a weight ratio of 0.2 to 0.4 water-soluble polymer to 1 tacrolimus, and the solid dispersion composition does not contain a disintegrator, or (2) the tacrolimus or its hydrate is present in the formulation as a fine powder having a particle size distribution within the range of 0.1 to 50 .mu.m and/or a mean particle diameter within the range of 0.2 to 20 .mu.m.

2. The sustained-release formulation of claim 1, wherein the solid dispersion composition comprises lactose or calcium hydrogen phosphate as an excipient and/or lubricant.

3. The sustained-release formulation of claim 1, wherein the water-soluble polymer is hydroxypropylmethyl cellulose.

4. The sustained release formulation of claim 3, wherein the solid dispersion composition comprises lactose as an excipient, and wherein the solid dispersion composition has a particle size equal to or smaller than 250 .mu.m.

5. The sustained-release formulation of claim 1, which is in a form of powder, granule, tablet or capsule.

6. The sustained-release formulation of claim 1, in which the time (T63.2%) is 1.0 to 12 hours.

7. The sustained-release formulation of claim 1, in which the time (T63.2%) is 1.3 to 8.2 hours.

8. The sustained-release formulation of claim 1, in which the time (T63.2%) is 2 to 5 hours.

9. The sustained-release formulation of claim 2, which is in a form of powder, granule, tablet or capsule.

10. The sustained-release formulation of claim 3, which is in a form of powder, granule, tablet or capsule.

11. The sustained-release formulation of claim 4, which is in a form of powder, granule, tablet or capsule.

12. The sustained-release formulation of claim 6, which is in a form of powder, granule, tablet or capsule.

13. The sustained-release formulation of claim 7, which is in a form of powder, granule, tablet or capsule.
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