JP5536753B2 - ベンダムスチン塩酸塩の新規固体形態 - Google Patents
ベンダムスチン塩酸塩の新規固体形態 Download PDFInfo
- Publication number
- JP5536753B2 JP5536753B2 JP2011501846A JP2011501846A JP5536753B2 JP 5536753 B2 JP5536753 B2 JP 5536753B2 JP 2011501846 A JP2011501846 A JP 2011501846A JP 2011501846 A JP2011501846 A JP 2011501846A JP 5536753 B2 JP5536753 B2 JP 5536753B2
- Authority
- JP
- Japan
- Prior art keywords
- bendamustine hydrochloride
- pharmaceutical composition
- bendamustine
- hydrochloride
- ray powder
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D235/00—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings
- C07D235/02—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings condensed with carbocyclic rings or ring systems
- C07D235/04—Benzimidazoles; Hydrogenated benzimidazoles
- C07D235/06—Benzimidazoles; Hydrogenated benzimidazoles with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached in position 2
- C07D235/16—Radicals substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dermatology (AREA)
- Oncology (AREA)
- Hematology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US3975208P | 2008-03-26 | 2008-03-26 | |
| US61/039,752 | 2008-03-26 | ||
| PCT/US2009/001956 WO2009120386A2 (en) | 2008-03-26 | 2009-03-26 | Novel solid forms of bendamustine hydrochloride |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2011515472A JP2011515472A (ja) | 2011-05-19 |
| JP2011515472A5 JP2011515472A5 (enExample) | 2013-05-23 |
| JP5536753B2 true JP5536753B2 (ja) | 2014-07-02 |
Family
ID=41051023
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011501846A Active JP5536753B2 (ja) | 2008-03-26 | 2009-03-26 | ベンダムスチン塩酸塩の新規固体形態 |
Country Status (12)
| Country | Link |
|---|---|
| US (9) | US20090264488A1 (enExample) |
| EP (2) | EP2271315B1 (enExample) |
| JP (1) | JP5536753B2 (enExample) |
| CN (3) | CN103550159B (enExample) |
| AR (1) | AR072777A1 (enExample) |
| CA (1) | CA2718939A1 (enExample) |
| CL (1) | CL2009000742A1 (enExample) |
| ES (1) | ES2605205T3 (enExample) |
| HK (1) | HK1220966A1 (enExample) |
| MX (2) | MX2010010398A (enExample) |
| TW (1) | TWI472515B (enExample) |
| WO (1) | WO2009120386A2 (enExample) |
Families Citing this family (42)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8436190B2 (en) | 2005-01-14 | 2013-05-07 | Cephalon, Inc. | Bendamustine pharmaceutical compositions |
| ES2583804T3 (es) * | 2007-10-09 | 2016-09-22 | Us Worldmeds Llc | Composiciones de codisolventes y métodos para la administración mejorada de agentes terapéuticos de dantroleno |
| AR072777A1 (es) | 2008-03-26 | 2010-09-22 | Cephalon Inc | Formas solidas de clorhidrato de bendamustina |
| JP5670335B2 (ja) * | 2008-09-25 | 2015-02-18 | セファロン、インク. | ベンダムスチン液体製剤 |
| UA107186C2 (xx) * | 2008-12-03 | 2014-12-10 | Тверді форми дозування бендамустину | |
| WO2010144675A1 (en) * | 2009-06-10 | 2010-12-16 | Plus Chemicals Sa | Polymorphs of bendamustine hcl and processes for preparation thereof |
| WO2011079193A2 (en) * | 2009-12-23 | 2011-06-30 | Dr. Reddy's Laboratories Ltd. | Preparation of bendamustine and its salts |
| LT3158991T (lt) * | 2010-01-28 | 2021-07-12 | Eagle Pharmaceuticals, Inc. | Bendamustino kompozicijos |
| JO3659B1 (ar) | 2010-06-02 | 2020-08-27 | Astellas Deutschland Gmbh | أشكال جرعات بينداموستين عن طريق الفم وإستخداماته العلاجية |
| MY173873A (en) | 2010-06-02 | 2020-02-25 | Astellas Deutschland Gmbh | Oral dosage forms of bendamustine |
| CN101948437B (zh) * | 2010-06-28 | 2012-08-29 | 江苏奥赛康药业股份有限公司 | 一种盐酸苯达莫司汀的精制方法 |
| WO2012059935A1 (en) | 2010-11-01 | 2012-05-10 | Shilpa Medicare Limited | Process for preparing bendamus tine hydrochloride monohydrate |
| US20140142153A1 (en) * | 2011-01-25 | 2014-05-22 | Dr. Reddy's Laboratories, Inc. | Bendamustine formulations |
| WO2012106117A1 (en) * | 2011-01-31 | 2012-08-09 | Cephalon, Inc. | Methods for the preparation of bendamustine |
| WO2013046223A1 (en) | 2011-09-26 | 2013-04-04 | Fresenius Kabi Oncology Ltd. | An improved process for the preparation of bendamustine hydrochloride |
| CN102351799B (zh) * | 2011-10-24 | 2014-02-26 | 江苏奥赛康药业股份有限公司 | 一种盐酸苯达莫司汀晶型及其制备方法 |
| EP2617716A1 (en) | 2012-01-18 | 2013-07-24 | Arevipharma GmbH | Process for the preparation of bendamustine hydrochloride and related compounds |
| PT2827862T (pt) | 2012-03-20 | 2024-03-06 | Eagle Pharmaceuticals Inc | Formulações de bendamustina |
| DK2827863T3 (en) | 2012-03-20 | 2019-04-23 | Eagle Pharmaceuticals Inc | LIQUID COMPOSITION FOR USE IN A PROCEDURE FOR TREATING BENDAMUSTIN-RESPONSIVE CONDITIONS OF PATIENTS REQUIRING REDUCED VOLUMES FOR ADMINISTRATION |
| WO2013150020A1 (en) | 2012-04-03 | 2013-10-10 | Synthon Bv | Process for making bendamustine |
| PL2656843T3 (pl) | 2012-04-26 | 2015-08-31 | Synbias Pharma Ag | Estry bendamustyny i związki pokrewne i ich medyczne zastosowanie |
| US20230241218A1 (en) * | 2012-07-10 | 2023-08-03 | Eagle Pharmaceuticals, Inc. | Formulations of bendamustine |
| US9801859B2 (en) * | 2012-09-18 | 2017-10-31 | Innopharma Licensing, Llc | Bendamustine formulations |
| TWI598341B (zh) | 2012-11-12 | 2017-09-11 | 伊格尼塔公司 | 苯達莫司汀衍生物及其使用方法 |
| EP2958554B1 (en) | 2013-02-19 | 2018-06-06 | Synthon BV | Stable compositions of bendamustine |
| US9315469B2 (en) | 2013-03-14 | 2016-04-19 | Johnson Matthey Public Limited Company | Process for drying bendamustine hydrochloride monohydrate |
| WO2014170769A2 (en) * | 2013-04-15 | 2014-10-23 | Shilpa Medicare Limited | Bendamustine lyophilized pharmaceutical compositions |
| AU2014311570C1 (en) | 2013-08-27 | 2018-08-02 | Vasilios VOUDOURIS | Bendamustine pharmaceutical compositions |
| AU2015229842B2 (en) * | 2014-03-13 | 2020-06-25 | Vasilios VOUDOURIS | Bendamustine solid dispersions and continuous infusion |
| EP2985038A1 (en) | 2014-08-12 | 2016-02-17 | Azad Pharma AG | Lyophilized API preparation |
| US10342769B2 (en) | 2014-11-14 | 2019-07-09 | Navinta Iii Inc | Carmustine pharmaceutical composition |
| US9603930B2 (en) | 2014-12-04 | 2017-03-28 | Navinta, Llc | Liquid bendamustine formulation |
| IL281424B2 (en) * | 2015-06-09 | 2023-10-01 | Rebiotix Inc | Microbiota restoration treatment preparations and production methods |
| US10905677B2 (en) | 2016-08-31 | 2021-02-02 | Navinta, Llc | Bendamustine solution formulations |
| US11826466B2 (en) | 2016-08-31 | 2023-11-28 | Navinta, Llc | Bendamustine solution formulations |
| JP7267290B2 (ja) | 2017-10-05 | 2023-05-01 | チューブ ファーマシューティカルズ ゲゼルシャフト ミット ベシュレンクテル ハフツング | 経口ベンダムスチン製剤 |
| TWI690514B (zh) | 2017-11-07 | 2020-04-11 | 大陸商江蘇恒瑞醫藥股份有限公司 | 一種鹽酸苯達莫司汀的晶體及其製備方法 |
| EA037673B1 (ru) * | 2018-07-04 | 2021-04-29 | Тютор С.А.С.И.Ф.И.А. | Способ получения фармацевтической композиции, содержащей бендамустин, фармацевтическая композиция бендамустина |
| WO2020035806A1 (en) | 2018-08-17 | 2020-02-20 | Hospira Australia Pty Ltd | Liquid bendamustine pharmaceutical compositions |
| US20240009133A1 (en) | 2020-11-16 | 2024-01-11 | Orcosa Inc. | Methods of treating autoimmune or inflammatory conditions with cannabidiol or its derivatives/analogs |
| US11672761B2 (en) | 2020-11-16 | 2023-06-13 | Orcosa Inc. | Rapidly infusing platform and compositions for therapeutic treatment in humans |
| AU2022374002A1 (en) | 2021-10-22 | 2024-05-02 | Project Pharmaceutics Gmbh | Liquid pharmaceutical formulation |
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| EP1674081A1 (de) * | 2004-12-23 | 2006-06-28 | KTB Tumorforschungsgesellschaft mbH | Herstellung von lipidbasierten Nanopartikeln unter Einsatz einer dualen asymmetrischen Zentrifuge |
| US8436190B2 (en) | 2005-01-14 | 2013-05-07 | Cephalon, Inc. | Bendamustine pharmaceutical compositions |
| UA94036C2 (ru) * | 2005-01-14 | 2011-04-11 | Сефалон, Инк. | Фармацевтическая композиция бендамустина, предназначенная для лиофилизации |
| US7872050B2 (en) | 2005-03-14 | 2011-01-18 | Yaupon Therapeutics Inc. | Stabilized compositions of volatile alkylating agents and methods of using thereof |
| AU2006235183B2 (en) | 2005-04-08 | 2011-02-10 | Amylin Pharmaceuticals, Llc | Pharmaceutical formulations comprising incretin peptide and aprotic polar solvent |
| US8158152B2 (en) | 2005-11-18 | 2012-04-17 | Scidose Llc | Lyophilization process and products obtained thereby |
| ITUD20070130A1 (it) | 2007-07-23 | 2009-01-24 | C M E Spa Sa | Macchina e procedimento per la produzione di elementi strutturali per l'edilizia in materiale cementizio aventi uno o piu' inserti in materiale polimerico |
| AR072777A1 (es) | 2008-03-26 | 2010-09-22 | Cephalon Inc | Formas solidas de clorhidrato de bendamustina |
| JP5670335B2 (ja) | 2008-09-25 | 2015-02-18 | セファロン、インク. | ベンダムスチン液体製剤 |
| CN102413816A (zh) | 2009-04-28 | 2012-04-11 | 赛福伦公司 | 苯达莫司汀的口服制剂 |
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