Composition and use
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.
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.