AR030276A1 - Preparacion sustancialmente homogenea de proteina estimuladora de eritropoyetina (nesp) modificada quimicamente, composicion farmaceutica y uso para la fabricacion de un medicamento para tratar un desorden hematopoyetico - Google Patents

Preparacion sustancialmente homogenea de proteina estimuladora de eritropoyetina (nesp) modificada quimicamente, composicion farmaceutica y uso para la fabricacion de un medicamento para tratar un desorden hematopoyetico

Info

Publication number
AR030276A1
AR030276A1 ARP010101644A ARP010101644A AR030276A1 AR 030276 A1 AR030276 A1 AR 030276A1 AR P010101644 A ARP010101644 A AR P010101644A AR P010101644 A ARP010101644 A AR P010101644A AR 030276 A1 AR030276 A1 AR 030276A1
Authority
AR
Argentina
Prior art keywords
nesp
pegylated
mono
preparation
pharmaceutical composition
Prior art date
Application number
ARP010101644A
Other languages
English (en)
Inventor
Olaf B Kinstler
Colin V Gegg
Aimee Freeman
Thomas Charles Boone
Original Assignee
Amgen 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 Amgen Inc filed Critical Amgen Inc
Publication of AR030276A1 publication Critical patent/AR030276A1/es

Links

Classifications

    • 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
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • 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
    • 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
    • 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

Abstract

Una preparacion sustancialmente homogénea de NESP modificada químicamente, optativamente en un diluyente, portador o auxiliar farmacéuticamente aceptable. La NESP es modificada químicamente con una sustancia química seleccionada del grupo formado por dextrano, poli(n-vinil pirrolidona), glicoles polietilénicos, homopolímeros de glicol propilénico, copolímeros de oxido de polipropileno/oxido de etileno, polioles polioxietilados y alcoholes polivinílicos. Una composicion farmacéutica que comprende: (a) una preparacion sustancialmente homogénea de NESP mono-PEGilada, consistiendo dicha NESP mono PEGilada en una fraccion de glicol polietilénico conectada a una fraccion NESP: i) solamente en su término N. ii) a través de aldehidos generados en dichas cadenas, de carbohidrato de la NESP, o iii) usando química metoxi-PEG-NHS, (b) menos de 5% en moléculas de NESP no pegiladas; y (c) un diluyente auxiliar o portador farmacéuticamente aceptable. Una composicion farmacéutica que comprende: (a) una preparacion sustancialmente homogénea de NESP mono-PEGilada que comprendiendo dicha NESP mono-PEGilada una poblacion de mixta de NESP mono-PEGilada y NESP poli-PEGilada; (b) menos de 5% de moléculas de NESP no pegiladas; y (c) un diluyente, auxiliar o portador farmacéuticamente aceptable. Uso de dicha preparacion para la fabricacion de un medicamento para tratar un desorden hematopoyético.
ARP010101644A 2000-04-07 2001-04-06 Preparacion sustancialmente homogenea de proteina estimuladora de eritropoyetina (nesp) modificada quimicamente, composicion farmaceutica y uso para la fabricacion de un medicamento para tratar un desorden hematopoyetico AR030276A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US09/545,335 US6586398B1 (en) 2000-04-07 2000-04-07 Chemically modified novel erythropoietin stimulating protein compositions and methods

Publications (1)

Publication Number Publication Date
AR030276A1 true AR030276A1 (es) 2003-08-20

Family

ID=24175806

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP010101644A AR030276A1 (es) 2000-04-07 2001-04-06 Preparacion sustancialmente homogenea de proteina estimuladora de eritropoyetina (nesp) modificada quimicamente, composicion farmaceutica y uso para la fabricacion de un medicamento para tratar un desorden hematopoyetico

Country Status (11)

Country Link
US (3) US6586398B1 (es)
EP (1) EP1267942B1 (es)
JP (1) JP5334347B2 (es)
AR (1) AR030276A1 (es)
AT (1) ATE510555T1 (es)
AU (2) AU2001255256B2 (es)
CA (1) CA2405716C (es)
ES (1) ES2365000T3 (es)
MX (1) MXPA02009896A (es)
TW (1) TWI315988B (es)
WO (1) WO2001076640A2 (es)

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US7262166B2 (en) 2007-08-28
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AU2001255256B2 (en) 2006-04-13
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