AR079946A1 - Formulaciones liquidas para conjugados de accion prolongada de eritropoyetina - Google Patents
Formulaciones liquidas para conjugados de accion prolongada de eritropoyetinaInfo
- Publication number
- AR079946A1 AR079946A1 ARP110100183A ARP110100183A AR079946A1 AR 079946 A1 AR079946 A1 AR 079946A1 AR P110100183 A ARP110100183 A AR P110100183A AR P110100183 A ARP110100183 A AR P110100183A AR 079946 A1 AR079946 A1 AR 079946A1
- Authority
- AR
- Argentina
- Prior art keywords
- liquid formulation
- formulation according
- epo
- combination
- group
- Prior art date
Links
- 239000012669 liquid formulation Substances 0.000 title abstract 13
- 102000003951 Erythropoietin Human genes 0.000 title 1
- 108090000394 Erythropoietin Proteins 0.000 title 1
- 229940105423 erythropoietin Drugs 0.000 title 1
- OXCMYAYHXIHQOA-UHFFFAOYSA-N potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,4-triaza-3-azanidacyclopenta-1,4-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol Chemical compound [K+].CCCCC1=NC(Cl)=C(CO)N1CC1=CC=C(C=2C(=CC=CC=2)C2=N[N-]N=N2)C=C1 OXCMYAYHXIHQOA-UHFFFAOYSA-N 0.000 title 1
- 230000002035 prolonged effect Effects 0.000 title 1
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- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 abstract 1
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 abstract 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 abstract 1
- 229920002101 Chitin Polymers 0.000 abstract 1
- SHZGCJCMOBCMKK-UHFFFAOYSA-N D-mannomethylose Natural products CC1OC(O)C(O)C(O)C1O SHZGCJCMOBCMKK-UHFFFAOYSA-N 0.000 abstract 1
- 229920002307 Dextran Polymers 0.000 abstract 1
- PNNNRSAQSRJVSB-SLPGGIOYSA-N Fucose Natural products C[C@H](O)[C@@H](O)[C@H](O)[C@H](O)C=O PNNNRSAQSRJVSB-SLPGGIOYSA-N 0.000 abstract 1
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- 239000004471 Glycine Substances 0.000 abstract 1
- 102000008100 Human Serum Albumin Human genes 0.000 abstract 1
- 108091006905 Human Serum Albumin Proteins 0.000 abstract 1
- 102000018071 Immunoglobulin Fc Fragments Human genes 0.000 abstract 1
- 108010091135 Immunoglobulin Fc Fragments Proteins 0.000 abstract 1
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 abstract 1
- SHZGCJCMOBCMKK-DHVFOXMCSA-N L-fucopyranose Chemical compound C[C@@H]1OC(O)[C@@H](O)[C@H](O)[C@@H]1O SHZGCJCMOBCMKK-DHVFOXMCSA-N 0.000 abstract 1
- AGPKZVBTJJNPAG-WHFBIAKZSA-N L-isoleucine Chemical compound CC[C@H](C)[C@H](N)C(O)=O AGPKZVBTJJNPAG-WHFBIAKZSA-N 0.000 abstract 1
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- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 abstract 1
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- MUPFEKGTMRGPLJ-UHFFFAOYSA-N UNPD196149 Natural products OC1C(O)C(CO)OC1(CO)OC1C(O)C(O)C(O)C(COC2C(C(O)C(O)C(CO)O2)O)O1 MUPFEKGTMRGPLJ-UHFFFAOYSA-N 0.000 abstract 1
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- 229920002988 biodegradable polymer Polymers 0.000 abstract 1
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- 238000009472 formulation Methods 0.000 abstract 1
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- 229920002674 hyaluronan Polymers 0.000 abstract 1
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Classifications
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- 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
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- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
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- A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
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Landscapes
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- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
Formulacion líquida que les confiere estabilidad durante períodos de tiempo prolongados a los conjugados de accion prolongada de EPO, que presentan una duracion y una estabilidad mejoradas in vivo. Comprende una composicion estabilizadora caracterizada por un amortiguador y manitol. Debido a que está libre de albumina de suero humano y de otros factores potencialmente nocivos para el cuerpo, la formulacion no presenta riesgos relacionados con las infecciones virales, al tiempo que garantiza una estabilidad excelente durante el almacenamiento de los conjugados de accion prolongada de EPO Reivindicacion 2: La formulacion líquida de acuerdo con la reivindicacion 1, caracterizada porque la concentracion del manitol varía entre 1 y 20% (p/v), sobre la base del volumen total de la formulacion líquida. Reivindicacion 6: La formulacion líquida de acuerdo con la reivindicacion 1, caracterizada porque el estabilizador libre de albumina también comprende un ingrediente seleccionado del grupo que consiste en un agente isotonico, un alcohol polihídrico, un azucar, un agente tensioactivo no ionico, un aminoácido neutro y una combinacion de éstos. Reivindicacion 7: La formulacion líquida de acuerdo con la reivindicacion 6, caracterizada porque el agente isotonico es una sal seleccionada del grupo que consiste en el cloruro de sodio, el sulfato de sodio, el citrato de sodio y una combinacion de éstas. Reivindicacion 9: La formulacion líquida de acuerdo con la reivindicacion 6, caracterizada porque el agente tensioactivo no ionico es un agente tensioactivo no ionico basado en polisorbato o basado en poloxámero. Reivindicacion 12: La formulacion líquida de acuerdo con la reivindicacion 6, caracterizada porque el azucar se selecciona del grupo que consiste en la manosa, la glucosa, la fucosa, la xilosa, la lactosa, la maltosa, la sacarosa, la rafinosa, el dextrano y una combinacion de éstos. Reivindicacion 14: La formulacion líquida de acuerdo con la reivindicacion 6, caracterizada porque el alcohol polihídrico se selecciona del grupo que consiste en el propilenglicol, el polietilenglicol de bajo peso molecular, el glicerol, el polipropileno de bajo peso molecular y una combinacion de éstos. Reivindicacion 16: La formulacion líquida de acuerdo con la reivindicacion 6, caracterizada porque el aminoácido neutro se selecciona del grupo que consiste en la glicina, la alanina, la leucina, la isoleucina y una combinacion de éstos. Reivindicacion 20: La formulacion líquida de acuerdo con la reivindicacion 1, caracterizada porque la EPO es una proteína EPO mutante modificada respecto de la EPO salvaje mediante la sustitucion, la supresion o la insercion de uno o más aminoácidos, o bien un péptido análogo con una actividad similar a la de la EPO salvaje. Reivindicacion 24: La formulacion líquida de acuerdo con la reivindicacion 22, caracterizada porque el fragmento Fc de inmunoglobulina toma la forma de un dímero o un multímero de inmunoglobulinas de cadena simple compuestas por dominios del mismo origen. Reivindicacion 27: La formulacion líquida de acuerdo con la reivindicacion 1, caracterizada porque el polímero no peptídico se selecciona del grupo que consiste en un polímero biodegradable, un polímero lipídico, la quitina, el ácido hialuronico y una combinacion de éstos.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR20100004840 | 2010-01-19 |
Publications (1)
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| AR079946A1 true AR079946A1 (es) | 2012-02-29 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
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| ARP110100183A AR079946A1 (es) | 2010-01-19 | 2011-01-19 | Formulaciones liquidas para conjugados de accion prolongada de eritropoyetina |
Country Status (14)
| Country | Link |
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| US (1) | US8829163B2 (es) |
| EP (1) | EP2525779B1 (es) |
| JP (1) | JP5638628B2 (es) |
| KR (1) | KR101335765B1 (es) |
| CN (1) | CN102753147B (es) |
| AR (1) | AR079946A1 (es) |
| AU (1) | AU2011207916B2 (es) |
| BR (1) | BR112012017982A2 (es) |
| CA (1) | CA2787652C (es) |
| ES (1) | ES2700925T3 (es) |
| MX (1) | MX2012008453A (es) |
| RU (2) | RU2012135505A (es) |
| TW (1) | TWI417104B (es) |
| WO (1) | WO2011090306A2 (es) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101303388B1 (ko) * | 2010-10-26 | 2013-09-03 | 한미사이언스 주식회사 | 지속형 인터페론 알파 결합체의 액상 제제 |
| EP2635310A2 (en) * | 2010-11-05 | 2013-09-11 | Rinat Neuroscience Corp. | Engineered polypeptide conjugates and methods for making thereof using transglutaminase |
| KR20130049671A (ko) | 2011-11-04 | 2013-05-14 | 한미사이언스 주식회사 | 생리활성 폴리펩타이드 결합체 제조 방법 |
| AR090281A1 (es) | 2012-03-08 | 2014-10-29 | Hanmi Science Co Ltd | Proceso mejorado para la preparacion de un complejo polipeptidico fisiologicamente activo |
| US10441665B2 (en) | 2012-07-25 | 2019-10-15 | Hanmi Pharm. Co., Ltd. | Liquid formulation of long acting insulinotropic peptide conjugate |
| AR092862A1 (es) * | 2012-07-25 | 2015-05-06 | Hanmi Pharm Ind Co Ltd | Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion |
| AR094821A1 (es) | 2012-07-25 | 2015-09-02 | Hanmi Pharm Ind Co Ltd | Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada |
| AR091902A1 (es) | 2012-07-25 | 2015-03-11 | Hanmi Pharm Ind Co Ltd | Formulacion liquida de un conjugado de insulina de accion prolongada |
| WO2015015448A2 (en) | 2013-07-31 | 2015-02-05 | Rinat Neuroscience Corp. | Engineered polypeptide conjugates |
| MX387560B (es) * | 2014-03-31 | 2025-03-18 | Hanmi Pharmaceutical Co Ltd | Procedimiento para mejorar la solubilidad de proteínas y péptidos usando un enlace del fragmento fc de inmunoglobulina. |
| PL3134127T3 (pl) | 2014-04-25 | 2020-07-27 | Rinat Neuroscience Corp. | Koniugaty przeciwciało-lek o dużym ładunku leku |
| CN104984323B (zh) * | 2015-06-12 | 2018-05-01 | 北京四环生物制药有限公司 | 注射用重组人促红素冻干粉针剂 |
| CN105311624A (zh) * | 2015-11-23 | 2016-02-10 | 哈药集团生物工程有限公司 | 一种含有重组人促红素的药物组合物 |
| CN106729627B (zh) * | 2016-12-14 | 2021-07-13 | 深圳未名新鹏生物医药有限公司 | 一种重组人促红细胞生成素制剂 |
| WO2018142514A1 (ja) * | 2017-02-01 | 2018-08-09 | 協和発酵キリン株式会社 | ダルベポエチンを含む液体医薬組成物 |
| GB201901547D0 (en) * | 2019-02-05 | 2019-03-27 | Arecor Ltd | Stabilized Fc Fusion protein solutions |
| WO2022033480A1 (zh) * | 2020-08-11 | 2022-02-17 | 隆延生物科技（上海）有限公司 | 一种液体制剂及其应用 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3729863A1 (de) * | 1987-09-05 | 1989-03-16 | Boehringer Mannheim Gmbh | Stabilisierte erythropoietin-lyophilisate |
| TW518219B (en) * | 1996-04-26 | 2003-01-21 | Chugai Pharmaceutical Co Ltd | Erythropoietin solution preparation |
| EP2130554B1 (en) * | 1999-02-22 | 2012-09-05 | University of Connecticut | Albumin-free factor VIII formulations |
| SI21258A (sl) * | 2002-07-17 | 2004-02-29 | LEK farmacevtska dru�ba d.d. | Stabilni farmacevtski pripravek, ki vsebuje eritropoietin in poloksamerni poliol |
| BRPI0317376B8 (pt) * | 2002-12-17 | 2021-05-25 | Merck Patent Gmbh | proteína de fusão de anticorpo-il2 designada como hu14.18-il2, usos da mesma, vetor e composição farmacêutica |
| US20050176108A1 (en) * | 2003-03-13 | 2005-08-11 | Young-Min Kim | Physiologically active polypeptide conjugate having prolonged in vivo half-life |
| RU2268067C2 (ru) | 2003-06-09 | 2006-01-20 | Государственное предприятие Государственный научный центр "Институт иммунологии Федерального медико-биологического агентства" (ГНЦ "Институт иммунологии ФМБА России") | Вирусные вакцины |
| EP1641486B1 (en) | 2003-06-10 | 2012-04-18 | LG Life Sciences Ltd. | Stable, aqueous solution of human erythropoietin, not containing serum albumin |
| KR100560697B1 (ko) | 2003-08-06 | 2006-03-16 | 씨제이 주식회사 | 알부민을 함유하지 않는 에리스로포이에틴 제제 |
| RU2352583C2 (ru) * | 2003-11-13 | 2009-04-20 | Ханми Фарм. Инд. Ко., Лтд. | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ Fc-ОБЛАСТЬ ИММУНОГЛОБУЛИНА В КАЧЕСТВЕ НОСИТЕЛЯ |
| US9283260B2 (en) * | 2006-04-21 | 2016-03-15 | Amgen Inc. | Lyophilized therapeutic peptibody formulations |
-
2011
- 2011-01-18 MX MX2012008453A patent/MX2012008453A/es active IP Right Grant
- 2011-01-18 KR KR1020110005162A patent/KR101335765B1/ko not_active Expired - Fee Related
- 2011-01-18 EP EP11734855.7A patent/EP2525779B1/en not_active Not-in-force
- 2011-01-18 AU AU2011207916A patent/AU2011207916B2/en not_active Ceased
- 2011-01-18 JP JP2012549940A patent/JP5638628B2/ja not_active Expired - Fee Related
- 2011-01-18 ES ES11734855T patent/ES2700925T3/es active Active
- 2011-01-18 TW TW100101721A patent/TWI417104B/zh not_active IP Right Cessation
- 2011-01-18 BR BR112012017982A patent/BR112012017982A2/pt not_active IP Right Cessation
- 2011-01-18 RU RU2012135505/15A patent/RU2012135505A/ru unknown
- 2011-01-18 US US13/574,029 patent/US8829163B2/en not_active Expired - Fee Related
- 2011-01-18 CA CA2787652A patent/CA2787652C/en not_active Expired - Fee Related
- 2011-01-18 WO PCT/KR2011/000370 patent/WO2011090306A2/en not_active Ceased
- 2011-01-18 RU RU2015103071A patent/RU2682720C2/ru not_active IP Right Cessation
- 2011-01-18 CN CN201180007147.8A patent/CN102753147B/zh not_active Expired - Fee Related
- 2011-01-19 AR ARP110100183A patent/AR079946A1/es not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| US20120296069A1 (en) | 2012-11-22 |
| TW201141512A (en) | 2011-12-01 |
| KR20110085918A (ko) | 2011-07-27 |
| CN102753147B (zh) | 2017-10-31 |
| CA2787652C (en) | 2015-06-02 |
| CN102753147A (zh) | 2012-10-24 |
| WO2011090306A3 (en) | 2011-12-01 |
| JP5638628B2 (ja) | 2014-12-10 |
| KR101335765B1 (ko) | 2013-12-02 |
| RU2682720C2 (ru) | 2019-03-21 |
| EP2525779B1 (en) | 2018-09-05 |
| RU2012135505A (ru) | 2014-02-27 |
| EP2525779A2 (en) | 2012-11-28 |
| RU2015103071A (ru) | 2015-06-20 |
| TWI417104B (zh) | 2013-12-01 |
| MX2012008453A (es) | 2012-11-21 |
| BR112012017982A2 (pt) | 2016-05-03 |
| EP2525779A4 (en) | 2014-07-09 |
| AU2011207916B2 (en) | 2014-01-23 |
| ES2700925T3 (es) | 2019-02-20 |
| JP2013517325A (ja) | 2013-05-16 |
| RU2015103071A3 (es) | 2018-09-06 |
| US8829163B2 (en) | 2014-09-09 |
| WO2011090306A2 (en) | 2011-07-28 |
| AU2011207916A1 (en) | 2012-08-23 |
| CA2787652A1 (en) | 2011-07-28 |
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