CA3004331A1 - Formulations of l-ornithine phenylacetate - Google Patents

Formulations of l-ornithine phenylacetate Download PDF

Info

Publication number
CA3004331A1
CA3004331A1 CA3004331A CA3004331A CA3004331A1 CA 3004331 A1 CA3004331 A1 CA 3004331A1 CA 3004331 A CA3004331 A CA 3004331A CA 3004331 A CA3004331 A CA 3004331A CA 3004331 A1 CA3004331 A1 CA 3004331A1
Authority
CA
Canada
Prior art keywords
phenylacetylglutamine
plasma
pharmaceutical formulation
phenylacetate
oral
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.)
Abandoned
Application number
CA3004331A
Other languages
English (en)
French (fr)
Inventor
Laurene WANG
Linda S. GRAIS
Stanley Bukofzer
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.)
Ocera Therapeutics Inc
Original Assignee
Ocera Therapeutics 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 US15/133,087 external-priority patent/US20160338982A1/en
Application filed by Ocera Therapeutics Inc filed Critical Ocera Therapeutics Inc
Publication of CA3004331A1 publication Critical patent/CA3004331A1/en
Abandoned 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
    • A61K9/0012Galenical 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
    • 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
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Obesity (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
CA3004331A 2015-11-13 2016-11-11 Formulations of l-ornithine phenylacetate Abandoned CA3004331A1 (en)

Applications Claiming Priority (7)

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

Publications (1)

Publication Number Publication Date
CA3004331A1 true CA3004331A1 (en) 2017-05-18

Family

ID=58695607

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3004331A Abandoned CA3004331A1 (en) 2015-11-13 2016-11-11 Formulations of l-ornithine phenylacetate

Country Status (12)

Country Link
EP (1) EP3373923A4 (cg-RX-API-DMAC7.html)
JP (2) JP7294807B2 (cg-RX-API-DMAC7.html)
KR (2) KR20180086431A (cg-RX-API-DMAC7.html)
CN (2) CN108366983A (cg-RX-API-DMAC7.html)
AU (2) AU2016353350B2 (cg-RX-API-DMAC7.html)
BR (1) BR112018009349A8 (cg-RX-API-DMAC7.html)
CA (1) CA3004331A1 (cg-RX-API-DMAC7.html)
IL (1) IL258630B2 (cg-RX-API-DMAC7.html)
MX (2) MX389926B (cg-RX-API-DMAC7.html)
RU (1) RU2018113801A (cg-RX-API-DMAC7.html)
SG (1) SG11201802987UA (cg-RX-API-DMAC7.html)
WO (1) WO2017083758A1 (cg-RX-API-DMAC7.html)

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
BR112020002419A2 (pt) 2017-08-14 2020-07-28 Axcella Health Inc. aminoácido para o tratamento de doença do fígado
CN112839643A (zh) 2018-06-20 2021-05-25 胺细拉健康公司 用于治疗肌肉中脂肪浸润的组合物及方法
PH12022550738A1 (en) * 2019-10-16 2023-05-08 Mallinckrodt Entpr Llc Dosages and uses of ornithine phenylacetate for treating hyperammonemia
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
MX2007006171A (es) * 2004-11-26 2007-10-08 Ucl Business Plc Composiciones que comprenden ornitina y acetato.
GB0426141D0 (en) * 2004-11-26 2004-12-29 Ucl Biomedica Plc Treatment
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
EP3263100B1 (en) * 2009-04-03 2020-04-01 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
AU2015221466B2 (en) * 2009-04-03 2017-02-02 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
KR101715008B1 (ko) * 2009-06-08 2017-03-22 유씨엘 비즈니스 피엘씨 L―오르니틴 페닐아세테이트를 사용한 문맥압 항진증의 치료 및 간 기능 회복
AU2014250643B2 (en) * 2009-06-08 2016-07-14 Ocera Therapeutics, Inc. Treatment of portal hypertension and restoration of liver function using L-ornithine phenylacetate
EP2625162B1 (en) * 2010-10-06 2019-03-13 Ocera Therapeutics, Inc. Methods of making l-ornithine phenyl acetate
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
CA2968544A1 (en) * 2014-11-24 2016-06-02 Ucl Business Plc Treatment of diseases associated with hepatic stellate cell activation using ammonia-lowering therapies
CA2983146C (en) * 2015-04-20 2023-09-12 Ocera Therapeutics, Inc. Formulations of l-ornithine phenylacetate
EP3337473A4 (en) * 2015-08-18 2019-04-17 Ocera Therapeutics, Inc. TREATMENT AND PREVENTION OF MUSCLE WOUND BY L-ORNITHIN IN COMBINATION WITH AT LEAST ONE PHENYL ACETATE AND PHENYL BUTYRATE
CA2998490A1 (en) * 2015-09-25 2017-03-30 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
MX2022001517A (es) 2022-11-16
IL258630B2 (en) 2023-08-01
CN108366983A (zh) 2018-08-03
KR20250023993A (ko) 2025-02-18
IL258630B1 (en) 2023-04-01
EP3373923A4 (en) 2019-07-03
KR20180086431A (ko) 2018-07-31
AU2021290236A1 (en) 2022-02-10
JP7294807B2 (ja) 2023-06-20
EP3373923A1 (en) 2018-09-19
IL258630A (en) 2018-06-28
BR112018009349A8 (pt) 2019-02-26
RU2018113801A (ru) 2019-12-16
AU2016353350A1 (en) 2018-05-10
AU2016353350B2 (en) 2021-09-23
MX2018005088A (es) 2019-05-16
WO2017083758A1 (en) 2017-05-18
BR112018009349A2 (pt) 2018-11-13
SG11201802987UA (en) 2018-05-30
MX389926B (es) 2025-03-20
JP2022058446A (ja) 2022-04-12
CN113768863A (zh) 2021-12-10

Similar Documents

Publication Publication Date Title
US20220202755A1 (en) Formulations of l-ornithine phenylacetate
US20220184014A1 (en) Formulations of l-ornithine phenylacetate
AU2021290236A1 (en) Formulations of L-ornithine phenylacetate
CA2827336C (en) Flumazenil complexes, compositions comprising same and uses thereof
RU2720204C1 (ru) Сублингвальная фармацевтическая композиция эдаравона и (+)-2-борнеола
KR20120138229A (ko) 정맥내 투여용 이부프로펜을 이용한 중증 환자의 치료
WO2008057464A2 (en) Compositions and methods for improving the bioavailability of liothyronine
RU2483715C2 (ru) Твердая лекарственная форма препаратов мемантина и его солей
RU2690372C2 (ru) Лекарственные средства, содержащие диацереин, и способы снижения уровней мочевой кислоты в крови с его использованием
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
CN101244278A (zh) 一种可供静脉注射的双氯芬酸钠注射用制剂及其制备方法
TWI527828B (zh) 新穎的三萜化合物及其用途
CN117298247A (zh) Mdp类似物在制备用于治疗炎症性肠病的药物中的用途
KR20150063040A (ko) 간 질환의 치료에 사용하기 위한 메타독신 및 메타독신 연장 방출성 제제
ITBO20100731A1 (it) Composizioni solide comprendenti antiinfiammatori non steroidei, processi per la loro preparazione e loro uso.

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20211103

EEER Examination request

Effective date: 20211103

EEER Examination request

Effective date: 20211103

EEER Examination request

Effective date: 20211103

FZDE Discontinued

Effective date: 20240402