ES2944311T3 - Formulaciones de fenilacetato de L-ornitina - Google Patents

Formulaciones de fenilacetato de L-ornitina Download PDF

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Publication number
ES2944311T3
ES2944311T3 ES16783692T ES16783692T ES2944311T3 ES 2944311 T3 ES2944311 T3 ES 2944311T3 ES 16783692 T ES16783692 T ES 16783692T ES 16783692 T ES16783692 T ES 16783692T ES 2944311 T3 ES2944311 T3 ES 2944311T3
Authority
ES
Spain
Prior art keywords
pharmaceutical formulation
immediate release
formulation
ornithine phenylacetate
phenylacetate
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.)
Active
Application number
ES16783692T
Other languages
English (en)
Spanish (es)
Inventor
Kenneth Ruettimann
Mark Coffin
James Bernstein
Gary Goodson
Laurene Wang
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
Application filed by Ocera Therapeutics Inc filed Critical Ocera Therapeutics Inc
Application granted granted Critical
Publication of ES2944311T3 publication Critical patent/ES2944311T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/222Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
    • 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/5089Processes
    • 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
    • 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
    • A61P9/12Antihypertensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Emergency Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Obesity (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
ES16783692T 2015-04-20 2016-04-19 Formulaciones de fenilacetato de L-ornitina Active ES2944311T3 (es)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201562150238P 2015-04-20 2015-04-20
US201562150676P 2015-04-21 2015-04-21
US201562211619P 2015-08-28 2015-08-28
US201562255300P 2015-11-13 2015-11-13
US201662276754P 2016-01-08 2016-01-08
PCT/US2016/028298 WO2016172112A1 (en) 2015-04-20 2016-04-19 Formulations of l-ornithine phenylacetate

Publications (1)

Publication Number Publication Date
ES2944311T3 true ES2944311T3 (es) 2023-06-20

Family

ID=57144228

Family Applications (1)

Application Number Title Priority Date Filing Date
ES16783692T Active ES2944311T3 (es) 2015-04-20 2016-04-19 Formulaciones de fenilacetato de L-ornitina

Country Status (13)

Country Link
US (2) US20160338982A1 (https=)
EP (2) EP3285756B1 (https=)
JP (2) JP2018513171A (https=)
KR (1) KR20180006904A (https=)
CN (2) CN107708684A (https=)
AU (2) AU2016252382A1 (https=)
CA (1) CA2983146C (https=)
DK (1) DK3285756T3 (https=)
ES (1) ES2944311T3 (https=)
HK (1) HK1251149A1 (https=)
MX (2) MX391167B (https=)
RU (1) RU2755904C2 (https=)
WO (1) WO2016172112A1 (https=)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI2153870T1 (sl) 2004-11-26 2014-05-30 Ucl Business Plc Sestavki, ki obsegajo ornitin in fenilacetat ali fenilbutirat, za zdravljenje hepatitične encefalopatije
HUE035921T2 (en) 2009-04-03 2018-05-28 Ocera Therapeutics Inc L-ornithine phenyl acetate and methods of making thereof
CN104434894A (zh) 2009-06-08 2015-03-25 Ucl商业有限公司 使用l-鸟氨酸苯乙酸盐治疗门静脉高压和恢复肝功能
ES2769000T3 (es) 2014-11-24 2020-06-24 Ucl Business Ltd Tratamiento de enfermedades asociadas con la activación de células estrelladas hepáticas utilizando terapias reductoras de amoníaco
WO2017031131A1 (en) 2015-08-18 2017-02-23 Ocera Therapeutics, Inc. Treatment and prevention of muscle loss using l-ornithine in combination with at least one of phenylacetate and phenylbutyrate
US11219611B2 (en) 2015-11-13 2022-01-11 Ocera Therapeutics, Inc. Formulations of L-ornithine phenylacetate
CN108366983A (zh) * 2015-11-13 2018-08-03 欧塞拉治疗有限公司 L-鸟氨酸苯乙酸盐制剂
JOP20190146A1 (ar) 2016-12-19 2019-06-18 Axcella Health Inc تركيبات حمض أميني وطرق لمعالجة أمراض الكبد
MX389665B (es) 2017-05-11 2025-03-20 Ocera Therapeutics Inc Procesos para producir fenilacetato de l-ornitina
MX2020001765A (es) 2017-08-14 2020-07-29 Axcella Health Inc Composiciones de aminoacidos para el tratamiento de enfermedad hepatica.
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
SG11202111509PA (en) 2019-05-09 2021-11-29 Ocera Therapeutics Inc Methods of assessing and treating hepatic encephalopathy
PH12022550738A1 (en) * 2019-10-16 2023-05-08 Mallinckrodt Entpr Llc Dosages and uses of ornithine phenylacetate for treating hyperammonemia
EP4096647A1 (en) 2020-01-30 2022-12-07 Yeda Research and Development Co. Ltd Treating acute liver disease with tlr-mik inhibitors
WO2024261477A1 (en) 2023-06-20 2024-12-26 Yaqrit Limited Combination of tlr4 antagonist, ornithine and phenylacetate or phenylbutyrate

Family Cites Families (8)

* 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
IL116674A (en) * 1995-01-09 2003-05-29 Mendell Co Inc Edward Microcrystalline cellulose-based excipient having improved compressibility, pharmaceutical compositions containing the same and methods for the preparation of said excipient and of solid dosage form thereof
SI2153870T1 (sl) * 2004-11-26 2014-05-30 Ucl Business Plc Sestavki, ki obsegajo ornitin in fenilacetat ali fenilbutirat, za zdravljenje hepatitične encefalopatije
AU2015221466B2 (en) * 2009-04-03 2017-02-02 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
HUE035921T2 (en) 2009-04-03 2018-05-28 Ocera Therapeutics Inc L-ornithine phenyl acetate and methods of making thereof
CN104434894A (zh) * 2009-06-08 2015-03-25 Ucl商业有限公司 使用l-鸟氨酸苯乙酸盐治疗门静脉高压和恢复肝功能
AU2014250643B2 (en) * 2009-06-08 2016-07-14 Ocera Therapeutics, Inc. Treatment of portal hypertension and restoration of liver function using L-ornithine phenylacetate
US8946473B2 (en) * 2010-10-06 2015-02-03 Ocera Therapeutics, Inc. Methods of making L-ornithine phenyl acetate

Also Published As

Publication number Publication date
WO2016172112A1 (en) 2016-10-27
HK1251149A1 (zh) 2019-01-25
RU2755904C2 (ru) 2021-09-22
CN113599350A (zh) 2021-11-05
EP3285756A1 (en) 2018-02-28
MX2017013170A (es) 2018-04-11
CA2983146A1 (en) 2016-10-27
EP4205735A1 (en) 2023-07-05
AU2016252382A1 (en) 2017-11-02
JP2018513171A (ja) 2018-05-24
CA2983146C (en) 2023-09-12
KR20180006904A (ko) 2018-01-19
RU2017137643A3 (https=) 2019-09-17
MX2022003855A (es) 2023-03-02
US20220184014A1 (en) 2022-06-16
JP2022101549A (ja) 2022-07-06
US20160338982A1 (en) 2016-11-24
DK3285756T3 (da) 2023-05-08
EP3285756B1 (en) 2023-02-22
EP3285756A4 (en) 2019-01-23
MX391167B (es) 2025-03-11
AU2021200740A1 (en) 2021-03-04
RU2017137643A (ru) 2019-05-20
CN107708684A (zh) 2018-02-16

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