EP3397269A4 - Stable glucagon peptide formulations - Google Patents

Stable glucagon peptide formulations Download PDF

Info

Publication number
EP3397269A4
EP3397269A4 EP16863067.1A EP16863067A EP3397269A4 EP 3397269 A4 EP3397269 A4 EP 3397269A4 EP 16863067 A EP16863067 A EP 16863067A EP 3397269 A4 EP3397269 A4 EP 3397269A4
Authority
EP
European Patent Office
Prior art keywords
glucagon peptide
peptide formulations
stable glucagon
stable
formulations
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.)
Pending
Application number
EP16863067.1A
Other languages
German (de)
French (fr)
Other versions
EP3397269A1 (en
Inventor
Mahmoud Ameri
Peter E. Daddona
Yi Ao
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.)
Emergex USA Corp
Original Assignee
Zp Opco 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
Priority claimed from US14/930,041 external-priority patent/US9782344B2/en
Application filed by Zp Opco Inc filed Critical Zp Opco Inc
Publication of EP3397269A1 publication Critical patent/EP3397269A1/en
Publication of EP3397269A4 publication Critical patent/EP3397269A4/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0046Solid microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0061Methods for using microneedles

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)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
EP16863067.1A 2015-11-02 2016-11-04 Stable glucagon peptide formulations Pending EP3397269A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/930,041 US9782344B2 (en) 2013-08-22 2015-11-02 Stable glucagon peptide formulations
PCT/US2016/060601 WO2017079611A1 (en) 2015-11-02 2016-11-04 Stable glucagon peptide formulations

Publications (2)

Publication Number Publication Date
EP3397269A1 EP3397269A1 (en) 2018-11-07
EP3397269A4 true EP3397269A4 (en) 2019-09-04

Family

ID=58662794

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16863067.1A Pending EP3397269A4 (en) 2015-11-02 2016-11-04 Stable glucagon peptide formulations

Country Status (2)

Country Link
EP (1) EP3397269A4 (en)
WO (1) WO2017079611A1 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3416618A1 (en) 2016-02-19 2018-12-26 ZP Opco, Inc. Method of rapidly achieving therapeutic concentrations of triptans for treatment of migraines
US11660264B2 (en) 2017-08-23 2023-05-30 Emergex USA Corporation Method of rapidly achieving therapeutic concentrations of triptans for treatment of migraines and cluster headaches
US11660265B2 (en) 2018-06-28 2023-05-30 Emergex USA Corporation Method of rapidly achieving therapeutic concentrations of triptans for treatment of migraines and cluster headaches

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09241295A (en) * 1996-03-06 1997-09-16 Shiseido Co Ltd Skin preparation for external use
US20110097386A1 (en) * 2009-10-22 2011-04-28 Biodel, Inc. Stabilized glucagon solutions

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE221400T1 (en) 1997-12-11 2002-08-15 Alza Corp DEVICE FOR INCREASE THE TRANSDERMAL FLOW OF ACTIVE INGREDIENTS
IL155389A0 (en) 2000-10-13 2003-11-23 Alza Corportion Microprotrusion member retainer for impact applicator
IL155583A0 (en) 2000-10-26 2003-11-23 Alza Corp Transdermal drug delivery devices having coated microprotrusions
US6855372B2 (en) 2001-03-16 2005-02-15 Alza Corporation Method and apparatus for coating skin piercing microprojections
WO2007011958A2 (en) * 2005-07-15 2007-01-25 Emisphere Technologies, Inc. Intraoral dosage forms of glucagon
WO2011162830A2 (en) * 2010-06-24 2011-12-29 Biousian Biosystems, Inc. Glucagon-like peptide-1 glycopeptides
US9782344B2 (en) * 2013-08-22 2017-10-10 Zp Opco, Inc. Stable glucagon peptide formulations
WO2015027173A1 (en) * 2013-08-22 2015-02-26 Zp Opco, Inc. Stable glucagon peptide formulations

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09241295A (en) * 1996-03-06 1997-09-16 Shiseido Co Ltd Skin preparation for external use
US20110097386A1 (en) * 2009-10-22 2011-04-28 Biodel, Inc. Stabilized glucagon solutions

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2017079611A1 *

Also Published As

Publication number Publication date
WO2017079611A1 (en) 2017-05-11
EP3397269A1 (en) 2018-11-07

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Owner name: EMERGEX USA CORPORATION