Process of making and using pharmaceutical formulations of antineoplastic agents
AssigneeMerck Sharp & Dohme Corp.
InventorsSydney O. Ugwu, Vinay Radhakrishnan, Peter M. Ihnat, Leonore C. Witchey-Lakshmanan
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Abstract
In its several embodiments, this invention discloses a pharmaceutical formulation comprising at least one antineoplastic agent or a pharmaceutically acceptable salt thereof, and at least one dissolution enhancing agent sufficient to substantially dissolve said at least one antineoplastic agent in at least one aqueous diluent, wherein said dissolution enhancing agent is urea, L-histidine, L-threonine, L-asparagine, L-serine, L-glutamine or mixtures thereof; a lyophilized powder comprising said pharmaceutical formulation, and articles of manufacture thereof.
Claims18
A process of making a pharmaceutical formulation comprising the steps of:
- (i) dissolving at least one dissolution enhancing agent in at least one aqueous diluent wherein said dissolution enhancing agent is selected from the group consisting of urea, L-histidine, L-threonine, L-asparagine, L-serine, and L-glutamine;
- and
- (ii) adding at least one antineoplastic agent or a pharmaceutically acceptable salt thereof.
A process for treating or preventing disease in a patient comprising administering a therapeutically effective amount of the pharmaceutical formulation comprising Temozolomide or a pharmaceutically acceptable salt thereof, at least one aqueous diluent, and at least one dissolution enhancing agent sufficient to substantially dissolve said Temozolomide, wherein said dissolution enhancing agent is selected from the group consisting of urea, L-histidine, L-threonine, L-asparagine, L-serine, and L-glutamine, to a patient in need thereof.
Dependencies are inferred from the claim text.