BR112018009349A8 - formulações de fenilacetato de l-ornitina - Google Patents
formulações de fenilacetato de l-ornitinaInfo
- Publication number
- BR112018009349A8 BR112018009349A8 BR112018009349A BR112018009349A BR112018009349A8 BR 112018009349 A8 BR112018009349 A8 BR 112018009349A8 BR 112018009349 A BR112018009349 A BR 112018009349A BR 112018009349 A BR112018009349 A BR 112018009349A BR 112018009349 A8 BR112018009349 A8 BR 112018009349A8
- Authority
- BR
- Brazil
- Prior art keywords
- ornithine phenylacetate
- disorders
- liver
- formulations
- patients
- Prior art date
Links
- LRSYFEZBIMVWRY-VWMHFEHESA-N (2s)-2,5-diaminopentanoic acid;2-phenylacetic acid Chemical compound NCCC[C@H](N)C(O)=O.OC(=O)CC1=CC=CC=C1 LRSYFEZBIMVWRY-VWMHFEHESA-N 0.000 title abstract 3
- 238000009472 formulation Methods 0.000 title abstract 3
- 239000000203 mixture Substances 0.000 title abstract 3
- 208000007788 Acute Liver Failure Diseases 0.000 abstract 1
- 206010000804 Acute hepatic failure Diseases 0.000 abstract 1
- 206010019663 Hepatic failure Diseases 0.000 abstract 1
- 206010020575 Hyperammonaemia Diseases 0.000 abstract 1
- 208000028547 Inborn Urea Cycle disease Diseases 0.000 abstract 1
- 230000001154 acute effect Effects 0.000 abstract 1
- 231100000836 acute liver failure Toxicity 0.000 abstract 1
- 230000001684 chronic effect Effects 0.000 abstract 1
- 208000019425 cirrhosis of liver Diseases 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- 208000035475 disorder Diseases 0.000 abstract 1
- 208000007386 hepatic encephalopathy Diseases 0.000 abstract 1
- 238000001990 intravenous administration Methods 0.000 abstract 1
- 208000019423 liver disease Diseases 0.000 abstract 1
- 208000007903 liver failure Diseases 0.000 abstract 1
- 231100000835 liver failure Toxicity 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 208000007232 portal hypertension Diseases 0.000 abstract 1
- 208000030954 urea cycle disease Diseases 0.000 abstract 1
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
- A61K9/0012—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
- 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
- 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
- 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
-
- 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
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)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Cardiology (AREA)
- Urology & Nephrology (AREA)
- Heart & Thoracic Surgery (AREA)
- Obesity (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
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 (2)
| Publication Number | Publication Date |
|---|---|
| BR112018009349A2 BR112018009349A2 (pt) | 2018-11-13 |
| BR112018009349A8 true BR112018009349A8 (pt) | 2019-02-26 |
Family
ID=58695607
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112018009349A BR112018009349A8 (pt) | 2015-11-13 | 2016-11-11 | formulações de fenilacetato de l-ornitina |
Country Status (12)
| Country | Link |
|---|---|
| EP (1) | EP3373923A4 (enExample) |
| JP (2) | JP7294807B2 (enExample) |
| KR (2) | KR20250023993A (enExample) |
| CN (2) | CN113768863A (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)
| 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 |
| US10682325B2 (en) | 2017-08-14 | 2020-06-16 | Axcella Health Inc. | Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting |
| JP2021527670A (ja) | 2018-06-20 | 2021-10-14 | アクセラ・ヘルス・インコーポレイテッドＡｘｃｅｌｌａ Ｈｅａｌｔｈ Ｉｎｃ． | 筋肉中の脂肪浸潤の治療のための組成物及び方法 |
| US20220362192A1 (en) * | 2019-10-16 | 2022-11-17 | Ocera Therapeutics, Inc. | 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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4783443A (en) | 1986-03-03 | 1988-11-08 | The University Of Chicago | Amino acyl cephalosporin derivatives |
| PL1824563T3 (pl) * | 2004-11-26 | 2010-07-30 | Ucl Business Plc | Kompozycje zawierające ornitynę i fenylooctan lub fenylomaślan do leczenia encefalopatii wątrobowej |
| 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 |
| SG174982A1 (en) * | 2009-04-03 | 2011-11-28 | 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 |
| JP5749255B2 (ja) * | 2009-06-08 | 2015-07-15 | ユーシーエル ビジネス ピーエルシー | Ｌ−オルニチンフェニル酢酸塩を用いる門脈圧亢進の治療及び肝機能の修復 |
| AU2014250643B2 (en) | 2009-06-08 | 2016-07-14 | Ocera Therapeutics, Inc. | Treatment of portal hypertension and restoration of liver function using L-ornithine phenylacetate |
| JP6087284B2 (ja) * | 2010-10-06 | 2017-03-01 | 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を製造するための方法 |
| 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 |
| IL281349B (en) * | 2014-11-24 | 2022-09-01 | Ucl Business Ltd | Treatment of diseases related to hepatic stellate cell activity using ammonia-lowering treatments |
| CA2983146C (en) | 2015-04-20 | 2023-09-12 | Ocera Therapeutics, Inc. | Formulations of l-ornithine phenylacetate |
| US10835506B2 (en) * | 2015-08-18 | 2020-11-17 | Ocera Therapeutics, Inc. | Treatment and prevention of muscle loss using L-ornithine in combination with at least one of phenylacetate and phenylbutyrate |
| HK1257679A1 (zh) * | 2015-09-25 | 2019-10-25 | Ocera Therapeutics, Inc. | 使用l-鸟苷酸与苯乙酸根和苯基丁酸根中至少一种的结合治疗和预防神经元细胞损失 |
-
2016
- 2016-11-11 SG SG11201802987UA patent/SG11201802987UA/en unknown
- 2016-11-11 BR BR112018009349A patent/BR112018009349A8/pt not_active Application Discontinuation
- 2016-11-11 MX MX2018005088A patent/MX389926B/es unknown
- 2016-11-11 CA CA3004331A patent/CA3004331A1/en not_active Abandoned
- 2016-11-11 EP EP16865158.6A patent/EP3373923A4/en not_active Withdrawn
- 2016-11-11 JP JP2018524369A patent/JP7294807B2/ja active Active
- 2016-11-11 WO PCT/US2016/061678 patent/WO2017083758A1/en not_active Ceased
- 2016-11-11 CN CN202111062923.6A patent/CN113768863A/zh active Pending
- 2016-11-11 CN CN201680066488.5A patent/CN108366983A/zh active Pending
- 2016-11-11 KR KR1020247042587A patent/KR20250023993A/ko active Pending
- 2016-11-11 RU RU2018113801A patent/RU2018113801A/ru not_active Application Discontinuation
- 2016-11-11 KR KR1020187016373A patent/KR20180086431A/ko not_active Ceased
- 2016-11-11 AU AU2016353350A patent/AU2016353350B2/en not_active Ceased
-
2018
- 2018-04-11 IL IL258630A patent/IL258630B2/en unknown
- 2018-04-25 MX MX2022001517A patent/MX2022001517A/es unknown
-
2021
- 2021-12-21 AU AU2021290236A patent/AU2021290236A1/en not_active Abandoned
- 2021-12-28 JP JP2021213640A patent/JP2022058446A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| IL258630B1 (en) | 2023-04-01 |
| RU2018113801A (ru) | 2019-12-16 |
| JP2022058446A (ja) | 2022-04-12 |
| AU2016353350A1 (en) | 2018-05-10 |
| CN108366983A (zh) | 2018-08-03 |
| AU2016353350B2 (en) | 2021-09-23 |
| SG11201802987UA (en) | 2018-05-30 |
| KR20250023993A (ko) | 2025-02-18 |
| MX2022001517A (es) | 2022-11-16 |
| WO2017083758A1 (en) | 2017-05-18 |
| MX389926B (es) | 2025-03-20 |
| EP3373923A4 (en) | 2019-07-03 |
| MX2018005088A (es) | 2019-05-16 |
| CA3004331A1 (en) | 2017-05-18 |
| AU2021290236A1 (en) | 2022-02-10 |
| CN113768863A (zh) | 2021-12-10 |
| JP7294807B2 (ja) | 2023-06-20 |
| KR20180086431A (ko) | 2018-07-31 |
| IL258630B2 (en) | 2023-08-01 |
| BR112018009349A2 (pt) | 2018-11-13 |
| IL258630A (en) | 2018-06-28 |
| JP2018533601A (ja) | 2018-11-15 |
| EP3373923A1 (en) | 2018-09-19 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] |
Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS. |
|
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
| B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
| B07A | Application suspended after technical examination (opinion) [chapter 7.1 patent gazette] | ||
| B09B | Patent application refused [chapter 9.2 patent gazette] |