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Claims for Patent: 8,486,993

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Claims for Patent: 8,486,993

Title:Solid dispersions comprising tacrolimus
Abstract: A pharmaceutical composition comprising tacrolimus (FK-506) dissolved and/or dispersed in a hydrophilic or water-miscible vehicle to form a solid dispersion or solid solution at ambient temperature have improved bioavailability.
Inventor(s): Holm; Per (Vanlose, DK)
Assignee: Veloxis Pharmaceuticals A/S (Horsholm, DK)
Application Number:13/178,280
Patent Claims: 1. A solid pharmaceutical composition comprising (i) a solid carrier and (ii) tacrolimus in a mixture of at least two hydrophilic or water-miscible vehicles having a melting point of at least 30.degree. C., wherein the tacrolimus is present in the composition at a concentration of between 0.01 w/w % and 15 w/w %, wherein one hydrophilic or water-miscible vehicle is a poloxamer.

2. The solid pharmaceutical composition of claim 1, wherein the poloxamer is poloxamer 188.

3. A solid pharmaceutical composition comprising agglomerated particles comprising a solid carrier and tacrolimus dispersed or dissolved in a mixture of at least two hydrophilic or water-miscible vehicles having a melting point of at least 30.degree. C., wherein (i) the tacrolimus is present in the composition at a concentration of between about 0.01 w/w % and about 15 w/w %, and (ii) the particles have a geometric weight mean diameter d.sub.gw, of from 100 to 1000 .mu.m, wherein one hydrophilic or water-miscible vehicle is a poloxamer.

4. The solid pharmaceutical composition of claim 3, wherein the poloxamer is poloxamer 188.

5. A solid pharmaceutical composition prepared by a process comprising the steps of: (a) spraying a solid carrier with tacrolimus dispersed or dissolved in a mixture of two hydrophilic or water-miscible vehicles, the vehicles having a melting point of at least 30.degree. C., (b) mechanically working the product from step (a) to form agglomerated particles having a geometric weight mean diameter d.sub.gw, of from 100 to 1000 .mu.m, and (c) compressing the agglomerated particles, wherein the tacrolimus is present in the composition at a concentration of between about 0.01 w/w % and about 15 w/w %, and one hydrophilic or water-miscible vehicle is a poloxamer.

6. The solid pharmaceutical composition of claim 5, wherein the poloxamer is poloxamer 188.

7. A method of suppressing rejection of a transplanted organ in a subject comprising administering an effective amount of the solid pharmaceutical composition of claim 1.

8. A method of suppressing rejection of a transplanted organ in a subject comprising administering an effective amount of the solid pharmaceutical composition of claim 5.

9. The solid pharmaceutical composition of claim 1, wherein the composition further comprises a release-modifying agent.

10. The solid pharmaceutical composition of claim 9, wherein the composition provides a W.sub.50 (the time where the plasma concentration is 50% or more of C.sub.max) of at least 12 hours.

11. The solid pharmaceutical composition of claim 10, wherein the composition provides a W.sub.50 (the time where the plasma concentration is 50% or more of C.sub.max) of at least 14 hours.

12. The solid pharmaceutical composition of claim 5, wherein the composition further comprises a release-modifying agent.

13. The solid pharmaceutical composition of claim 12, wherein the composition provides a W.sub.50 (the time where the plasma concentration is 50% or more of C.sub.max) of at least 12 hours.

14. The solid pharmaceutical composition of claim 13, wherein the composition provides a W.sub.50 (the time where the plasma concentration is 50% or more of C.sub.max) of at least 14 hours.
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