ES2180511T3 - Formulaciones monodispersas de analogos de insulina acilados hexamericos. - Google Patents

Formulaciones monodispersas de analogos de insulina acilados hexamericos.

Info

Publication number
ES2180511T3
ES2180511T3 ES00904496T ES00904496T ES2180511T3 ES 2180511 T3 ES2180511 T3 ES 2180511T3 ES 00904496 T ES00904496 T ES 00904496T ES 00904496 T ES00904496 T ES 00904496T ES 2180511 T3 ES2180511 T3 ES 2180511T3
Authority
ES
Spain
Prior art keywords
formulations
human insulin
modified
acylated
analog
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
ES00904496T
Other languages
English (en)
Inventor
Kingman Ng
Shun Li
Eric Alan Watts
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eli Lilly and Co
Original Assignee
Eli Lilly and Co
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 Eli Lilly and Co filed Critical Eli Lilly and Co
Application granted granted Critical
Publication of ES2180511T3 publication Critical patent/ES2180511T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • 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 farmacéutica adecuada para su administración a un paciente, que comprende: una solución acuosa con un pH mayor de aproximadamente 7, 9, comprendiendo la solución acuosa: a) un agente de isotonicidad; b) un derivado fenólico; c) iones de cinc; y d) un análogo de insulina humana monoacilado o una sal farmacéuticamente aceptable del análogo de insulina humana monoacilado, comprendiendo el análogo de insulina humana monoacilado o la sal farmacéuticamente aceptable del análogo de insulina humana monoacilado el polipéptido de la SEC ID NO:1 entrecruzado de manera apropiada con la SEC ID NO:2, en el que Xaa en la posición 21 de la SEC ID NO:1 se selecciona entre el grupo compuesto por Asn, Asp, Gly y Glx; Xaa en la posición 3 de la SEC ID NO:2 se selecciona entre el grupo compuesto por Asn, Asp y Glx; Xaa en la posición 28 de la SEC ID NO:2 se selecciona entre el grupo compuesto por Asp, Leu, Val, Ala y Lys acilada; y Xaa en la posición 29 de la SEC ID NO:2 se selecciona entre el grupo compuesto por Pro y Lys acilada; y además, en el que la posición 28 o la posición 29 es Lys acilada, y si la posición 28 es Lys acilada, la posición 29 no es Lys acilada, y si la posición 29 es Lys acilada, la posición 28 no es Lys acilada.
ES00904496T 1999-01-26 2000-01-26 Formulaciones monodispersas de analogos de insulina acilados hexamericos. Expired - Lifetime ES2180511T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US11729199P 1999-01-26 1999-01-26

Publications (1)

Publication Number Publication Date
ES2180511T3 true ES2180511T3 (es) 2003-02-16

Family

ID=22372048

Family Applications (1)

Application Number Title Priority Date Filing Date
ES00904496T Expired - Lifetime ES2180511T3 (es) 1999-01-26 2000-01-26 Formulaciones monodispersas de analogos de insulina acilados hexamericos.

Country Status (9)

Country Link
EP (1) EP1146896B1 (es)
JP (1) JP2002535287A (es)
AT (1) ATE220917T1 (es)
AU (1) AU2624400A (es)
DE (1) DE60000288T2 (es)
DK (1) DK1146896T3 (es)
ES (1) ES2180511T3 (es)
PT (1) PT1146896E (es)
WO (1) WO2000043034A2 (es)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7060675B2 (en) * 2001-02-15 2006-06-13 Nobex Corporation Methods of treating diabetes mellitus
US6835802B2 (en) 2001-06-04 2004-12-28 Nobex Corporation Methods of synthesizing substantially monodispersed mixtures of polymers having polyethylene glycol moieties
ES2360182T3 (es) * 2002-05-07 2011-06-01 Novo Nordisk A/S Formulaciones solubles que comprenden insulina monomérica e insulina acilada.
WO2003094951A1 (en) * 2002-05-07 2003-11-20 Novo Nordisk A/S Soluble formulations comprising insulin aspart and insulin detemir
DE60331584D1 (de) 2002-11-26 2010-04-15 Biocon Ltd Modifizierte natriuretic verbindungen, konjugate und ihre verwendungen
US7648962B2 (en) 2002-11-26 2010-01-19 Biocon Limited Natriuretic compounds, conjugates, and uses thereof
US7872095B2 (en) 2004-07-19 2011-01-18 Biocon Limited Insulin-oligomer conjugates, formulations and uses thereof
CN101389650B (zh) 2005-12-28 2012-10-10 诺沃-诺迪斯克有限公司 包含酰化胰岛素和锌的组合物以及制备所述组合物的方法
WO2008015099A2 (en) 2006-07-31 2008-02-07 Novo Nordisk A/S Pegylated, extended insulins
CN101541830A (zh) 2006-09-22 2009-09-23 诺沃-诺迪斯克有限公司 蛋白酶抗性的胰岛素类似物
EP2152245B1 (en) 2007-04-30 2015-12-02 Novo Nordisk A/S Method for drying a protein composition, a dried protein composition and a pharmaceutical composition comprising the dried protein
ES2744384T3 (es) 2007-06-13 2020-02-24 Novo Nordisk As Formulación farmacéutica que comprende un derivado de insulina
JP5762001B2 (ja) 2008-03-14 2015-08-12 ノボ・ノルデイスク・エー／エス プロテアーゼ安定化インスリンアナログ
US8691759B2 (en) 2008-03-18 2014-04-08 Novo Nordisk A/S Protease stabilized, acylated insulin analogues
BRPI0919946A2 (pt) 2008-10-30 2016-02-16 Novo Nordisk As tratamento de diabetes melito usando injeções de insulina com frequência de injeção menor que diariamente
DK2632478T3 (da) 2010-10-27 2019-10-07 Novo Nordisk As Behandling af diabetes melitus under anvendelse af insulinindsprøjtninger indgivet med varierende indsprøjtningsintervaller
BR112014025132A2 (pt) 2012-04-11 2017-07-11 Novo Nordisk As formulações de insulina
EA034393B1 (ru) 2012-11-13 2020-02-03 Адосиа Состав инсулина быстрого действия, содержащий замещенное анионное соединение
US10137172B2 (en) 2013-04-30 2018-11-27 Novo Nordisk A/S Administration regime
BR112016007166A2 (pt) 2013-10-07 2017-09-12 Novo Nordisk As derivado de um análogo de insulina
AR102869A1 (es) 2014-12-16 2017-03-29 Lilly Co Eli Composiciones de insulina de rápida acción
JO3749B1 (ar) 2015-08-27 2021-01-31 Lilly Co Eli تركيبات إنسولين سريعة المفعول
JP6690062B2 (ja) * 2016-12-16 2020-04-28 ノヴォ ノルディスク アー／エス インスリン含有医薬組成物
EA201992351A1 (ru) 2017-06-01 2020-03-26 Эли Лилли Энд Компани Быстродействующие композиции инсулина
PE20211264A1 (es) 2017-08-17 2021-07-15 Novo Nordisk As Analogos de insulina acilados novedosos y usos de estos
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
EP4013778A4 (en) * 2019-08-16 2023-09-13 Lamark Biotech PVT Limited FORMULATION OF INSULIN BASED ON CRYSTAL VACCINATION OF HYDROGELS AND METHOD THEREOF

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2182015C2 (ru) * 1996-06-20 2002-05-10 Ново Нордиск А/С ПРЕПАРАТ ИНСУЛИНА, СОДЕРЖАЩИЙ NaCl, ПАРЕНТЕРАЛЬНАЯ ГОТОВАЯ ФОРМА, СПОСОБ ПОВЫШЕНИЯ ХИМИЧЕСКОЙ СТАБИЛЬНОСТИ ПРЕПАРАТА ИНСУЛИНА
EP0966482B1 (en) * 1997-02-07 2005-04-27 Novo Nordisk A/S Crystallisation of proteins
DE69924232D1 (de) * 1998-01-09 2005-04-21 Novo Nordisk As Stabilisierte insulin-zubereitungen

Also Published As

Publication number Publication date
ATE220917T1 (de) 2002-08-15
WO2000043034A2 (en) 2000-07-27
DE60000288T2 (de) 2003-01-16
AU2624400A (en) 2000-08-07
DK1146896T3 (da) 2002-09-02
EP1146896A2 (en) 2001-10-24
EP1146896B1 (en) 2002-07-24
WO2000043034A3 (en) 2000-12-28
PT1146896E (pt) 2002-10-31
DE60000288D1 (de) 2002-08-29
JP2002535287A (ja) 2002-10-22

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