RU2018101248A - Полимерные белковые микрочастицы - Google Patents
Полимерные белковые микрочастицы Download PDFInfo
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- RU2018101248A RU2018101248A RU2018101248A RU2018101248A RU2018101248A RU 2018101248 A RU2018101248 A RU 2018101248A RU 2018101248 A RU2018101248 A RU 2018101248A RU 2018101248 A RU2018101248 A RU 2018101248A RU 2018101248 A RU2018101248 A RU 2018101248A
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- protein
- polymer
- organic solvent
- spray drying
- combination
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- 102000004169 proteins and genes Human genes 0.000 title claims 17
- 108090000623 proteins and genes Proteins 0.000 title claims 17
- 239000011859 microparticle Substances 0.000 title claims 4
- 238000000034 method Methods 0.000 claims 21
- 239000003960 organic solvent Substances 0.000 claims 10
- 229920000642 polymer Polymers 0.000 claims 10
- 239000002245 particle Substances 0.000 claims 8
- 238000001694 spray drying Methods 0.000 claims 6
- 239000007864 aqueous solution Substances 0.000 claims 5
- 239000000843 powder Substances 0.000 claims 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims 3
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims 3
- 239000001856 Ethyl cellulose Substances 0.000 claims 3
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical group CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 3
- 229920001710 Polyorthoester Polymers 0.000 claims 3
- 238000009835 boiling Methods 0.000 claims 3
- 239000011248 coating agent Substances 0.000 claims 3
- 238000000576 coating method Methods 0.000 claims 3
- 229920001249 ethyl cellulose Polymers 0.000 claims 3
- 235000019325 ethyl cellulose Nutrition 0.000 claims 3
- 239000002745 poly(ortho ester) Substances 0.000 claims 3
- 239000000243 solution Substances 0.000 claims 3
- 238000005507 spraying Methods 0.000 claims 3
- 239000000725 suspension Substances 0.000 claims 3
- 102000009109 Fc receptors Human genes 0.000 claims 2
- 108010087819 Fc receptors Proteins 0.000 claims 2
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 claims 2
- 108010073929 Vascular Endothelial Growth Factor A Proteins 0.000 claims 2
- 102000005789 Vascular Endothelial Growth Factors Human genes 0.000 claims 2
- 108010019530 Vascular Endothelial Growth Factors Proteins 0.000 claims 2
- 108020001507 fusion proteins Proteins 0.000 claims 2
- 102000037865 fusion proteins Human genes 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 229920001610 polycaprolactone Polymers 0.000 claims 2
- 238000013268 sustained release Methods 0.000 claims 2
- 239000012730 sustained-release form Substances 0.000 claims 2
- 229920002988 biodegradable polymer Polymers 0.000 claims 1
- 239000004621 biodegradable polymer Substances 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229920000620 organic polymer Polymers 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 claims 1
- 239000007921 spray Substances 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 claims 1
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- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5089—Processes
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
- A61K38/179—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
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- A—HUMAN NECESSITIES
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- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
- A61K9/1611—Inorganic compounds
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- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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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
- A61K9/14—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
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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
- A61K9/14—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)
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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
- A61K9/14—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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Inorganic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Gastroenterology & Hepatology (AREA)
- Cell Biology (AREA)
- Zoology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
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Claims (26)
1. Способ получения фармацевтической композиции с пролонгированным высвобождением, включающий:
(а) распылительную сушку водного раствора, содержащего белок, с образованием совокупности белковых частиц; а также
(b) нанесения покрытия на каждую белковую частицу указанной совокупности белковых частиц с помощью полимера с образованием совокупности микрочастиц белок-полимер,
где указанная фармацевтическая композиция с пролонгированным высвобождением включает (i) белковые частицы, покрытые биологически разрушаемым полимером, или (ii) сбор частиц полимер-белок, имеющих диаметр в диапазоне от приблизительно 2 мкм до приблизительно 70 мкм.
2. Способ по п.1, где водный раствор, содержащий белок, не лиофилизируют.
3. Способ по п.1 или 2, где совокупность микрочастиц белок-полимер не лиофилизирована.
4. Способ по любому из пп.1-3, где стадия распылительной сушки (а) включает (i) распыление водного раствора, содержащего белок; и (ii) подачу тепла в распыленный водный раствор, содержащий белок.
5. Способ по п.4, где тепло подается при температуре, превышающей температуру кипения воды.
6. Способ по п.5, где температура, превышающая температуру кипения воды, составляет 130 °С.
7. Способ по любому из пп.1-6, где стадия покрытия (b) включает (i) суспендирование указанной совокупности белковых частиц в органическом растворителе, включающем полимер и органический растворитель; и (ii) распылительную сушку суспензии с образованием совокупности микрочастиц белок-полимер.
8. Способ по п.7, где стадия распылительной сушки (b)(ii) включает распыление суспензии и затем подачу тепла на распыленную суспензию при температуре, превышающей температуру воспламенения органического растворителя, для выпаривания органического растворителя.
9. Способ по п.8, где температура, превышающая температуру воспламенения органического растворителя, составляет 90 °С.
10. Способ по любому из пп.7-9, где органический растворитель выбран из группы, состоящей из метиленхлорида, тетрагидрофурана и этилацетата.
11. Способ по любому из пп.1-10, где указанный водный раствор содержит 25-50 мг/мл указанного белка и один или более наполнителей, выбранных из группы, состоящей из сахара, буфера и поверхностно-активного вещества.
12. Способ по любому из пп.1-11, где указанный полимер выбран из группы, состоящей из этилцеллюлозы (ЕС), поли-D,L-лактид-со-гликолида (PLGA), поли-ε-капролактона (PCL) и полиортоэфира (POE).
13. Способ по любому из пп.7-12, где указанный полимер находится в концентрации 10 мг/мл - 300 мг/мл в указанном органическом растворителе.
14. Способ по любому из пп.7-13, где указанную совокупность белковых частиц суспендируют в указанном органическом растворителе в концентрации 10 мг/мл - 100 мг/мл.
15. Способ по любому из пп.7-14, где указанную совокупность белковых частиц суспендируют в указанном органическом растворителе в концентрации 50 мг/мл и указанная концентрация указанного полимера в указанном органическом растворителе составляет 50 мг/мл, 100 мг/мл, 200 мг/мл или 250 мг/мл.
16. Способ по любому из пп.1-15, где белок выбран из группы, состоящей из слитого белка-Fc-рецептора, антитела, белка ловушечного типа и ловушки сосудистого эндотелиального фактора роста (VEGF).
17. Способ получения фармацевтического порошка, причем указанный способ включает:
(а) распыление раствора, содержащего воду и белок; а также
(b) распылительную сушку указанного распыленного раствора при температуре, превышающей температуру кипения воды, с образованием указанного фармацевтического порошка.
18. Способ по п.17, где указанный фармацевтический порошок не подвергают лиофилизации.
19. Способ по п.17 или 18, дополнительно включающий объединение указанного фармацевтического порошка с раствором органического полимера и распылительную сушку комбинации для получения фармацевтического порошка с полимерным покрытием.
20. Способ по любому из пп.17-19, где указанный белок представляет собой антитело или слитый белок-Fc-рецептор.
21. Способ по п.19 или 20, где указанный полимер представляет собой этилцеллюлозу или полиортоэфир.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161561525P | 2011-11-18 | 2011-11-18 | |
| US61/561,525 | 2011-11-18 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2014124682A Division RU2642664C2 (ru) | 2011-11-18 | 2012-11-18 | Полимерные белковые микрочастицы |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2022105668A Division RU2022105668A (ru) | 2011-11-18 | 2022-03-03 | Полимерные белковые микрочастицы |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2018101248A true RU2018101248A (ru) | 2019-02-21 |
| RU2018101248A3 RU2018101248A3 (ru) | 2021-02-18 |
| RU2768492C2 RU2768492C2 (ru) | 2022-03-24 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2018101248A RU2768492C2 (ru) | 2011-11-18 | 2012-11-18 | Полимерные белковые микрочастицы |
| RU2014124682A RU2642664C2 (ru) | 2011-11-18 | 2012-11-18 | Полимерные белковые микрочастицы |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2014124682A RU2642664C2 (ru) | 2011-11-18 | 2012-11-18 | Полимерные белковые микрочастицы |
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| Country | Link |
|---|---|
| US (4) | US20130129830A1 (ru) |
| EP (4) | EP4026543B1 (ru) |
| JP (5) | JP6267649B2 (ru) |
| KR (4) | KR20220063293A (ru) |
| CN (2) | CN103957898B (ru) |
| AU (1) | AU2012340107B2 (ru) |
| BR (1) | BR112014011915B1 (ru) |
| CA (2) | CA2855749C (ru) |
| DK (3) | DK3574897T3 (ru) |
| ES (4) | ES2775104T5 (ru) |
| FI (1) | FI2790681T4 (ru) |
| HU (2) | HUE048597T2 (ru) |
| IL (4) | IL303832A (ru) |
| MX (2) | MX362286B (ru) |
| PL (3) | PL3384903T3 (ru) |
| PT (2) | PT3574897T (ru) |
| RU (2) | RU2768492C2 (ru) |
| SG (2) | SG10202103003RA (ru) |
| WO (1) | WO2013075068A1 (ru) |
| ZA (4) | ZA201403379B (ru) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11291636B2 (en) | 2011-11-18 | 2022-04-05 | Regeneron Pharmaceuticals, Inc. | Polymer protein microparticles |
Families Citing this family (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2807552A1 (en) | 2010-08-06 | 2012-02-09 | Moderna Therapeutics, Inc. | Engineered nucleic acids and methods of use thereof |
| SMT202200321T1 (it) | 2010-10-01 | 2022-09-14 | Modernatx Inc | Acidi ribonucleici contenenti n1-metil-pseudouracili e loro usi |
| WO2012135805A2 (en) | 2011-03-31 | 2012-10-04 | modeRNA Therapeutics | Delivery and formulation of engineered nucleic acids |
| US9464124B2 (en) | 2011-09-12 | 2016-10-11 | Moderna Therapeutics, Inc. | Engineered nucleic acids and methods of use thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US11291636B2 (en) | 2011-11-18 | 2022-04-05 | Regeneron Pharmaceuticals, Inc. | Polymer protein microparticles |
| US11951216B2 (en) | 2011-11-18 | 2024-04-09 | Regeneron Pharmaceuticals, Inc. | Polymer protein microparticles |
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