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
Classifications
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- 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
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- 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
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- 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
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- 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
Abstract
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. A presente invenção provê formulações farmacêuticas de bendamustina liofihizada apropriada para uso farmacêutico. A presente invenção ainda provê métodos de produção de bendamustina liofilizada. As formulações farmacêuticas podem ser usadas para qualquer doença que e sensível ao tratamento com bendamustina, como doenças neoplásicas.
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 (20)
Country | Link |
---|---|
US (9) | US8436190B2 (pt) |
EP (2) | EP1863452B1 (pt) |
JP (3) | JP2008526991A (pt) |
KR (4) | KR101918188B1 (pt) |
CN (1) | CN102078305B (pt) |
AR (1) | AR052877A1 (pt) |
AU (1) | AU2006204817B2 (pt) |
BR (1) | BRPI0606332A2 (pt) |
CA (1) | CA2593582A1 (pt) |
EA (1) | EA013324B1 (pt) |
ES (1) | ES2405611T3 (pt) |
HK (1) | HK1116073A1 (pt) |
IL (1) | IL184394A0 (pt) |
MX (1) | MX2007008562A (pt) |
MY (1) | MY157661A (pt) |
NO (1) | NO343659B1 (pt) |
NZ (1) | NZ556435A (pt) |
SG (1) | SG158870A1 (pt) |
TW (1) | TWI380830B (pt) |
WO (1) | WO2006076620A2 (pt) |
Families Citing this family (72)
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CN105012953B (zh) | 2005-07-25 | 2018-06-22 | 阿普泰沃研发有限责任公司 | 用cd37-特异性和cd20-特异性结合分子减少b-细胞 |
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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 |
EP2365003A1 (en) * | 2008-04-11 | 2011-09-14 | Emergent Product Development Seattle, LLC | CD37 immunotherapeutic and combination with bifunctional chemotherapeutic thereof |
CN104224703A (zh) | 2008-09-25 | 2014-12-24 | 赛福伦公司 | 苯达莫司汀的液体配制品 |
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 |
UA102120C2 (ru) * | 2008-12-03 | 2013-06-10 | Астеллас Дойчленд Гмбх | Пероральная форма дозирования бендамустина |
UA107186C2 (xx) * | 2008-12-03 | 2014-12-10 | Тверді форми дозування бендамустину | |
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