MX2021003271A - Formulaciones de analogos del peptido similar a glucagon tipo 2 (glp-2). - Google Patents

Formulaciones de analogos del peptido similar a glucagon tipo 2 (glp-2).

Info

Publication number
MX2021003271A
MX2021003271A MX2021003271A MX2021003271A MX2021003271A MX 2021003271 A MX2021003271 A MX 2021003271A MX 2021003271 A MX2021003271 A MX 2021003271A MX 2021003271 A MX2021003271 A MX 2021003271A MX 2021003271 A MX2021003271 A MX 2021003271A
Authority
MX
Mexico
Prior art keywords
glp
analogues
formulations
liquid formulations
glucagon
Prior art date
Application number
MX2021003271A
Other languages
English (en)
Inventor
Lise Giehm
Claes Melander
Eva Horn Møller
Original Assignee
Zealand Pharma As
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 Zealand Pharma As filed Critical Zealand Pharma As
Publication of MX2021003271A publication Critical patent/MX2021003271A/es

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
    • A61K9/08—Solutions
    • 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
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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

Landscapes

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

Abstract

Se describen formulaciones líquidas de análogos del GLP-2 que las hacen adecuadas para un almacenamiento a largo plazo como líquidos y/o que las hacen especialmente adecuadas para su administración mediante un dispositivo de administración de fármacos. También se describen composiciones sólidas que comprenden sales de acetato de análogos del péptido similar a glucagón tipo 2 (GLP-2) útiles para preparar las formulaciones líquidas. El desarrollo de estas formulaciones líquidas se basa en el hallazgo de que el acetato presente en la formulación que proviene de los análogos del GLP-2 tiene un efecto sobre la viscosidad de la formulación, que durante un almacenamiento a largo plazo a 2-8 °C de los análogos del GLP-2, la dependencia con la concentración para la formación de oligómeros covalentes es inversamente dependiente del aumento de la concentración del análogo del GLP-2, y que los análogos del GLP-2 usados en las formulaciones no son compatibles con el tampón fosfato usado habitualmente en la técnica anterior para composiciones de GLP-2 reconstituidas en polvo o liofilizadas.
MX2021003271A 2018-09-28 2019-09-27 Formulaciones de analogos del peptido similar a glucagon tipo 2 (glp-2). MX2021003271A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18197755.4A EP3628683A1 (en) 2018-09-28 2018-09-28 Formulations of glucagon-like-peptide-2 (glp-2) analogues
PCT/EP2019/076305 WO2020065064A1 (en) 2018-09-28 2019-09-27 Formulations of glucagon-like-peptide-2 (glp-2) analogues

Publications (1)

Publication Number Publication Date
MX2021003271A true MX2021003271A (es) 2021-05-12

Family

ID=63794308

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021003271A MX2021003271A (es) 2018-09-28 2019-09-27 Formulaciones de analogos del peptido similar a glucagon tipo 2 (glp-2).

Country Status (13)

Country Link
US (2) US20220265551A1 (es)
EP (2) EP3628683A1 (es)
JP (1) JP7566730B2 (es)
KR (1) KR20210069056A (es)
CN (2) CN118267455A (es)
AU (1) AU2019348538A1 (es)
BR (1) BR112021005858A2 (es)
CA (1) CA3114330A1 (es)
CL (1) CL2021000678A1 (es)
IL (1) IL281362A (es)
MX (1) MX2021003271A (es)
SG (1) SG11202102383VA (es)
WO (1) WO2020065064A1 (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL298298A (en) * 2020-05-22 2023-01-01 Hanmi Pharm Ind Co Ltd A liquid formulation of a long-acting conjugate of glp–2
US20240091317A1 (en) * 2020-12-16 2024-03-21 Zealand Pharma A/S Use of glp-2 analogues in patients with renal insufficiency
CA3231402A1 (en) * 2021-09-10 2023-03-16 Eva Horn Moller Process for formulating compositions comprising glucagon-like-peptide-2 (glp-2) analogues
IL313732A (en) 2021-12-23 2024-08-01 Zealand Pharma As Processes for the synthesis of glucagon-like peptide 2 (Galfi-2) analogs
WO2024068933A1 (en) 2022-09-30 2024-04-04 Zealand Pharma A/S Glucagon-like-peptide-2 (glp-2) analogues and their medical uses for the treatment of short bowel syndrome (sbs)
WO2024075135A1 (en) * 2022-10-03 2024-04-11 Orbicular Pharmaceutical Technologies Private Limited "stable injectable compositions of glp-2 peptide"
WO2024156884A1 (en) 2023-01-27 2024-08-02 Zealand Pharma A/S Glucagon-like-peptide-2 (glp-2) analogues and their medical uses for the treatment of short bowel syndrome (sbs)

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HU225496B1 (en) * 1993-04-07 2007-01-29 Scios Inc Pharmaceutical compositions of prolonged delivery, containing peptides
US5789379A (en) 1995-04-14 1998-08-04 Allelix Biopharmaceutical Inc. Glucagon-like peptide-2 analogs
US6184201B1 (en) 1995-04-14 2001-02-06 Nps Allelix Corp. Intestinotrophic glucagon-like peptide-2 analogs
DK1231219T3 (da) 1996-04-12 2010-12-20 Ontario Inc 1149336 GLucagon-lignende peptid-2 analoger
EP1076066A1 (en) 1999-07-12 2001-02-14 Zealand Pharmaceuticals A/S Peptides for lowering blood glucose levels
US20030040478A1 (en) 1999-12-08 2003-02-27 Drucker Daniel J Chemotherapy treatment
GB9930882D0 (en) 1999-12-30 2000-02-23 Nps Allelix Corp GLP-2 formulations
CA2436399A1 (en) 2001-02-16 2002-08-29 Conjuchem Inc. Long lasting glucagon-like peptide 2 (glp-2) for the treatment of gastrointestinal diseases and disorders
NZ591178A (en) * 2005-05-04 2012-06-29 Zealand Pharma As Glucagon-like-peptide-2 (glp-2) analogues
US20090105341A1 (en) * 2005-12-24 2009-04-23 Teagasc Dairy Products Research Centre Process for the production of trans-10, cis 12 octadecadienoic acid
US20090028832A1 (en) * 2006-08-10 2009-01-29 Chung Leland F Compositions and methods for targeted tumor therapy
NZ576260A (en) * 2006-11-08 2012-04-27 Zealand Pharma As GLUCAGON-LIKE-PEPTIDE-2 (GLP-2) ANALOGUES comprising one of more substitutions as compared to h[Gly2]GLP-2
KR101247665B1 (ko) * 2006-12-29 2013-04-02 입센 파마 에스.에이.에스 Ｇｌｐ―１ 약학 조성물
JP2013533217A (ja) * 2010-05-17 2013-08-22 セビックス・インコーポレイテッド Ｐｅｇ化ｃ−ペプチド
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JP2019535734A (ja) * 2016-11-21 2019-12-12 アイガー・バイオファーマシューティカルズ・インコーポレイテッドＥｉｇｅｒ Ｂｉｏｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． エキセンディン（９−３９）の緩衝製剤

Also Published As

Publication number Publication date
CA3114330A1 (en) 2020-04-02
US20220265551A1 (en) 2022-08-25
CN118267455A (zh) 2024-07-02
WO2020065064A1 (en) 2020-04-02
EP3856766A1 (en) 2021-08-04
KR20210069056A (ko) 2021-06-10
US20240065978A1 (en) 2024-02-29
JP2022502432A (ja) 2022-01-11
EP3628683A1 (en) 2020-04-01
IL281362A (en) 2021-04-29
SG11202102383VA (en) 2021-04-29
JP7566730B2 (ja) 2024-10-15
CN112771073A (zh) 2021-05-07
BR112021005858A2 (pt) 2021-07-27
CL2021000678A1 (es) 2021-08-06
AU2019348538A1 (en) 2021-05-20

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