CY1108418T1 - Φαρμακευτικες συνθεσεις της ερυθροποιητινης - Google Patents

Φαρμακευτικες συνθεσεις της ερυθροποιητινης

Info

Publication number
CY1108418T1
CY1108418T1 CY20081101147T CY081101147T CY1108418T1 CY 1108418 T1 CY1108418 T1 CY 1108418T1 CY 20081101147 T CY20081101147 T CY 20081101147T CY 081101147 T CY081101147 T CY 081101147T CY 1108418 T1 CY1108418 T1 CY 1108418T1
Authority
CY
Cyprus
Prior art keywords
pharmaceutical compositions
erythropoietin
amount
amino acid
present
Prior art date
Application number
CY20081101147T
Other languages
English (en)
Inventor
Wing K Cheung
Jaya Natarajan
Marilyn Sanders
Els Vercamen
Basant Sharma
Selima Begun
Original Assignee
Ortho-Mcneil Pharmaceutical, Inc.
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.)
Filing date
Publication date
Application filed by Ortho-Mcneil Pharmaceutical, Inc. filed Critical Ortho-Mcneil Pharmaceutical, Inc.
Publication of CY1108418T1 publication Critical patent/CY1108418T1/el

Links

Classifications

    • 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
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1816—Erythropoietin [EPO]
    • 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
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Diabetes (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Η παρούσα εφεύρεση παρέχει υδατικές φαρμακευτικές συνθέσεις ερυθροποιητίνης οι οποίες είναι απαλλαγμένες από προϊόντα ανθρώπινου ορού του αίματος, σταθεροποιημένες με μία ποσότητα ενός αμινοξέως και ενός παραγώγου πολυ(οξυ-1,2-αιθανιοδιυλ) μονο-9-δεκαοκτενοϊκής σορβιτάνης. Η παρούσα εφεύρεση παρέχει επίσης υδατικές σταθερές, συντηρούμενες φαρμακευτικές συνθέσεις της ερυθροποιητίνης οι οποίες περιέχουν μία αντιμικροβιακή ποσότητα κρεσόλης και μία ποσότητα ενός αμινοξέως.
CY20081101147T 1999-04-09 2008-10-16 Φαρμακευτικες συνθεσεις της ερυθροποιητινης CY1108418T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12859699P 1999-04-09 1999-04-09
EP00921929A EP1181036B1 (en) 1999-04-09 2000-04-07 Pharmaceutical compositions of erythropoietin

Publications (1)

Publication Number Publication Date
CY1108418T1 true CY1108418T1 (el) 2014-04-09

Family

ID=22436082

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20081101147T CY1108418T1 (el) 1999-04-09 2008-10-16 Φαρμακευτικες συνθεσεις της ερυθροποιητινης

Country Status (27)

Country Link
US (2) US6696056B1 (el)
EP (1) EP1181036B1 (el)
JP (1) JP2002541208A (el)
KR (1) KR100740794B1 (el)
CN (1) CN1165339C (el)
AR (1) AR029623A1 (el)
AT (1) ATE401908T1 (el)
AU (1) AU775041B2 (el)
BG (1) BG106046A (el)
BR (1) BR0010665A (el)
CA (1) CA2369444C (el)
CY (1) CY1108418T1 (el)
DE (1) DE60039598D1 (el)
DK (1) DK1181036T3 (el)
ES (1) ES2308978T3 (el)
HK (1) HK1041445B (el)
HU (1) HUP0201068A3 (el)
IL (1) IL145816A0 (el)
MX (1) MXPA01010208A (el)
NO (1) NO20014893L (el)
NZ (1) NZ515380A (el)
PL (1) PL203797B1 (el)
PT (1) PT1181036E (el)
RU (1) RU2225221C2 (el)
TR (1) TR200103788T2 (el)
WO (1) WO2000061169A1 (el)
ZA (1) ZA200109236B (el)

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ES2308978T3 (es) * 1999-04-09 2008-12-16 Ortho-Mcneil Pharmaceutical, Inc. Composicion farmaceutica de eritropoyetina.
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ATE291436T2 (de) * 2000-05-15 2005-04-15 Hoffmann La Roche Flüssige arzneizubereitung enthaltend ein erythropoietin derivat
US6818613B2 (en) 2001-11-07 2004-11-16 Ortho-Mcneil Pharmaceutical, Inc. Aqueous sustained-release formulations of proteins
KR100610003B1 (ko) * 2003-06-10 2006-08-08 주식회사 엘지생명과학 혈청 알부민을 함유하지 않는 안정한 인 에리쓰로포이에틴용액 제형
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
CA2539023A1 (en) * 2003-09-23 2005-04-14 Alcon Inc. Triamcinolone acetonide and anecortave acetate formulations for injection
US7141544B2 (en) * 2003-10-10 2006-11-28 Baxter International, Inc. Stabilization of pharmaceutical protein formulations with small peptides
DE102004011663B4 (de) * 2004-03-10 2006-04-27 Bioceuticals Arzneimittel Ag Erythropoietin-Flüssigformulierung
US7588745B2 (en) * 2004-04-13 2009-09-15 Si Options, Llc Silicon-containing products
US20050255112A1 (en) * 2004-05-17 2005-11-17 Lee Jong Y Compositions and methods for preventing erythropoietin-associated hypertension
JP2008513356A (ja) * 2004-08-09 2008-05-01 アリオス バイオファーマ インク． 合成高度糖鎖付加プロテアーゼ耐性ポリペプチド変異体、それを使用する経口製剤および方法
US7597884B2 (en) * 2004-08-09 2009-10-06 Alios Biopharma, Inc. Hyperglycosylated polypeptide variants and methods of use
BRPI0611901A2 (pt) 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
CA2915270C (en) * 2005-08-05 2017-07-11 Amgen Inc. Stable aqueous protein or antibody pharmaceutical formulations and their preparation
CN101015684B (zh) * 2006-02-10 2011-08-24 华北制药集团新药研究开发有限责任公司 一种重组人红细胞生成素溶液制剂
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TWI698253B (zh) 2012-09-07 2020-07-11 美商柯赫勒斯生物科學有限公司 阿達木單抗（ａｄａｌｉｍｕｍａｂ）之穩定水性調配物
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
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AU2018281334A1 (en) * 2017-06-06 2019-12-19 Kindred Biosciences, Inc. Erythropoietin and analogs for veterinary use
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Also Published As

Publication number Publication date
US20040248797A1 (en) 2004-12-09
ES2308978T3 (es) 2008-12-16
JP2002541208A (ja) 2002-12-03
NO20014893L (no) 2001-11-15
HUP0201068A2 (en) 2002-08-28
RU2225221C2 (ru) 2004-03-10
AU775041B2 (en) 2004-07-15
CN1165339C (zh) 2004-09-08
HK1041445B (zh) 2009-07-03
PL351837A1 (en) 2003-06-16
EP1181036A4 (en) 2004-04-21
CN1354669A (zh) 2002-06-19
CA2369444A1 (en) 2000-10-19
EP1181036A1 (en) 2002-02-27
ZA200109236B (en) 2003-12-08
DE60039598D1 (de) 2008-09-04
NZ515380A (en) 2003-10-31
MXPA01010208A (es) 2003-07-21
PL203797B1 (pl) 2009-11-30
IL145816A0 (en) 2002-07-25
HUP0201068A3 (en) 2002-10-28
TR200103788T2 (tr) 2002-05-21
HK1041445A1 (en) 2002-07-12
PT1181036E (pt) 2008-10-03
BG106046A (en) 2002-05-31
KR20020016770A (ko) 2002-03-06
BR0010665A (pt) 2004-03-09
ATE401908T1 (de) 2008-08-15
DK1181036T3 (da) 2008-11-24
AR029623A1 (es) 2003-07-10
AU4218600A (en) 2000-11-14
WO2000061169A1 (en) 2000-10-19
KR100740794B1 (ko) 2007-07-20
EP1181036B1 (en) 2008-07-23
CA2369444C (en) 2009-08-18
NO20014893D0 (no) 2001-10-08
US6696056B1 (en) 2004-02-24

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