WO2008133908A3 - Suspension formulations of insulinotropic peptides and uses thereof - Google Patents

Suspension formulations of insulinotropic peptides and uses thereof Download PDF

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Publication number
WO2008133908A3
WO2008133908A3 PCT/US2008/005235 US2008005235W WO2008133908A3 WO 2008133908 A3 WO2008133908 A3 WO 2008133908A3 US 2008005235 W US2008005235 W US 2008005235W WO 2008133908 A3 WO2008133908 A3 WO 2008133908A3
Authority
WO
WIPO (PCT)
Prior art keywords
peptide
vehicle
suspension formulations
suspension
insulinotropic peptides
Prior art date
Application number
PCT/US2008/005235
Other languages
French (fr)
Other versions
WO2008133908A2 (en
Inventor
Thomas R Alessi
Ryan D Mercer
Catherine M Rohloff
Bing Yang
Original Assignee
Intarcia Therapeutics Inc
Thomas R Alessi
Ryan D Mercer
Catherine M Rohloff
Bing Yang
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
Priority to DK08743213.4T priority Critical patent/DK2157967T3/en
Application filed by Intarcia Therapeutics Inc, Thomas R Alessi, Ryan D Mercer, Catherine M Rohloff, Bing Yang filed Critical Intarcia Therapeutics Inc
Priority to EP08743213A priority patent/EP2157967B1/en
Priority to MX2009011123A priority patent/MX2009011123A/en
Priority to AU2008244523A priority patent/AU2008244523B2/en
Priority to CN200880012205A priority patent/CN101715340A/en
Priority to PL08743213T priority patent/PL2157967T3/en
Priority to JP2010506245A priority patent/JP5351884B2/en
Priority to CA2683610A priority patent/CA2683610C/en
Priority to SI200830938T priority patent/SI2157967T1/en
Priority to NZ580447A priority patent/NZ580447A/en
Priority to ES08743213T priority patent/ES2402172T3/en
Publication of WO2008133908A2 publication Critical patent/WO2008133908A2/en
Publication of WO2008133908A3 publication Critical patent/WO2008133908A3/en
Priority to IL201175A priority patent/IL201175A/en
Priority to HRP20130259AT priority patent/HRP20130259T1/en
Priority to IL235813A priority patent/IL235813A/en
Priority to IL250929A priority patent/IL250929B/en
Priority to IL280217A priority patent/IL280217B/en
Priority to IL290847A priority patent/IL290847A/en

Links

Classifications

    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/605—Glucagons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04—Linear peptides containing only normal peptide links
    • C07K7/06—Linear peptides containing only normal peptide links having 5 to 11 amino acids
    • C07K7/067—Hemoregulatory peptides based on sequence Glp-Glu-Asp-Cys-Lys
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/494—Fluidic or fluid actuated device making

Abstract

A suspension formulation of an insulinotropic peptide (e.g., glucagon-like peptide- 1 (GLP-1) or exenatide) is described. The suspension formulation comprises (i) a non¬ aqueous, single-phase vehicle, comprising one or more polymer and one or more one solvent, wherein the vehicle exhibits viscous fluid characteristics, and (ii) a particle formulation comprising the insulinotropic peptide, wherein the peptide is dispersed in the vehicle. The particle formulation further includes a stabilizing component comprising one or more stabilizers, for example, carbohydrates, antioxidants, amino acids, and buffers. Devices for delivering the suspension formulations and methods of use are also described.
PCT/US2008/005235 2007-04-23 2008-04-22 Suspension formulations of insulinotropic peptides and uses thereof WO2008133908A2 (en)

Priority Applications (17)

Application Number Priority Date Filing Date Title
CA2683610A CA2683610C (en) 2007-04-23 2008-04-22 Suspension formulations of insulinotropic peptides and uses thereof
EP08743213A EP2157967B1 (en) 2007-04-23 2008-04-22 Suspension formulations of insulinotropic peptides and uses thereof
MX2009011123A MX2009011123A (en) 2007-04-23 2008-04-22 Suspension formulations of insulinotropic peptides and uses thereof.
AU2008244523A AU2008244523B2 (en) 2007-04-23 2008-04-22 Suspension formulations of insulinotropic peptides and uses thereof
CN200880012205A CN101715340A (en) 2007-04-23 2008-04-22 The mixed suspension preparation of insulinotropic peptide and application thereof
PL08743213T PL2157967T3 (en) 2007-04-23 2008-04-22 Suspension formulations of insulinotropic peptides and uses thereof
NZ580447A NZ580447A (en) 2007-04-23 2008-04-22 Suspension formulations of insulinotropic peptides and uses thereof
SI200830938T SI2157967T1 (en) 2007-04-23 2008-04-22 Suspension formulations of insulinotropic peptides and uses thereof
JP2010506245A JP5351884B2 (en) 2007-04-23 2008-04-22 Suspension preparation and use of insulin secretagogue peptide
DK08743213.4T DK2157967T3 (en) 2007-04-23 2008-04-22 Suspension formulations of insulinotropic peptides and applications thereof
ES08743213T ES2402172T3 (en) 2007-04-23 2008-04-22 Suspension formulation of insulinotropic peptides and uses thereof
IL201175A IL201175A (en) 2007-04-23 2009-09-24 Osmotic delivery device containing suspension formulation of insulinotropic peptides and uses thereof
HRP20130259AT HRP20130259T1 (en) 2007-04-23 2013-03-22 Suspension formulations of insulinotropic peptides and uses thereof
IL235813A IL235813A (en) 2007-04-23 2014-11-20 Suspension formulations of insulinotropic peptides and uses thereof
IL250929A IL250929B (en) 2007-04-23 2017-03-05 Suspension formulations of insulinotropic peptides and uses thereof
IL280217A IL280217B (en) 2007-04-23 2021-01-17 Method of manufacturing an osmotic device
IL290847A IL290847A (en) 2007-04-23 2022-02-23 Suspension formulations of insulinotropic peptides and uses thereof

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US92600507P 2007-04-23 2007-04-23
US60/926,005 2007-04-23
US7220208P 2008-03-28 2008-03-28
US61/072,202 2008-03-28

Publications (2)

Publication Number Publication Date
WO2008133908A2 WO2008133908A2 (en) 2008-11-06
WO2008133908A3 true WO2008133908A3 (en) 2009-02-19

Family

ID=39651340

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/005235 WO2008133908A2 (en) 2007-04-23 2008-04-22 Suspension formulations of insulinotropic peptides and uses thereof

Country Status (19)

Country Link
US (5) US8299025B2 (en)
EP (1) EP2157967B1 (en)
JP (7) JP5351884B2 (en)
KR (1) KR101208381B1 (en)
CN (3) CN105688191A (en)
AU (1) AU2008244523B2 (en)
CA (1) CA2683610C (en)
CY (1) CY1114178T1 (en)
DK (1) DK2157967T3 (en)
ES (1) ES2402172T3 (en)
HK (2) HK1200336A1 (en)
HR (1) HRP20130259T1 (en)
IL (5) IL201175A (en)
MX (1) MX2009011123A (en)
NZ (1) NZ580447A (en)
PL (1) PL2157967T3 (en)
PT (1) PT2157967E (en)
RU (1) RU2440097C2 (en)
WO (1) WO2008133908A2 (en)

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US9364519B2 (en) 2011-09-01 2016-06-14 Sanofi-Aventis Deutschland Gmbh Pharmaceutical composition for use in the treatment of a neurodegenerative disease
US9408893B2 (en) 2011-08-29 2016-08-09 Sanofi-Aventis Deutschland Gmbh Pharmaceutical combination for use in glycemic control in diabetes type 2 patients

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