IL258630B2 - Formulation of l.-ornithine phenylacetate - Google Patents

Formulation of l.-ornithine phenylacetate

Info

Publication number
IL258630B2
IL258630B2 IL258630A IL25863018A IL258630B2 IL 258630 B2 IL258630 B2 IL 258630B2 IL 258630 A IL258630 A IL 258630A IL 25863018 A IL25863018 A IL 25863018A IL 258630 B2 IL258630 B2 IL 258630B2
Authority
IL
Israel
Prior art keywords
pharmaceutical formulation
oral pharmaceutical
plasma
phenylacetylglutamine
oral
Prior art date
Application number
IL258630A
Other languages
English (en)
Hebrew (he)
Other versions
IL258630B1 (en
IL258630A (en
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 IL258630A publication Critical patent/IL258630A/en
Publication of IL258630B1 publication Critical patent/IL258630B1/en
Publication of IL258630B2 publication Critical patent/IL258630B2/en

Links

Classifications

    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5073—Microcapsules 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
    • A61K9/5078—Microcapsules 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
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic 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
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • 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
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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
    • 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

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)
IL258630A 2015-11-13 2018-04-11 Formulation of l.-ornithine phenylacetate IL258630B2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562255300P 2015-11-13 2015-11-13
US201662276754P 2016-01-08 2016-01-08
US15/133,087 US20160338982A1 (en) 2015-04-20 2016-04-19 Formulations of l-ornithine phenylacetate
PCT/US2016/061678 WO2017083758A1 (en) 2015-11-13 2016-11-11 Formulation of l-ornithine phenylacetate

Publications (3)

Publication Number Publication Date
IL258630A IL258630A (en) 2018-06-28
IL258630B1 IL258630B1 (en) 2023-04-01
IL258630B2 true IL258630B2 (en) 2023-08-01

Family

ID=58695607

Family Applications (1)

Application Number Title Priority Date Filing Date
IL258630A IL258630B2 (en) 2015-11-13 2018-04-11 Formulation of l.-ornithine phenylacetate

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

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006056794A1 (en) * 2004-11-26 2006-06-01 Ucl Business Plc Compositions comprising ornithine and phenylacetate or phenylbutyrate for treating hepatic encephalopathy
WO2010144498A2 (en) * 2009-06-08 2010-12-16 Ucl Business Plc Treatment of portal hypertension and restoration of liver function using l-ornithine phenylacetate
WO2012048043A1 (en) * 2010-10-06 2012-04-12 Ocera Therapeutics, Inc. Methods of making l-ornithine phenyl acetate

Family Cites Families (12)

* 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
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
AU2014250643B2 (en) 2009-06-08 2016-07-14 Ocera Therapeutics, Inc. Treatment of portal hypertension and restoration of liver function using L-ornithine phenylacetate
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

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006056794A1 (en) * 2004-11-26 2006-06-01 Ucl Business Plc Compositions comprising ornithine and phenylacetate or phenylbutyrate for treating hepatic encephalopathy
WO2010144498A2 (en) * 2009-06-08 2010-12-16 Ucl Business Plc Treatment of portal hypertension and restoration of liver function using l-ornithine phenylacetate
WO2012048043A1 (en) * 2010-10-06 2012-04-12 Ocera Therapeutics, Inc. Methods of making l-ornithine phenyl acetate

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
BOSOI, C. R. ET AL.,, LONG TERM ORAL TREATMENT OF ORNITHINE PHENYLACETATE INCREASES LEAN MASS AND ATTENUATES BRAIN EDEMA IN BILE-DUCT LIGATED RATS, 30 October 2015 (2015-10-30) *

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
KR20250023993A (ko) 2025-02-18
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

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