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 aceitável

Info

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
Application number
BRPI0606332-2A
Other languages
English (en)
Inventor
Jason Edward Brittain
Joe Craig Franklin
Original Assignee
Cephalon Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36678237&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0606332(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Cephalon Inc filed Critical Cephalon Inc
Publication of BRPI0606332A2 publication Critical patent/BRPI0606332A2/pt

Links

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)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (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)
  • Oncology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Transplantation (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)

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.
BRPI0606332-2A 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 BRPI0606332A2 (pt)

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 (pt)
EP (2) EP2574334A1 (pt)
JP (3) JP2008526991A (pt)
KR (4) KR20160098530A (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)
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)

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