RU2014149362A - Полиморфные композиции, способы их получения и применение - Google Patents
Полиморфные композиции, способы их получения и применение Download PDFInfo
- Publication number
- RU2014149362A RU2014149362A RU2014149362A RU2014149362A RU2014149362A RU 2014149362 A RU2014149362 A RU 2014149362A RU 2014149362 A RU2014149362 A RU 2014149362A RU 2014149362 A RU2014149362 A RU 2014149362A RU 2014149362 A RU2014149362 A RU 2014149362A
- Authority
- RU
- Russia
- Prior art keywords
- dlg
- microparticles
- active agent
- biologically active
- nimodipine
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract 44
- 239000000203 mixture Substances 0.000 title claims abstract 24
- 239000011859 microparticle Substances 0.000 claims abstract 30
- 239000013543 active substance Substances 0.000 claims abstract 17
- 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 group 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 claims abstract 15
- 229960000715 nimodipine Drugs 0.000 claims abstract 13
- 229920002988 biodegradable polymer Polymers 0.000 claims abstract 10
- 239000004621 biodegradable polymer Substances 0.000 claims abstract 10
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims abstract 9
- 229920000642 polymer Polymers 0.000 claims abstract 8
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims abstract 6
- 238000001035 drying Methods 0.000 claims abstract 6
- 229920001710 Polyorthoester Polymers 0.000 claims abstract 4
- 150000008064 anhydrides Chemical class 0.000 claims abstract 4
- 239000002745 poly(ortho ester) Substances 0.000 claims abstract 4
- 239000002904 solvent Substances 0.000 claims abstract 4
- RKDVKSZUMVYZHH-UHFFFAOYSA-N 1,4-dioxane-2,5-dione Chemical compound O=C1COC(=O)CO1 RKDVKSZUMVYZHH-UHFFFAOYSA-N 0.000 claims abstract 2
- 239000000839 emulsion Substances 0.000 claims abstract 2
- 238000000605 extraction Methods 0.000 claims abstract 2
- JJTUDXZGHPGLLC-UHFFFAOYSA-N lactide Chemical compound CC1OC(=O)C(C)OC1=O JJTUDXZGHPGLLC-UHFFFAOYSA-N 0.000 claims abstract 2
- 229920000747 poly(lactic acid) Polymers 0.000 claims abstract 2
- 238000000634 powder X-ray diffraction Methods 0.000 claims 18
- 210000001627 cerebral artery Anatomy 0.000 claims 8
- 238000001228 spectrum Methods 0.000 claims 7
- 150000001875 compounds Chemical class 0.000 claims 6
- 238000013268 sustained release Methods 0.000 claims 6
- 239000012730 sustained-release form Substances 0.000 claims 6
- 230000001225 therapeutic effect Effects 0.000 claims 5
- 210000001175 cerebrospinal fluid Anatomy 0.000 claims 4
- 239000000243 solution Substances 0.000 claims 4
- 210000002330 subarachnoid space Anatomy 0.000 claims 4
- 206010047163 Vasospasm Diseases 0.000 claims 3
- 230000003111 delayed effect Effects 0.000 claims 3
- 239000003937 drug carrier Substances 0.000 claims 3
- 230000000694 effects Effects 0.000 claims 3
- 238000002347 injection Methods 0.000 claims 3
- 239000007924 injection Substances 0.000 claims 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 2
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Polymers OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 claims 2
- 229920000954 Polyglycolide Polymers 0.000 claims 2
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 2
- 230000015572 biosynthetic process Effects 0.000 claims 2
- 238000009826 distribution Methods 0.000 claims 2
- 239000012530 fluid Substances 0.000 claims 2
- 208000001286 intracranial vasospasm Diseases 0.000 claims 2
- 239000011159 matrix material Substances 0.000 claims 2
- 230000000149 penetrating effect Effects 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 2
- 239000000843 powder Substances 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- 239000004094 surface-active agent Substances 0.000 claims 2
- 239000000725 suspension Substances 0.000 claims 2
- 230000001839 systemic circulation Effects 0.000 claims 2
- 201000006474 Brain Ischemia Diseases 0.000 claims 1
- 206010008120 Cerebral ischaemia Diseases 0.000 claims 1
- 238000001069 Raman spectroscopy Methods 0.000 claims 1
- 238000002083 X-ray spectrum Methods 0.000 claims 1
- 238000004458 analytical method Methods 0.000 claims 1
- 210000004556 brain Anatomy 0.000 claims 1
- 230000006931 brain damage Effects 0.000 claims 1
- 231100000874 brain damage Toxicity 0.000 claims 1
- 208000029028 brain injury Diseases 0.000 claims 1
- 206010008118 cerebral infarction Diseases 0.000 claims 1
- 210000004289 cerebral ventricle Anatomy 0.000 claims 1
- 230000001054 cortical effect Effects 0.000 claims 1
- 238000000113 differential scanning calorimetry Methods 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 230000009969 flowable effect Effects 0.000 claims 1
- 208000028867 ischemia Diseases 0.000 claims 1
- 230000000144 pharmacologic effect Effects 0.000 claims 1
- 238000009827 uniform distribution Methods 0.000 claims 1
- 238000005406 washing Methods 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 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 (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261644523P | 2012-05-09 | 2012-05-09 | |
| US61/644,523 | 2012-05-09 | ||
| US13/800,480 US9399019B2 (en) | 2012-05-09 | 2013-03-13 | Polymorph compositions, methods of making, and uses thereof |
| US13/800,480 | 2013-03-13 | ||
| 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 |
|---|---|
| RU2014149362A true RU2014149362A (ru) | 2016-06-27 |
Family
ID=49548793
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2014149362A RU2014149362A (ru) | 2012-05-09 | 2013-05-09 | Полиморфные композиции, способы их получения и применение |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US9399019B2 (enExample) |
| EP (1) | EP2846775A4 (enExample) |
| JP (1) | JP6338573B2 (enExample) |
| KR (1) | KR101784260B1 (enExample) |
| CN (1) | CN104955445A (enExample) |
| AU (1) | AU2013259476B2 (enExample) |
| BR (1) | BR112014027965A2 (enExample) |
| CA (2) | CA2961123A1 (enExample) |
| GB (1) | GB2517096A (enExample) |
| HK (2) | HK1202264A1 (enExample) |
| IL (1) | IL235262A0 (enExample) |
| NZ (1) | NZ629727A (enExample) |
| RU (1) | RU2014149362A (enExample) |
| SG (1) | SG11201407266PA (enExample) |
| WO (1) | WO2013169979A2 (enExample) |
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 |
| CA2986692A1 (en) * | 2015-05-29 | 2016-12-08 | Edge Therapeutics, Inc. | Compositions and methods for reducing visual loss |
| WO2017176914A1 (en) * | 2016-04-07 | 2017-10-12 | Edge Therapeutics, Inc. | Formulations of site-specific, microparticulate compositions and their use to improve outcome after aneurysmal 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 |
| JP2021535932A (ja) * | 2018-09-08 | 2021-12-23 | 江蘇九旭海天薬業有限公司 | ニモジピン注射用組成物及びその調製方法 |
| 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 |
| KR102181231B1 (ko) * | 2018-11-22 | 2020-11-20 | 주식회사 메디포럼제약 | 로티고틴 함유 고분자 미립자의 제조방법 |
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| 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 KR KR1020147034606A patent/KR101784260B1/ko not_active Expired - Fee Related
- 2013-05-09 GB GB1418703.3A patent/GB2517096A/en not_active Withdrawn
- 2013-05-09 RU RU2014149362A patent/RU2014149362A/ru not_active Application Discontinuation
- 2013-05-09 HK HK15102813.4A patent/HK1202264A1/xx unknown
- 2013-05-09 EP EP13787017.6A patent/EP2846775A4/en not_active Withdrawn
- 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 CA CA2961123A patent/CA2961123A1/en not_active Abandoned
- 2013-05-09 NZ NZ629727A patent/NZ629727A/en not_active IP Right Cessation
- 2013-05-09 SG SG11201407266PA patent/SG11201407266PA/en unknown
- 2013-05-09 CN CN201380023989.1A patent/CN104955445A/zh active Pending
- 2013-05-09 BR BR112014027965A patent/BR112014027965A2/pt not_active Application Discontinuation
- 2013-05-09 CA CA2872887A patent/CA2872887C/en not_active Expired - Fee Related
- 2013-05-09 AU AU2013259476A patent/AU2013259476B2/en not_active Ceased
- 2013-05-09 JP JP2015511680A patent/JP6338573B2/ja not_active Expired - Fee Related
- 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 |
|---|---|
| JP2015522534A (ja) | 2015-08-06 |
| NZ629727A (en) | 2016-06-24 |
| SG11201407266PA (en) | 2014-12-30 |
| CN104955445A (zh) | 2015-09-30 |
| CA2872887A1 (en) | 2013-11-14 |
| HK1202264A1 (en) | 2015-09-25 |
| AU2013259476B2 (en) | 2016-10-06 |
| BR112014027965A2 (pt) | 2017-06-27 |
| US20140271895A1 (en) | 2014-09-18 |
| US9399019B2 (en) | 2016-07-26 |
| HK1207824A1 (en) | 2016-02-12 |
| KR20150021517A (ko) | 2015-03-02 |
| AU2013259476A1 (en) | 2014-10-30 |
| WO2013169979A2 (en) | 2013-11-14 |
| CA2872887C (en) | 2017-08-22 |
| JP6338573B2 (ja) | 2018-06-06 |
| GB201418703D0 (en) | 2014-12-03 |
| CA2961123A1 (en) | 2013-11-14 |
| EP2846775A2 (en) | 2015-03-18 |
| GB2517096A (en) | 2015-02-11 |
| KR101784260B1 (ko) | 2017-11-06 |
| US20130302431A1 (en) | 2013-11-14 |
| WO2013169979A3 (en) | 2015-06-18 |
| EP2846775A4 (en) | 2016-04-13 |
| US8821944B1 (en) | 2014-09-02 |
| IL235262A0 (en) | 2014-12-31 |
| WO2013169979A9 (en) | 2015-01-08 |
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