CO4750643A1 - Formulacion estable de la insulina que contiene l-arginina y protamina - Google Patents

Formulacion estable de la insulina que contiene l-arginina y protamina

Info

Publication number
CO4750643A1
CO4750643A1 CO98030641A CO98030641A CO4750643A1 CO 4750643 A1 CO4750643 A1 CO 4750643A1 CO 98030641 A CO98030641 A CO 98030641A CO 98030641 A CO98030641 A CO 98030641A CO 4750643 A1 CO4750643 A1 CO 4750643A1
Authority
CO
Colombia
Prior art keywords
human insulin
lis
group
arginin
protamine
Prior art date
Application number
CO98030641A
Other languages
English (en)
Inventor
Michael Rosario Defelippis
Michael Allen Dobbins
Bruce Hill Frank
Nmn Li Shun
Dawn Marie Rebhun
Original Assignee
Lilly Co Eli
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 Lilly Co Eli filed Critical Lilly Co Eli
Publication of CO4750643A1 publication Critical patent/CO4750643A1/es

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
    • A61K38/28—Insulins
    • 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
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino 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
    • A61K47/16—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Abstract

Una formulación en solución que comprende: un buffer fisiológicamente tolerado seleccionado del grupo conformado por TRIS y L-arginina; y un complejo hexamérico de un análogo monomérico de la insulina que comprende: a) seis moléculas de un análogo de la insulina humana, en donde el análogo de la insulina humana se selecciona del grupo conformado por: (i) insulina humana insulina en donde la Pro en la posición B28 se encuentra sustituida por Asp, Lis, Leu, Val, ó Ala, y la Lis en la posición B29 es Lis ó Pro, (ii) insulina humana AlaB26, (iii) insulina humana des (B28-B30), y (iv) insulina humana des (B27); b) dos iones de zinc; y c) por lo menos tres moléculas de un preservativo fenólico seleccionado del grupo conformado por: (i) clorocresol, (ii) m-cresol, (iii) fenol, y (iv) mezcla de clorocresol, m-cresol, y fenol.
CO98030641A 1997-06-13 1998-06-01 Formulacion estable de la insulina que contiene l-arginina y protamina CO4750643A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US5308997P 1997-06-13 1997-06-13

Publications (1)

Publication Number Publication Date
CO4750643A1 true CO4750643A1 (es) 1999-03-31

Family

ID=21981869

Family Applications (1)

Application Number Title Priority Date Filing Date
CO98030641A CO4750643A1 (es) 1997-06-13 1998-06-01 Formulacion estable de la insulina que contiene l-arginina y protamina

Country Status (31)

Country Link
US (3) US6034054A (es)
EP (1) EP0884053B1 (es)
JP (1) JP2002504908A (es)
KR (1) KR100597500B1 (es)
CN (1) CN1293916C (es)
AR (1) AR012894A1 (es)
AT (2) ATE226088T1 (es)
AU (1) AU734781B2 (es)
BR (1) BR9810116B1 (es)
CA (1) CA2295140C (es)
CO (1) CO4750643A1 (es)
CZ (1) CZ299637B6 (es)
DE (2) DE69808695T2 (es)
DK (1) DK0884053T3 (es)
EA (1) EA002880B1 (es)
ES (2) ES2185113T3 (es)
HK (1) HK1030747A1 (es)
HU (1) HUP0002877A3 (es)
ID (1) ID24310A (es)
IL (1) IL133348A0 (es)
NO (1) NO996131L (es)
NZ (1) NZ501382A (es)
PE (1) PE79099A1 (es)
PL (1) PL194244B1 (es)
PT (2) PT884053E (es)
SV (1) SV1998000065A (es)
TR (1) TR199903036T2 (es)
TW (1) TW577753B (es)
UA (1) UA61109C2 (es)
WO (1) WO1998056406A1 (es)
ZA (1) ZA984697B (es)

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