STABLE CRYSTALLINE POLYMORPHS OF THE DIPOTASSIUM SALT OF (S)-2-{4-[2-(2,4-DIAMIN0-QUINAZ0LIN-6-YL)-ETHYL]-BENZOYLAMINO}-4-METHYLENE-PENTA NEDIOIC ACID

摘要

The present invention provides stable crystalline polymorphic forms of antifolate compounds, particularly (5)-2-{4-[2-(2,4-diamino-quinazolin-6-yl)-ethyl]- benzoylamino}-4-methylene-pentanedioic acid, dipotassium salt, and methods of preparation thereof. The polymorphs may be in the form of hydrates. The invention further provides pharmaceutical compositions comprising the polymorphs and methods of treatment using the polymorphs. The polymorphs are useful in the treatment of multiple conditions, including abnormal cell proliferation, inflammatory diseases, asthma, and arthritis, and the polymorphs may be administered alone in or combination with on or more further active agents.