Stable pharmaceutical compositions of bendamustine

Stable, injectable pharmaceutical compositions are provided, which are useful as ready-to-dilute (RTD) or ready-to-use (RTU) liquid injectable compositions comprising bendamustine or a pharmaceutically acceptable salt thereof, which are suitable for intravenous administration. Preferably, solution f...

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Bibliographic Details
Main Authors Thippabattuni, Lourdu Chinnu, Chinnari, Harish Govindaraja Setty, Balasubramanian, Satheesh, Battini, Somashekhar, Pillai, Sumitra Ashokkumar
Format Patent
LanguageEnglish
Published 25.07.2023
Subjects
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Summary:Stable, injectable pharmaceutical compositions are provided, which are useful as ready-to-dilute (RTD) or ready-to-use (RTU) liquid injectable compositions comprising bendamustine or a pharmaceutically acceptable salt thereof, which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine or its pharmaceutically acceptable salts, solvates, or hydrates thereof, (b) at least one pharmaceutically acceptable non-aqueous solvent; (c) optionally, at least one pharmaceutically acceptable excipient, and (d) optionally, a pH adjuster, where the pharmaceutical composition is antioxidant-free, and formulated as a ready-to-dilute or ready-to-use liquid composition suitable for parenteral administration. The invention further relates to methods for manufacturing stable, antioxidant-free injectable solutions of bendamustine.
Bibliography:Application Number: US202217877476