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
Links
- 239000000203 mixture Substances 0.000 title abstract 4
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical class N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 title 1
- PBGKTOXHQIOBKM-FHFVDXKLSA-N insulin (human) Chemical class C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@H]1CSSC[C@H]2C(=O)N[C@H](C(=O)N[C@@H](CO)C(=O)N[C@H](C(=O)N[C@H](C(N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3C=CC(O)=CC=3)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3NC=NC=3)NC(=O)[C@H](CO)NC(=O)CNC1=O)C(=O)NCC(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(O)=O)C(=O)N[C@@H](CC(N)=O)C(O)=O)=O)CSSC[C@@H](C(N2)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)[C@@H](C)CC)[C@@H](C)O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)CC=1C=CC=CC=1)C(C)C)C1=CN=CN1 PBGKTOXHQIOBKM-FHFVDXKLSA-N 0.000 abstract 4
- 238000009472 formulation Methods 0.000 abstract 3
- 239000007864 aqueous solution Substances 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- 101500025353 Homo sapiens Insulin A chain Proteins 0.000 abstract 1
- 101500025354 Homo sapiens Insulin B chain Proteins 0.000 abstract 1
- PTFCDOFLOPIGGS-UHFFFAOYSA-N Zinc dication Chemical compound [Zn+2] PTFCDOFLOPIGGS-UHFFFAOYSA-N 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 125000005313 fatty acid group Chemical group 0.000 abstract 1
- 201000001421 hyperglycemia Diseases 0.000 abstract 1
- 125000003588 lysine group Chemical group [H]N([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])(N([H])[H])C(*)=O 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N phenol group Chemical group C1(=CC=CC=C1)O ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 abstract 1
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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Emergency Medicine (AREA)
- Hematology (AREA)
- Inorganic Chemistry (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Endocrinology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Obesity (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
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.
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) |
Families Citing this family (30)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7169889B1 (en) | 1999-06-19 | 2007-01-30 | Biocon Limited | Insulin prodrugs hydrolyzable in vivo to yield peglylated insulin |
| 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 |
| EP1506003A1 (en) * | 2002-05-07 | 2005-02-16 | Novo Nordisk A/S | Soluble formulations comprising insulin aspart and insulin detemir |
| JP5599543B2 (ja) | 2002-05-07 | 2014-10-01 | ノヴォ ノルディスク アー／エス | 単量体インスリン及びアシル化インスリンを含む可溶性製剤 |
| AU2003297583B2 (en) | 2002-11-26 | 2010-01-14 | Biocon, Ltd | Modified naturetic compounds, conjugates, and uses thereof |
| US7648962B2 (en) | 2002-11-26 | 2010-01-19 | Biocon Limited | Natriuretic compounds, conjugates, and uses thereof |
| BRPI0513508B1 (pt) * | 2004-07-19 | 2021-06-01 | Biocon Limited | Conjugados de insulina-oligômero, formulações e usos desses |
| JP4808785B2 (ja) | 2005-12-28 | 2011-11-02 | ノボ・ノルデイスク・エー／エス | インスリン組成物および組成物の製造方法 |
| ES2542146T3 (es) | 2006-07-31 | 2015-07-31 | Novo Nordisk A/S | Insulinas extendidas PEGiladas. |
| DK2074141T3 (en) | 2006-09-22 | 2016-11-28 | Novo Nordisk As | The protease resistant insulin analogues. |
| US9387176B2 (en) | 2007-04-30 | 2016-07-12 | Novo Nordisk A/S | Method for drying a protein composition, a dried protein composition and a pharmaceutical composition comprising the dried protein |
| US9034818B2 (en) | 2007-06-13 | 2015-05-19 | Novo Nordisk A/S | Pharmaceutical formulations comprising an insulin derivative |
| WO2009112583A2 (en) | 2008-03-14 | 2009-09-17 | Novo Nordisk A/S | Protease-stabilized insulin analogues |
| CN102037008B (zh) | 2008-03-18 | 2016-08-31 | 诺沃-诺迪斯克有限公司 | 蛋白酶稳定化的、酰化胰岛素类似物 |
| AU2009309623B9 (en) | 2008-10-30 | 2014-10-02 | Novo Nordisk A/S | Treating diabetes melitus using insulin injections with less than daily injection frequency |
| DK2632478T3 (da) | 2010-10-27 | 2019-10-07 | Novo Nordisk As | Behandling af diabetes melitus under anvendelse af insulinindsprøjtninger indgivet med varierende indsprøjtningsintervaller |
| US9481721B2 (en) | 2012-04-11 | 2016-11-01 | Novo Nordisk A/S | Insulin formulations |
| EP2919804B1 (fr) | 2012-11-13 | 2018-01-31 | Adocia | Formulation à action rapide d'insuline comprenant un composé anionique substitué |
| JP2016519127A (ja) | 2013-04-30 | 2016-06-30 | ノヴォ ノルディスク アー／エス | 新規投与レジメン |
| AU2014333979B2 (en) | 2013-10-07 | 2018-02-15 | Novo Nordisk A/S | Novel derivative of an insulin analogue |
| 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 |
| TWI700091B (zh) * | 2016-12-16 | 2020-08-01 | 丹麥商諾佛 儂迪克股份有限公司 | 含胰島素醫藥組成物 |
| KR20190140048A (ko) | 2017-06-01 | 2019-12-18 | 일라이 릴리 앤드 캄파니 | 신속-작용 인슐린 조성물 |
| CN111032685A (zh) | 2017-08-17 | 2020-04-17 | 诺沃挪第克公司 | 新型酰化胰岛素类似物及其用途 |
| US10335464B1 (en) | 2018-06-26 | 2019-07-02 | Novo Nordisk A/S | Device for titrating basal insulin |
| US12343383B2 (en) | 2019-07-12 | 2025-07-01 | Novo Nordisk A/S | High concentration insulin formulation |
| US20220289811A1 (en) * | 2019-08-16 | 2022-09-15 | Lamark Biotech Pvt Limited | A formulation of insulin based on crystal-seeding in hydrogels and method thereof |
| WO2025061146A1 (zh) * | 2023-09-20 | 2025-03-27 | 上海迈晋生物医药科技有限公司 | 一种人胰岛素类似物融合蛋白的药物组合物及其医药用途 |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ATE208208T1 (de) * | 1996-06-20 | 2001-11-15 | Novo Nordisk As | Halogenid-enthaltende insulinzubereitungen |
| ES2242270T3 (es) * | 1997-02-07 | 2005-11-01 | Novo Nordisk A/S | Cristalizacion de proteinas. |
| EP1044016B1 (en) * | 1998-01-09 | 2005-03-16 | Novo Nordisk A/S | Stabilised insulin compositions |
-
2000
- 2000-01-26 ES ES00904496T patent/ES2180511T3/es not_active Expired - Lifetime
- 2000-01-26 WO PCT/US2000/001627 patent/WO2000043034A2/en not_active Ceased
- 2000-01-26 PT PT00904496T patent/PT1146896E/pt unknown
- 2000-01-26 DK DK00904496T patent/DK1146896T3/da active
- 2000-01-26 EP EP00904496A patent/EP1146896B1/en not_active Expired - Lifetime
- 2000-01-26 JP JP2000594487A patent/JP2002535287A/ja not_active Withdrawn
- 2000-01-26 AU AU26244/00A patent/AU2624400A/en not_active Abandoned
- 2000-01-26 AT AT00904496T patent/ATE220917T1/de not_active IP Right Cessation
- 2000-01-26 DE DE60000288T patent/DE60000288T2/de not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| AU2624400A (en) | 2000-08-07 |
| EP1146896B1 (en) | 2002-07-24 |
| DE60000288T2 (de) | 2003-01-16 |
| ATE220917T1 (de) | 2002-08-15 |
| DE60000288D1 (de) | 2002-08-29 |
| WO2000043034A2 (en) | 2000-07-27 |
| DK1146896T3 (da) | 2002-09-02 |
| EP1146896A2 (en) | 2001-10-24 |
| WO2000043034A3 (en) | 2000-12-28 |
| JP2002535287A (ja) | 2002-10-22 |
| PT1146896E (pt) | 2002-10-31 |
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