[go: up one dir, main page]

DK1687019T3 - Propylengykol peptidformuleringer som er optimale til produktion og anvendelse i injektionsanordninger - Google Patents

Propylengykol peptidformuleringer som er optimale til produktion og anvendelse i injektionsanordninger Download PDF

Info

Publication number
DK1687019T3
DK1687019T3 DK04797453.0T DK04797453T DK1687019T3 DK 1687019 T3 DK1687019 T3 DK 1687019T3 DK 04797453 T DK04797453 T DK 04797453T DK 1687019 T3 DK1687019 T3 DK 1687019T3
Authority
DK
Denmark
Prior art keywords
formulation
formulations
propylene glycol
concentration
peptide
Prior art date
Application number
DK04797453.0T
Other languages
English (en)
Inventor
Claude Bonde
Dorthe Kot Engelund
Tina Bjeldskov Pedersen
Original Assignee
Novo Nordisk As
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34609967&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK1687019(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novo Nordisk As filed Critical Novo Nordisk As
Application granted granted Critical
Publication of DK1687019T3 publication Critical patent/DK1687019T3/da

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
    • A61K47/08—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
    • 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
    • A61K38/26—Glucagons
    • 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
    • A61K47/06—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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
    • A61K47/26—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
    • 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
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • 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
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • 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
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin

Landscapes

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

Claims (17)

  1. Pateetkrav
    1. Farmaceutisk formulering omfattende peptidet Argj4, Lys26(Ns(y-Glu(N“-hexadecanoyl)))-GLP~ 1(7-37) og propylenglykol, hvor nævnte propylenglykol er til stede i nævnte formulering i en slutkoncentration fra 1 mg/ml til 100 mg/ml, og hvor nævnte formulering har en pH fra 7,0 til 10,0.
  2. 2. Formulering ifølge krav 1, hvor nævnte formulering er egnet til parenteral administration udført ved subkutan, intramuskulær eller intravenøs injektion ved hjælp af en sprøjte, eventuelt en pen-lignende sprøjte.
  3. 3. Formulering ifølge et hvilket som helst af de foregående krav, hvor koncentrationen af propylenglykol er fra 1 mg/ml til 50 mg/ml.
  4. 4. Formulering ifølge et hvilket som helst af de foregående krav, hvor koncentrationen af propylenglykol er fra 5 mg/ml til 25 mg/ml.
  5. 5. Formulering ifølge et hvilket som helst af de foregående krav, hvor koncentrationen af propylenglykol er fra 8 mg/ml til 16 mg/ml.
  6. 6. Formulering ifølge et hvilket som helst af de foregående krav, hvor nævnte formulerings pH er 7,0 til 9,5.
  7. 7. Formulering ifølge et hvilket som helst af de foregående krav, hvor nævnte peptid består af Arg34, Lys26(N£(rGlu(N“-hexadecanoyl)))-GLP- l (7-37).
  8. 8. Formulering ifølge krav 7, hvor nævnte formulerings pH er 7,0 til 8,3.
  9. 9. Formulering ifølge krav 8, hvor nævnte formulerings pH er 7,3 til 8,3.
  10. 10. Formulering ifølge krav 9, hvor nævnte formulerings pH er 8,0 til 8,3.
  11. 11. Formulering ifølge et hvilket som helst af de foregående krav, yderligere omfattende et konserveringsmiddel.
  12. 12. Formulering ifølge krav 11, hvor nævnte konserveringsmiddel er til stede i en koncentration fra 0,1 mg/ml til 20 mg/ml.
  13. 13. Formulering ifølge krav 11 eller 12, hvor nævnte konserveringsmiddelet er phenol.
  14. 14. Formulering ifølge et hvilket som helst af de foregående krav, yderligere omfattende en buffer.
  15. 15. Formulering ifølge krav 14, hvor nævnte buffer er udvalgt blandt gruppen bestående af glycylglycin, natriumdihydrogenfosfat, dinatriumhydrogenfosfat, natriumfosfat eller blandinger deraf.
  16. 16. Formulering ifølge krav 14, hvor nævnte buffer er dinatriumfosfatdihydrat.
  17. 17. Formulering ifølge et hvilket som helst af de foregående krav, hvor koncentrationen af Arg34, Lys26(NE(y-Glu(Na-hexadecanoyl)))-GLP-l (7-37) er fra 0,1 mg/ml til 50 mg/ml eller fra 0,1 mg/ml til 10 mg/ml.
DK04797453.0T 2003-11-20 2004-11-18 Propylengykol peptidformuleringer som er optimale til produktion og anvendelse i injektionsanordninger DK1687019T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200301719 2003-11-20
PCT/DK2004/000792 WO2005049061A2 (en) 2003-11-20 2004-11-18 Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices

Publications (1)

Publication Number Publication Date
DK1687019T3 true DK1687019T3 (da) 2018-02-12

Family

ID=34609967

Family Applications (2)

Application Number Title Priority Date Filing Date
DK04797453.0T DK1687019T3 (da) 2003-11-20 2004-11-18 Propylengykol peptidformuleringer som er optimale til produktion og anvendelse i injektionsanordninger
DK17196501.5T DK3300721T4 (da) 2003-11-20 2004-11-18 Propylenglycol-holdige peptidformuleringer hvilke er optimale til fremstilling og til anvendelse i injektionsindretninger

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK17196501.5T DK3300721T4 (da) 2003-11-20 2004-11-18 Propylenglycol-holdige peptidformuleringer hvilke er optimale til fremstilling og til anvendelse i injektionsindretninger

Country Status (20)

Country Link
US (5) US8114833B2 (da)
EP (3) EP3300721B2 (da)
JP (2) JP5558655B2 (da)
KR (1) KR101243648B1 (da)
CN (4) CN104826116A (da)
AU (1) AU2004290862B2 (da)
BR (1) BRPI0416743A (da)
CA (1) CA2545034C (da)
CY (1) CY1119723T1 (da)
DK (2) DK1687019T3 (da)
ES (2) ES2727854T5 (da)
FI (1) FI3300721T4 (da)
HK (1) HK1246683B (da)
HU (2) HUE043210T2 (da)
MX (1) MXPA06005581A (da)
PL (2) PL1687019T3 (da)
PT (2) PT3300721T (da)
SI (2) SI3300721T2 (da)
TR (1) TR201906789T4 (da)
WO (1) WO2005049061A2 (da)

Families Citing this family (78)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT1412384E (pt) * 2001-06-28 2008-03-28 Novo Nordisk As Formulação estável de glp-1 modificado
EP3300721B2 (en) * 2003-11-20 2025-01-08 Novo Nordisk A/S Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
US9018161B2 (en) 2006-09-22 2015-04-28 Novo Nordisk A/S 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
EP2514406A1 (en) * 2007-06-01 2012-10-24 Novo Nordisk A/S Spontaneously dispersible preconcentrates including a peptide drug in a solid or semisolid carrier
AU2008257505B2 (en) * 2007-06-01 2013-05-16 Novo Nordisk A/S Stable non-aqueous pharmaceutical compositions
ES2618073T3 (es) 2008-03-14 2017-06-20 Novo Nordisk A/S Análogos de insulina estabilizados frente a proteasas
HUE032284T2 (en) 2008-03-18 2017-09-28 Novo Nordisk As Protease-stabilized, acylated insulin analogues
EP2111871A1 (de) * 2008-04-26 2009-10-28 Sandoz AG Stabilisierte Flüssigformulierung
US8031419B2 (en) 2009-07-28 2011-10-04 Hong Kong Applied Science and Technology Research Institute, Co., Ltd. Compact imaging device
US9610329B2 (en) * 2009-10-22 2017-04-04 Albireo Pharma, Inc. Stabilized glucagon solutions
US20110097386A1 (en) * 2009-10-22 2011-04-28 Biodel, Inc. Stabilized glucagon solutions
KR101530942B1 (ko) 2010-03-18 2015-06-23 이노파르마, 인코포레이티드 안정한 보르테조밉 포뮬레이션
US8263578B2 (en) 2010-03-18 2012-09-11 Innopharma, Inc. Stable bortezomib formulations
RS56998B1 (sr) 2010-12-16 2018-05-31 Novo Nordisk As Čvrste kompozicije koje sadrže agonist glp-1 i so n-(8-(2-hidroksibenzoil)amino)kaprilne kiseline
EP2696687B1 (en) 2011-04-12 2016-10-26 Novo Nordisk A/S Double-acylated glp-1 derivatives
RU2578460C2 (ru) * 2011-08-10 2016-03-27 Адосиа Приемлемый для инъекций раствор по меньшей мере одного базального инсулина
CN104203266B (zh) 2012-03-22 2017-12-26 诺和诺德股份有限公司 Glp‑1肽组合物及其制备
EP2836508B1 (en) 2012-04-11 2016-06-29 Novo Nordisk A/S Insulin formulations
CN104487056A (zh) 2012-06-20 2015-04-01 诺和诺德A/S（股份有限公司） 包含肽和递送剂的片剂制剂
MX366405B (es) 2012-07-01 2019-07-08 Novo Nordisk As Uso de peptidos glp-1 de accion prolongada.
UA116217C2 (uk) 2012-10-09 2018-02-26 Санофі Пептидна сполука як подвійний агоніст рецепторів glp1-1 та глюкагону
LT2934567T (lt) 2012-12-21 2018-09-10 Sanofi Eksendino-4 dariniai kaip dvigubi glp1/gip arba trigubi glp1/gip/gliukagono agonistai
CN103893744B (zh) * 2012-12-24 2017-12-19 杭州九源基因工程有限公司 一种治疗糖尿病的药物制剂及其制备方法
TWI641381B (zh) * 2013-02-04 2018-11-21 法商賽諾菲公司 胰島素類似物及／或胰島素衍生物之穩定化醫藥調配物
BR112015026325A2 (pt) 2013-05-02 2017-07-25 Novo Nordisk As dosagem oral de compostos glp-1
WO2014209886A1 (en) 2013-06-23 2014-12-31 Wisconsin Alumni Research Foundation Alpha/beta-polypeptide analogs of glucagon-like peptid-1
CN104415326A (zh) * 2013-08-28 2015-03-18 深圳翰宇药业股份有限公司 一种含有利拉鲁肽的药物制剂组合物及其制备方法
JP6499184B2 (ja) 2013-10-07 2019-04-10 ノヴォ ノルディスク アー／エス インスリン類似体の新規な誘導体
WO2015086730A1 (en) 2013-12-13 2015-06-18 Sanofi Non-acylated exendin-4 peptide analogues
EP3080154B1 (en) 2013-12-13 2018-02-07 Sanofi Dual glp-1/gip receptor agonists
EP3080150B1 (en) 2013-12-13 2018-08-01 Sanofi Exendin-4 peptide analogues as dual glp-1/gip receptor agonists
TW201609797A (zh) 2013-12-13 2016-03-16 賽諾菲公司 雙重ｇｌｐ－１／升糖素受體促效劑
EP3091995B1 (en) 2014-01-09 2024-03-20 Sanofi Stabilized pharmaceutical formulations of insulin aspart
TW201625668A (zh) 2014-04-07 2016-07-16 賽諾菲公司 作為胜肽性雙重ｇｌｐ－１／昇糖素受體激動劑之艾塞那肽－４衍生物
TW201625669A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自艾塞那肽－４（Ｅｘｅｎｄｉｎ－４）之肽類雙重ＧＬＰ－１／升糖素受體促效劑
TW201625670A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自ｅｘｅｎｄｉｎ－４之雙重ｇｌｐ－１／升糖素受體促效劑
US9932381B2 (en) 2014-06-18 2018-04-03 Sanofi Exendin-4 derivatives as selective glucagon receptor agonists
WO2016038521A1 (en) * 2014-09-08 2016-03-17 Sun Pharmaceutical Industries Limited Pharmaceutical compositions of liraglutide
WO2016059593A1 (en) * 2014-10-16 2016-04-21 Piramal Enterprises Limited Stable injectable composition of protein drugs and process for its preparation
EP3295952B1 (en) * 2015-05-13 2021-02-17 Hangzhou Jiuyuan Gene Engineering Co., Ltd Pharmaceutical formulation comprising glp-1 analogue and preparation method thereof
BR112017024997A2 (pt) 2015-05-22 2018-07-31 The Bot Of The Leland Stanford Junior University tratamento de hipoglicemia pós-bariátrica com antagonistas de glp-1
AR105319A1 (es) 2015-06-05 2017-09-27 Sanofi Sa Profármacos que comprenden un conjugado agonista dual de glp-1 / glucagón conector ácido hialurónico
TW201706291A (zh) 2015-07-10 2017-02-16 賽諾菲公司 作為選擇性肽雙重ｇｌｐ－１／升糖素受體促效劑之新毒蜥外泌肽（ｅｘｅｎｄｉｎ－４）衍生物
EP3424521A4 (en) * 2016-03-01 2019-12-18 Hybio Pharmaceutical Co., Ltd PHARMACEUTICAL COMPOSITION AND PRODUCTION METHOD THEREFOR
MA43684A (fr) * 2016-03-04 2018-11-28 Novo Nordisk As Liraglutide utilisé dans le traitement de maladies rénales
US10653753B2 (en) 2016-03-04 2020-05-19 Eiger Biopharmaceuticals, Inc. Treatment of hyperinsulinemic hypoglycemia with exendin-4 derivatives
US9968659B2 (en) * 2016-03-04 2018-05-15 Novo Nordisk A/S Liraglutide in cardiovascular conditions
JP7115803B2 (ja) * 2016-06-20 2022-08-09 アイエスエー ファーマシューティカルズ ビー．ヴイ． ペプチドワクチン製剤
US10350293B2 (en) 2016-08-23 2019-07-16 Pharmacotherapia d.o.o. Compositions and methods for treating symptoms associated with multiple sclerosis
US20190224122A1 (en) 2016-09-23 2019-07-25 Delpor, Inc. Stable compositions for incretin mimetic compounds
PL3541366T3 (pl) 2016-11-21 2025-04-28 Amylyx Pharmaceuticals, Inc. Buforowe preparaty eksendyny (9-39)
EP3821905B1 (en) 2016-12-16 2022-10-12 Novo Nordisk A/S Insulin containing pharmaceutical compositions
GB201621987D0 (en) * 2016-12-22 2017-02-08 Archer Virgil L See Archer Sheri A Arecor Ltd Novel composition
JP7200238B2 (ja) 2017-06-16 2023-01-06 ジーランド・ファルマ・アー／エス グルカゴン様ペプチド２（ｇｌｐ－２）類似体の投与の投薬方針
CN118903386A (zh) 2017-08-24 2024-11-08 诺和诺德股份有限公司 Glp-1组合物及其用途
IL322968A (en) 2017-10-12 2025-10-01 Novo Nordisk As Semaglutide in medical treatment
WO2019149880A1 (en) 2018-02-02 2019-08-08 Novo Nordisk A/S Solid compositions comprising a glp-1 agonist, a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid and a lubricant
WO2019200594A1 (zh) * 2018-04-19 2019-10-24 杭州先为达生物科技有限公司 酰化的glp-1衍生物
TWI705820B (zh) 2018-06-22 2020-10-01 美商美國禮來大藥廠 Gip/glp1促效劑組合物
EP3628682A1 (en) 2018-09-28 2020-04-01 Zealand Pharma A/S Formulations of glucagon-like-peptide-2 (glp-2) analogues
US11058745B1 (en) 2018-10-04 2021-07-13 Good Health, Llc Stable liquid pharmaceutical compositions of daptomycin
CA3115770C (en) * 2018-10-09 2023-11-14 Justin B. Schaal Compositions and methods for enhancing systemic deliverability, tolerability, and efficacy of cationic macrocyclic peptides
JP7422754B2 (ja) * 2018-10-26 2024-01-26 ノヴォ ノルディスク アー／エス 安定性セマグルチド組成物およびその使用
EP3897570A1 (en) 2018-12-19 2021-10-27 KRKA, d.d., Novo mesto Pharmaceutical composition comprising glp-1 analogue
US11471512B2 (en) 2019-03-01 2022-10-18 Merck Sharp & Dohme Llc Pharmaceutical compositions of a peptide
WO2020208541A1 (en) * 2019-04-08 2020-10-15 Enzene Biosciences Limited Composition comprising glp-1 analogue
WO2021123228A1 (en) 2019-12-18 2021-06-24 Krka, D.D., Novo Mesto Pharmaceutical composition comprising glp-1 analogue
KR20220143036A (ko) 2020-02-18 2022-10-24 노보 노르디스크 에이/에스 약학적 제형
EP4126004A1 (en) 2020-03-30 2023-02-08 Zealand Pharma A/S Agonist combination
US11478533B2 (en) 2020-04-27 2022-10-25 Novo Nordisk A/S Semaglutide for use in medicine
MX2023006281A (es) * 2020-12-16 2023-06-13 Zealand Pharma As Composicion farmaceutica de agonistas duales de glp-1/glp-2.
AU2022263996A1 (en) 2021-04-27 2023-11-02 Aardvark Therapeutics, Inc. Combination of bitter receptor agonist and gut-signaling compound
JP2024522892A (ja) * 2021-06-25 2024-06-21 エクストロヴィス・アーゲー 薬学的組成物
AU2022386166A1 (en) 2021-11-10 2024-06-20 I2O Therapeutics, Inc. Ionic liquid compositions
CN118946368A (zh) * 2022-01-18 2024-11-12 维京治疗公司 用于治疗代谢病症和肝病的药物制剂和方法
US20250352622A1 (en) 2024-05-15 2025-11-20 Rose Pharma Inc. Glp-1 formulations and their uses
GR1010977B (el) * 2024-05-23 2025-06-13 Φαρματεν Α.Β.Ε.Ε., Παρεντερικο σκευασμα ενος αναλογου του γλυκογονομορφου πεπτιδιου 1 και μεθοδος παραγωγης αυτου

Family Cites Families (118)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK159414C (da) 1980-03-21 1991-03-18 Wellcome Found Isotonisk vaeskeformigt farmaceutisk praeparat indeholdende trimethoprim og polymyxin, samt fremgangsmaade til at goere et med en kviksoelvforbindelse konserveret farmaceutisk praeparat isotonisk
US4483849A (en) 1983-01-07 1984-11-20 Carter William A Stabilization and purification of interferon with propylene glycol, resulting in a non-toxic product
US4468346A (en) * 1983-10-27 1984-08-28 The United States Of America As Represented By The Secretary Of Agriculture Monoclonal antibodies to porcine immunoglobulins
PH25772A (en) 1985-08-30 1991-10-18 Novo Industri As Insulin analogues, process for their preparation
JP2583257B2 (ja) 1986-05-05 1997-02-19 ザ・ジェネラル・ホスピタル・コーポレーション インシュリン向性ホルモン
AU616411B2 (en) * 1987-05-14 1991-10-31 Commonwealth Scientific And Industrial Research Organisation Whey protein fractions
WO1990000200A1 (en) 1988-06-27 1990-01-11 Genex Corporation Thermal release of recombinant protein into culture media
DE3837825A1 (de) 1988-11-08 1990-05-10 Hoechst Ag Neue insulinderivate, ihre verwendung und eine sie enthaltende pharmazeutische zubereitung
JPH04502465A (ja) 1988-12-23 1992-05-07 ノボ　ノルディスク　アクティーゼルスカブ ヒトインシュリン類似物質
PT93057B (pt) 1989-02-09 1995-12-29 Lilly Co Eli Processo para a preparacao de analogos da insulina
JPH04504246A (ja) 1989-03-20 1992-07-30 ザ・ジェネラル・ホスピタル・コーポレーション インシュリン刺激ホルモン
JP2822447B2 (ja) * 1989-05-19 1998-11-11 住友電気工業株式会社 酸化物超電導線材の製造方法および装置
US5216011A (en) 1989-09-01 1993-06-01 Bristol-Myers Squibb Co. Stable solutions of mitomycin c
DE69013471T2 (de) 1989-12-05 1995-03-30 Merck & Co Inc Methode zur Stabilisierung von rekombinanten Hepatitis-B-Virus-Oberflächenproteinen aus Hefe.
CA2073856C (en) 1990-01-24 2002-12-03 Douglas I. Buckley Glp-1 analogs useful for diabetes treatment
DE4002066A1 (de) 1990-01-25 1991-08-01 Basf Ag Verfahren zur abtrennung von riboflavin aus fermentationssuspensionen
EP0482608B1 (en) * 1990-10-26 1994-07-27 The Furukawa Electric Co., Ltd. A polyphenylenesulfide composition for powder coating
US5272135A (en) 1991-03-01 1993-12-21 Chiron Ophthalmics, Inc. Method for the stabilization of methionine-containing polypeptides
SE9101381D0 (sv) * 1991-05-07 1991-05-07 Tomas Moks Peptide hormone solution
US5206219A (en) * 1991-11-25 1993-04-27 Applied Analytical Industries, Inc. Oral compositions of proteinaceous medicaments
DK36492D0 (da) 1992-03-19 1992-03-19 Novo Nordisk As Praeparat
DK39892D0 (da) 1992-03-25 1992-03-25 Bernard Thorens Peptid
SG45449A1 (en) * 1992-05-13 1998-01-16 Sandoz Ltd Ophthalmic compositions
US6284727B1 (en) * 1993-04-07 2001-09-04 Scios, Inc. Prolonged delivery of peptides
US5424286A (en) 1993-05-24 1995-06-13 Eng; John Exendin-3 and exendin-4 polypeptides, and pharmaceutical compositions comprising same
WO1995000550A1 (en) 1993-06-21 1995-01-05 Novo Nordisk A/S Aspb28 insulin crystals
AU7531094A (en) * 1993-08-24 1995-03-21 Novo Nordisk A/S Protracted glp-1
BR9407508A (pt) 1993-09-17 1997-01-07 Novo Nordisk As Derivado de insulina composição farmaceutica e processo para o tratamento de diabete em um paciente com necessidade deste tratamento
US6011007A (en) 1993-09-17 2000-01-04 Novo Nordisk A/S Acylated insulin
GB9320782D0 (en) * 1993-10-08 1993-12-01 Univ Leeds Innovations Ltd Stabilising of proteins on solution
DK0729362T3 (da) * 1993-11-19 2000-05-08 Searle & Co Transdermal sammensætning af N-(N-(5-(4-aminoiminomethyl)-phenyl)-1-oxypentyl)-L-alfa-aspartyl)-L-phenylalanin eller estere
US5705483A (en) * 1993-12-09 1998-01-06 Eli Lilly And Company Glucagon-like insulinotropic peptides, compositions and methods
WO1995022560A1 (en) * 1994-02-22 1995-08-24 The Syntex-Synergen Neuroscience Joint Venture Pharmaceutical formulations of cntf
US5652216A (en) * 1994-05-26 1997-07-29 Novo Nordisk A/S Pharmaceutical preparation
US5504188A (en) 1994-06-16 1996-04-02 Eli Lilly And Company Preparation of stable zinc insulin analog crystals
US5574008A (en) 1994-08-30 1996-11-12 Eli Lilly And Company Biologically active fragments of glucagon-like insulinotropic peptide
DE69532492T2 (de) 1994-08-31 2004-12-02 Mitsubishi Pharma Corp. Verfahren zur Reinigung von rekombinantem menschlichem Serumalbumin
US5512549A (en) 1994-10-18 1996-04-30 Eli Lilly And Company Glucagon-like insulinotropic peptide analogs, compositions, and methods of use
WO1996020005A1 (en) 1994-12-23 1996-07-04 Novo Nordisk A/S Protracted glp-1 compositions
EP0820299B1 (en) 1995-02-06 2002-04-24 Genetics Institute, Inc. Formulations for il-12
US5834428A (en) * 1995-04-14 1998-11-10 1149336 Ontario Inc. Glucagon-like peptide-2 and its therapeutic use
US6184201B1 (en) * 1995-04-14 2001-02-06 Nps Allelix Corp. Intestinotrophic glucagon-like peptide-2 analogs
CN1114613C (zh) 1995-06-02 2003-07-16 诺沃奇梅兹有限公司 蛋白质溶液的铝/铁处理和膜浓缩方法
US5631347A (en) 1995-06-07 1997-05-20 Eli Lilly And Company Reducing gelation of a fatty acid-acylated protein
ATE316100T1 (de) 1996-06-05 2006-02-15 Roche Diagnostics Gmbh Exendin-analoga, verfahren zu deren herstellung und diese enthaltende arzneimittel
AU737664B2 (en) * 1996-07-03 2001-08-30 Alza Corporation Non-aqueous protic peptide formulations
US5981489A (en) 1996-07-18 1999-11-09 Alza Corporation Non-aqueous protic peptide formulations
JPH10101696A (ja) 1996-08-08 1998-04-21 Shinotesuto:Kk 形質転換体にて発現される蛋白質に含まれる夾雑物質の除去方法及び精製蛋白質
ES2319936T5 (es) 1996-08-08 2013-06-24 Amylin Pharmaceuticals, Inc. Regulación de la motilidad gastrointestinal
US6384016B1 (en) * 1998-03-13 2002-05-07 Novo Nordisk A/S Stabilized aqueous peptide solutions
JP3149958B2 (ja) 1996-08-30 2001-03-26 ノボ ノルディスク アクティーゼルスカブ Ｇｌｐ―１誘導体
US6268343B1 (en) * 1996-08-30 2001-07-31 Novo Nordisk A/S Derivatives of GLP-1 analogs
ATE304864T1 (de) 1997-01-07 2005-10-15 Amylin Pharmaceuticals Inc Verwendung von exedinen und deren antagonisten zur verminderung der lebensmittelaufnahme
RU2180218C2 (ru) 1997-01-20 2002-03-10 Джапэн Энерджи Корпорейшн Способ стабилизации гирудина и/или вариантов гирудина, лиофилизированная фармацевтическая композиция, полученная с применением данного способа
WO1998043658A1 (en) 1997-03-31 1998-10-08 Eli Lilly And Company Glucagon-like peptide-1 analogs
CA2236519C (en) * 1997-05-02 2011-09-13 1149336 Ontario Inc. Methods of enhancing functioning of the large intestine
AR012894A1 (es) 1997-06-13 2000-11-22 Lilly Co Eli Formulacion de insulina en solucion estable, su uso para preparar un medicamento y proceso para la preparacion de la misma.
ES2293875T3 (es) * 1997-10-01 2008-04-01 Novadel Pharma Inc. Aerosol bucal no polar.
ATE237636T1 (de) 1997-10-24 2003-05-15 Genentech Inc Reinigung von molekülen
WO1999029336A1 (en) 1997-12-05 1999-06-17 Eli Lilly And Company Glp-1 formulations
ZA9811127B (en) 1997-12-09 2000-07-11 Lilly Co Eli Stabilized teriparatide solutions.
US6380357B2 (en) 1997-12-16 2002-04-30 Eli Lilly And Company Glucagon-like peptide-1 crystals
JP2002512175A (ja) 1998-02-27 2002-04-23 ノボ ノルディスク アクティーゼルスカブ Ｇｌｐ−１類似体の誘導体類
EP1056774A1 (en) 1998-02-27 2000-12-06 Novo Nordisk A/S N-terminally truncated glp-1 derivatives
DE69916811T2 (de) 1998-02-27 2005-04-14 Novo Nordisk A/S Glp-1 derivate mit einem helix-gehalt über 25 %, die partiell strukturierte mizellenartige aggregate bilden
WO1999043708A1 (en) 1998-02-27 1999-09-02 Novo Nordisk A/S Glp-1 derivatives of glp-1 and exendin with protracted profile of action
JP2002506792A (ja) 1998-02-27 2002-03-05 ノボ ノルディスク アクティーゼルスカブ Ｎ末端修飾ｇｌｐ−１誘導体
CA2343268A1 (en) 1998-09-17 2000-03-23 Eli Lilly And Company Protein formulations
DK1140148T3 (da) 1998-12-22 2006-01-30 Lilly Co Eli Lagerholdbar formulering af glucagon-agtigt peptid-1
DE122007000001I1 (de) 1999-01-14 2007-06-28 Amylin Pharmaceuticals Inc Neue exendin agonist Formulierungen und deren Verabreichung
US6444788B1 (en) * 1999-03-15 2002-09-03 Novo Nordisk A/S Ion exchange chromatography of GLP-1, analogs and derivatives thereof
ATE409193T1 (de) 1999-03-17 2008-10-15 Novo Nordisk As Verfahren zur acylierung von peptiden und proteinen
CA2369839A1 (en) 1999-06-25 2001-01-04 Minimed, Inc. Compositions of insulin and insulin-related peptide for treating diabetes
EP1076066A1 (en) 1999-07-12 2001-02-14 Zealand Pharmaceuticals A/S Peptides for lowering blood glucose levels
AU7363000A (en) 1999-09-20 2001-04-24 Eli Lilly And Company Method for reducing the risk of cancer
US7022674B2 (en) * 1999-12-16 2006-04-04 Eli Lilly And Company Polypeptide compositions with improved stability
IL150129A0 (en) 1999-12-16 2002-12-01 Lilly Co Eli Polypeptide compositions with improved stability
GB9930882D0 (en) * 1999-12-30 2000-02-23 Nps Allelix Corp GLP-2 formulations
WO2001051071A2 (en) 2000-01-11 2001-07-19 Novo Nordisk A/S Transepithelial delivery of glp-1 derivatives
US20010012829A1 (en) * 2000-01-11 2001-08-09 Keith Anderson Transepithelial delivery GLP-1 derivatives
US6734162B2 (en) 2000-01-24 2004-05-11 Minimed Inc. Mixed buffer system for stabilizing polypeptide formulations
EP1396499A3 (en) 2000-01-27 2004-12-29 Eli Lilly And Company Process for solubilizing glucagon-like peptide 1 (GLP-1) compounds
MXPA02007231A (es) * 2000-01-27 2002-12-09 Lilly Co Eli Proceso para solubilizar los compuestos de peptido 1 similares a glucagon.
US6569901B2 (en) * 2000-01-28 2003-05-27 Novo Nordisk A/S Alkynyl-substituted propionic acid derivatives, their preparation and use
US6844321B2 (en) * 2000-01-31 2005-01-18 Novo Nordisk A/S Crystallization of a GLP-1 analogue
AU2001248277A1 (en) 2000-04-06 2001-10-23 Novo-Nordisk A/S Shock heat treatment of polypeptides
MXPA02012203A (es) 2000-06-16 2003-06-06 Lilly Co Eli Analogos de peptido 1 tipo glucagon.
JP4798833B2 (ja) 2000-10-24 2011-10-19 一般財団法人化学及血清療法研究所 加熱処理工程を含むヒト血清アルブミンの製造方法
HU230603B1 (hu) 2000-12-07 2017-03-28 Eli Lilly And Company GLP1 fúziós fehérjék
US7259233B2 (en) 2000-12-13 2007-08-21 Eli Lilly And Company Chronic treatment regimen using glucagon-like insulinotropic peptides
US7199217B2 (en) 2000-12-13 2007-04-03 Eli Lilly And Company Amidated glucagon-like peptide-1
US20020151467A1 (en) 2000-12-21 2002-10-17 Leung Frank K. Methods and compositions for oral insulin delivery
GB2371227A (en) 2001-01-10 2002-07-24 Grandis Biotech Gmbh Crystallisation - resistant aqueous growth hormone formulations
ATE396202T1 (de) * 2001-02-16 2008-06-15 Conjuchem Biotechnologies Inc Lang wirkendes glucagon-ähnliches peptid-2 für die behandlung von gastrointestinalen krankheiten und störungen
US6573237B2 (en) * 2001-03-16 2003-06-03 Eli Lilly And Company Protein formulations
WO2002074978A2 (en) * 2001-03-19 2002-09-26 President And Fellows Of Harvard College Nucleic acid shuffling
JP5052736B2 (ja) * 2001-05-30 2012-10-17 中外製薬株式会社 タンパク質製剤
PT1412384E (pt) * 2001-06-28 2008-03-28 Novo Nordisk As Formulação estável de glp-1 modificado
US6872705B2 (en) 2001-07-13 2005-03-29 Allergan, Inc. Use of antimicrobial peptides as preservatives in ophthalmic preparations, including solutions, emulsions, and suspensions
CN1335182A (zh) * 2001-08-08 2002-02-13 华中科技大学 胰岛素口腔喷剂及其制备工艺
EP1432430A4 (en) 2001-08-28 2006-05-10 Lilly Co Eli PREMIXTURES OF GLP-1 AND BASALINSULIN
AU2002348469B2 (en) 2001-10-18 2008-03-13 Bristol-Myers Squibb Company Human glucagon-like-peptide-1 mimics and their use in the treatment of diabetes and related conditions
US7179788B2 (en) 2001-10-19 2007-02-20 Eli Lilly And Company Biphasic mixtures of GLP-1 and insulin
JP2005526084A (ja) 2002-03-15 2005-09-02 ナットイムネ・アクティーゼルスカブ マンノース結合レクチンを含む医薬組成物
JP2005535569A (ja) * 2002-04-04 2005-11-24 ノボ・ノルデイスク・エー／エス Ｇｌｐ−１アゴニスト及び心臓血管合併症
EP1546187B1 (en) 2002-09-25 2008-06-04 Novo Nordisk A/S Purification process comprising microfiltration at elevated temperatures
US6969702B2 (en) 2002-11-20 2005-11-29 Neuronova Ab Compounds and methods for increasing neurogenesis
WO2004089985A1 (en) * 2003-04-11 2004-10-21 Novo Nordisk A/S Stable pharmaceutical compositions
EP1631308B1 (en) 2003-05-30 2013-07-31 Amylin Pharmaceuticals, LLC Novel methods and compositions for enhanced transmucosal delivery of peptides and proteins
WO2004105781A2 (en) 2003-06-03 2004-12-09 Novo Nordisk A/S Stabilized pharmaceutical peptide compositions
EP1684793B1 (en) * 2003-11-13 2011-09-21 Novo Nordisk A/S Pharmaceutical composition comprising an insulinotropic glp-1(7-37) analogue, asp(b28)-insulin, and a surfactant
US20060287221A1 (en) 2003-11-13 2006-12-21 Novo Nordisk A/S Soluble pharmaceutical compositions for parenteral administration comprising a GLP-1 peptide and an insulin peptide of short time action for treatment of diabetes and bulimia
EP3300721B2 (en) * 2003-11-20 2025-01-08 Novo Nordisk A/S Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
US20060286129A1 (en) * 2003-12-19 2006-12-21 Emisphere Technologies, Inc. Oral GLP-1 formulations
JP5248113B2 (ja) * 2004-11-12 2013-07-31 ノヴォ ノルディスク アー／エス ペプチドの安定な処方
GB0704846D0 (en) * 2007-03-13 2007-04-18 Futura Medical Dev Ltd Topical pharmaceutical formulation
RU2016138830A (ru) * 2011-02-04 2018-12-12 ИнФёрст Хэлткэр Лимитед Составы и способы для лечения сердечно-сосудистых заболеваний
CN102579350B (zh) * 2012-03-02 2013-04-24 海南灵康制药有限公司 右旋布洛芬脂质体固体制剂

Also Published As

Publication number Publication date
US20200316204A1 (en) 2020-10-08
WO2005049061A2 (en) 2005-06-02
HK1246683B (en) 2019-11-15
ES2727854T3 (es) 2019-10-21
AU2004290862A1 (en) 2005-06-02
SI1687019T1 (en) 2018-04-30
CA2545034C (en) 2013-03-05
EP3300721B2 (en) 2025-01-08
US20190231876A1 (en) 2019-08-01
WO2005049061A8 (en) 2005-12-01
BRPI0416743A (pt) 2007-01-16
HUE038395T2 (hu) 2018-10-29
CN113304250A (zh) 2021-08-27
CA2545034A1 (en) 2005-06-02
RU2006116414A (ru) 2007-12-27
PT3300721T (pt) 2019-06-06
CN104826116A (zh) 2015-08-12
EP3300721A1 (en) 2018-04-04
RU2421238C2 (ru) 2011-06-20
US8114833B2 (en) 2012-02-14
CN1882356A (zh) 2006-12-20
JP5558655B2 (ja) 2014-07-23
EP1687019B1 (en) 2017-11-22
SI3300721T2 (sl) 2025-05-30
EP2394656A2 (en) 2011-12-14
US20070010424A1 (en) 2007-01-11
EP2394656A3 (en) 2012-01-18
KR101243648B1 (ko) 2013-03-14
EP3300721B1 (en) 2019-03-06
PT1687019T (pt) 2018-02-26
FI3300721T4 (fi) 2025-01-27
US20120225810A1 (en) 2012-09-06
WO2005049061A3 (en) 2005-10-20
CN102784386A (zh) 2012-11-21
CN1882356B (zh) 2015-02-25
JP2007513084A (ja) 2007-05-24
EP1687019A2 (en) 2006-08-09
PL3300721T5 (pl) 2025-11-17
AU2004290862B2 (en) 2010-06-03
DK3300721T3 (da) 2019-05-27
PL1687019T3 (pl) 2018-05-30
HUE043210T2 (hu) 2019-08-28
ES2727854T5 (en) 2025-03-24
JP2012188424A (ja) 2012-10-04
TR201906789T4 (tr) 2019-05-21
KR20060100428A (ko) 2006-09-20
JP5670373B2 (ja) 2015-02-18
EP2394656B1 (en) 2023-12-13
CY1119723T1 (el) 2018-06-27
PL3300721T3 (pl) 2019-08-30
ES2660320T3 (es) 2018-03-21
US20230364241A1 (en) 2023-11-16
DK3300721T4 (da) 2025-03-03
MXPA06005581A (es) 2006-08-11
SI3300721T1 (sl) 2019-07-31

Similar Documents

Publication Publication Date Title
DK1687019T3 (da) Propylengykol peptidformuleringer som er optimale til produktion og anvendelse i injektionsanordninger
HK1246683A1 (en) Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
US7235627B2 (en) Derivatives of GLP-1 analogs
EP1412384B1 (en) Stable formulation of modified glp-1
US20090060861A1 (en) Stabilized Polypeptide Formulations
US20090011987A1 (en) Use of Glp-2 for the Treatment of Ischemia-Reperfusion Injury
RU2831321C2 (ru) Пептидная композиция, содержащая пропиленгликоль, являющаяся оптимальной для изготовления и применения в инъекционных устройствах
RS51806B (sr) Formulacije paratiroidnog hormona i njihova upotreba