WO2001087322A3 - Peptide pharmaceutical formulations - Google Patents

Peptide pharmaceutical formulations Download PDF

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Publication number
WO2001087322A3
WO2001087322A3 PCT/US2001/015872 US0115872W WO0187322A3 WO 2001087322 A3 WO2001087322 A3 WO 2001087322A3 US 0115872 W US0115872 W US 0115872W WO 0187322 A3 WO0187322 A3 WO 0187322A3
Authority
WO
WIPO (PCT)
Prior art keywords
composition
molecule
pharmaceutical formulations
peptide pharmaceutical
peptide
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.)
Ceased
Application number
PCT/US2001/015872
Other languages
French (fr)
Other versions
WO2001087322A2 (en
Inventor
Barton Holmquist
Daniel C Dormady
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.)
BioNebraska Inc
Original Assignee
BioNebraska 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 BioNebraska Inc filed Critical BioNebraska Inc
Priority to IL14773101A priority Critical patent/IL147731A0/en
Priority to AU74839/01A priority patent/AU785444B2/en
Priority to EP01941488A priority patent/EP1301200A2/en
Priority to CA002380423A priority patent/CA2380423A1/en
Priority to JP2001583789A priority patent/JP2004513069A/en
Publication of WO2001087322A2 publication Critical patent/WO2001087322A2/en
Publication of WO2001087322A3 publication Critical patent/WO2001087322A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61K38/25—Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
    • 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
    • A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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

Landscapes

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

Abstract

A pharmaceutical composition for administration to a mammal is disclosed. The composition includes a therapeutically effective amount of a peptide, such as a GLP-1 molecule, a PTH molecule, or a GRF molecule. The composition further includes a buffer including a weak acid having an acid dissociation constant value of greater than about 1x10-5, such as acetic acid. The composition also includes an excipient for making the composition generally isotonic, such as D-mannitol.
PCT/US2001/015872 2000-05-17 2001-05-17 Peptide pharmaceutical formulations Ceased WO2001087322A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
IL14773101A IL147731A0 (en) 2000-05-19 2001-05-17 Peptide pharmaceutical formulations
AU74839/01A AU785444B2 (en) 2000-05-19 2001-05-17 Peptide pharmaceutical formulations
EP01941488A EP1301200A2 (en) 2000-05-19 2001-05-17 Peptide pharmaceutical formulations
CA002380423A CA2380423A1 (en) 2000-05-17 2001-05-17 Peptide pharmaceutical formulations
JP2001583789A JP2004513069A (en) 2000-05-19 2001-05-17 Peptide drug formulation

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US20537700P 2000-05-17 2000-05-17
US60/205,377 2000-05-17
US20526200P 2000-05-19 2000-05-19
US60/205,262 2000-05-19

Publications (2)

Publication Number Publication Date
WO2001087322A2 WO2001087322A2 (en) 2001-11-22
WO2001087322A3 true WO2001087322A3 (en) 2002-07-18

Family

ID=26900257

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/015872 Ceased WO2001087322A2 (en) 2000-05-17 2001-05-17 Peptide pharmaceutical formulations

Country Status (3)

Country Link
US (2) US20020061838A1 (en)
CA (1) CA2380423A1 (en)
WO (1) WO2001087322A2 (en)

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FR2686899B1 (en) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa NOVEL BIOLOGICALLY ACTIVE POLYPEPTIDES, THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM.
US6284725B1 (en) * 1998-10-08 2001-09-04 Bionebraska, Inc. Metabolic intervention with GLP-1 to improve the function of ischemic and reperfused tissue
US7259136B2 (en) * 1999-04-30 2007-08-21 Amylin Pharmaceuticals, Inc. Compositions and methods for treating peripheral vascular disease
US6926898B2 (en) 2000-04-12 2005-08-09 Human Genome Sciences, Inc. Albumin fusion proteins
PT1326630E (en) 2000-09-18 2008-09-02 Sanos Bioscience As Use of glp-2 peptides
US7186683B2 (en) 2000-09-18 2007-03-06 Sanos Bioscience A/S Use of GLP for the treatment, prevention, diagnosis, and prognosis of bone-related and nutrition-related disorders
CU23157A1 (en) * 2001-01-03 2006-07-18 Ct Ingenieria Genetica Biotech PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF TISSULAR DANE DUE TO LACK OF BLOOD IRRIGATION ARTERIAL
CA2841097A1 (en) 2001-12-21 2003-07-24 Human Genome Sciences, Inc. Albumin and g-csf fusion proteins
WO2005003296A2 (en) 2003-01-22 2005-01-13 Human Genome Sciences, Inc. Albumin fusion proteins
JP5000848B2 (en) * 2002-05-21 2012-08-15 第一三共株式会社 Ghrelin-containing pharmaceutical composition
EP1539959A2 (en) * 2002-09-18 2005-06-15 Centre Hospitalier de l'Université de Montréal (CHUM) Ghrh analogues
US7790681B2 (en) 2002-12-17 2010-09-07 Amylin Pharmaceuticals, Inc. Treatment of cardiac arrhythmias with GLP-1 receptor ligands
EP1610811A4 (en) * 2002-12-17 2008-03-26 Amylin Pharmaceuticals Inc Prevention and treatment of cardiac arrhythmias
US7530968B2 (en) 2003-04-23 2009-05-12 Valeritas, Inc. Hydraulically actuated pump for long duration medicament administration
CA2530531A1 (en) * 2003-06-30 2005-01-20 Alza Corporation Formulations for coated microprojections containing non-volatile counterions
US9089636B2 (en) 2004-07-02 2015-07-28 Valeritas, Inc. Methods and devices for delivering GLP-1 and uses thereof
BRPI0514408B8 (en) * 2004-08-24 2021-05-25 Asubio Pharma Co Ltd liquid preparation of physiologically active peptide
CA2606902A1 (en) * 2005-05-27 2006-11-30 Asubio Pharma Co., Ltd. Insulin resistance improver
KR100700869B1 (en) * 2005-06-03 2007-03-29 재단법인 목암생명공학연구소 Stable PTH Compositions Including PTH, Buffers, and Stabilizers
CN103239773B (en) 2006-03-30 2015-08-26 瓦莱里塔斯公司 Multi-cartridge fluid delivery device
US20080177089A1 (en) * 2007-01-19 2008-07-24 Eugene Steven Sadlowski Novel whitening agents for cellulosic substrates
US8889632B2 (en) 2007-01-31 2014-11-18 Dana-Farber Cancer Institute, Inc. Stabilized p53 peptides and uses thereof
EP2508531B1 (en) 2007-03-28 2016-10-19 President and Fellows of Harvard College Stitched polypeptides
MX2009010675A (en) * 2007-04-04 2009-10-23 Theratechnologies Inc Pharmaceutical formulations of ghrh molecules.
SI2603600T1 (en) 2010-08-13 2019-04-30 Aileron Therapeutics, Inc. Peptidomimetic macrocycles
TW201806968A (en) 2011-10-18 2018-03-01 艾利倫治療公司 Peptidomimetic macrocycles
HK1205454A1 (en) 2012-02-15 2015-12-18 Aileron Therapeutics, Inc. Triazole-crosslinked and thioether-crosslinked peptidomimetic macrocycles
KR102112373B1 (en) 2012-02-15 2020-05-18 에일러론 테라퓨틱스 인코포레이티드 Peptidomimetic macrocycles
UA116217C2 (en) 2012-10-09 2018-02-26 Санофі Exendin-4 derivatives as dual glp1/glucagon agonists
WO2014071241A1 (en) 2012-11-01 2014-05-08 Aileron Therapeutics, Inc. Disubstituted amino acids and methods of preparation and use thereof
HUE035803T2 (en) 2012-12-21 2018-05-28 Sanofi Sa Dual glp1/gip or trigonal glp1/gip/glucagon agonists
US20200354428A9 (en) 2013-06-23 2020-11-12 Wisconsin Alumni Research Foundation Analogues of parathyroid hormone (1-34) that function as agonists of the parathyroid hormone receptor-1 and display modified activity profiles
CN103405753B (en) * 2013-08-13 2016-05-11 上海仁会生物制药股份有限公司 Stable insulin secretion accelerating peptide liquid drugs injection pharmaceutical composition
TW201609797A (en) 2013-12-13 2016-03-16 賽諾菲公司 Dual GLP-1/glucagon receptor agonists
WO2015086728A1 (en) 2013-12-13 2015-06-18 Sanofi Exendin-4 peptide analogues as dual glp-1/gip receptor agonists
EP3080154B1 (en) 2013-12-13 2018-02-07 Sanofi Dual glp-1/gip receptor agonists
WO2015086730A1 (en) 2013-12-13 2015-06-18 Sanofi Non-acylated exendin-4 peptide analogues
TW201625670A (en) 2014-04-07 2016-07-16 賽諾菲公司 Dual GLP-1/glucagon receptor agonists derived from EXENDIN-4
TW201625668A (en) 2014-04-07 2016-07-16 賽諾菲公司 Exendin-4 derivatives as peptidic dual GLP-1/glucagon receptor agonists
TW201625669A (en) 2014-04-07 2016-07-16 賽諾菲公司 Peptidic dual GLP-1/glucagon receptor agonists derived from Exendin-4
US9932381B2 (en) 2014-06-18 2018-04-03 Sanofi Exendin-4 derivatives as selective glucagon receptor agonists
BR112017005598A2 (en) 2014-09-24 2017-12-12 Aileron Therapeutics Inc peptidomimetic macrocycles and their uses
WO2016154058A1 (en) 2015-03-20 2016-09-29 Aileron Therapeutics, Inc. Peptidomimetic macrocycles and uses thereof
AR105319A1 (en) 2015-06-05 2017-09-27 Sanofi Sa PROPHARMS THAT INCLUDE A DUAL AGONIST GLU-1 / GLUCAGON CONJUGATE HIALURONIC ACID CONNECTOR
TW201706291A (en) 2015-07-10 2017-02-16 賽諾菲公司 New EXENDIN-4 derivatives as selective peptidic dual GLP-1/glucagon receptor agonists
CN107952064B (en) * 2016-10-14 2023-10-20 江苏豪森药业集团有限公司 Pharmaceutical preparations containing polyethylene glycol loxenatide and preparation methods thereof
WO2018098163A1 (en) * 2016-11-23 2018-05-31 Vaxiion Therapeutics, Llc Immunomodulatory & oncolytic minicells and methods of use
WO2018165462A1 (en) * 2017-03-08 2018-09-13 Intarcia Therapeutics, Inc Apparatus and methods for administration of a nauseogenic compound from a drug delivery device
BR112020002804A2 (en) 2017-08-24 2020-07-28 Novo Nordisk A/S liquid pharmaceutical composition and kit
US20200289621A1 (en) * 2017-09-22 2020-09-17 Asahi Kasei Pharma Corporation Teriparatide-containing liquid pharmaceutical composition having excellent stability
IL294521A (en) 2020-02-18 2022-09-01 Novo Nordisk As Glp-1 compositions and uses thereof

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4963529A (en) * 1984-12-24 1990-10-16 Sumitomo Pharmaceuticals Company, Limited Stable growth hormone releasing factor preparation
WO1991018621A1 (en) * 1990-06-07 1991-12-12 Genentech, Inc. The combination of growth hormone and insulin-like growth factor-i enhances growth
WO1994003198A1 (en) * 1992-07-31 1994-02-17 Genentech, Inc. Human growth hormone aqueous formulation
EP0658568A1 (en) * 1993-12-09 1995-06-21 Eli Lilly And Company Glucagon-like insulinotropic peptides, compositions and methods
WO1995017207A1 (en) * 1993-12-23 1995-06-29 Allelix Biopharmaceuticals Inc. Parathyroid hormone formulation
WO1998019698A1 (en) * 1996-11-05 1998-05-14 Eli Lilly And Company Use of glp-1 analogs and derivatives administered peripherally in regulation of obesity
WO1999029337A1 (en) * 1997-12-09 1999-06-17 Eli Lilly And Company Stabilized teriparatide solutions
WO1999030731A1 (en) * 1997-12-16 1999-06-24 Eli Lilly And Company Glucagon-like peptide-1 crystals
WO1999047160A1 (en) * 1998-03-13 1999-09-23 Novo Nordisk A/S Stabilized aqueous peptide solutions

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US5162302A (en) * 1988-03-18 1992-11-10 University Of Delaware Endocrine manipulation to improve body composition of poultry
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US20010012829A1 (en) * 2000-01-11 2001-08-09 Keith Anderson Transepithelial delivery GLP-1 derivatives

Patent Citations (9)

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Publication number Priority date Publication date Assignee Title
US4963529A (en) * 1984-12-24 1990-10-16 Sumitomo Pharmaceuticals Company, Limited Stable growth hormone releasing factor preparation
WO1991018621A1 (en) * 1990-06-07 1991-12-12 Genentech, Inc. The combination of growth hormone and insulin-like growth factor-i enhances growth
WO1994003198A1 (en) * 1992-07-31 1994-02-17 Genentech, Inc. Human growth hormone aqueous formulation
EP0658568A1 (en) * 1993-12-09 1995-06-21 Eli Lilly And Company Glucagon-like insulinotropic peptides, compositions and methods
WO1995017207A1 (en) * 1993-12-23 1995-06-29 Allelix Biopharmaceuticals Inc. Parathyroid hormone formulation
WO1998019698A1 (en) * 1996-11-05 1998-05-14 Eli Lilly And Company Use of glp-1 analogs and derivatives administered peripherally in regulation of obesity
WO1999029337A1 (en) * 1997-12-09 1999-06-17 Eli Lilly And Company Stabilized teriparatide solutions
WO1999030731A1 (en) * 1997-12-16 1999-06-24 Eli Lilly And Company Glucagon-like peptide-1 crystals
WO1999047160A1 (en) * 1998-03-13 1999-09-23 Novo Nordisk A/S Stabilized aqueous peptide solutions

Also Published As

Publication number Publication date
WO2001087322A2 (en) 2001-11-22
US20060183685A1 (en) 2006-08-17
US20020061838A1 (en) 2002-05-23
CA2380423A1 (en) 2001-11-22

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