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|Title:||Processes of making and using pharmaceutical formulations of antineoplastic agents|
|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.|
|Inventor(s):||Ugwu; Sydney (Gurnee, IL), Radhakrishnan; Vinay (Thousand Oaks, CA), Ihnat; Peter M. (Brooklyn, NY), Witchey-Lakshmanan; Lenore C. (Piscataway, NJ)|
|Assignee:||Merck Sharp & Dohme Corp. (Rahway, NJ)|
1. A lyophilized powder comprising temozolomide or a pharmaceutically acceptable salt thereof; and L-threonine.
2. The lyophilized powder of claim 1, further comprising: mannitol, a citrate buffer and hydrochloric acid.
3. The lyophilized powder of claim 2, further comprising a polysorbate 80.