Bendamustine pharmaceutical compositions
OwnerVasilios Voudourisinventor
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Abstract
Provided herein are pharmaceutical formulations of dry-powder bendamustine suitable for pharmaceutical use. Also provided are methods of producing dry-powder bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.
Claims17
A spray-dried solid dispersion comprising bendamustine, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients, diluents, or carriers wherein said solid dispersion is substantially free of hydrolysis degradants of bendamustine, or a pharmaceutically acceptable salt thereof, and wherein said spray-dried solid dispersion is produced with a spray drier having an air flow temperature between about 40° C. to about 120° C. or an outlet spray chamber temperature between about 50° C. and about 120° C.
A spray-dried solid dispersion comprising bendamustine, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients, diluents, or carriers wherein said solid dispersion is substantially free of hydrolysis degradants of bendamustine, or a pharmaceutically acceptable salt thereof, and wherein said spray-dried solid dispersion comprises less than 1% by weight water.
Dependencies are inferred from the claim text.