MX2019005775A - Formulacion farmaceutica parenteral que contiene acido carglumico. - Google Patents
Formulacion farmaceutica parenteral que contiene acido carglumico.Info
- Publication number
- MX2019005775A MX2019005775A MX2019005775A MX2019005775A MX2019005775A MX 2019005775 A MX2019005775 A MX 2019005775A MX 2019005775 A MX2019005775 A MX 2019005775A MX 2019005775 A MX2019005775 A MX 2019005775A MX 2019005775 A MX2019005775 A MX 2019005775A
- Authority
- MX
- Mexico
- Prior art keywords
- pka
- pharmaceutical formulation
- carglumic acid
- formulation containing
- parenteral pharmaceutical
- Prior art date
Links
- LCQLHJZYVOQKHU-VKHMYHEASA-N carglumic acid Chemical compound NC(=O)N[C@H](C(O)=O)CCC(O)=O LCQLHJZYVOQKHU-VKHMYHEASA-N 0.000 title abstract 3
- 229960002779 carglumic acid Drugs 0.000 title abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 239000003795 chemical substances by application Substances 0.000 abstract 3
- 230000001105 regulatory effect Effects 0.000 abstract 3
- 239000004067 bulking agent 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
- 238000009472 formulation Methods 0.000 abstract 1
- 238000004108 freeze drying Methods 0.000 abstract 1
- 239000012931 lyophilized formulation 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
- 239000000203 mixture Substances 0.000 abstract 1
- 238000007911 parenteral administration Methods 0.000 abstract 1
- 239000000843 powder Substances 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
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
La presente invención se refiere a una formulación farmacéutica que es adecuada para su administración parenteral, la cual contiene ácido carglúmico y un agente regulador del pH que tiene una pKa de 5.5 a 9.0 a 25°C; de acuerdo con una modalidad, el agente regulador del pH puede tener una pKa de 7.5 a 8.5, de preferencia una pKa de aproximadamente 8.07, tal como el trometamol. La formulación también puede contener por lo menos un agente de aumento de volumen, tal como el manitol. La invención también incluye un método para la elaboración de una formulación estéril liofilizada por medio de un secado por congelación de una solución en agua que contiene ácido carglúmico, un agente regulador del pH que tiene una pKa de 5.5 a 9.0 a 25°C, de preferencia de 7.5 a 8.5, y de una forma opcional un agente de aumento de volumen, con el fin de obtener un polvo secado por congelación.
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 |
|---|---|
| MX2019005775A true MX2019005775A (es) | 2019-08-12 |
| MX387019B MX387019B (es) | 2025-03-19 |
Family
ID=57389297
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2019005775A MX387019B (es) | 2016-11-22 | 2017-11-20 | Formulacion farmaceutica parenteral que contiene acido carglumico. |
Country Status (19)
| Country | Link |
|---|---|
| US (1) | US11103474B2 (es) |
| EP (2) | EP3323410A1 (es) |
| JP (1) | JP6942182B2 (es) |
| KR (1) | KR102459213B1 (es) |
| AU (1) | AU2017364135B2 (es) |
| CA (1) | CA3040018A1 (es) |
| CO (1) | CO2019003876A2 (es) |
| DK (1) | DK3544584T3 (es) |
| EA (1) | EA039003B1 (es) |
| ES (1) | ES2837804T3 (es) |
| HR (1) | HRP20201696T1 (es) |
| HU (1) | HUE052207T2 (es) |
| IL (1) | IL266755B (es) |
| LT (1) | LT3544584T (es) |
| MX (1) | MX387019B (es) |
| PT (1) | PT3544584T (es) |
| RS (1) | RS61184B1 (es) |
| SI (1) | SI3544584T1 (es) |
| WO (1) | WO2018095848A1 (es) |
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 |
| CN115770225B (zh) * | 2022-11-25 | 2024-09-17 | 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 |
| KR20080012825A (ko) | 2005-01-21 | 2008-02-12 | 인트로겐 테라페티스, 인코퍼레이티드 | 표적 세포가 치료적 및 예방적 핵산에 지속 노출되게 하는국소 투여 |
| JP5785077B2 (ja) * | 2008-08-05 | 2015-09-24 | ワイス・エルエルシー | 崩壊温度より高温での凍結乾燥 |
| 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 AU AU2017364135A patent/AU2017364135B2/en active Active
- 2017-11-20 US US16/339,591 patent/US11103474B2/en active Active
- 2017-11-20 ES ES17800854T patent/ES2837804T3/es active Active
- 2017-11-20 HR HRP20201696TT patent/HRP20201696T1/hr unknown
- 2017-11-20 HU HUE17800854A patent/HUE052207T2/hu unknown
- 2017-11-20 PT PT178008546T patent/PT3544584T/pt unknown
- 2017-11-20 RS RS20201499A patent/RS61184B1/sr unknown
- 2017-11-20 EP EP17800854.6A patent/EP3544584B1/en active Active
- 2017-11-20 EA EA201991023A patent/EA039003B1/ru unknown
- 2017-11-20 SI SI201730490T patent/SI3544584T1/sl unknown
- 2017-11-20 CA CA3040018A patent/CA3040018A1/en active Pending
- 2017-11-20 LT LTEP17800854.6T patent/LT3544584T/lt unknown
- 2017-11-20 DK DK17800854.6T patent/DK3544584T3/da active
- 2017-11-20 JP JP2019527213A patent/JP6942182B2/ja active Active
- 2017-11-20 MX MX2019005775A patent/MX387019B/es unknown
- 2017-11-20 KR KR1020197011016A patent/KR102459213B1/ko active Active
- 2017-11-20 WO PCT/EP2017/079738 patent/WO2018095848A1/en not_active Ceased
-
2019
- 2019-04-16 CO CONC2019/0003876A patent/CO2019003876A2/es unknown
- 2019-05-20 IL IL266755A patent/IL266755B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| HRP20201696T1 (hr) | 2020-12-25 |
| JP2019535736A (ja) | 2019-12-12 |
| EA201991023A1 (ru) | 2019-12-30 |
| IL266755B (en) | 2022-01-01 |
| RS61184B1 (sr) | 2021-01-29 |
| CO2019003876A2 (es) | 2019-06-28 |
| US20190282526A1 (en) | 2019-09-19 |
| IL266755A (en) | 2019-07-31 |
| JP6942182B2 (ja) | 2021-09-29 |
| AU2017364135A1 (en) | 2019-04-18 |
| DK3544584T3 (da) | 2020-11-23 |
| BR112019009848A2 (pt) | 2019-08-20 |
| EP3323410A1 (en) | 2018-05-23 |
| MX387019B (es) | 2025-03-19 |
| KR20190086662A (ko) | 2019-07-23 |
| AU2017364135A2 (en) | 2019-05-02 |
| EP3544584B1 (en) | 2020-09-16 |
| LT3544584T (lt) | 2021-01-11 |
| ES2837804T3 (es) | 2021-07-01 |
| AU2017364135B2 (en) | 2023-06-15 |
| SI3544584T1 (sl) | 2020-12-31 |
| US11103474B2 (en) | 2021-08-31 |
| CA3040018A1 (en) | 2018-05-31 |
| KR102459213B1 (ko) | 2022-10-27 |
| WO2018095848A1 (en) | 2018-05-31 |
| EP3544584A1 (en) | 2019-10-02 |
| HUE052207T2 (hu) | 2021-04-28 |
| PT3544584T (pt) | 2020-10-29 |
| EA039003B1 (ru) | 2021-11-19 |
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