WO2007121411A3 - Glucagon-like peptide 1(glp-1) pharmaceutical formulations - Google Patents

Glucagon-like peptide 1(glp-1) pharmaceutical formulations Download PDF

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Publication number
WO2007121411A3
WO2007121411A3 PCT/US2007/066728 US2007066728W WO2007121411A3 WO 2007121411 A3 WO2007121411 A3 WO 2007121411A3 US 2007066728 W US2007066728 W US 2007066728W WO 2007121411 A3 WO2007121411 A3 WO 2007121411A3
Authority
WO
WIPO (PCT)
Prior art keywords
glp
glucagon
peptide
pharmaceutical formulations
composition
Prior art date
Application number
PCT/US2007/066728
Other languages
French (fr)
Other versions
WO2007121411A2 (en
Inventor
Stephanie Greene
David Brandt
Cohava Gelber
Mark King
Wayman Wendell Cheatham
Keith Oberg
Andrea Leone-Bay
Mark J Hokenson
Mary Faris
Original Assignee
Mannkind Corp
Stephanie Greene
David Brandt
Cohava Gelber
Mark King
Wayman Wendell Cheatham
Keith Oberg
Andrea Leone-Bay
Mark J Hokenson
Mary Faris
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 Mannkind Corp, Stephanie Greene, David Brandt, Cohava Gelber, Mark King, Wayman Wendell Cheatham, Keith Oberg, Andrea Leone-Bay, Mark J Hokenson, Mary Faris filed Critical Mannkind Corp
Priority to KR1020087027774A priority Critical patent/KR101438839B1/en
Priority to KR1020157008571A priority patent/KR20150042304A/en
Priority to AU2007238000A priority patent/AU2007238000B2/en
Priority to JP2009505655A priority patent/JP5415938B2/en
Priority to BRPI0709964-9A priority patent/BRPI0709964A2/en
Priority to CA002646400A priority patent/CA2646400A1/en
Priority to EP20070760728 priority patent/EP2010155A2/en
Priority to MX2008013216A priority patent/MX2008013216A/en
Priority to KR1020147011316A priority patent/KR101558829B1/en
Publication of WO2007121411A2 publication Critical patent/WO2007121411A2/en
Publication of WO2007121411A3 publication Critical patent/WO2007121411A3/en

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    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P3/04—Anorexiants; Antiobesity agents
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    • 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
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Abstract

A composition is disclosed comprising glucagon- like peptide 1 (GLP-I) particles in combination with diketopiperazine (DKP) that is stable both in vitro and in vivo. The composition has utility as a pharmaceutical formulation for treating diseases such as diabetes, cancers, and obesity but is not limited to such diseases or conditions. In particularly, the composition has utility as a pharmaceutical formulation for pulmonary delivery.
PCT/US2007/066728 2006-04-14 2007-04-16 Glucagon-like peptide 1(glp-1) pharmaceutical formulations WO2007121411A2 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
KR1020087027774A KR101438839B1 (en) 2006-04-14 2007-04-16 Glucagon-like peptide 1 （ｇｌｐ-1）pharmaceutical formulations
KR1020157008571A KR20150042304A (en) 2006-04-14 2007-04-16 Glucagon-like peptide 1 （ｇｌｐ-1）pharmaceutical formulations
AU2007238000A AU2007238000B2 (en) 2006-04-14 2007-04-16 Glucagon-like peptide 1(GLP-1) pharmaceutical formulations
JP2009505655A JP5415938B2 (en) 2006-04-14 2007-04-16 Glucagon-like peptide 1 (GLP-1) pharmaceutical preparation
BRPI0709964-9A BRPI0709964A2 (en) 2006-04-14 2007-04-16 pharmaceutical formulations containing type 1 glucagon peptide (glp-1)
CA002646400A CA2646400A1 (en) 2006-04-14 2007-04-16 Glucagon-like peptide 1(glp-1) pharmaceutical formulations
EP20070760728 EP2010155A2 (en) 2006-04-14 2007-04-16 Glucagon-like peptide 1(glp-1) pharmaceutical formulations
MX2008013216A MX2008013216A (en) 2006-04-14 2007-04-16 Glucagon-like peptide 1(glp-1) pharmaceutical formulations.
KR1020147011316A KR101558829B1 (en) 2006-04-14 2007-04-16 Glucagon-like peptide 1 (glp-1)pharmaceutical formulations

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US74488206P 2006-04-14 2006-04-14
US60/744,882 2006-04-14

Publications (2)

Publication Number Publication Date
WO2007121411A2 WO2007121411A2 (en) 2007-10-25
WO2007121411A3 true WO2007121411A3 (en) 2007-12-13

Family

ID=38567214

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/066728 WO2007121411A2 (en) 2006-04-14 2007-04-16 Glucagon-like peptide 1(glp-1) pharmaceutical formulations

Country Status (11)

Country Link
EP (1) EP2010155A2 (en)
JP (3) JP5415938B2 (en)
KR (3) KR101558829B1 (en)
CN (2) CN104288756A (en)
AU (1) AU2007238000B2 (en)
BR (1) BRPI0709964A2 (en)
CA (1) CA2646400A1 (en)
HK (1) HK1206241A1 (en)
MX (1) MX2008013216A (en)
RU (3) RU2409349C2 (en)
WO (1) WO2007121411A2 (en)

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US8623817B2 (en) 2008-08-11 2014-01-07 Mannkind Corporation Method of treating diabetes type 2 by administering ultrarapid acting insulin
US8785396B2 (en) 2007-10-24 2014-07-22 Mannkind Corporation Method and composition for treating migraines
US8871772B2 (en) 2008-05-27 2014-10-28 Ampio Pharmaceuticals, Inc. Therapeutic methods and compounds
US8889099B2 (en) 1999-06-29 2014-11-18 Mannkind Corporation Methods and compositions for delivering peptides
US8912193B2 (en) 2008-06-13 2014-12-16 Mannkind Corporation Dry powder inhaler and system for drug delivery
US8980834B2 (en) 2011-10-10 2015-03-17 Ampio Pharmaceuticals, Inc. Treatment of degenerative joint disease
US9006175B2 (en) 1999-06-29 2015-04-14 Mannkind Corporation Potentiation of glucose elimination
US9034878B2 (en) 2010-09-07 2015-05-19 Ampio Pharmaceuticals, Inc. Treatment of diseases
US9220687B2 (en) 2008-12-29 2015-12-29 Mannkind Corporation Substituted diketopiperazine analogs for use as drug delivery agents
US9233159B2 (en) 2011-10-24 2016-01-12 Mannkind Corporation Methods and compositions for treating pain
US9241903B2 (en) 2006-02-22 2016-01-26 Mannkind Corporation Method for improving the pharmaceutic properties of microparticles comprising diketopiperazine and an active agent
US9283193B2 (en) 2005-09-14 2016-03-15 Mannkind Corporation Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
US9358352B2 (en) 2008-06-13 2016-06-07 Mannkind Corporation Dry powder drug delivery system and methods
US9364619B2 (en) 2008-06-20 2016-06-14 Mannkind Corporation Interactive apparatus and method for real-time profiling of inhalation efforts
US9364436B2 (en) 2011-06-17 2016-06-14 Mannkind Corporation High capacity diketopiperazine microparticles and methods
US9393372B2 (en) 2008-06-13 2016-07-19 Mannkind Corporation Dry powder drug delivery system
US9675674B2 (en) 2004-08-23 2017-06-13 Mannkind Corporation Diketopiperazine salts for drug delivery and related methods

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US8921311B2 (en) 2003-08-01 2014-12-30 Mannkind Corporation Method for treating hyperglycemia
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CA2646400A1 (en) * 2006-04-14 2007-10-25 Mannkind Corporation Glucagon-like peptide 1(glp-1) pharmaceutical formulations
WO2009055740A2 (en) * 2007-10-24 2009-04-30 Mannkind Corporation Method of preventing adverse effects by glp-1
WO2009055742A2 (en) * 2007-10-24 2009-04-30 Mannkind Corporation Delivery of active agents
DK2379100T3 (en) * 2009-01-08 2014-12-01 Mannkind Corp Treatment of hyperglycemia with GLP-1
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BR112014008036A2 (en) 2011-10-28 2017-04-11 Ampio Pharmaceuticals Inc rhinitis treatment
MX366405B (en) * 2012-07-01 2019-07-08 Novo Nordisk As Use of long-acting glp-1 peptides.
US9802012B2 (en) 2012-07-12 2017-10-31 Mannkind Corporation Dry powder drug delivery system and methods
JP2015526523A (en) * 2012-08-29 2015-09-10 マンカインド コーポレイション Methods and compositions for the treatment of hyperglycemia
UA116217C2 (en) 2012-10-09 2018-02-26 Санофі Exendin-4 derivatives as dual glp1/glucagon agonists
WO2014066856A1 (en) 2012-10-26 2014-05-01 Mannkind Corporation Inhalable influenza vaccine compositions and methods
PL2934567T3 (en) 2012-12-21 2018-10-31 Sanofi Exendin-4 derivatives as dual glp1/gip- or trigonal glp1/gip/glucagon agonists
US9808454B2 (en) 2013-03-15 2017-11-07 Ampio Pharmaceuticals, Inc. Compositions for the mobilization, homing, expansion and differentiation of stem cells and methods of using the same
KR102391750B1 (en) * 2013-03-15 2022-04-28 맨카인드 코포레이션 Microcrystalline diketopiperazine compositions and methods
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US11446127B2 (en) 2013-08-05 2022-09-20 Mannkind Corporation Insufflation apparatus and methods
US9173924B2 (en) 2013-08-22 2015-11-03 Zp Opco, Inc. Stable glucagon peptide formulations
US9782344B2 (en) 2013-08-22 2017-10-10 Zp Opco, Inc. Stable glucagon peptide formulations
TW201609799A (en) 2013-12-13 2016-03-16 賽諾菲公司 Dual GLP-1/GIP receptor agonists
EP3080149A1 (en) 2013-12-13 2016-10-19 Sanofi Dual glp-1/glucagon receptor agonists
WO2015086730A1 (en) 2013-12-13 2015-06-18 Sanofi Non-acylated exendin-4 peptide analogues
WO2015086728A1 (en) 2013-12-13 2015-06-18 Sanofi Exendin-4 peptide analogues as dual glp-1/gip receptor agonists
JP6397984B2 (en) 2014-03-18 2018-09-26 アペプティコ・フォルシュング・ウント・エントヴィックルング・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツングＡｐｅｐｔｉｃｏ Ｆｏｒｓｃｈｕｎｇ Ｕｎｄ Ｅｎｔｗｉｃｋｌｕｎｇ Ｇｍｂｈ Dry powder peptide medicine
US10307464B2 (en) 2014-03-28 2019-06-04 Mannkind Corporation Use of ultrarapid acting insulin
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
TW201625670A (en) 2014-04-07 2016-07-16 賽諾菲公司 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
KR20170045274A (en) 2014-08-18 2017-04-26 앰피오 파마슈티컬스 인코퍼레이티드 Treatment of joint conditions
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