| 摘要 |
1. A hydrate crystal form of disodium N-[4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]-pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid salt ("heptahydrate crystalline form"), having an X-ray diffraction pattern, which comprises the following peaks corresponding to d spacing: 7.780 +- 04 A when obtained at 22 +- 2 degree C and ambient 20-80% relative humidity from a copper radiation source. 2. The compound which is disodium N-[4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]-pynmidin-5-yl)ethyl]benzoyl]-L-glutamate, heptahydrate. 3. The heptahydrate crystalline form as claimed in Claim1, for use in therapy. 4. A process for preparing a medicament comprising combining the heptahydrate crystalline form with a buffer in an aqueous solution. 5. A process for the preparation of a pharmaceutical formulation of disodium N-[[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamate, which comprises bringing disodium N-[4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamate heptahydrate into association with a pharmaceutically acceptable carrier. 6. An article of manufacture comprising packaging material and a composition comprising the heptahydrate crystalline form contained within said packaging material, wherein said crystalline salt is effective in the treatment of cancer and wherein said packaging material comprises a label which indicates that said crystalline salt can be used to treat cancer. 7. The article of manufacture of Claim 6 wherein the cancer is mesothelioma. 8. A compound as claimed in Claim 1 for the manufacture of a medicament for the treatment of cancer. 9. A compound as claimed in Claim 8 wherein the cancer is mesothelioma. 10. A process for preparing the heptahydrate of Claim 1, which comprises crystallizing disodium N-[4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]-pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid salt from a solution comprising disodium N-[4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]-pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid, water, and a water miscible solvent; and drying the crystalline disodium N-[4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]-pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid salt with humid nitrogen. 11. The process of Claim 10, wherein the solvent is acetone.
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