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Claims for Patent: 8,236,345

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Claims for Patent: 8,236,345

Title:Composition and use
Abstract: A pharmaceutical composition, comprising a thiazolidinedione, such as Compound (I), metformin hydrochloride and a pharmaceutically acceptable carrier, wherein the thiazolidinedione and metformin hydrochloride are each dispersed within its own pharmaceutically acceptable carrier in the pharmaceutical composition and the use of such a composition in medicine.
Inventor(s): Lewis; Karen (Verona, IT), Lilliott; Nicola Jayne (London, GB), MacKenzie; Donald Colin (Harlow, GB)
Assignee: SmithKline Beecham Limited (Brentford, Middlesex, GB)
Application Number:11/779,546
Patent Claims: 1. A pharmaceutical composition comprising a thiazolidinedione dispersed in a first pharmaceutically acceptable carrier and metformin hydrochloride dispersed in a second pharmaceutically acceptable carrier, wherein: the thiazolidinedione is 5-[4-[2-(N-methyl-N-(2-pyridyl)amino)ethoxy]benzyl]thiazolidine-2,4-dione- , or a tautomer thereof, in a pharmaceutically acceptable form, the first carrier consists essentially of hydroxypropyl methyl cellulose, microcrystalline cellulose, sodium starch glycollate, and lactose; and the second carrier consists essentially of polyvinyl pyrollidone and hydroxypropyl methyl cellulose.

2. A composition according to claim 1, which comprises 2 mg of said 5-[4-[2-(N-methyl-N-(2-pyridyl)amino)ethoxy]benzyl]thiazolidine-2,4-dione- , or a tautomer thereof, in a pharmaceutically acceptable form.

3. A composition according to claim 1, which comprises 4 mg of said 5-[4-[2-(N-methyl-N-(2-pyridyl)amino)ethoxy]benzyl]thiazolidine-2,4-dione- , or a tautomer thereof, in a pharmaceutically acceptable form.

4. A composition according to claim 1, wherein the composition comprises 500 mg of metformin hydrochloride.

5. A composition according to claim 1, wherein the composition comprises 1000 mg of metformin hydrochloride.

6. A composition according to claim 1, wherein said pharmaceutically acceptable form is a maleate salt.

7. A composition according claim 1, wherein said pharmaceutically acceptable form is a hydrate.

8. A composition according to claim 1, wherein said pharmaceutically acceptable form is a hydrate of a maleate salt.

9. A composition according to claim 1, wherein the thiazolidinedione/first carrier dispersion is substantially in homogenous admixture with the metformin hydrochloride/ second carrier dispersion.

10. A composition according to claim 1, wherein the thiazolidinedione/first carrier dispersion is compacted with the metformin hydrochloride/second carrier dispersion in the composition.

11. A composition according to claim 1, wherein the composition is in the form of a tablet.

12. A composition according to claim 1, wherein the thiazolidinedione/first carrier dispersion and metformin hydrochloride/second carrier dispersion are located in discrete zones with respect to each other in the composition.

13. A composition according to claim 12, in the form of a multilayer tablet, wherein the thiazolidinedione/first carrier dispersion and the metformin hydrochloride/second carrier dispersion are in separate layers.

14. A composition according to claim 12, wherein the discrete zones are separated by a barrier layer.

15. A composition according to claim 14, wherein the barrier layer comprises a filler and a lubricant.

16. A composition according to claim 12, wherein one zone is a compressed layer and the other is in a powder form.

17. A composition according to claim 16, wherein the compressed layer is a tablet and the tablet and powder are encapsulated in a capsule form.
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