EA201991023A1 - Фармацевтическая композиция для парентерального введения, содержащая карглумовую кислоту - Google Patents
Фармацевтическая композиция для парентерального введения, содержащая карглумовую кислотуInfo
- Publication number
- EA201991023A1 EA201991023A1 EA201991023A EA201991023A EA201991023A1 EA 201991023 A1 EA201991023 A1 EA 201991023A1 EA 201991023 A EA201991023 A EA 201991023A EA 201991023 A EA201991023 A EA 201991023A EA 201991023 A1 EA201991023 A1 EA 201991023A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- pharmaceutical composition
- parenteral administration
- acid
- karglum
- administration containing
- Prior art date
Links
- 238000007911 parenteral administration Methods 0.000 title abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 239000002253 acid Substances 0.000 title 1
- 239000006172 buffering agent Substances 0.000 abstract 3
- 239000004067 bulking agent Substances 0.000 abstract 2
- LCQLHJZYVOQKHU-VKHMYHEASA-N carglumic acid Chemical compound NC(=O)N[C@H](C(O)=O)CCC(O)=O LCQLHJZYVOQKHU-VKHMYHEASA-N 0.000 abstract 2
- 229960002779 carglumic acid Drugs 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- 239000007864 aqueous solution Substances 0.000 abstract 1
- 238000004108 freeze drying Methods 0.000 abstract 1
- 239000008176 lyophilized powder Substances 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 abstract 1
- 229960000281 trometamol Drugs 0.000 abstract 1
Classifications
-
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61P5/00—Drugs for disorders of the endocrine system
-
- 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
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Obesity (AREA)
- Endocrinology (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Настоящее изобретение относится к фармацевтической композиции, подходящей для парентерального введения, содержащей карглумовую кислоту и буферный агент, имеющий pKот 5,5 до 9,0 при 25°C; в соответствии с одним вариантом осуществления, буферный агент может иметь pKот 7,5 до 8,5, предпочтительно pKоколо 8,07, такой как трометамол. Композиция также может содержать по меньшей мере один объемообразующий агент, такой как маннит. Настоящее изобретение также включает способ получения лиофилизированной стерильной композиции путем лиофильной сушки водного раствора, содержащего карглумовую кислоту, буферный агент, имеющий pKот 5,5 до 9,0 при 25°C, предпочтительно от 7,5 до 8,5, и, необязательно, объемообразующий агент для получения лиофилизированного порошка.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP16199942.0A EP3323410A1 (en) | 2016-11-22 | 2016-11-22 | Pharmaceutical parenteral formulation containing carglumic acid |
| PCT/EP2017/079738 WO2018095848A1 (en) | 2016-11-22 | 2017-11-20 | Pharmaceutical parenteral formulation containing carglumic acid |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EA201991023A1 true EA201991023A1 (ru) | 2019-12-30 |
| EA039003B1 EA039003B1 (ru) | 2021-11-19 |
Family
ID=57389297
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA201991023A EA039003B1 (ru) | 2016-11-22 | 2017-11-20 | Фармацевтическая композиция для парентерального введения, содержащая карглумовую кислоту |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US11103474B2 (ru) |
| EP (2) | EP3323410A1 (ru) |
| JP (1) | JP6942182B2 (ru) |
| KR (1) | KR102459213B1 (ru) |
| AU (1) | AU2017364135B2 (ru) |
| BR (1) | BR112019009848A2 (ru) |
| CA (1) | CA3040018A1 (ru) |
| CO (1) | CO2019003876A2 (ru) |
| DK (1) | DK3544584T3 (ru) |
| EA (1) | EA039003B1 (ru) |
| ES (1) | ES2837804T3 (ru) |
| HR (1) | HRP20201696T1 (ru) |
| HU (1) | HUE052207T2 (ru) |
| IL (1) | IL266755B (ru) |
| LT (1) | LT3544584T (ru) |
| MX (1) | MX2019005775A (ru) |
| PT (1) | PT3544584T (ru) |
| RS (1) | RS61184B1 (ru) |
| SI (1) | SI3544584T1 (ru) |
| WO (1) | WO2018095848A1 (ru) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20200368192A1 (en) | 2019-05-22 | 2020-11-26 | Recordati S.P.A. | Treatment of hyperammonemia in patients with renal insufficiency |
| WO2020239882A1 (en) | 2019-05-30 | 2020-12-03 | Recordati Industria Chimica E Farmaceutica S.P.A. | Pharmaceutical formulation for carglumic acid |
| CN111407754A (zh) * | 2020-04-07 | 2020-07-14 | 中国科学院深圳先进技术研究院 | 卡谷氨酸在制备预防和治疗冠状病毒的药物中的应用 |
| US11628143B1 (en) | 2022-06-14 | 2023-04-18 | Novitium Pharma LLC | Tablet for oral suspension |
| CN115770225A (zh) * | 2022-11-25 | 2023-03-10 | 远大医药（中国）有限公司 | 一种卡谷氨酸冻干固体制剂及其制备方法 |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1112347A (en) * | 1965-08-20 | 1968-05-01 | Pierre Wirth | Salts of organic bases with n-carbamyl-l-glutamic acid |
| US5056246A (en) * | 1989-10-27 | 1991-10-15 | Nikolaus Balonier | Device for taking trousers off an ironing machine |
| AU2006206267A1 (en) | 2005-01-21 | 2006-07-27 | Introgen Therapeutics, Inc. | Topical administration permitting prolonged exposure of target cells to therapeutic and prophylactic nucleic acids |
| ES2968301T3 (es) * | 2008-08-05 | 2024-05-08 | Wyeth Llc | Liofilización por encima del colapso |
| US8541360B2 (en) * | 2008-11-19 | 2013-09-24 | Ben Venue Laboratories, Inc. | Parenteral formulations comprising sugar-based esters and ethers |
| US10064826B2 (en) | 2013-03-15 | 2018-09-04 | Navinta, Llc | Direct compression and dry granulation processes for preparing carglumic acid tablets having less impurities than those produced by wet granulation process |
| CN105056246A (zh) | 2015-08-18 | 2015-11-18 | 武汉武药科技有限公司 | 一种卡谷氨酸固体组合物及其制备方法 |
-
2016
- 2016-11-22 EP EP16199942.0A patent/EP3323410A1/en not_active Withdrawn
-
2017
- 2017-11-20 ES ES17800854T patent/ES2837804T3/es active Active
- 2017-11-20 WO PCT/EP2017/079738 patent/WO2018095848A1/en active Application Filing
- 2017-11-20 EP EP17800854.6A patent/EP3544584B1/en active Active
- 2017-11-20 RS RS20201499A patent/RS61184B1/sr unknown
- 2017-11-20 MX MX2019005775A patent/MX2019005775A/es unknown
- 2017-11-20 HU HUE17800854A patent/HUE052207T2/hu unknown
- 2017-11-20 US US16/339,591 patent/US11103474B2/en active Active
- 2017-11-20 JP JP2019527213A patent/JP6942182B2/ja active Active
- 2017-11-20 SI SI201730490T patent/SI3544584T1/sl unknown
- 2017-11-20 BR BR112019009848A patent/BR112019009848A2/pt active IP Right Grant
- 2017-11-20 DK DK17800854.6T patent/DK3544584T3/da active
- 2017-11-20 PT PT178008546T patent/PT3544584T/pt unknown
- 2017-11-20 LT LTEP17800854.6T patent/LT3544584T/lt unknown
- 2017-11-20 EA EA201991023A patent/EA039003B1/ru unknown
- 2017-11-20 CA CA3040018A patent/CA3040018A1/en active Pending
- 2017-11-20 AU AU2017364135A patent/AU2017364135B2/en active Active
- 2017-11-20 KR KR1020197011016A patent/KR102459213B1/ko active IP Right Grant
-
2019
- 2019-04-16 CO CONC2019/0003876A patent/CO2019003876A2/es unknown
- 2019-05-20 IL IL266755A patent/IL266755B/en unknown
-
2020
- 2020-10-20 HR HRP20201696TT patent/HRP20201696T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| BR112019009848A2 (pt) | 2019-08-20 |
| KR20190086662A (ko) | 2019-07-23 |
| EP3544584A1 (en) | 2019-10-02 |
| JP2019535736A (ja) | 2019-12-12 |
| EP3323410A1 (en) | 2018-05-23 |
| IL266755B (en) | 2022-01-01 |
| IL266755A (en) | 2019-07-31 |
| AU2017364135A1 (en) | 2019-04-18 |
| MX2019005775A (es) | 2019-08-12 |
| ES2837804T3 (es) | 2021-07-01 |
| WO2018095848A1 (en) | 2018-05-31 |
| DK3544584T3 (da) | 2020-11-23 |
| CO2019003876A2 (es) | 2019-06-28 |
| KR102459213B1 (ko) | 2022-10-27 |
| PT3544584T (pt) | 2020-10-29 |
| HRP20201696T1 (hr) | 2020-12-25 |
| AU2017364135B2 (en) | 2023-06-15 |
| RS61184B1 (sr) | 2021-01-29 |
| SI3544584T1 (sl) | 2020-12-31 |
| AU2017364135A2 (en) | 2019-05-02 |
| US11103474B2 (en) | 2021-08-31 |
| HUE052207T2 (hu) | 2021-04-28 |
| JP6942182B2 (ja) | 2021-09-29 |
| US20190282526A1 (en) | 2019-09-19 |
| EP3544584B1 (en) | 2020-09-16 |
| LT3544584T (lt) | 2021-01-11 |
| CA3040018A1 (en) | 2018-05-31 |
| EA039003B1 (ru) | 2021-11-19 |
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