BR112014027965A2 - composições de polimorfos, métodos de produção, e usos das mesmas - Google Patents

composições de polimorfos, métodos de produção, e usos das mesmas

Info

Publication number
BR112014027965A2
BR112014027965A2 BR112014027965A BR112014027965A BR112014027965A2 BR 112014027965 A2 BR112014027965 A2 BR 112014027965A2 BR 112014027965 A BR112014027965 A BR 112014027965A BR 112014027965 A BR112014027965 A BR 112014027965A BR 112014027965 A2 BR112014027965 A2 BR 112014027965A2
Authority
BR
Brazil
Prior art keywords
production methods
substantially pure
bioactive agent
brain injury
crystalline form
Prior art date
Application number
BR112014027965A
Other languages
English (en)
Inventor
R Stella Angela
R Davis Cara
Winchester Gary
Burton Kevin
Loch Macdonald R
Original Assignee
Edge Therapeutics Inc
Evonik Corp
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
Application filed by Edge Therapeutics Inc, Evonik Corp filed Critical Edge Therapeutics Inc
Publication of BR112014027965A2 publication Critical patent/BR112014027965A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4418Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647Polyesters, e.g. poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

resumo “composições de polimorfos, métodos de produção, e usos das mesmas” a invenção descrita fornece um sistema de distribuição biodegradável, biocompatível da composição de microparticulado de libertação sustentada fluível de uma forma cristalina substancialmente pura de um agente bioativo, tal como, por exemplo, a nimodipina, um processo de preparação de uma forma terapêutica de uma forma cristalina substancialmente pura do agente bioativo e um método para o tratamento de uma interrupção de uma artéria cerebral em um espaço subaracnóide em risco de interrupção causada por lesão cerebral em um mamífero, que reduz os sinais ou sintomas de pelo menos uma complicação retardada associada com lesão cerebral.
BR112014027965A 2012-05-09 2013-05-09 composições de polimorfos, métodos de produção, e usos das mesmas BR112014027965A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261644523P 2012-05-09 2012-05-09
US13/800,480 US9399019B2 (en) 2012-05-09 2013-03-13 Polymorph compositions, methods of making, and uses thereof
PCT/US2013/040265 WO2013169979A2 (en) 2012-05-09 2013-05-09 Polymorph compositions, methods of making, and uses thereof

Publications (1)

Publication Number Publication Date
BR112014027965A2 true BR112014027965A2 (pt) 2017-06-27

Family

ID=49548793

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014027965A BR112014027965A2 (pt) 2012-05-09 2013-05-09 composições de polimorfos, métodos de produção, e usos das mesmas

Country Status (15)

Country Link
US (2) US9399019B2 (pt)
EP (1) EP2846775A4 (pt)
JP (1) JP6338573B2 (pt)
KR (1) KR101784260B1 (pt)
CN (1) CN104955445A (pt)
AU (1) AU2013259476B2 (pt)
BR (1) BR112014027965A2 (pt)
CA (2) CA2961123A1 (pt)
GB (1) GB2517096A (pt)
HK (2) HK1202264A1 (pt)
IL (1) IL235262A0 (pt)
NZ (1) NZ629727A (pt)
RU (1) RU2014149362A (pt)
SG (1) SG11201407266PA (pt)
WO (1) WO2013169979A2 (pt)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
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US10092524B2 (en) * 2008-06-11 2018-10-09 Edge Therapeutics, Inc. Compositions and their use to treat complications of aneurysmal subarachnoid hemorrhage
US9399019B2 (en) * 2012-05-09 2016-07-26 Evonik Corporation Polymorph compositions, methods of making, and uses thereof
CA2986692A1 (en) * 2015-05-29 2016-12-08 Edge Therapeutics, Inc. Compositions and methods for reducing visual loss
US20190054022A1 (en) * 2016-04-07 2019-02-21 Edge Therapeutics, Inc. Formulations of site-specific, microparticulate compositions and their use to improve outcome after aneursymal subarachnoid hemorrhage
CN105944152B (zh) * 2016-06-13 2019-02-12 龙岩紫荆创新研究院 可吸收防粘医用膜的制备方法
US20180098977A1 (en) * 2016-08-23 2018-04-12 Edge Therapeutics, Inc. Scalable microparticulate formulations containing polymorphic nimodipine form 2 prepared by a solvent evaporation process
WO2019018306A1 (en) * 2017-07-17 2019-01-24 Edge Therapeutics, Inc. ADVANCED MICROPARTICULAR FORMULATIONS CONTAINING FORM 2 OF MICRONIZED POLYMORPHIC NIMODIPINE
EP3848021A4 (en) * 2018-09-08 2023-11-29 Jiangsu Jiuxu Pharmaceutical Co., Ltd. NIMODIPINE INJECTION COMPOSITION AND PROCESS FOR PRODUCTION THEREOF
CN113227250B (zh) * 2018-10-04 2024-01-30 亚历山德拉·乌尼诺夫 无聚氯乙烯的芳香的基于亲脂的聚合物的塑料溶胶
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Also Published As

Publication number Publication date
JP6338573B2 (ja) 2018-06-06
CN104955445A (zh) 2015-09-30
AU2013259476B2 (en) 2016-10-06
NZ629727A (en) 2016-06-24
IL235262A0 (en) 2014-12-31
KR101784260B1 (ko) 2017-11-06
EP2846775A4 (en) 2016-04-13
RU2014149362A (ru) 2016-06-27
JP2015522534A (ja) 2015-08-06
HK1202264A1 (en) 2015-09-25
SG11201407266PA (en) 2014-12-30
US9399019B2 (en) 2016-07-26
GB201418703D0 (en) 2014-12-03
CA2872887A1 (en) 2013-11-14
WO2013169979A2 (en) 2013-11-14
US8821944B1 (en) 2014-09-02
WO2013169979A3 (en) 2015-06-18
HK1207824A1 (en) 2016-02-12
KR20150021517A (ko) 2015-03-02
US20140271895A1 (en) 2014-09-18
EP2846775A2 (en) 2015-03-18
GB2517096A (en) 2015-02-11
AU2013259476A1 (en) 2014-10-30
CA2961123A1 (en) 2013-11-14
WO2013169979A9 (en) 2015-01-08
CA2872887C (en) 2017-08-22
US20130302431A1 (en) 2013-11-14

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06I Publication of requirement cancelled [chapter 6.9 patent gazette]

Free format text: ANULADA A PUBLICACAO CODIGO 6.6.1 NA RPI NO 2462 DE 13/03/2018 POR TER SIDO INDEVIDA.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements