KR20220011697A - 테를리프레신 제형 - Google Patents

테를리프레신 제형 Download PDF

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Publication number
KR20220011697A
KR20220011697A KR1020217041832A KR20217041832A KR20220011697A KR 20220011697 A KR20220011697 A KR 20220011697A KR 1020217041832 A KR1020217041832 A KR 1020217041832A KR 20217041832 A KR20217041832 A KR 20217041832A KR 20220011697 A KR20220011697 A KR 20220011697A
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KR
South Korea
Prior art keywords
composition
terlipressin
acid
pharmaceutically acceptable
agent
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
KR1020217041832A
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English (en)
Korean (ko)
Inventor
페네로프 마크햄
조나단 아담스
데니스 스미스
조지 바카르딧 카바도
Original Assignee
바이오비에 아이앤씨.
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Application filed by 바이오비에 아이앤씨. filed Critical 바이오비에 아이앤씨.
Publication of KR20220011697A publication Critical patent/KR20220011697A/ko
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/095—Oxytocins; Vasopressins; Related peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • A61K38/2278—Vasoactive intestinal peptide [VIP]; Related peptides (e.g. Exendin)
    • 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
    • A61K47/12—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
    • A61K47/16—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
    • 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
    • A61K9/08—Solutions
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
KR1020217041832A 2019-05-22 2020-05-22 테를리프레신 제형 Pending KR20220011697A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962851366P 2019-05-22 2019-05-22
US62/851,366 2019-05-22
PCT/US2020/034269 WO2020237170A1 (en) 2019-05-22 2020-05-22 Formulations of terlipressin

Publications (1)

Publication Number Publication Date
KR20220011697A true KR20220011697A (ko) 2022-01-28

Family

ID=73458147

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020217041832A Pending KR20220011697A (ko) 2019-05-22 2020-05-22 테를리프레신 제형

Country Status (11)

Country Link
US (3) US12156898B2 (enExample)
EP (1) EP3972628A4 (enExample)
JP (1) JP7579811B2 (enExample)
KR (1) KR20220011697A (enExample)
CN (1) CN114096267B (enExample)
AU (1) AU2020279395B2 (enExample)
BR (1) BR112021023274A2 (enExample)
CA (1) CA3141488A1 (enExample)
CL (1) CL2021003065A1 (enExample)
MX (1) MX2021014310A (enExample)
WO (1) WO2020237170A1 (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2020013389A (es) 2018-06-15 2021-03-31 Ferring Bv Composiciones de terlipresina y usos de las mismas.
US20240156895A1 (en) * 2022-10-28 2024-05-16 Mallinckrodt Pharmaceuticals Ireland Limited Compositions for improving kidney function in patients with hepatorenal syndrome
CN115856149B (zh) * 2022-12-26 2023-12-05 哈尔滨吉象隆生物技术有限公司 一种特利加压素中杂质的检测方法

Family Cites Families (47)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5482931A (en) 1993-06-29 1996-01-09 Ferring Ab Stabilized pharmaceutical peptide compositions
AT409081B (de) 2000-02-16 2002-05-27 Gebro Pharma Gmbh Stabile, nasal, oral oder sublingual anwendbare pharmazeutische zubereitung
EP1188443A1 (en) 2000-09-15 2002-03-20 Ferring BV Improved protocol for paracentesis
DE10114178A1 (de) 2001-03-23 2002-10-10 Aventis Pharma Gmbh Zinkfreie und zinkarme Insulinzubereitungen mit verbesserter Stabilität
US20040153032A1 (en) * 2002-04-23 2004-08-05 Garribotto John T. Dispenser for patient infusion device
US6991800B2 (en) 2002-06-13 2006-01-31 Vicuron Pharmaceuticals Inc. Antifungal parenteral products
US20040022792A1 (en) * 2002-06-17 2004-02-05 Ralph Klinke Method of stabilizing proteins at low pH
BRPI0406668A (pt) * 2003-01-09 2005-12-20 Baxter Healthcare Sa Recipiente de segurança, processo para a produção do mesmo, e, uso de um meio que contém pelo menos um polìmero
GT200600031A (es) 2005-01-28 2006-08-29 Formulacion anticuerpo anti a beta
WO2006138181A2 (en) 2005-06-14 2006-12-28 Amgen Inc. Self-buffering protein formulations
DK1984012T3 (en) 2006-02-13 2016-03-29 Ferring Bv USE OF peptidic vasopressin receptor agonists
GB0700523D0 (en) 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
US20100311655A1 (en) 2007-06-07 2010-12-09 Mdrna, Inc. Intranasal carbetocin formulations and methods for the treatment of autism
US7960336B2 (en) 2007-08-03 2011-06-14 Pharmain Corporation Composition for long-acting peptide analogs
US9050286B2 (en) 2007-08-14 2015-06-09 Ferring B.V. Use of peptidic vasopression receptor agonists
US20100311642A1 (en) 2007-09-28 2010-12-09 Ferring B.V. Use of v2 receptor antagonists in combination with vaso pressinergic agnosts
WO2009062174A1 (en) 2007-11-08 2009-05-14 University Of Utah Research Foundation Use of angiogenesis antagonists in conditions of abnormal venous proliferation
KR20210049186A (ko) 2007-11-30 2021-05-04 애브비 바이오테크놀로지 리미티드 단백질 제형 및 이의 제조방법
US8815232B2 (en) 2008-08-26 2014-08-26 Kyon Biotech Ag Compositions and methods for treating cancer
EP2161030A1 (en) * 2008-09-09 2010-03-10 Rijksuniversiteit te Groningen Oxytocin formulations and uses thereof
EP2344200A2 (en) * 2008-09-19 2011-07-20 Nektar Therapeutics Modified therapeutics peptides, methods of their preparation and use
EP2346901A1 (en) 2008-10-20 2011-07-27 Abbott Laboratories Antibodies that bind to il-18 and methods of purifying the same
US20100203014A1 (en) 2009-02-04 2010-08-12 Aegis Therapeutics Llc Zwitterionic buffered acidic peptide and protein formulations
US20100260739A1 (en) 2009-03-09 2010-10-14 Bioatla, Llc Mirac Proteins
EP2440200B8 (en) 2009-06-08 2014-10-15 UCL Business PLC Treatment of portal hypertension using l-ornithine phenylacetate
EP2446552B1 (en) * 2009-06-24 2016-08-10 Nokia Solutions and Networks Oy Relay node and method for changing the timeslot type according to the received information
US8613892B2 (en) * 2009-06-30 2013-12-24 Abbott Diabetes Care Inc. Analyte meter with a moveable head and methods of using the same
AU2011279144A1 (en) 2010-07-14 2013-01-24 Cumberland Emerging Technologies, Inc Methods of treating hepatorenal syndrome and hepatic encephalopathy with thromboxane-A2 receptor antagonists
JO3400B1 (ar) 2010-09-30 2019-10-20 Ferring Bv مركب صيدلاني من كاربيتوسين
CN102440957B (zh) * 2011-12-16 2013-09-25 深圳市健元医药科技有限公司 醋酸特利加压素鼻腔喷雾剂及其制备方法
WO2013106072A1 (en) 2012-01-10 2013-07-18 Sorbent Therapeutics, Inc. Compositions comprising crosslinked cation-binding polymers and uses thereof
JO3109B1 (ar) 2012-05-10 2017-09-20 Ferring Bv منبهات لمستقبلات v1a
CA2891281C (en) 2012-11-12 2023-11-28 The Regents Of The University Of Colorado, A Body Corporate Disease severity index for assessment of chronic liver disease and method for diagnosis of three distinct subtypes of primary sclerosing cholangitis
AU2014256944B2 (en) 2013-04-26 2019-06-27 La Jolla Pharma, Llc Compositions and methods for treating renal failure
US20150056194A1 (en) 2013-08-21 2015-02-26 Georgia Regents Research Institute, Inc. Modified green tea polyphenols and methods thereof for treating liver disease
US20150328317A1 (en) 2014-05-13 2015-11-19 Eagle Pharmaceuticals, Inc. Aqueous buffer-free bivalirudin compositions
US20200237856A1 (en) 2014-10-24 2020-07-30 Mallinckrodt Hospital Products IP Limited Method of treating patients with hepatorenal syndrome type 1
US20200046798A1 (en) 2014-10-24 2020-02-13 Mallinckrodt Hospital Products IP Limited Method of treating patients with hepatorenal syndrome type 1
CN107206049B (zh) 2014-10-24 2021-12-07 马林克罗特医疗产品知识产权公司 治疗患1型肝肾综合征的患者的方法
WO2017150824A1 (ko) 2016-03-03 2017-09-08 가천대학교 산학협력단 마이크로 니들 및 이의 제조방법
US20190249173A1 (en) * 2016-05-04 2019-08-15 Chandra Vargeese Methods and compositions of biologically active agents
GB201721846D0 (en) 2017-12-22 2018-02-07 Arecor Ltd Novel composition
US11318183B2 (en) * 2018-03-20 2022-05-03 Mankind Pharma Ltd. Stable pharmaceutical composition of vasopressin
MX2020013389A (es) 2018-06-15 2021-03-31 Ferring Bv Composiciones de terlipresina y usos de las mismas.
CN108659104B (zh) * 2018-07-03 2020-06-09 北京市新里程医药科技有限公司 一种特利加压素的制备方法及其药物组合物
CN109010795B (zh) * 2018-09-12 2021-10-22 南京康舟医药科技有限公司 醋酸特利加压素注射液以及其制备方法
WO2020128499A1 (en) * 2018-12-21 2020-06-25 Arecor Limited Novel composition

Also Published As

Publication number Publication date
CN114096267A (zh) 2022-02-25
WO2020237170A1 (en) 2020-11-26
CN114096267B (zh) 2025-03-18
MX2021014310A (es) 2022-01-26
CL2021003065A1 (es) 2023-01-06
JP7579811B2 (ja) 2024-11-08
US20250249066A1 (en) 2025-08-07
AU2020279395A1 (en) 2021-12-16
CA3141488A1 (en) 2020-11-26
JP2022533759A (ja) 2022-07-25
BR112021023274A2 (pt) 2022-03-08
US20220233634A1 (en) 2022-07-28
EP3972628A1 (en) 2022-03-30
AU2020279395B2 (en) 2025-08-28
US20220202907A1 (en) 2022-06-30
EP3972628A4 (en) 2023-01-18
US12156898B2 (en) 2024-12-03

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