BR112014027965A2 - composições de polimorfos, métodos de produção, e usos das mesmas - Google Patents
composições de polimorfos, métodos de produção, e usos das mesmasInfo
- 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
Links
- 238000004519 manufacturing process Methods 0.000 title abstract 3
- 239000000203 mixture Substances 0.000 title abstract 3
- 239000012867 bioactive agent Substances 0.000 abstract 2
- 208000029028 brain injury Diseases 0.000 abstract 2
- UIAGMCDKSXEBJQ-IBGZPJMESA-N 3-o-(2-methoxyethyl) 5-o-propan-2-yl (4s)-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate Chemical compound COCCOC(=O)C1=C(C)NC(C)=C(C(=O)OC(C)C)[C@H]1C1=CC=CC([N+]([O-])=O)=C1 UIAGMCDKSXEBJQ-IBGZPJMESA-N 0.000 abstract 1
- 241000124008 Mammalia Species 0.000 abstract 1
- 210000001627 cerebral artery Anatomy 0.000 abstract 1
- 230000003111 delayed effect Effects 0.000 abstract 1
- 230000009969 flowable effect Effects 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 229960000715 nimodipine Drugs 0.000 abstract 1
- 210000002330 subarachnoid space Anatomy 0.000 abstract 1
- 238000013268 sustained release Methods 0.000 abstract 1
- 239000012730 sustained-release form Substances 0.000 abstract 1
- 208000024891 symptom Diseases 0.000 abstract 1
- 230000001225 therapeutic effect Effects 0.000 abstract 1
Classifications
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- 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
- A61K9/141—Intimate 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
- A61K9/146—Intimate 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
-
- 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
- A61K31/435—Heterocyclic 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4418—Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
-
- 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
- A61K31/435—Heterocyclic 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
- A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs 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)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Hematology (AREA)
- Inorganic Chemistry (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Diabetes (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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 (https=) |
| EP (1) | EP2846775A4 (https=) |
| JP (1) | JP6338573B2 (https=) |
| KR (1) | KR101784260B1 (https=) |
| CN (1) | CN104955445A (https=) |
| AU (1) | AU2013259476B2 (https=) |
| BR (1) | BR112014027965A2 (https=) |
| CA (2) | CA2872887C (https=) |
| GB (1) | GB2517096A (https=) |
| HK (2) | HK1202264A1 (https=) |
| IL (1) | IL235262A0 (https=) |
| NZ (1) | NZ629727A (https=) |
| RU (1) | RU2014149362A (https=) |
| SG (1) | SG11201407266PA (https=) |
| WO (1) | WO2013169979A2 (https=) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN107921036A (zh) * | 2015-05-29 | 2018-04-17 | 优势医疗公司 | 用于减少视力丧失的组合物和方法 |
| 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 |
| WO2018039039A1 (en) * | 2016-08-23 | 2018-03-01 | 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 |
| CN112912066B (zh) * | 2018-09-08 | 2022-03-29 | 江苏九旭药业有限公司 | 一种尼莫地平注射液组合物及其制备方法 |
| US12281226B2 (en) | 2018-10-04 | 2025-04-22 | Organo Plastica | Polyvinyl chloride-free lipophilic polymer based aromatized plastisol |
| KR102181231B1 (ko) * | 2018-11-22 | 2020-11-20 | 주식회사 메디포럼제약 | 로티고틴 함유 고분자 미립자의 제조방법 |
Family Cites Families (47)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2117571C3 (de) | 1971-04-10 | 1979-10-11 | Bayer Ag, 5090 Leverkusen | Unsymmetrische 1,4-Dihydropyridin-33-dicarbonsäureester, Verfahren zu ihrer Herstellung sowie ihre Verwendung als Arzneimittel |
| US3932645A (en) | 1971-04-10 | 1976-01-13 | Farbenfabriken Bayer Ag | Pharmaceutical compositions containing unsymmetrical esters of 1,4-dihydropyridine 3,5-dicarboxylic acid |
| US4757128A (en) | 1986-08-01 | 1988-07-12 | Massachusetts Institute Of Technology | High molecular weight polyanhydride and preparation thereof |
| DK0471036T4 (da) * | 1989-05-04 | 2004-07-19 | Southern Res Inst | Indkapslingsfremgangsmåde |
| US5650489A (en) | 1990-07-02 | 1997-07-22 | The Arizona Board Of Regents | Random bio-oligomer library, a method of synthesis thereof, and a method of use thereof |
| DE4130173A1 (de) | 1991-09-11 | 1993-03-18 | Bayer Ag | Pharmazeutische zubereitungen mit einer speziellen kristallmodifikation des 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridindicarbonsaeure-isopropyl-(2-methoxyethyl)-esters |
| IT1255792B (it) | 1992-08-05 | 1995-11-16 | Bayer Italia Spa | Composizioni farmaceutiche per la somministrazione orale di diidropiridine in forma di bevanda |
| US5399665A (en) | 1992-11-05 | 1995-03-21 | Massachusetts Institute Of Technology | Biodegradable polymers for cell transplantation |
| AU704183B2 (en) | 1994-01-05 | 1999-04-15 | Arqule, Inc. | Systematic modular production of aminimide- and oxazolone-based molecules having selected properties |
| US5712171A (en) | 1995-01-20 | 1998-01-27 | Arqule, Inc. | Method of generating a plurality of chemical compounds in a spatially arranged array |
| US5968542A (en) | 1995-06-07 | 1999-10-19 | Southern Biosystems, Inc. | High viscosity liquid controlled delivery system as a device |
| US5747058A (en) | 1995-06-07 | 1998-05-05 | Southern Biosystems, Inc. | High viscosity liquid controlled delivery system |
| JP2909418B2 (ja) | 1995-09-18 | 1999-06-23 | 株式会社資生堂 | 薬物の遅延放出型マイクロスフイア |
| CN1304058C (zh) | 1996-03-12 | 2007-03-14 | Pg－Txl有限公司 | 水溶性紫杉醇产品 |
| KR100236771B1 (ko) | 1997-04-01 | 2000-02-01 | 성재갑 | 히아루론산을 이용한 약물의 서방성 미세입자 제형 |
| US6123956A (en) | 1997-07-10 | 2000-09-26 | Keith Baker | Methods for universally distributing therapeutic agents to the brain |
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| JP5769626B2 (ja) | 2008-09-18 | 2015-08-26 | エボニック コーポレイションＥｖｏｎｉｋ Ｃｏｒｐｏｒａｔｉｏｎ | 溶媒および塩を用いるマイクロカプセル封入プロセス |
| CN101416963A (zh) | 2008-12-02 | 2009-04-29 | 沈阳万爱普利德医药科技有限公司 | 注射用尼莫地平冻干亚微乳剂及其制备方法 |
| US20130059008A1 (en) | 2009-01-23 | 2013-03-07 | Jeffrey L. Atkinson | Drying methods for tuning microparticle properties |
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| CN101485632B (zh) | 2009-02-11 | 2011-05-18 | 西安德天药业股份有限公司 | 尼莫地平脂质微球注射液及其制备方法 |
| US20100291027A1 (en) | 2009-05-14 | 2010-11-18 | Jason Campbell | Hyaluronic acid (ha) injection vehicle |
| CA2784287C (en) | 2009-12-22 | 2017-07-18 | Evonik Degussa Corporation | Emulsion-based process for preparing microparticles and workhead assembly for use with same |
| EP2538956A4 (en) | 2010-02-22 | 2015-04-22 | Edge Therapeutics Inc | METHODS AND COMPOSITIONS FOR TREATING HEMORRHAGIC BRAIN DISORDERS |
| CA2794328C (en) | 2010-03-29 | 2018-01-16 | Evonik Degussa Corporation | Compositions and methods for improved retention of a pharmaceutical composition at a local administration site |
| KR20140063513A (ko) | 2011-02-11 | 2014-05-27 | 에쥐 세라피틱스, 인코포레이티드 | 거미막밑 출혈을 갖는 인간의 예후를 개선시키기 위한 조성물 및 방법 |
| RU2606169C2 (ru) | 2011-04-05 | 2017-01-10 | Эдж Терапьютикс | Система интравентрикулярной доставки лекарственного средства для улучшения исхода после повреждения головного мозга, нарушающего мозговое кровообращение |
| CN102274176B (zh) | 2011-08-04 | 2013-11-20 | 上海天氏利医药科技有限公司 | 一种尼莫地平注射液的组合物及其制备方法与应用 |
| US9399019B2 (en) * | 2012-05-09 | 2016-07-26 | Evonik Corporation | Polymorph compositions, methods of making, and uses thereof |
-
2013
- 2013-03-13 US US13/800,480 patent/US9399019B2/en not_active Expired - Fee Related
- 2013-05-09 GB GB1418703.3A patent/GB2517096A/en not_active Withdrawn
- 2013-05-09 NZ NZ629727A patent/NZ629727A/en not_active IP Right Cessation
- 2013-05-09 RU RU2014149362A patent/RU2014149362A/ru not_active Application Discontinuation
- 2013-05-09 JP JP2015511680A patent/JP6338573B2/ja not_active Expired - Fee Related
- 2013-05-09 KR KR1020147034606A patent/KR101784260B1/ko not_active Expired - Fee Related
- 2013-05-09 HK HK15102813.4A patent/HK1202264A1/xx unknown
- 2013-05-09 SG SG11201407266PA patent/SG11201407266PA/en unknown
- 2013-05-09 WO PCT/US2013/040265 patent/WO2013169979A2/en not_active Ceased
- 2013-05-09 HK HK15108503.6A patent/HK1207824A1/xx unknown
- 2013-05-09 BR BR112014027965A patent/BR112014027965A2/pt not_active Application Discontinuation
- 2013-05-09 EP EP13787017.6A patent/EP2846775A4/en not_active Withdrawn
- 2013-05-09 AU AU2013259476A patent/AU2013259476B2/en not_active Ceased
- 2013-05-09 CN CN201380023989.1A patent/CN104955445A/zh active Pending
- 2013-05-09 CA CA2872887A patent/CA2872887C/en not_active Expired - Fee Related
- 2013-05-09 CA CA2961123A patent/CA2961123A1/en not_active Abandoned
- 2013-07-16 US US13/943,547 patent/US8821944B1/en not_active Expired - Fee Related
-
2014
- 2014-10-22 IL IL235262A patent/IL235262A0/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| HK1202264A1 (en) | 2015-09-25 |
| AU2013259476A1 (en) | 2014-10-30 |
| JP2015522534A (ja) | 2015-08-06 |
| GB201418703D0 (en) | 2014-12-03 |
| US8821944B1 (en) | 2014-09-02 |
| GB2517096A (en) | 2015-02-11 |
| AU2013259476B2 (en) | 2016-10-06 |
| NZ629727A (en) | 2016-06-24 |
| IL235262A0 (en) | 2014-12-31 |
| CA2872887C (en) | 2017-08-22 |
| EP2846775A2 (en) | 2015-03-18 |
| JP6338573B2 (ja) | 2018-06-06 |
| SG11201407266PA (en) | 2014-12-30 |
| CN104955445A (zh) | 2015-09-30 |
| US9399019B2 (en) | 2016-07-26 |
| WO2013169979A3 (en) | 2015-06-18 |
| KR101784260B1 (ko) | 2017-11-06 |
| RU2014149362A (ru) | 2016-06-27 |
| HK1207824A1 (en) | 2016-02-12 |
| CA2872887A1 (en) | 2013-11-14 |
| KR20150021517A (ko) | 2015-03-02 |
| WO2013169979A9 (en) | 2015-01-08 |
| US20130302431A1 (en) | 2013-11-14 |
| CA2961123A1 (en) | 2013-11-14 |
| WO2013169979A2 (en) | 2013-11-14 |
| EP2846775A4 (en) | 2016-04-13 |
| US20140271895A1 (en) | 2014-09-18 |
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