WO2026053005 - STABLE AQUEOUS BENDAMUSTINE-CYCLODEXTRIN COMPOSITION

National phase entry is expected:
Publication Number WO/2026/053005
Publication Date 12.03.2026
International Application No. PCT/IB2025/000531
International Filing Date 05.09.2025
Title **
[English] STABLE AQUEOUS BENDAMUSTINE-CYCLODEXTRIN COMPOSITION
[French] COMPOSITION AQUEUSE STABLE DE BENDAMUSTINE-CYCLODEXTRINE
Applicants **
SOFTKEMO PHARMA CORP.
Inventors
PATEL, Kishore
Priority Data
63/732,657   06.09.2024   US
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Quotation for National Phase entry

Country StagesTotal
China Filing, Examination, Granting2013
EPO Filing, Examination, Granting11624
Japan Filing, Examination, Granting2077
South Korea Filing, Examination, Granting1919
USA Filing, Examination, Granting4740
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Total: 22,373
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Abstract[English] A pharmaceutical composition comprising: (a) bendamustine; (b) sulfobutyl ether beta-cyclodextrin ("SBECD"); (c) optionally, sodium chloride; and (d) aqueous diluent; characterized in that the SBECD concentration is between 40% and 60% (w/w) based upon the combined weight of the SBECD and aqueous diluent. In addition, a kit comprising (a) a vial of such liquid pharmaceutical composition and (b) a stabilizing agent; as well as a method of treating a cancer patient comprising administering to such patient an effective dose of such pharmaceutical composition.[French] L'invention concerne une composition pharmaceutique comprenant : (a) de la bendamustine ; (b) de la sulfobutyl éther bêta-cyclodextrine sodique ("SBECD") ; (c) éventuellement, du chlorure de sodium ; et (d) un diluant aqueux ; caractérisée en ce que la concentration en SBECD est comprise entre 40 % et 60 % (p/p) sur la base du poids combiné de la SBECD et du diluant aqueux. De plus, l'invention concerne un kit comprenant (a) un flacon d'une telle composition pharmaceutique liquide et (b) un agent stabilisant ; ainsi qu'une méthode de traitement d'un patient cancéreux comprenant l'administration à un tel patient d'une dose efficace d'une telle composition pharmaceutique.

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