KR20010034654A - Peg-인터페론 알파 결합체의 보호를 위한 약제 - Google Patents
Peg-인터페론 알파 결합체의 보호를 위한 약제 Download PDFInfo
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- KR20010034654A KR20010034654A KR1020007010588A KR20007010588A KR20010034654A KR 20010034654 A KR20010034654 A KR 20010034654A KR 1020007010588 A KR1020007010588 A KR 1020007010588A KR 20007010588 A KR20007010588 A KR 20007010588A KR 20010034654 A KR20010034654 A KR 20010034654A
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- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
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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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- 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
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
- A61K38/212—IFN-alpha
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- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- Gastroenterology & Hepatology (AREA)
- Tropical Medicine & Parasitology (AREA)
- AIDS & HIV (AREA)
- Biotechnology (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Other Resins Obtained By Reactions Not Involving Carbon-To-Carbon Unsaturated Bonds (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Abstract
Description
성분 | mg/바이알* |
인터페론 알파-2b-PEG12000 | 0.1*** |
이염기 인산 나트륨 무수물 | 0.75 |
일염기 인산 나트륨 디하이드레이트 | 0.75 |
수크로즈 | 40 |
폴리소르베이트 80 | 0.05 |
주입용 물(q.s.ad) | 0.5ml** |
시간 | 온도 | 항바이러스성 평가 | 단백질 함량 | PEG-IFN 순도 | 개시(Descr.) | |||||
월 | ℃ | ×106IU/바이알* | %LS | ㎍/바이알* | 초기% | % 디-PEG-IFN | % 모노-PEG-IFN | %IFN | %기타 | |
초기 | 4.33 | 76 | 95.8 | 95.8 | 3.90 | 94.19 | 1.91 | CCS** | ||
1 | 5 | 6.60 | 115 | 95.6 | 95.6 | 3.70 | 94.20 | 2.10 | 0 | CCS |
25 | 7.50 | 131 | 96.4 | 96.4 | 3.84 | 93.76 | 2.40 | 0 | CCS | |
40 | 7.30 | 128 | 96.2 | 96.2 | 3.52 | 92.11 | 4.37 | 0 | CCS | |
3 | 5 | 6.60 | 116 | 97.1 | 97.1 | 3.48 | 94.27 | 2.25 | 0 | CCS |
25 | 6.55 | 115 | 98.0 | 98.0 | 3.47 | 93.82 | 2.72 | 0 | CCS | |
6 | 5 | 6.20 | 109 | 92.6 | 92.6 | 3.95 | 93.60 | 2.45 | 0 | CCS |
25 | 6.25 | 110 | 93.3 | 93.3 | 3.76 | 92.96 | 3.28 | 0 | CCS | |
9 | 5 | 6.85 | 120 | 94.1 | 94.1 | 3.59 | 94.02 | 2.39 | 0 | CCS |
25 | 5.75 | 101 | 96.1 | 96.1 | 3.69 | 92.91 | 3.40 | 0 | CCS |
Claims (23)
- PEG-인터페론 알파 결합체, 완충제, 안정화제, 한랭 보호제 및 용매를 포함하는 수성 조성물.
- 제1항에 있어서, 완충제가 인산 나트륨이고, 안정화제가 폴리(옥시-1,2-에탄에디일) 유도체이며, 한랭 보호제가 수크로즈이고, 용매가 물인 수성 조성물.
- 제2항에 있어서, 인산 나트륨이 이염기 인산 나트륨 무수물 및 일염기 인산 나트륨 디하이드레이트를 포함하는 수성 조성물.
- 제2항에 있어서, PEG-인터페론 알파 결합체의 농도는 인터페론 알파가 0.03 내지 2.0mg/ml이고, 인산 나트륨의 농도가 0.005 내지 0.1몰이며, 폴리(옥시-1,2-에탄에디일) 유도체의 농도가 0.01 내지 1.0mg/ml이고, 수크로즈의 농도가 20 내지 100mg/ml인 수성 조성물.
- 제3항에 있어서, PEG-인터페론 알파 결합체의 질량이 인터페론 알파 0.1mg이고, 이염기 인산 나트륨 무수물의 질량이 0.75mg이며, 일염기 인산 나트륨 디하이드레이트의 질량이 0.75mg이고, 수크로즈의 질량이 40mg이며, 폴리(옥시-1,2-에탄에디일) 유도체의 질량이 0.05mg이고, 물의 체적이 0.5ml인 수성 조성물.
- 제5항에 있어서, PEG-인터페론 알파 결합체가 하나의 인터페론 알파 분자에 하나의 PEG 분자가 결합한 결합체를 포함하는 수성 조성물.
- 제6항에 있어서, 인터페론 알파 분자가 인터페론 알파-2a, 인터페론 알파-2b, 인터페론 알파-2c 및 이와 상동적인 인터페론으로 이루어진 그룹중에서 선택되는 수성 조성물.
- 제7항에 있어서, 폴리에틸렌 글리콜(PEG)이 PEG12000인 수성 조성물.
- 제8항에 있어서, 인터페론 알파 분자가 인터페론 알파-2b인 수성 조성물.
- 제9항에 있어서, 인터페론 알파-2b 분자가 우레탄 결합을 통해 PEG12000분자에 결합된 수성 조성물.
- 제10항에 있어서, PEG-인터페론 알파 결합체가 위치 이성체의 혼합물을 포함하는 수성 조성물.
- 제11항에 있어서, 위치 이성체 중의 하나가 인터페론 알파-2b 분자상의 히스티딘 잔기에 PEG12000분자가 결합한 인터페론 알파-2b 분자를 포함하는 수성 조성물.
- 제12항에 따른 조성물을 동결 건조시켜 동결 건조 분산물을 제조하는 단계를 포함하는 동결 건조 방법.
- 제13항에 있어서, 동결 건조된 분산물을 물로 재구성하여 재구성된 용액을 제조하는 단계를 추가로 포함하는 동결 건조 방법.
- 제14항에 있어서, 물이 정균수를 포함하는 동결 건조 방법.
- 제12항의 조성물을 동결 건조하여 제조한 동결 건조 분산물.
- 제16항에 있어서, PEG-인터페론 알파 결합체 0.08 중량%(인터페론 알파의 중량으로 측정), 인산 나트륨 3.6 중량%, 폴리(옥시-1,2-에탄에디일) 유도체 0.12 중량%, 및 물 96.2 중량%를 포함하는 동결 건조 분산물.
- 유효량의 제16항에 따른 분산물을 포함하는 주사제 조성물.
- 제18항에 있어서, 분산물을 재구성하는 데에 사용하기 위한 일정 체적의 물을 추가로 포함하는 주사제 조성물.
- 제19항에 있어서, 물이 정균수를 포함하는 주사제 조성물.
- 유효량의 제16항에 따른 분산물을 포함하는 바이알 조성물.
- 제21항에 있어서, 분산물을 재구성하는 데에 사용하기 위한 일정 체적의 물을 추가로 포함하는 바이알 조성물.
- 제22항에 있어서, 물이 정균수를 포함하는 바이알 조성물.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US4890798A | 1998-03-26 | 1998-03-26 | |
US09/048,907 | 1998-03-26 |
Publications (2)
Publication Number | Publication Date |
---|---|
KR20010034654A true KR20010034654A (ko) | 2001-04-25 |
KR100420642B1 KR100420642B1 (ko) | 2004-03-02 |
Family
ID=21957085
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR10-2000-7010588A KR100420642B1 (ko) | 1998-03-26 | 1999-03-24 | Peg-인터페론 알파 결합체의 보호에 사용되는 제형 |
Country Status (26)
Country | Link |
---|---|
EP (1) | EP1066059B1 (ko) |
JP (3) | JP3643034B2 (ko) |
KR (1) | KR100420642B1 (ko) |
CN (1) | CN1191863C (ko) |
AR (1) | AR014772A1 (ko) |
AT (1) | ATE297761T1 (ko) |
AU (1) | AU754002B2 (ko) |
BR (1) | BR9909087A (ko) |
CA (1) | CA2324467C (ko) |
CO (1) | CO5080738A1 (ko) |
CZ (1) | CZ302005B6 (ko) |
DE (1) | DE69925820T2 (ko) |
ES (1) | ES2241272T3 (ko) |
HK (1) | HK1029754A1 (ko) |
HU (1) | HU228877B1 (ko) |
ID (1) | ID28470A (ko) |
IL (2) | IL138221A0 (ko) |
MY (1) | MY119227A (ko) |
NO (1) | NO329916B1 (ko) |
NZ (1) | NZ506631A (ko) |
PE (1) | PE20000338A1 (ko) |
PL (1) | PL193286B1 (ko) |
PT (1) | PT1066059E (ko) |
SK (1) | SK285284B6 (ko) |
TW (2) | TWI250024B (ko) |
WO (1) | WO1999048535A1 (ko) |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ATE297761T1 (de) * | 1998-03-26 | 2005-07-15 | Schering Corp | Zubereitungen zur stabilisierung von peg- interferon alpha konjugaten |
US6605273B2 (en) | 1999-04-08 | 2003-08-12 | Schering Corporation | Renal cell carcinoma treatment |
US6923966B2 (en) | 1999-04-08 | 2005-08-02 | Schering Corporation | Melanoma therapy |
CO5170412A1 (es) * | 1999-04-08 | 2002-06-27 | Schering Corp | Tratamiento del carcinoma de celula renal |
US6362162B1 (en) | 1999-04-08 | 2002-03-26 | Schering Corporation | CML Therapy |
EP1908477A3 (en) * | 2000-01-24 | 2008-06-11 | Schering Corporation | Combination of temozolomide and pegylated interferon-alpha for treating cancer |
JP2003520247A (ja) * | 2000-01-24 | 2003-07-02 | シェーリング コーポレイション | 癌を処置するためのテモゾロミドとペグ化インターフェロンαとの組み合せ |
KR100353392B1 (ko) * | 2000-03-13 | 2002-09-18 | 선바이오(주) | 높은 생체 활성도를 갖는 생체 활성 단백질과 peg의결합체 제조방법 |
CN100479862C (zh) | 2000-04-03 | 2009-04-22 | 参天制药株式会社 | 释放物质和采用该物质的药物释放*** |
ES2307905T3 (es) | 2002-02-22 | 2008-12-01 | Schering Corporation | Formulaciones farmaceuticas de agentes antineoplasicos, en particular temozolomida, procedimientos de obtencion y de uso. |
AU2008201682B2 (en) * | 2004-02-02 | 2011-02-24 | Ambrx, Inc. | Modified human interferon polypeptides and their uses |
CA2576549C (en) * | 2004-08-12 | 2011-01-18 | Schering Corporation | Stable pegylated interferon formulation |
EA201070773A1 (ru) | 2007-12-20 | 2010-12-30 | Мерк Сероно С. А. | Составы пэг-интерферона-бета |
KR101303388B1 (ko) * | 2010-10-26 | 2013-09-03 | 한미사이언스 주식회사 | 지속형 인터페론 알파 결합체의 액상 제제 |
KR20150074167A (ko) * | 2012-10-26 | 2015-07-01 | 루핀 리미티드 | Peg 인터페론 알파-2b의 안정한 약학 조성물 |
KR101736870B1 (ko) | 2014-08-20 | 2017-05-18 | 한국코러스 주식회사 | 인터페론 접합체를 포함하는 복합체 및 이의 제조방법 |
SI3463308T1 (sl) | 2016-06-01 | 2022-04-29 | Servier IP UK Limited | Formulacije polialkilenoksidne asparaginaze in postopki za pripravo in uporabo le-teh |
CN112358541B (zh) * | 2020-11-25 | 2022-04-01 | 广州迪澳医疗科技有限公司 | 一种重组人γ-干扰素的冻干保护剂 |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2024046A1 (en) * | 1989-09-28 | 1991-03-29 | Alberto Ferro | Stabilized leukocyte-interferons |
US5382657A (en) * | 1992-08-26 | 1995-01-17 | Hoffmann-La Roche Inc. | Peg-interferon conjugates |
PT730470E (pt) * | 1993-11-10 | 2002-08-30 | Enzon Inc | Conjugados melhorados de interferao-polimero |
US5766582A (en) * | 1994-10-11 | 1998-06-16 | Schering Corporation | Stable, aqueous alfa interferon solution formulations |
US5738846A (en) * | 1994-11-10 | 1998-04-14 | Enzon, Inc. | Interferon polymer conjugates and process for preparing the same |
JP2000510813A (ja) * | 1995-02-06 | 2000-08-22 | ジェネテイックス・インスティテュート・インコーポレイテッド | Il−12用処方 |
JP2758154B2 (ja) * | 1995-04-06 | 1998-05-28 | エフ・ホフマン−ラ ロシユ アーゲー | インターフェロンを含む液体製剤 |
EP1516628B1 (en) * | 1995-07-27 | 2013-08-21 | Genentech, Inc. | Stable isotonic lyophilized protein formulation |
CA2329474C (en) * | 1995-11-02 | 2002-02-26 | Schering Corporation | Continuous low-dose cytokine infusion therapy |
US5908621A (en) * | 1995-11-02 | 1999-06-01 | Schering Corporation | Polyethylene glycol modified interferon therapy |
TW517067B (en) * | 1996-05-31 | 2003-01-11 | Hoffmann La Roche | Interferon conjugates |
ATE297761T1 (de) * | 1998-03-26 | 2005-07-15 | Schering Corp | Zubereitungen zur stabilisierung von peg- interferon alpha konjugaten |
-
1999
- 1999-03-24 AT AT99913822T patent/ATE297761T1/de active
- 1999-03-24 EP EP99913822A patent/EP1066059B1/en not_active Expired - Lifetime
- 1999-03-24 NZ NZ506631A patent/NZ506631A/xx not_active IP Right Cessation
- 1999-03-24 ES ES99913822T patent/ES2241272T3/es not_active Expired - Lifetime
- 1999-03-24 ID IDW20001920A patent/ID28470A/id unknown
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