| 摘要 |
1. The hydrochloride salt of 5-[4-[2-(N-methyl-N-(2-pyridyl) amino) ethoxy] benzyl] thiazolidine 2,4-dione, characterised in that it provides: (i) an infrared spectrum substantially in accordance with Figure 1; and/or (ii) a Raman spectrum substantially in accordance with Figure 2; and/or (iii) an X-Ray powder diffraction pattern(XRPD) substantially in accordance with Figure 3; and (iv) a Solid State <13>C NMR spectrum substantially in accordance with Figure 4. 2. A compound according to claim 1, characterised in that it provides two or more of: (i) provides an infrared spectrum substantially in accordance with Figure 1; (ii) a Raman spectrum substantially in accordance with Figure 2; (iii) an X-Ray powder diffraction pattern (XRPD) substantially in accordance with Figure 3; (iv) a Solid State <13>C NMR spectrum substantially in accordance with Figure 4; and (v) a melting point in the range of from 160 to168 degree C. 3. A compound according to claim 1 or claim 2, in purified form. 4. A compound according to claim 1 or claim 2, in a solid dosage form. 5. A compound according to claim 1 or claim 2, in a pharmaceutically acceptable form capable of being milled or in a milled form. 6. A compound according to claim 1 or claim 2, in a pharmaceutically acceptable form and having good flow properties. 7. A process for preparing the hydrochloride, according to claim 1, characterised in that 5-[4-[2-(N-methyl-N-(2-pyridyl) amino) ethoxy] benzyl] thiazolidine-2,4-dione (Compound I) or salt thereof, preferably dispersed or dissolved in a suitable solvent, is reacted with a source of chloride ion; and thereafter the hydrochloride is recovered. 8. A pharmaceutical composition comprising the hydrochloride according to claim 1, and a pharmaceutically acceptable carrier therefor. 9. A hydrochloride, according to claim 1, for use as an active therapeutic substance. 10. A use of the Hydrochloride according to claim 1, for the manufacture of a medicament for the treatment and/or prophylaxis of diabetes mellitus, conditions associated with diabetes mellitus and certain complications thereof.
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