WO2001087322A3 - Peptide pharmaceutical formulations - Google Patents

Peptide pharmaceutical formulations Download PDF

Info

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 EP01941488A priority patent/EP1301200A2/en
Priority to JP2001583789A priority patent/JP2004513069A/en
Priority to CA002380423A priority patent/CA2380423A1/en
Priority to AU74839/01A priority patent/AU785444B2/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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (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
EP01941488A EP1301200A2 (en) 2000-05-19 2001-05-17 Peptide pharmaceutical formulations
JP2001583789A JP2004513069A (en) 2000-05-19 2001-05-17 Peptide drug formulation
CA002380423A CA2380423A1 (en) 2000-05-17 2001-05-17 Peptide pharmaceutical formulations
AU74839/01A AU785444B2 (en) 2000-05-19 2001-05-17 Peptide pharmaceutical formulations

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.
US7259136B2 (en) * 1999-04-30 2007-08-21 Amylin Pharmaceuticals, Inc. Compositions and methods for treating peripheral vascular disease
US6284725B1 (en) * 1998-10-08 2001-09-04 Bionebraska, Inc. Metabolic intervention with GLP-1 to improve the function of ischemic and reperfused tissue
EP1274720A4 (en) 2000-04-12 2004-08-18 Human Genome Sciences Inc ALBUMIN FUSED PROTEINS
WO2002022151A2 (en) * 2000-09-18 2002-03-21 Osteometer Bio Tech A/S Use of glp-1 and flp-2 peptides for treatment of bone disorders
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
PT1463751E (en) 2001-12-21 2013-08-26 Human Genome Sciences Inc ALBUMINE FUSION PROTEINS
ES2615484T3 (en) * 2002-05-21 2017-06-07 Daiichi Sankyo Company, Limited Medicinal compositions containing ghrelin
US20060128615A1 (en) * 2002-09-18 2006-06-15 Pierrette Gaudreau Ghrh analogues
US7790681B2 (en) 2002-12-17 2010-09-07 Amylin Pharmaceuticals, Inc. Treatment of cardiac arrhythmias with GLP-1 receptor ligands
AU2003297356A1 (en) * 2002-12-17 2004-07-14 Amylin Pharmaceuticals, Inc. Prevention and treatment of cardiac arrhythmias
CA2513213C (en) 2003-01-22 2013-07-30 Human Genome Sciences, Inc. Albumin fusion proteins
AU2004232858B2 (en) 2003-04-23 2009-07-09 Mannkind Corporation Hydraulically actuated pump for long duration medicament administration
BRPI0412029A (en) * 2003-06-30 2006-09-05 Alza Corp formulations for coated microprojections containing nonvolatile counterions
WO2006014425A1 (en) 2004-07-02 2006-02-09 Biovalve Technologies, Inc. Methods and devices for delivering glp-1 and uses thereof
KR101149454B1 (en) * 2004-08-24 2012-05-25 간가와 겐지 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
AU2007233231B2 (en) 2006-03-30 2011-02-24 Mannkind Corporation Multi-cartridge fluid delivery device
US20080177089A1 (en) * 2007-01-19 2008-07-24 Eugene Steven Sadlowski Novel whitening agents for cellulosic substrates
PL2118123T3 (en) 2007-01-31 2016-06-30 Dana Farber Cancer Inst Inc Stabilized p53 peptides and uses thereof
JP5631201B2 (en) 2007-03-28 2014-11-26 プレジデント アンド フェローズ オブ ハーバード カレッジ Stitched polypeptide
US20080249017A1 (en) * 2007-04-04 2008-10-09 Theratechnologies Inc. Pharmaceutical formulations of ghrh molecules
KR102104762B1 (en) 2010-08-13 2020-04-24 에일러론 테라퓨틱스 인코포레이티드 Peptidomimetic macrocycles
EP2768518A4 (en) 2011-10-18 2015-05-27 Aileron Therapeutics Inc PEPTIDOMIMETIC MACROCYCLES
CA2864120A1 (en) 2012-02-15 2013-08-22 Aileron Therapeutics, Inc. Triazole-crosslinked and thioether-crosslinked peptidomimetic macrocycles
RU2642299C2 (en) 2012-02-15 2018-01-24 Эйлерон Терапьютикс, Инк. p53 PEPTIDOMIMETIC MACROCYCLES
UA116217C2 (en) 2012-10-09 2018-02-26 Санофі Exendin-4 derivatives as dual glp1/glucagon agonists
BR112015009470A2 (en) 2012-11-01 2019-12-17 Aileron Therapeutics Inc disubstituted amino acids and their methods of preparation and use
JP2016506401A (en) 2012-12-21 2016-03-03 サノフイ Exendin-4 derivatives as dual GLP1 / GIP or three-way 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
WO2015086733A1 (en) 2013-12-13 2015-06-18 Sanofi Dual glp-1/glucagon receptor agonists
TW201609799A (en) 2013-12-13 2016-03-16 賽諾菲公司 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
TW201609796A (en) 2013-12-13 2016-03-16 賽諾菲公司 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
TW201625669A (en) 2014-04-07 2016-07-16 賽諾菲公司 Peptidic 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
US9932381B2 (en) 2014-06-18 2018-04-03 Sanofi Exendin-4 derivatives as selective glucagon receptor agonists
EP3197478A4 (en) 2014-09-24 2018-05-30 Aileron Therapeutics, Inc. Peptidomimetic macrocycles and uses thereof
JP2018516844A (en) 2015-03-20 2018-06-28 エルロン・セラピューティクス・インコーポレイテッド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
AU2017365028B2 (en) * 2016-11-23 2024-11-28 Vaxiion Therapeutics, Llc Immunomodulatory and oncolytic minicells and methods of use
JP2020510028A (en) * 2017-03-08 2020-04-02 インターシア セラピューティクス，インコーポレイティド Apparatus and method for administration of a nausea-inducing compound from a drug delivery device
HUE066356T2 (en) 2017-08-24 2024-07-28 Novo Nordisk As GLP-1 preparations and their applications
US20200289621A1 (en) * 2017-09-22 2020-09-17 Asahi Kasei Pharma Corporation Teriparatide-containing liquid pharmaceutical composition having excellent stability
PE20221575A1 (en) 2020-02-18 2022-10-06 Novo Nordisk As PHARMACEUTICAL FORMULATIONS

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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ATE269103T1 (en) * 1998-03-13 2004-07-15 Novo Nordisk As STABILIZED AQUEOUS GLUCAGON SOLUTIONS CONTAINING DETERGENTS
US20010012829A1 (en) * 2000-01-11 2001-08-09 Keith Anderson Transepithelial delivery GLP-1 derivatives

Patent 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

Also Published As

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

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