TR200801968T2 - HFSH sulu formülasyon. - Google Patents
HFSH sulu formülasyon.Info
- Publication number
- TR200801968T2 TR200801968T2 TR2008/01968T TR200801968T TR200801968T2 TR 200801968 T2 TR200801968 T2 TR 200801968T2 TR 2008/01968 T TR2008/01968 T TR 2008/01968T TR 200801968 T TR200801968 T TR 200801968T TR 200801968 T2 TR200801968 T2 TR 200801968T2
- Authority
- TR
- Turkey
- Prior art keywords
- hfsh
- aqueous formulation
- stabilized
- longer period
- time
- Prior art date
Links
- 239000013011 aqueous formulation Substances 0.000 title abstract 3
- 102000003864 Human Follicle Stimulating Hormone Human genes 0.000 abstract 4
- 108010082302 Human Follicle Stimulating Hormone Proteins 0.000 abstract 4
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 abstract 2
- 239000004471 Glycine Substances 0.000 abstract 1
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 abstract 1
- 229920001213 Polysorbate 20 Polymers 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 229930182817 methionine Natural products 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000002736 nonionic surfactant Substances 0.000 abstract 1
- 239000008363 phosphate buffer Substances 0.000 abstract 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 abstract 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 abstract 1
- 229940068977 polysorbate 20 Drugs 0.000 abstract 1
Classifications
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K38/22—Hormones
- A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- 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
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Reproductive Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
hFSH'nin daha uzun bir süre boyunca faaliyet göstermesini sağlamak amacıyla stabilize edilen bir insan follikül uyarıcı hormonunun sulu bir formülasyonu sağlanmaktadır. Mevcut buluşa göre formülasyon daha uzun bir süre boyunca hFSH'nin faaliyet göstermesini sağlayabilen ve glisin, metiyonin ve non-iyonik bir yüzey aktif madde, tercihen polisorbat 20 içeren bir fosfat tamponu içerisinde stabilize edilen hFSH'den terapötik olarak etkili bir miktarda içeren sulu bir formülasyondur.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020050089853A KR101105871B1 (ko) | 2005-09-27 | 2005-09-27 | 인 난포자극호르몬의 안정한 용액 제형 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| TR200801968T2 true TR200801968T2 (tr) | 2008-06-23 |
Family
ID=37899985
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TR2008/01968T TR200801968T2 (tr) | 2005-09-27 | 2006-09-25 | HFSH sulu formülasyon. |
Country Status (18)
| Country | Link |
|---|---|
| US (2) | US20110201554A1 (tr) |
| EP (1) | EP1928413B1 (tr) |
| JP (1) | JP5364374B2 (tr) |
| KR (1) | KR101105871B1 (tr) |
| CN (1) | CN101272764B (tr) |
| AR (1) | AR056538A1 (tr) |
| AT (1) | ATE466570T1 (tr) |
| AU (1) | AU2006295570B2 (tr) |
| BR (1) | BRPI0616300A2 (tr) |
| DE (1) | DE602006014175D1 (tr) |
| ES (1) | ES2345058T3 (tr) |
| GT (1) | GT200600431A (tr) |
| PE (1) | PE20070437A1 (tr) |
| RU (1) | RU2407514C2 (tr) |
| SA (1) | SA06270332B1 (tr) |
| TR (1) | TR200801968T2 (tr) |
| TW (1) | TW200735897A (tr) |
| WO (1) | WO2007037607A1 (tr) |
Families Citing this family (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8617568B2 (en) | 2007-07-10 | 2013-12-31 | Medy-Tox, Inc. | Pharmaceutical liquid composition of botulinum toxin with improved stability |
| CN102007143B (zh) | 2008-01-09 | 2015-08-26 | 塞诺菲-安万特德国有限公司 | 具有超延迟时效特征的新型胰岛素衍生物 |
| EP2249869B1 (en) * | 2008-02-08 | 2011-09-07 | BioGeneriX AG | Liquid formulation of fsh |
| CN102256618A (zh) | 2008-10-17 | 2011-11-23 | 赛诺菲-安万特德国有限公司 | 胰岛素和glp-1激动剂的组合 |
| CA2742659C (en) | 2008-11-04 | 2016-09-27 | Aska Pharmaceutical Co., Ltd. | Aqueous composition containing follicle-stimulating hormone |
| PL2451437T3 (pl) | 2009-07-06 | 2017-05-31 | Sanofi-Aventis Deutschland Gmbh | Wodne preparaty insuliny zawierające metioninę |
| NZ599847A (en) | 2009-11-13 | 2013-09-27 | Sanofi Aventis Deutschland | Pharmaceutical composition comprising a glp-1 agonist and methionine |
| TR201809460T4 (tr) | 2009-11-13 | 2018-07-23 | Sanofi Aventis Deutschland | Bir GLP- 1-agonisti, bir insülin ve metiyonin içeren farmasötik bileşim. |
| RU2553375C2 (ru) * | 2010-02-12 | 2015-06-10 | Интас Биофармасьютикалс Лимитед | Жидкий состав фолликулостимулирующего гормона |
| EP2417982A1 (en) * | 2010-07-30 | 2012-02-15 | Ferring B.V. | Stabilization of gonadotropins |
| WO2012028172A1 (en) | 2010-08-30 | 2012-03-08 | Sanofi-Aventis Deutschland Gmbh | Use of ave0010 for the manufacture of a medicament for the treatment of diabetes mellitus type 2 |
| US9821032B2 (en) | 2011-05-13 | 2017-11-21 | Sanofi-Aventis Deutschland Gmbh | Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin |
| AR087693A1 (es) | 2011-08-29 | 2014-04-09 | Sanofi Aventis Deutschland | Combinacion farmaceutica para uso en el control glucemico en pacientes con diabetes de tipo 2 |
| TWI559929B (en) | 2011-09-01 | 2016-12-01 | Sanofi Aventis Deutschland | Pharmaceutical composition for use in the treatment of a neurodegenerative disease |
| TWI780236B (zh) | 2013-02-04 | 2022-10-11 | 法商賽諾菲公司 | 胰島素類似物及/或胰島素衍生物之穩定化醫藥調配物 |
| WO2015075743A1 (en) * | 2013-11-12 | 2015-05-28 | Cadila Healthcare Limited | Formulation for gonadotropins |
| JP6723921B2 (ja) | 2014-01-09 | 2020-07-15 | サノフイSanofi | インスリンアナログおよび/またはインスリン誘導体の、グリセリンを含まない安定化された医薬製剤 |
| CN105960249B (zh) | 2014-01-09 | 2021-03-16 | 赛诺菲 | 胰岛素类似物和/或胰岛素衍生物的稳定化药物制剂 |
| US9895423B2 (en) | 2014-01-09 | 2018-02-20 | Sanofi | Stabilized pharmaceutical formulations of insulin aspart |
| PE20171622A1 (es) | 2014-12-12 | 2017-11-02 | Sanofi Aventis Deutschland | Formulacion de relacion fija de insulina glargina/lixisenatida |
| TWI748945B (zh) | 2015-03-13 | 2021-12-11 | 德商賽諾菲阿凡提斯德意志有限公司 | 第2型糖尿病病患治療 |
| TW201705975A (zh) | 2015-03-18 | 2017-02-16 | 賽諾菲阿凡提斯德意志有限公司 | 第2型糖尿病病患之治療 |
| GB201603280D0 (en) * | 2016-02-24 | 2016-04-13 | Ferring Bv | Stable liquid gonadotropin formulation |
| WO2020004368A1 (ja) * | 2018-06-25 | 2020-01-02 | Jcrファーマ株式会社 | 蛋白質含有水性液剤 |
| CN115429751B (zh) * | 2022-09-21 | 2023-11-17 | 景泽生物医药(合肥)股份有限公司 | 一种人重组卵泡刺激素注射剂及其制备方法 |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5270057A (en) * | 1990-03-20 | 1993-12-14 | Akzo N.V. | Stabilized gonadotropin containing preparations |
| IT1250075B (it) * | 1991-12-18 | 1995-03-30 | Serono Cesare Ist Ricerca | Composizioni farmaceutiche contenenti gonadotropine. |
| RU2062619C1 (ru) * | 1994-02-08 | 1996-06-27 | Курский сельскохозяйственный институт им.проф.И.И.Иванова | Способ получения препарата фолликулостимулирующего гормона из аденогипофизов животных |
| WO1996029095A1 (en) * | 1995-03-21 | 1996-09-26 | Applied Research Systems Ars Holding N.V. | Hcg liquid formulations |
| US6685940B2 (en) * | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
| US6267958B1 (en) * | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| IL122732A0 (en) * | 1997-01-15 | 1998-08-16 | Akzo Nobel Nv | Liquid gonadotropin-containing formulation its preparation and a device containing same |
| CN1309567A (zh) * | 1998-07-23 | 2001-08-22 | 伊莱利利公司 | Fsh和fsh变体制剂,产品和方法 |
| JP4360758B2 (ja) * | 1999-04-08 | 2009-11-11 | ジェネンテック・インコーポレーテッド | 逆の電荷のポリペプチド類をベースにした組成物 |
| US7514239B2 (en) * | 2000-03-28 | 2009-04-07 | Amgen Inc. | Nucleic acid molecules encoding beta-like glycoprotein hormone polypeptides and heterodimers thereof |
| CA2422076A1 (en) * | 2000-09-18 | 2002-03-21 | Idec Pharmaceutical Corporation | Combination therapy for treatment of autoimmune diseases using b cell depleting/immunoregulatory antibody combination |
| JP5290489B2 (ja) * | 2001-11-08 | 2013-09-18 | アッヴィ・バイオセラピューティクス・インコーポレイテッド | Igg抗体の安定な液体医薬製剤 |
| EP1471891A4 (en) * | 2002-02-08 | 2007-04-11 | Alkermes Inc | POLYMER BASED COMPOSITIONS WITH DELAYED RELEASE |
| US20050232899A1 (en) * | 2002-05-31 | 2005-10-20 | Aradigm Corporation | Compositions methods and systems for pulmonary delivery of recombinant human interferon alpha-2b |
| CN1195069C (zh) * | 2002-11-28 | 2005-03-30 | 南京医科大学 | 人卵泡刺激素β亚基单克隆抗体的制备方法 |
| CA2518903C (en) * | 2003-04-02 | 2013-02-05 | Ares Trading S.A. | Liquid pharmaceutical formulations of fsh and lh together with a non-ionic surfactant |
| US20060069021A1 (en) * | 2004-08-13 | 2006-03-30 | Nastech Pharmaceutical Company Inc. | Compositions and methods for intranasal administration of inactive analogs of PTH or inactivated preparations of PTH or PTH analogs |
| TW200640492A (en) * | 2005-02-21 | 2006-12-01 | Lg Life Sciences Ltd | Sustained release composition of protein drug |
| MX2007015476A (es) * | 2005-06-14 | 2008-02-25 | Amgen Inc | Formulaciones de proteina autoamortiguadoras. |
| EP2249869B1 (en) * | 2008-02-08 | 2011-09-07 | BioGeneriX AG | Liquid formulation of fsh |
-
2005
- 2005-09-27 KR KR1020050089853A patent/KR101105871B1/ko not_active Expired - Lifetime
-
2006
- 2006-09-01 TW TW095132376A patent/TW200735897A/zh unknown
- 2006-09-19 SA SA06270332A patent/SA06270332B1/ar unknown
- 2006-09-21 PE PE2006001144A patent/PE20070437A1/es not_active Application Discontinuation
- 2006-09-25 DE DE602006014175T patent/DE602006014175D1/de active Active
- 2006-09-25 RU RU2008111632/15A patent/RU2407514C2/ru active
- 2006-09-25 ES ES06798894T patent/ES2345058T3/es active Active
- 2006-09-25 AT AT06798894T patent/ATE466570T1/de not_active IP Right Cessation
- 2006-09-25 TR TR2008/01968T patent/TR200801968T2/tr unknown
- 2006-09-25 US US12/066,190 patent/US20110201554A1/en not_active Abandoned
- 2006-09-25 CN CN2006800355835A patent/CN101272764B/zh active Active
- 2006-09-25 AU AU2006295570A patent/AU2006295570B2/en active Active
- 2006-09-25 WO PCT/KR2006/003811 patent/WO2007037607A1/en not_active Ceased
- 2006-09-25 EP EP06798894A patent/EP1928413B1/en not_active Revoked
- 2006-09-25 GT GT200600431A patent/GT200600431A/es unknown
- 2006-09-25 JP JP2008532167A patent/JP5364374B2/ja active Active
- 2006-09-25 BR BRPI0616300-9A patent/BRPI0616300A2/pt not_active Application Discontinuation
- 2006-09-26 AR ARP060104208A patent/AR056538A1/es not_active Application Discontinuation
-
2016
- 2016-05-04 US US15/146,250 patent/US20160243242A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| EP1928413A1 (en) | 2008-06-11 |
| EP1928413A4 (en) | 2008-12-03 |
| CN101272764B (zh) | 2011-05-04 |
| JP5364374B2 (ja) | 2013-12-11 |
| ES2345058T3 (es) | 2010-09-14 |
| EP1928413B1 (en) | 2010-05-05 |
| CN101272764A (zh) | 2008-09-24 |
| US20110201554A1 (en) | 2011-08-18 |
| BRPI0616300A2 (pt) | 2011-06-14 |
| GT200600431A (es) | 2007-08-28 |
| AR056538A1 (es) | 2007-10-10 |
| TW200735897A (en) | 2007-10-01 |
| RU2008111632A (ru) | 2009-10-10 |
| WO2007037607A1 (en) | 2007-04-05 |
| AU2006295570A1 (en) | 2007-04-05 |
| SA06270332B1 (ar) | 2011-01-15 |
| RU2407514C2 (ru) | 2010-12-27 |
| KR101105871B1 (ko) | 2012-01-16 |
| AU2006295570B2 (en) | 2012-08-30 |
| US20160243242A1 (en) | 2016-08-25 |
| ATE466570T1 (de) | 2010-05-15 |
| KR20070035232A (ko) | 2007-03-30 |
| PE20070437A1 (es) | 2007-04-26 |
| JP2009509953A (ja) | 2009-03-12 |
| DE602006014175D1 (de) | 2010-06-17 |
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