UA80331C2 - Human serum albumin-free stabilised interferon liquid formulations - Google Patents

Human serum albumin-free stabilised interferon liquid formulations Download PDF

Info

Publication number: UA80331C2
Authority: UA; Ukraine
Prior art keywords: composition according; concentration; composition; interferon; solution
Prior art date: 2003-05-01

Application number

UAA200509798A

Other languages

English (en)

Ukrainian (uk)

Inventor

Fabrizio Samaritani

Original Assignee

Ares Trading Sa

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2003-05-01

Filing date

2004-04-29

Publication date

2007-09-10

2004-04-29 Application filed by Ares Trading Sa filed Critical Ares Trading Sa

2007-09-10 Publication of UA80331C2 publication Critical patent/UA80331C2/uk

Links

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UAA200509798A 2003-05-01 2004-04-29 Human serum albumin-free stabilised interferon liquid formulations UA80331C2 (en)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
EP03101210		2003-05-01
PCT/EP2004/004806 WO2004096263A2 (en)	2003-05-01	2004-04-29	Human serum albumin-free stabilized interferon liquid formulations

Publications (1)

Publication Number	Publication Date
UA80331C2 true UA80331C2 (en)	2007-09-10

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Application Number	Title	Priority Date	Filing Date
UAA200509798A UA80331C2 (en)	2003-05-01	2004-04-29	Human serum albumin-free stabilised interferon liquid formulations
UAA200704143A UA94032C2 (ru)	2003-05-01	2004-04-29	Жидкая стабализированная композиция интерферона без hsa

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UAA200704143A UA94032C2 (ru)	2003-05-01	2004-04-29	Жидкая стабализированная композиция интерферона без hsa

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US (1)	US8309069B2 (ru)
EP (1)	EP1617861B1 (ru)
JP (2)	JP4870550B2 (ru)
KR (1)	KR101116058B1 (ru)
CN (1)	CN1816347B (ru)
AR (1)	AR044147A1 (ru)
AU (2)	AU2004233603B2 (ru)
BR (1)	BRPI0410488B8 (ru)
CA (1)	CA2521560A1 (ru)
DK (1)	DK1617861T3 (ru)
EA (2)	EA009995B1 (ru)
ES (1)	ES2417061T3 (ru)
HR (1)	HRP20130512T1 (ru)
IL (1)	IL171709A (ru)
ME (1)	ME00404B (ru)
MX (1)	MXPA05011718A (ru)
MY (1)	MY151121A (ru)
NO (1)	NO335674B1 (ru)
NZ (2)	NZ542912A (ru)
PL (1)	PL1617861T3 (ru)
PT (1)	PT1617861E (ru)
RS (1)	RS52869B (ru)
SG (1)	SG159389A1 (ru)
SI (1)	SI1617861T1 (ru)
TW (1)	TWI272948B (ru)
UA (2)	UA80331C2 (ru)
WO (1)	WO2004096263A2 (ru)
ZA (2)	ZA200508124B (ru)

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US7846427B2 (en) *	2003-12-11	2010-12-07	Ares Trading S.A.	Stabilized interferon liquid formulations
ZA200609412B (en) *	2004-05-17	2008-07-30	Ares Trading Sa	Hydrogel interferon formulations
EP1750751B1 (en) *	2004-06-01	2013-04-10	Ares Trading S.A.	Stabilized interferon liquid formulations
BRPI0510527A (pt) *	2004-06-01	2007-10-30	Ares Trading Sa	método de estabilização de proteìnas
JP4897814B2 (ja) *	2005-09-14	2012-03-14	アレストレーディングソシエテアノニム	ポロキサマーの定量方法
MX2008014971A (es)	2006-05-24	2008-12-05	Serono Lab	Regimen de cladribine para tratar esclerosis multiple.
WO2008066322A1 (en) *	2006-11-28	2008-06-05	Daewoong Co., Ltd.	A stable hsa-free and antioxidant-free pharmaceutical composition comprising interferon-beta
WO2008065752A1 (fr) *	2006-11-30	2008-06-05	National University Corporation Hokkaido University	Agent immunothérapeutique contenant un arndi en tant que principe actif
HUE033256T2 (hu)	2007-03-30	2017-11-28	Xisle Pharma Ventures Trust	Kétfázisú lipidvezikulum készítmény és eljárás cervikális diszplázia kezelésére intravaginális adagolással
WO2008145323A1 (en) *	2007-05-31	2008-12-04	F. Hoffmann-La Roche Ag	Pharmaceutical formulation for interferons
ES2387236T3 (es) *	2007-12-20	2012-09-18	Merck Serono S.A.	Formulaciones de interferón beta pegilado
KR20150074167A (ko)	2012-10-26	2015-07-01	루핀 리미티드	Ｐｅｇ 인터페론 알파-2ｂ의 안정한 약학 조성물
US8986732B2 (en)	2013-08-12	2015-03-24	Helix Biopharma Corporation	Biphasic lipid-vesicle compositions and methods for treating cervical dysplasia by intravaginal delivery
US10159646B2 (en)	2013-08-12	2018-12-25	Altum-Avro Pharma Partnership	Biphasic lipid-vesicle compositions and methods for treating cervical dysplasia by intravaginal delivery
CN107073080A (zh) *	2014-09-23	2017-08-18	豪夫迈·罗氏有限公司	包含α‑型干扰素的稳定的不含苄醇的水溶液制剂
US9925233B2 (en)	2015-01-30	2018-03-27	Par Pharmaceutical, Inc.	Vasopressin formulations for use in treatment of hypotension
US9750785B2 (en)	2015-01-30	2017-09-05	Par Pharmaceutical, Inc.	Vasopressin formulations for use in treatment of hypotension
US9687526B2 (en)	2015-01-30	2017-06-27	Par Pharmaceutical, Inc.	Vasopressin formulations for use in treatment of hypotension
US9744209B2 (en)	2015-01-30	2017-08-29	Par Pharmaceutical, Inc.	Vasopressin formulations for use in treatment of hypotension
US9744239B2 (en)	2015-01-30	2017-08-29	Par Pharmaceutical, Inc.	Vasopressin formulations for use in treatment of hypotension
US9937223B2 (en)	2015-01-30	2018-04-10	Par Pharmaceutical, Inc.	Vasopressin formulations for use in treatment of hypotension
KR101943160B1 (ko) *	2016-10-06	2019-01-30	에이비온 주식회사	인터페론 베타 변이체의 안정화 제제
CN111356460A (zh)	2017-11-24	2020-06-30	默克专利股份公司	用于治疗进展型形式的多发性硬化症的克拉屈滨疗法
CA3194812A1 (en)	2020-09-10	2022-03-17	Merck Patent Gmbh	Novel treatment regimen for the treatment of autoimmune disorders
KR20240118230A (ko) *	2023-01-26	2024-08-05	에이비온 주식회사	인터페론 베타 건조 분말 제제 및 이의 제조방법

Family Cites Families (25)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US6936694B1 (en)	1982-05-06	2005-08-30	Intermune, Inc.	Manufacture and expression of large structural genes
US4737462A (en)	1982-10-19	1988-04-12	Cetus Corporation	Structural genes, plasmids and transformed cells for producing cysteine depleted muteins of interferon-β
US4588585A (en)	1982-10-19	1986-05-13	Cetus Corporation	Human recombinant cysteine depleted interferon-β muteins
US4959314A (en)	1984-11-09	1990-09-25	Cetus Corporation	Cysteine-depleted muteins of biologically active proteins
US5116943A (en)	1985-01-18	1992-05-26	Cetus Corporation	Oxidation-resistant muteins of Il-2 and other protein
US5017691A (en)	1986-07-03	1991-05-21	Schering Corporation	Mammalian interleukin-4
US4879111A (en)	1986-04-17	1989-11-07	Cetus Corporation	Treatment of infections with lymphokines
US4965195A (en)	1987-10-26	1990-10-23	Immunex Corp.	Interleukin-7
US4904584A (en)	1987-12-23	1990-02-27	Genetics Institute, Inc.	Site-specific homogeneous modification of polypeptides
IT1272252B (it) *	1994-05-16	1997-06-16	Applied Research Systems	Formulazioni liquide di interferone beta
TW426523B (en) *	1995-04-06	2001-03-21	Hoffmann La Roche	Interferon solution
ZA9610374B (en) *	1995-12-11	1997-06-23	Elan Med Tech	Cartridge-based drug delivery device
KR101042660B1 (ko)	1996-12-24	2011-06-20	바이오겐 아이덱 엠에이 인코포레이티드	안정한 액체 인터페론 제제
US6013253A (en)	1997-08-15	2000-01-11	Amgen, Inc.	Treatment of multiple sclerosis using consensus interferon and IL-1 receptor antagonist
DE59805732D1 (de) *	1997-09-23	2002-10-31	Rentschler Biotech Gmbh	Flüssige interferon-beta-formulierungen
JP2001526033A (ja) *	1997-12-08	2001-12-18	ジェネンテク・インコーポレイテッド	ヒトインターフェロン−イプシロンというｉ型インターフェロン
BR9910023A (pt)	1998-04-28	2000-12-26	Applied Research Systems	Conjugados de poliol-ifn-beta
EP1852424B1 (de) *	1998-05-11	2012-04-04	Basf Se	Verfahren zur Herstellung von Isoxazolin-3-YL-Acylbenzolen
CN1175901C (zh)	1999-12-06	2004-11-17	天津华立达生物工程有限公司	一种稳定的干扰素水溶液
US6465425B1 (en) *	2000-02-10	2002-10-15	Alkermes Controlled Therapeutics, Inc.	Microencapsulation and sustained release of biologically active acid-stable or free sulfhydryl-containing proteins
US6887462B2 (en) *	2001-04-09	2005-05-03	Chiron Corporation	HSA-free formulations of interferon-beta
UY27373A1 (es) *	2001-07-09	2003-02-28	Schering Ag	Formulaciones de interferón beta-humano
US7846427B2 (en)	2003-12-11	2010-12-07	Ares Trading S.A.	Stabilized interferon liquid formulations
ZA200609412B (en)	2004-05-17	2008-07-30	Ares Trading Sa	Hydrogel interferon formulations
BRPI0510527A (pt)	2004-06-01	2007-10-30	Ares Trading Sa	método de estabilização de proteìnas

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Also Published As

Publication number	Publication date
SG159389A1 (en)	2010-03-30
WO2004096263A3 (en)	2004-12-02
BRPI0410488B8 (pt)	2021-09-08
BRPI0410488A (pt)	2006-06-13
JP2006525280A (ja)	2006-11-09
NZ542912A (en)	2008-04-30
HRP20130512T1 (hr)	2013-07-31
WO2004096263A2 (en)	2004-11-11
KR20060011976A (ko)	2006-02-06
AR044147A1 (es)	2005-08-24
UA94032C2 (ru)	2011-04-11
IL171709A (en)	2016-03-31
CN1816347B (zh)	2010-07-21
TWI272948B (en)	2007-02-11
TW200503754A (en)	2005-02-01
RS52869B (sr)	2013-12-31
AU2004233603A1 (en)	2004-11-11
NO20055666L (no)	2005-11-30
RS20050821A (sr)	2007-12-31
EA009995B1 (ru)	2008-06-30
MXPA05011718A (es)	2006-01-23
ME00404B (me)	2011-10-10
PT1617861E (pt)	2013-08-28
MEP60408A (en)	2011-05-10
JP2011225599A (ja)	2011-11-10
HK1088847A1 (zh)	2006-11-17
BRPI0410488B1 (pt)	2021-06-22
EP1617861A2 (en)	2006-01-25
ES2417061T3 (es)	2013-08-05
DK1617861T3 (da)	2013-07-29
NZ566625A (en)	2010-02-26
KR101116058B1 (ko)	2012-04-12
EA200800327A1 (ru)	2008-10-30
AU2004233603B2 (en)	2009-02-26
PL1617861T3 (pl)	2013-10-31
CN1816347A (zh)	2006-08-09
AU2009201261A1 (en)	2009-04-23
EA200501699A1 (ru)	2006-06-30
ZA200708484B (en)	2008-10-29
NO335674B1 (no)	2015-01-19
MY151121A (en)	2014-04-30
JP5346065B2 (ja)	2013-11-20
EP1617861B1 (en)	2013-05-29
US20070059285A1 (en)	2007-03-15
CA2521560A1 (en)	2004-11-11
SI1617861T1 (sl)	2013-09-30
JP4870550B2 (ja)	2012-02-08
ZA200508124B (en)	2009-02-25
US8309069B2 (en)	2012-11-13

Publication	Publication Date	Title
UA80331C2 (en)	2007-09-10	Human serum albumin-free stabilised interferon liquid formulations
KR102740102B1 (ko)	2024-12-06	Il-2의 약학 조성물
JP4988562B2 (ja)	2012-08-01	安定化したインターフェロン液体製剤
AU2001282607B2 (en)	2006-08-17	Solution preparations stabilized over long time
AU2004298781B2 (en)	2010-04-01	Stabilized interferon liquid formulations
KR19990022542A (ko)	1999-03-25	트롬보포이에틴 조성물
RU2783864C2 (ru)	2022-11-21	Фармацевтические композиции с il-2
HK1088847B (en)	2010-12-03	Human serum albumin-free stabilized interferon liquid formulations
HK1102563B (en)	2011-08-05	Stabilized interferon liquid formulations
HK1056122A (en)	2004-02-06	Solution formulations having long-term stability