BRPI0606332A2 - composição farmacêutica de bendamustina, preparação liofilizada, forma de dosagem farmacêutica, método para obter aprovação oficial para um produto de bendamustina, processo para fabricar uma preparação liofilizada de bendamustina, solução ou dispersão de pré-liofilização de bendamustina, pó liofilizado, método para preparar uma preparação liofilizada de bendamustina, formulação para liofilização, e, uso de uma solução farmaceuticamente aceitável - Google Patents
composição farmacêutica de bendamustina, preparação liofilizada, forma de dosagem farmacêutica, método para obter aprovação oficial para um produto de bendamustina, processo para fabricar uma preparação liofilizada de bendamustina, solução ou dispersão de pré-liofilização de bendamustina, pó liofilizado, método para preparar uma preparação liofilizada de bendamustina, formulação para liofilização, e, uso de uma solução farmaceuticamente aceitávelInfo
- Publication number
- BRPI0606332A2 BRPI0606332A2 BRPI0606332-2A BRPI0606332A BRPI0606332A2 BR PI0606332 A2 BRPI0606332 A2 BR PI0606332A2 BR PI0606332 A BRPI0606332 A BR PI0606332A BR PI0606332 A2 BRPI0606332 A2 BR PI0606332A2
- Authority
- BR
- Brazil
- Prior art keywords
- bendamustine
- lyophilized
- preparation
- lyophilization
- solution
- Prior art date
Links
- YTKUWDBFDASYHO-UHFFFAOYSA-N bendamustine Chemical compound ClCCN(CCCl)C1=CC=C2N(C)C(CCCC(O)=O)=NC2=C1 YTKUWDBFDASYHO-UHFFFAOYSA-N 0.000 title abstract 8
- 229960002707 bendamustine Drugs 0.000 title abstract 8
- 238000002360 preparation method Methods 0.000 title abstract 8
- 238000000034 method Methods 0.000 title abstract 6
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 4
- 238000004108 freeze drying Methods 0.000 title abstract 3
- 239000002552 dosage form Substances 0.000 title abstract 2
- 238000009472 formulation Methods 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- 239000006185 dispersion Substances 0.000 title 1
- 239000008176 lyophilized powder Substances 0.000 title 1
- 239000000243 solution Substances 0.000 title 1
- 201000010099 disease Diseases 0.000 abstract 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 2
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 230000001613 neoplastic effect Effects 0.000 abstract 1
Classifications
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Hematology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Transplantation (AREA)
- Dispersion Chemistry (AREA)
- Oncology (AREA)
- Biomedical Technology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US64435405P | 2005-01-14 | 2005-01-14 | |
| US11/330,868 US8436190B2 (en) | 2005-01-14 | 2006-01-12 | Bendamustine pharmaceutical compositions |
| PCT/US2006/001308 WO2006076620A2 (en) | 2005-01-14 | 2006-01-13 | Bendamustine pharmaceutical compositions for lyophilisation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BRPI0606332A2 true BRPI0606332A2 (pt) | 2009-11-17 |
Family
ID=36678237
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0606332-2A BRPI0606332A2 (pt) | 2005-01-14 | 2006-01-13 | composição farmacêutica de bendamustina, preparação liofilizada, forma de dosagem farmacêutica, método para obter aprovação oficial para um produto de bendamustina, processo para fabricar uma preparação liofilizada de bendamustina, solução ou dispersão de pré-liofilização de bendamustina, pó liofilizado, método para preparar uma preparação liofilizada de bendamustina, formulação para liofilização, e, uso de uma solução farmaceuticamente aceitável |
Country Status (19)
| Country | Link |
|---|---|
| US (9) | US8436190B2 (enExample) |
| EP (2) | EP2574334A1 (enExample) |
| JP (3) | JP2008526991A (enExample) |
| KR (4) | KR101648495B1 (enExample) |
| CN (1) | CN102078305B (enExample) |
| AR (1) | AR052877A1 (enExample) |
| AU (1) | AU2006204817B2 (enExample) |
| BR (1) | BRPI0606332A2 (enExample) |
| CA (1) | CA2593582A1 (enExample) |
| EA (1) | EA013324B1 (enExample) |
| ES (1) | ES2405611T3 (enExample) |
| IL (1) | IL184394A0 (enExample) |
| MX (1) | MX2007008562A (enExample) |
| MY (1) | MY157661A (enExample) |
| NO (1) | NO343659B1 (enExample) |
| NZ (1) | NZ556435A (enExample) |
| SG (1) | SG158870A1 (enExample) |
| TW (1) | TWI380830B (enExample) |
| WO (1) | WO2006076620A2 (enExample) |
Families Citing this family (74)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8436190B2 (en) | 2005-01-14 | 2013-05-07 | Cephalon, Inc. | Bendamustine pharmaceutical compositions |
| SG10201403526YA (en) | 2005-07-25 | 2014-10-30 | Emergent Product Dev Seattle | B-cell reduction using cd37-specific and cd20-specific binding molecules |
| US20090082416A1 (en) * | 2007-09-25 | 2009-03-26 | Protia, Llc | Deuterium-enriched bendamustine |
| JP5406197B2 (ja) * | 2007-10-09 | 2014-02-05 | ユーエス ワールドメッズ リミテッド ライアビリティ カンパニー | ダントロレン治療剤の送達を改善するための、共溶媒組成物および方法 |
| AR072777A1 (es) * | 2008-03-26 | 2010-09-22 | Cephalon Inc | Formas solidas de clorhidrato de bendamustina |
| ES2368700T3 (es) * | 2008-04-11 | 2011-11-21 | Emergent Product Development Seattle, Llc | Agente inmunoterapéutico para cd37 y combinación con un agente quimioterapéutico bifuncional del mismo. |
| EP2889029A1 (en) * | 2008-09-25 | 2015-07-01 | Cephalon, Inc. | Liquid formulations of bendamustine |
| WO2010056733A1 (en) * | 2008-11-13 | 2010-05-20 | Indiana University Research And Technology Corporation | Combined use of bendamustine, doxorubicin and bortezomib for the treatment of multiple myeloma |
| UA107186C2 (xx) * | 2008-12-03 | 2014-12-10 | Тверді форми дозування бендамустину | |
| NZ592970A (en) * | 2008-12-03 | 2013-05-31 | Astellas Deutschland Gmbh | Oral dosage forms of bendamustine |
| US8076366B2 (en) * | 2009-01-15 | 2011-12-13 | Cephalon, Inc. | Forms of bendamustine free base |
| SI2389375T1 (sl) | 2009-01-23 | 2015-11-30 | Euro-Celtique S.A. | Derivati hidroksamske kisline |
| CA2753641C (en) | 2009-02-25 | 2014-09-16 | Supratek Pharma, Inc. | Bendamustine cyclopolysaccharide compositions |
| EP2424506A1 (en) * | 2009-04-28 | 2012-03-07 | Cephalon, Inc. | Oral formulations of bendamustine |
| WO2010144675A1 (en) | 2009-06-10 | 2010-12-16 | Plus Chemicals Sa | Polymorphs of bendamustine hcl and processes for preparation thereof |
| US8389558B2 (en) * | 2009-07-20 | 2013-03-05 | Supratek Pharma Inc. | Bendamustine amphiphilic anionic compositions |
| US20110015245A1 (en) * | 2009-07-20 | 2011-01-20 | Valery Alakhov | Bendamustine amphiphilic cationic compositions |
| HUE054836T2 (hu) * | 2010-01-28 | 2021-10-28 | Eagle Pharmaceuticals Inc | Bendamusztin kiszerelései |
| WO2011103150A2 (en) * | 2010-02-18 | 2011-08-25 | Cephalon, Inc. | Lyophilized preparations of bendamustine |
| JO3659B1 (ar) * | 2010-06-02 | 2020-08-27 | Astellas Deutschland Gmbh | أشكال جرعات بينداموستين عن طريق الفم وإستخداماته العلاجية |
| JP6209446B2 (ja) * | 2010-06-02 | 2017-10-04 | アステラス ドイチュランド ゲゼルシャフト ミット ベシュレンクテル ハフツング | ベンダムスチンの経口投与形 |
| CN103052407A (zh) * | 2010-07-13 | 2013-04-17 | 赛福伦公司 | 苯达莫司汀的改进灭菌方法 |
| US8383663B2 (en) | 2010-07-19 | 2013-02-26 | Supratek Pharma Inc. | Bendamustine anionic-catioinic cyclopolysaccharide compositions |
| WO2012103226A2 (en) * | 2011-01-25 | 2012-08-02 | Dr. Reddy's Laboratories Ltd. | Bendamustine formulations |
| WO2012109429A2 (en) * | 2011-02-09 | 2012-08-16 | Glaxosmithkline Llc | Lyophilized formulations |
| US20120237492A1 (en) | 2011-02-18 | 2012-09-20 | Kythera Biopharmaceuticals, Inc. | Treatment of submental fat |
| KR101892788B1 (ko) * | 2011-09-13 | 2018-08-28 | 파마싸이클릭스 엘엘씨 | 벤다무스틴과 조합된 히스톤 디아세틸라제 억제제의 제제 및 그의 용도 |
| EP2760842B1 (en) | 2011-09-26 | 2016-11-16 | Fresenius Kabi Oncology Ltd | An improved process for the preparation of bendamustine hydrochloride |
| WO2013102920A1 (en) | 2011-11-18 | 2013-07-11 | Astron Research Limited | Stable lyophilized formulation of bendamustine |
| US20130210878A1 (en) * | 2012-01-24 | 2013-08-15 | Innopharma, Inc. | Bendamustine compositions and methods therefore |
| AR092790A1 (es) * | 2012-02-01 | 2015-05-06 | Euro Celtique Sa | Derivados bencimidazolicos del acido hidroxamico |
| US9872873B2 (en) | 2012-02-06 | 2018-01-23 | Fresenius Kabi Oncology Limited | Process for preparing stable pharmaceutical compositions of compounds susceptible to hydrolysis |
| JP2015506989A (ja) * | 2012-02-14 | 2015-03-05 | イーグル・ファーマシューティカルズ・インコーポレーテッド | ベンダムスチン製剤 |
| HRP20240056T1 (hr) | 2012-03-20 | 2024-03-29 | Eagle Pharmaceuticals, Inc. | Formulacije bendamustina |
| JP6224064B2 (ja) | 2012-03-20 | 2017-11-01 | イーグル・ファーマシューティカルズ・インコーポレーテッド | 低減された投与容量を必要とする患者におけるベンダムスチン応答性症状の治療方法 |
| WO2013148919A1 (en) | 2012-03-30 | 2013-10-03 | The Regents Of The University Of Colorado, A Body Corporate | Treatment of multiple myeloma |
| 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 |
| EP2917183A1 (en) * | 2012-11-12 | 2015-09-16 | Ignyta, Inc. | Bendamustine derivatives and methods of using same |
| PL2732811T3 (pl) | 2012-11-19 | 2016-05-31 | Oncotec Pharma Produktion Gmbh | Proces otrzymywania kompozycji liofilizowanej |
| CN103860482B (zh) * | 2012-12-12 | 2016-08-24 | 海口市制药厂有限公司 | 一种盐酸苯达莫司汀冻干粉针剂的制备方法、其产品及用途 |
| CN103040769A (zh) * | 2013-02-05 | 2013-04-17 | 南京碧迪可医药科技有限公司 | 一种稳定的诺卡沙星粉针冻干剂 |
| EP2958554B1 (en) | 2013-02-19 | 2018-06-06 | Synthon BV | Stable compositions of bendamustine |
| WO2014170769A2 (en) * | 2013-04-15 | 2014-10-23 | Shilpa Medicare Limited | Bendamustine lyophilized pharmaceutical compositions |
| ITMI20131013A1 (it) * | 2013-06-19 | 2014-12-20 | Chemi Spa | Formulazioni liofilizzate di bendamustina cloridrato |
| JP2016153374A (ja) * | 2013-06-25 | 2016-08-25 | シンバイオ製薬株式会社 | 炎症性疾患を治療又は予防するための医薬組成物 |
| CN103351347A (zh) * | 2013-07-29 | 2013-10-16 | 东南大学 | 盐酸苯达莫司汀杂质dce的制备方法 |
| CN109953954A (zh) * | 2013-08-27 | 2019-07-02 | V·沃道里斯 | 苯达莫司汀医药组合物 |
| US20150087681A1 (en) * | 2013-09-25 | 2015-03-26 | Pranav Patel | Bendamustine HCL Stable Lyophilized Formulations |
| WO2015054550A1 (en) * | 2013-10-11 | 2015-04-16 | Luitpold Pharmaceuticals, Inc. | Bendamustine pharmaceutical compositions |
| IN2014CH00151A (enExample) * | 2014-01-13 | 2015-07-17 | Hetero Research Foundation | |
| WO2015138199A1 (en) | 2014-03-13 | 2015-09-17 | Voudouris Vasilios | Bendamustine solid dispersions and continuous infusion |
| US9662342B2 (en) | 2014-05-09 | 2017-05-30 | AuroMedics Pharma LLC | Formulations of cyclophosphamide liquid concentrate |
| GB201409471D0 (en) | 2014-05-28 | 2014-07-09 | Euro Celtique Sa | Pharmaceutical composition |
| GB201409488D0 (en) | 2014-05-28 | 2014-07-09 | Euro Celtique Sa | Pharmaceutical composition |
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| 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 |
| WO2017079700A1 (en) * | 2015-11-04 | 2017-05-11 | Kythera Biopharmaceuticals, Inc. | Treatments of accumulated fat with deoxycholic acid and salts thereof |
| 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 |
| CA3040155C (en) | 2016-10-11 | 2024-01-16 | Euro-Celtique S.A. | Compound for use in the treatment of hodgkin lymphoma |
| US10688222B2 (en) | 2016-11-21 | 2020-06-23 | Warsaw Orthopedic, Inc. | Lyophilized moldable implants containing an oxysterol |
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| JP2022522928A (ja) | 2018-12-18 | 2022-04-21 | ムンディファーマ・インターナショナル・コーポレーション・リミテッド | 多発性骨髄腫を治療するための化合物 |
| US11406598B2 (en) | 2019-09-20 | 2022-08-09 | Nivagen Pharmaceuticals, Inc. | Lyophilized compositions of phenobarbital sodium salt |
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