Novel compositions comprising trimetrexate and methods of their synthesis and use
AssigneeMedImmune Oncology, Inc.
InventorsMartin Stogniew, Javad M. Zadei
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Abstract
This invention is directed to the novel composition of matter trimetrexate ascorbate, to compositions comprising trimetrexate ascorbate, and to compositions comprising trimetrexate and ascorbic acid. These compositions are useful in the treatment of diseases in mammals such as, but not limited to, cancer, bacterial and protozoal infections, malaria, psoriasis, and rheumatoid arthritis. The invention is further related to methods of stabilizing trimetrexate to degradation caused by heat, light, oxygen, or water.
Claims75
Trimetrexate ascorbate.
A composition comprising trimetrexate ascorbate.
A composition comprising trimetrexate and ascorbic acid.
A liquid pharmaceutical composition comprising trimetrexate wherein said liquid pharmaceutical composition forms less than about 5 weight percent of impurities when sealed in a vial and maintained at a temperature of about 40° C. for about one month, said weight percent being based upon the weight of trimetrexate.
A liquid pharmaceutical composition comprising trimetrexate wherein said liquid pharmaceutical composition forms less than about 2 weight percent of impurities when sealed in a vial and maintained at a temperature of about 25° C. for about six months, said weight percent being based upon the weight of trimetrexate.
A liquid pharmaceutical composition comprising-trimetrexate wherein said liquid pharmaceutical composition forms less than about 2 weight percent of impurities when sealed in a vial and maintained at a temperature of about 5° C. for about one year, said weight percent being based upon (the weight of trimetrexate.
A dosage form of trimetrexate which comprises sterile trimetrexate ascorbate.
A dosage form of trimetrexate which comprises sterile trimetrexate and sterile ascorbic acid.
A pharmaceutical composition of trimetrexate which is prepared from a solution comprising trimetrexate and ascorbic acid.
A sterile lyophilized dosage form suitable for reconstitution and parenteral administration to a patient which comprises trimetrexate ascorbate.
A sterile lyophilized dosage form suitable for reconstitution and parenteral administration to a patient which comprises trimetrexate and ascorbic acid.
A pharmaceutical composition which comprises trimetrexate, ascorbic acid, and monothioglycerol.
A method of treating a disease or condition associated with dihydrofolate reductase activity comprising administering to a subject in need of such treatment a therapeutically effective amount of trimetrexate ascorbate.
A method of treating a disease or condition associated with dihydrofolate reductase activity comprising administering to a subject in need of such treatment a therapeutically effective amount of a composition comprising trimetrexate and ascorbic acid.
Dependencies are inferred from the claim text.