BR112021020941A2 - Composição farmacêutica parenteral isotônica, método para melhoria da estabilidade química da dita composição e uso de manitol - Google Patents

Composição farmacêutica parenteral isotônica, método para melhoria da estabilidade química da dita composição e uso de manitol

Info

Publication number
BR112021020941A2
BR112021020941A2 BR112021020941A BR112021020941A BR112021020941A2 BR 112021020941 A2 BR112021020941 A2 BR 112021020941A2 BR 112021020941 A BR112021020941 A BR 112021020941A BR 112021020941 A BR112021020941 A BR 112021020941A BR 112021020941 A2 BR112021020941 A2 BR 112021020941A2
Authority
BR
Brazil
Prior art keywords
composition
mannitol
improving
chemical stability
pharmaceutical composition
Prior art date
Application number
BR112021020941A
Other languages
English (en)
Inventor
Vincent Gordon Edwards Alistair
Lise Giehm
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 BR112021020941A2 publication Critical patent/BR112021020941A2/pt

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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
    • 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
    • A61K9/0029—Parenteral nutrition; Parenteral nutrition compositions as drug carriers
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/26—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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/542—Carboxylic acids, e.g. a fatty acid or an amino acid
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • 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
    • 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
    • A61P1/12—Antidiarrhoeals
    • 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
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • 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
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • 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
    • A61P3/06—Antihyperlipidemics
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/001—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof by chemical synthesis
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Landscapes

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

Abstract

composição farmacêutica parenteral isotônica, método para melhoria da estabilidade química da dita composição e uso de manitol. a presente invenção se refere a composições farmacêuticas adequadas para a administração parenteral em sujeitos humanos. em particular, a presente invenção se refere a composições farmacêuticas isotônicas para a administração parenteral.
BR112021020941A 2019-06-14 2020-06-12 Composição farmacêutica parenteral isotônica, método para melhoria da estabilidade química da dita composição e uso de manitol BR112021020941A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP19180233 2019-06-14
PCT/EP2020/066376 WO2020249778A1 (en) 2019-06-14 2020-06-12 Pharmaceutical parenteral composition of dual glp1/2 agonist

Publications (1)

Publication Number Publication Date
BR112021020941A2 true BR112021020941A2 (pt) 2021-12-21

Family

ID=66867001

Family Applications (2)

Application Number Title Priority Date Filing Date
BR112021020941A BR112021020941A2 (pt) 2019-06-14 2020-06-12 Composição farmacêutica parenteral isotônica, método para melhoria da estabilidade química da dita composição e uso de manitol
BR112021024651A BR112021024651A2 (pt) 2019-06-14 2020-06-12 Composição farmacêutica parenteral isotônica, método para melhoria da estabilidade química da dita composição e uso de manitol ou um sal

Family Applications After (1)

Application Number Title Priority Date Filing Date
BR112021024651A BR112021024651A2 (pt) 2019-06-14 2020-06-12 Composição farmacêutica parenteral isotônica, método para melhoria da estabilidade química da dita composição e uso de manitol ou um sal

Country Status (14)

Country Link
US (2) US20230212227A1 (pt)
EP (2) EP3982920A1 (pt)
JP (2) JP2022535555A (pt)
KR (2) KR20220020819A (pt)
CN (2) CN113966226A (pt)
AU (2) AU2020293576A1 (pt)
BR (2) BR112021020941A2 (pt)
CA (2) CA3138716A1 (pt)
CL (2) CL2021003273A1 (pt)
IL (2) IL286990A (pt)
MX (2) MX2021015153A (pt)
SG (2) SG11202111311WA (pt)
WO (2) WO2020249778A1 (pt)
ZA (1) ZA202107825B (pt)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240316155A1 (en) 2021-02-18 2024-09-26 Zealand Pharma A/S Composition for treating short bowel syndrome
CA3228429A1 (en) 2021-09-03 2023-03-09 Mikkel Askjar Agersnap Dosage regime
CN116655772A (zh) * 2022-02-18 2023-08-29 成都奥达生物科技有限公司 一种长效的glp-1/glp-2双激动剂化合物
EP4323413A1 (en) * 2022-03-30 2024-02-21 Beijing QL Biopharmaceutical Co., Ltd. Liquid pharmaceutical compositions of polypeptide conjugates and methods of uses thereof
WO2024061919A1 (en) * 2022-09-19 2024-03-28 Zealand Pharma A/S Combination therapy

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CZ295838B6 (cs) 1996-09-09 2005-11-16 Zealand Pharma A/S Způsob výroby peptidů
BR112014027345A2 (pt) 2012-05-03 2019-09-03 Zealand Pharma As análogos de peptídeo 2 semelhante ao glucagon (glp-2)
JP6682432B2 (ja) * 2013-11-06 2020-04-15 ジーランド ファーマ アクティーゼルスカブ Ｇｉｐ−ｇｌｐ−１デュアルアゴニスト化合物及び方法
US20180280480A1 (en) 2014-10-31 2018-10-04 Gubra Aps Compositions and peptides having dual glp-1r and glp-2r agonist activity
WO2018104558A1 (en) * 2016-12-09 2018-06-14 Zealand Pharma A/S Acylated glp-1/glp-2 dual agonists
MX2019006486A (es) 2016-12-09 2019-08-01 Zealand Pharma As Agonistas duales acilados de glp-1/glp-2.

Also Published As

Publication number Publication date
WO2020249782A1 (en) 2020-12-17
JP2022535555A (ja) 2022-08-09
US20230212227A1 (en) 2023-07-06
MX2021015153A (es) 2022-01-18
SG11202111311WA (en) 2021-12-30
ZA202107825B (en) 2024-02-28
CN113966225A (zh) 2022-01-21
EP3982920A1 (en) 2022-04-20
CN113966226A (zh) 2022-01-21
KR20220020819A (ko) 2022-02-21
KR20220020821A (ko) 2022-02-21
MX2021015154A (es) 2022-01-18
JP2022535556A (ja) 2022-08-09
CA3138716A1 (en) 2020-12-17
WO2020249778A1 (en) 2020-12-17
CL2021003273A1 (es) 2022-07-22
AU2020290014A1 (en) 2021-11-04
AU2020290014B2 (en) 2022-10-27
US20220202704A1 (en) 2022-06-30
CA3138715A1 (en) 2020-12-17
EP3982919A1 (en) 2022-04-20
SG11202111312UA (en) 2021-12-30
AU2020293576A1 (en) 2021-11-04
IL286991A (en) 2021-12-01
BR112021024651A2 (pt) 2022-01-04
CL2021003272A1 (es) 2022-07-22
IL286990A (en) 2021-12-01

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