19 results about "Bendamustine" patented technology

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, and which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine, or 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.

Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.

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.

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, and which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine, or 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.

Treatment methods using bendamustine formulations designed for intravenous administration of small volumes are described. These methods allow for faster administration without precipitation of the active ingredient, compared to currently available formulations.

Methods of treatment using bendamustine formulations designed for small volume intravenous administration are disclosed. The methods conveniently allow shorter administration time without the active ingredient coming out of solution as compared to presently available formulations.

Described herein are lyophilized compositions comprising bendamustine and sulfobutyl ether beta-cyclodextrin (SBECD), the composition (a) comprising a molar excess of SBECD relative to bendamustine; (b) no mannitol is contained; and (c) having a moisture content of less than about 1 wt%. The composition can be prepared into a cake with a good form and shows ideal storage stability. The lyophilized composition can be rapidly redissolved and then rapidly administered to cancer patients with reduced sodium and / or sugar intake. In addition, methods of treating cancer patients with the compositions and methods of making the lyophilized compositions are described herein.

Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.

One embodiment of the present disclosure addresses the problem of providing an agent for inhibiting a T-cell decrease caused by bendamustine or a pharmaceutically acceptable salt thereof.　This T-cell decrease inhibitor, which is used to inhibit a T-cell decrease caused by bendamustine or a pharmaceutically acceptable salt thereof, contains a substance that impedes at least one signal transduction transmitted by a TNFR superfamily member expressed in the T cell.

Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.

Described herein is a lyophilized composition comprising bendamustine and sulfobutyl ether beta-cyclodextrin (SBECD), (a) comprising a molar excess of SBECD relative to bendamustine; (b) not comprising mannitol; and (c) comprising less than about 1% by weight of moisture. Such compositions can be prepared in the form of well-formed cakes and exhibit desirable storage stability. The lyophilized compositions can be readily reconstituted and then rapidly administered to cancer patients with reduced sodium and / or sugar intake. Additionally, methods for treating cancer patients using the described compositions and methods for preparing the lyophilized compositions are described.

Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.

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.

Provided are a method and a use for treating cancers by using a CD20 / CD47 double-blocking bifunctional fusion protein in combination with a bifunctional alkylating agent, in particular a method and a use for treating cancers (especially non-Hodgkin lymphoma) by using a CD20 / CD47 double-blocking bifunctional fusion protein in combination with bendamustine or a salt thereof.

(3R, 4S)-3-(4-hydroxy-3,5-dimethoxyphenyl)-4-(4-hydroxyphenyl)-8-methyl-3,4-dihydro-2H- chromen-7-ol (TRX-E-002-1) for use in a method of treatment for a hematological cancer being acute myeloid leukemia or multiple myeloma in a subject in need thereof, the method comprising administering to the subject an effective amount of TRX-E-002-1. The method may further comprise administering to the subject an effective amount of a second compound selected from the group consisting of (i) a BCL-2 inhibitor such as venetoclax, navitoclax or obatoclax, (ii) a deoxycytidine analogue chemotherapeutic such as cytarabine or gemcitabine, (iii) a hypomethylating agent such as azacitidine or decitabine, (iv) an anthracycline chemotherapeutic such as daunorubicin, doxorubicin, epirubicin, idarubicin, valrubicin or mitoxantrone, (v) a proteasome inhibitor such as carfilzomib, bortezomib, and ixazomib, (vi) an immunomodulatory drug such as pomalidomide, lenalidomide, and thalidomide and(vii) a corticosteroid drug such as dexamethasone or prednisone, and (viii) an alkylator such as bendamustine, cyclophosphamide, melphalan, and melflufen. Corresponding combination pharmaceutical compositions.

The present invention discloses a 2-amino substituted bendamustine derivative having HDAC inhibitory effect, a preparation method and application thereof, wherein the structure of the bendamustine derivative is shown in formula (I): the bendamustine derivative can be prepared into a hydrochloride, a sulfate or a tartrate. The compound has a dual effect of HDAC inhibitory effect and alkylation, and has a good efficacy in inhibiting the growth of blood tumors.

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.

Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.