Novel solid forms of bendamustine hydrochloride

a technology of bendamustine and hydrochloride, which is applied in the field of solid forms of bendamustine hydrochloride, can solve problems such as difficulties in its preparation and administration

Inactive Publication Date: 2009-10-22
CEPHALON INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

While bendamustine has been demonstrated as efficacious, it is known to be unstable, especially in aqueous solutions, leading to technical difficulties in its preparation and administration.

Method used

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  • Novel solid forms of bendamustine hydrochloride
  • Novel solid forms of bendamustine hydrochloride
  • Novel solid forms of bendamustine hydrochloride

Examples

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Embodiment Construction

[0029]Four polymorphs of crystalline bendamustine hydrochloride are disclosed herein (referred to herein as Form 1, Form 2, Form 3, and Form 4). Also described is amorphous (i.e., non-crystalline) bendamustine hydrochloride. Spectral data relating to these solid forms of bendamustine hydrochloride is depicted in FIGS. 1-14, and methods of preparing each of these forms is presented

[0030]In preferred embodiments are solid forms of bendamustine hydrochloride that comprise Form 1, Form 2, Form 3, Form 4, or mixtures thereof. More preferred embodiments are solid forms of bendamustine hydrochloride that are Form 1, Form 3, Form 4, amorphous bendamustine hydrochloride, or mixtures thereof. In other embodiments, solid forms of the invention may further comprise bendamustine hydrochloride Form 2. These polymorphic solid forms may be identified, for example, by X-ray powder diffraction and characterized by one, two, three, four, five, or more reflection peaks that are characteristic of each p...

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Abstract

Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims priority of to U.S. Provisional Application Ser. No. 61 / 039,752, filed Mar. 26, 2008. The disclosure of this prior application is incorporated herein by reference in its entirety for all purposes.FIELD OF THE INVENTION[0002]This invention pertains to bendamustine-containing compositions, pharmaceutical compositions comprising bendamustine, processes to reproducibly make them, and methods of treating patients using them.BACKGROUND OF THE INVENTION[0003]Active pharmaceutical ingredients (APIs) can be prepared in a variety of different forms, for example, chemical derivatives, solvates, hydrates, co-crystals, or salts. APIs may also be prepared in different solid forms, in that they may be amorphous, may exist as different crystalline polymorphs, and / or in different salvation or hydration states. By varying the form of an API, it is possible to vary the physical properties thereof. For instance, solid forms of an API t...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/4184C07D235/12A61P35/02A61P35/00
CPCA61K9/14C07D235/16A61K31/4184A61K9/19A61K47/26A61P35/00A61P35/02A61K9/0019
Inventor COOPER, MARTIN IANCOURVOISIER, LAURENT D.EDDLESTON, MARKMCKEAN, ROBERT E.
Owner CEPHALON INC
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