KR20250023993A - L-오르니틴 페닐아세테이트의 제제 - Google Patents

L-오르니틴 페닐아세테이트의 제제 Download PDF

Info

Publication number
KR20250023993A
KR20250023993A KR1020247042587A KR20247042587A KR20250023993A KR 20250023993 A KR20250023993 A KR 20250023993A KR 1020247042587 A KR1020247042587 A KR 1020247042587A KR 20247042587 A KR20247042587 A KR 20247042587A KR 20250023993 A KR20250023993 A KR 20250023993A
Authority
KR
South Korea
Prior art keywords
phenylacetylglutamine
plasma
phenylacetate
auc
oral pharmaceutical
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
KR1020247042587A
Other languages
English (en)
Korean (ko)
Inventor
로렌 왕
린다 에스 그레이스
스탠리 버코프저
Original Assignee
오세라 테라퓨틱스, 아이엔씨.
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 US15/133,087 external-priority patent/US20160338982A1/en
Application filed by 오세라 테라퓨틱스, 아이엔씨. filed Critical 오세라 테라퓨틱스, 아이엔씨.
Publication of KR20250023993A publication Critical patent/KR20250023993A/ko
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/02Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Obesity (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
KR1020247042587A 2015-11-13 2016-11-11 L-오르니틴 페닐아세테이트의 제제 Pending KR20250023993A (ko)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US201562255300P 2015-11-13 2015-11-13
US62/255,300 2015-11-13
US201662276754P 2016-01-08 2016-01-08
US62/276,754 2016-01-08
US15/133,087 US20160338982A1 (en) 2015-04-20 2016-04-19 Formulations of l-ornithine phenylacetate
US15/133,087 2016-04-19
PCT/US2016/061678 WO2017083758A1 (en) 2015-11-13 2016-11-11 Formulation of l-ornithine phenylacetate
KR1020187016373A KR20180086431A (ko) 2015-11-13 2016-11-11 L-오르니틴 페닐아세테이트의 제제

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020187016373A Division KR20180086431A (ko) 2015-11-13 2016-11-11 L-오르니틴 페닐아세테이트의 제제

Publications (1)

Publication Number Publication Date
KR20250023993A true KR20250023993A (ko) 2025-02-18

Family

ID=58695607

Family Applications (2)

Application Number Title Priority Date Filing Date
KR1020247042587A Pending KR20250023993A (ko) 2015-11-13 2016-11-11 L-오르니틴 페닐아세테이트의 제제
KR1020187016373A Ceased KR20180086431A (ko) 2015-11-13 2016-11-11 L-오르니틴 페닐아세테이트의 제제

Family Applications After (1)

Application Number Title Priority Date Filing Date
KR1020187016373A Ceased KR20180086431A (ko) 2015-11-13 2016-11-11 L-오르니틴 페닐아세테이트의 제제

Country Status (12)

Country Link
EP (1) EP3373923A4 (enExample)
JP (2) JP7294807B2 (enExample)
KR (2) KR20250023993A (enExample)
CN (2) CN108366983A (enExample)
AU (2) AU2016353350B2 (enExample)
BR (1) BR112018009349A8 (enExample)
CA (1) CA3004331A1 (enExample)
IL (1) IL258630B2 (enExample)
MX (2) MX389926B (enExample)
RU (1) RU2018113801A (enExample)
SG (1) SG11201802987UA (enExample)
WO (1) WO2017083758A1 (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20190146A1 (ar) 2016-12-19 2019-06-18 Axcella Health Inc تركيبات حمض أميني وطرق لمعالجة أمراض الكبد
CN111295187A (zh) 2017-08-14 2020-06-16 胺细拉健康公司 用于治疗肝脏疾病的氨基酸组合物
MA52971A (fr) 2018-06-20 2021-04-28 Axcella Health Inc Compositions et procédés pour le traitement de l'infiltration de graisse dans le muscle
JP2022552016A (ja) * 2019-10-16 2022-12-14 オセラ セラピューティクス, インコーポレイテッド 高アンモニア血症を治療するためのオルニチンフェニル酢酸塩の投与量および使用
WO2024261477A1 (en) 2023-06-20 2024-12-26 Yaqrit Limited Combination of tlr4 antagonist, ornithine and phenylacetate or phenylbutyrate

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4783443A (en) 1986-03-03 1988-11-08 The University Of Chicago Amino acyl cephalosporin derivatives
GB0426141D0 (en) * 2004-11-26 2004-12-29 Ucl Biomedica Plc Treatment
WO2006056794A1 (en) * 2004-11-26 2006-06-01 Ucl Business Plc Compositions comprising ornithine and phenylacetate or phenylbutyrate for treating hepatic encephalopathy
DE102007009243A1 (de) * 2007-02-22 2008-09-18 Evonik Röhm Gmbh Pellets mit einer Wirkstoff-Matrix und einem Polymerüberzug, sowie ein Verfahren zur Herstellung der Pellets
AU2015221466B2 (en) * 2009-04-03 2017-02-02 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
CN104230730B (zh) * 2009-04-03 2017-05-24 欧塞拉治疗有限公司 L‑鸟氨酸苯乙酸盐及其制备方法
NZ615091A (en) * 2009-06-08 2015-03-27 Ucl Business Plc Treatment of portal hypertension and restoration of liver function using l-ornithine phenylacetate
AU2014250643B2 (en) 2009-06-08 2016-07-14 Ocera Therapeutics, Inc. Treatment of portal hypertension and restoration of liver function using L-ornithine phenylacetate
KR101888215B1 (ko) 2010-10-06 2018-09-20 오세라 테라퓨틱스, 아이엔씨. L-오르니틴 페닐아세테이트의 제조 방법
CN102993037B (zh) * 2012-11-20 2015-03-04 南京工业大学 一种l-鸟氨酸苯乙酸盐的制备方法
CN103705490B (zh) * 2013-10-31 2016-08-17 蚌埠丰原医药科技发展有限公司 一种门冬氨酸鸟氨酸的缓释制剂及其制备工艺
NZ732632A (en) * 2014-11-24 2021-07-30 Ucl Business Ltd Treatment of diseases associated with hepatic stellate cell activation using ammonia-lowering therapies
JP2018513171A (ja) * 2015-04-20 2018-05-24 オセラ セラピューティクス, インコーポレイテッド L−オルニチンフェニルアセテート製剤
JP6990170B2 (ja) * 2015-08-18 2022-01-12 オセラ セラピューティクス, インコーポレイテッド L-オルニチンをフェニルアセテートおよびフェニルブチレートのうちの少なくとも1つと組み合わせて用いる筋肉喪失の治療および予防
US20200206174A1 (en) * 2015-09-25 2020-07-02 Ocera Therapeutics, Inc. Treatment and prevention of neuronal cell loss using l-ornithine in combination with at least one of phenylacetate and phenylbutyrate

Also Published As

Publication number Publication date
JP2018533601A (ja) 2018-11-15
JP2022058446A (ja) 2022-04-12
BR112018009349A8 (pt) 2019-02-26
IL258630B1 (en) 2023-04-01
EP3373923A1 (en) 2018-09-19
BR112018009349A2 (pt) 2018-11-13
AU2016353350A1 (en) 2018-05-10
EP3373923A4 (en) 2019-07-03
AU2021290236A1 (en) 2022-02-10
MX2018005088A (es) 2019-05-16
JP7294807B2 (ja) 2023-06-20
MX2022001517A (es) 2022-11-16
CN108366983A (zh) 2018-08-03
RU2018113801A (ru) 2019-12-16
CN113768863A (zh) 2021-12-10
IL258630A (en) 2018-06-28
MX389926B (es) 2025-03-20
AU2016353350B2 (en) 2021-09-23
CA3004331A1 (en) 2017-05-18
WO2017083758A1 (en) 2017-05-18
KR20180086431A (ko) 2018-07-31
SG11201802987UA (en) 2018-05-30
IL258630B2 (en) 2023-08-01

Similar Documents

Publication Publication Date Title
US20220202755A1 (en) Formulations of l-ornithine phenylacetate
US20220184014A1 (en) Formulations of l-ornithine phenylacetate
JP2022058446A (ja) L-オルニチンフェニルアセテート製剤
CA2827336C (en) Flumazenil complexes, compositions comprising same and uses thereof
JP6837835B2 (ja) トレハロースの非経口投与によるタンパク質凝集ミオパシーおよび神経変性疾患の治療
KR20120138229A (ko) 정맥내 투여용 이부프로펜을 이용한 중증 환자의 치료
KR20120089623A (ko) 정맥내 투여용 이부프로펜을 이용한 환자의 치료
WO2008057464A2 (en) Compositions and methods for improving the bioavailability of liothyronine
WO2017177160A1 (en) Formulation for use in a method of treatment of pain
JP5128003B2 (ja) 腹膜透析患者用の経口医薬組成物及びその用法
WO2023245470A1 (zh) Mdp类似物在制备用于治疗炎症性肠病的药物中的用途
RU2690372C2 (ru) Лекарственные средства, содержащие диацереин, и способы снижения уровней мочевой кислоты в крови с его использованием
CN115778957A (zh) 千金藤素及包含其的组合物用于预防或治疗酒精性肝病的应用
CN117547537A (zh) Fn-1501及其药物组合物的应用

Legal Events

Date Code Title Description
A107 Divisional application of patent
PA0104 Divisional application for international application

Comment text: Divisional Application for International Patent

Patent event code: PA01041R01D

Patent event date: 20241223

Application number text: 1020187016373

Filing date: 20180608

A201 Request for examination
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20250121

Comment text: Request for Examination of Application

PG1501 Laying open of application