JO3817B1 - تركيبة سائلة مستقرة ل " amg 416 " (فيلكالسيتيد) - Google Patents
تركيبة سائلة مستقرة ل " amg 416 " (فيلكالسيتيد)Info
- Publication number
- JO3817B1 JO3817B1 JOP/2014/0204A JOP20140204A JO3817B1 JO 3817 B1 JO3817 B1 JO 3817B1 JO P20140204 A JOP20140204 A JO P20140204A JO 3817 B1 JO3817 B1 JO 3817B1
- Authority
- JO
- Jordan
- Prior art keywords
- philcalcitide
- amg
- stable liquid
- liquid formula
- formulation
- Prior art date
Links
- ANIAZGVDEUQPRI-ZJQCGQFWSA-N etelcalcetide Chemical compound NC(N)=NCCC[C@H](C(N)=O)NC(=O)[C@@H](C)NC(=O)[C@@H](CCCN=C(N)N)NC(=O)[C@@H](CCCN=C(N)N)NC(=O)[C@@H](CCCN=C(N)N)NC(=O)[C@@H](C)NC(=O)[C@@H](CSSC[C@H](N)C(O)=O)NC(C)=O ANIAZGVDEUQPRI-ZJQCGQFWSA-N 0.000 title 1
- 229950006502 etelcalcetide Drugs 0.000 title 1
- 108091022127 etelcalcetide hydrochloride Proteins 0.000 title 1
- 239000007788 liquid Substances 0.000 title 1
- 102000013830 Calcium-Sensing Receptors Human genes 0.000 abstract 1
- 108010050543 Calcium-Sensing Receptors Proteins 0.000 abstract 1
- 229940122985 Peptide agonist Drugs 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000012669 liquid formulation Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
Classifications
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04D—NON-POSITIVE-DISPLACEMENT PUMPS
- F04D25/00—Pumping installations or systems
- F04D25/02—Units comprising pumps and their driving means
- F04D25/06—Units comprising pumps and their driving means the pump being electrically driven
- F04D25/0606—Units comprising pumps and their driving means the pump being electrically driven the electric motor being specially adapted for integration in the pump
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
-
- 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
- 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
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
- A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F01—MACHINES OR ENGINES IN GENERAL; ENGINE PLANTS IN GENERAL; STEAM ENGINES
- F01D—NON-POSITIVE DISPLACEMENT MACHINES OR ENGINES, e.g. STEAM TURBINES
- F01D15/00—Adaptations of machines or engines for special use; Combinations of engines with devices driven thereby
- F01D15/10—Adaptations for driving, or combinations with, electric generators
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- General Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Rheumatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Inorganic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
الصيغة السائلة تتضمن ناهض البيبتيد الخاص بالمستقبل الحساس للكالسيوم وطريقة لتحضير ويتم تقديم استخدام الصيغة.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361840618P | 2013-06-28 | 2013-06-28 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JO3817B1 true JO3817B1 (ar) | 2021-01-31 |
Family
ID=51213030
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JOP/2014/0204A JO3817B1 (ar) | 2013-06-28 | 2014-06-29 | تركيبة سائلة مستقرة ل " amg 416 " (فيلكالسيتيد) |
Country Status (38)
| Country | Link |
|---|---|
| US (4) | US9820938B2 (ar) |
| EP (3) | EP3878433A1 (ar) |
| JP (1) | JP6027708B2 (ar) |
| KR (1) | KR102231957B1 (ar) |
| CN (2) | CN114376970A (ar) |
| AP (1) | AP2015008936A0 (ar) |
| AR (1) | AR096773A1 (ar) |
| AU (1) | AU2014302122B2 (ar) |
| CA (1) | CA2916222C (ar) |
| CL (1) | CL2015003738A1 (ar) |
| CR (2) | CR20160002A (ar) |
| CY (1) | CY1120811T1 (ar) |
| DK (1) | DK3013318T3 (ar) |
| EA (1) | EA030220B1 (ar) |
| ES (1) | ES2633989T3 (ar) |
| HR (1) | HRP20171092T1 (ar) |
| HU (1) | HUE034209T2 (ar) |
| IL (1) | IL243210B (ar) |
| JO (1) | JO3817B1 (ar) |
| LT (1) | LT3013318T (ar) |
| MA (1) | MA38724B1 (ar) |
| ME (1) | ME02818B (ar) |
| MX (1) | MX2015017952A (ar) |
| MY (1) | MY180276A (ar) |
| PE (2) | PE20160549A1 (ar) |
| PH (1) | PH12015502816B1 (ar) |
| PL (1) | PL3013318T3 (ar) |
| PT (1) | PT3013318T (ar) |
| RS (1) | RS56238B1 (ar) |
| SG (1) | SG11201510647TA (ar) |
| SI (1) | SI3013318T1 (ar) |
| SM (1) | SMT201700401T1 (ar) |
| TN (1) | TN2015000569A1 (ar) |
| TW (1) | TWI635874B (ar) |
| UA (1) | UA115373C2 (ar) |
| UY (1) | UY35636A (ar) |
| WO (1) | WO2014210489A1 (ar) |
| ZA (1) | ZA201600238B (ar) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20160549A1 (es) | 2013-06-28 | 2016-06-15 | Amgen Inc | Formulacion liquida estable de etelcalcetida (amg 416) |
| WO2015154031A1 (en) | 2014-04-03 | 2015-10-08 | Amgen Inc. | Method for preparing amg 416 |
| JP6783787B2 (ja) * | 2015-03-26 | 2020-11-11 | アムジェン インコーポレイテッド | エテルカルセチドの調製のための液相方法 |
| CN106137979A (zh) * | 2015-03-31 | 2016-11-23 | 深圳翰宇药业股份有限公司 | 一种冻干粉针剂及其制备方法 |
| CN106928321B (zh) * | 2015-12-31 | 2019-07-26 | 深圳翰宇药业股份有限公司 | 一种合成Etelcalcetide的方法 |
| CN106928320B (zh) * | 2015-12-31 | 2021-01-15 | 深圳翰宇药业股份有限公司 | 一种合成Etelcalcetide的方法 |
| CN110054662B (zh) * | 2018-01-18 | 2021-03-02 | 成都圣诺生物制药有限公司 | 一种固相合成Etelcalcetide的方法 |
| WO2021231960A1 (en) | 2020-05-15 | 2021-11-18 | Amgen Inc. | Methods of treating left ventricle hypertrophy |
| CN111925415A (zh) * | 2020-08-10 | 2020-11-13 | 海南中和药业股份有限公司 | 一种维拉卡肽杂质的制备方法 |
| WO2022034545A1 (en) * | 2020-08-14 | 2022-02-17 | Aurobindo Pharma Limited | Etelcalcetide formulations for parenteral use |
| MX2023013066A (es) * | 2021-05-06 | 2023-11-15 | Amgen Inc | Formulaciones de etelcalcetida. |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6365712B1 (en) | 1996-10-25 | 2002-04-02 | The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services | Methods and compositions for inhibiting inflammation and angiogenesis comprising a mammalian CD97 α subunit |
| AT409081B (de) | 2000-02-16 | 2002-05-27 | Gebro Pharma Gmbh | Stabile, nasal, oral oder sublingual anwendbare pharmazeutische zubereitung |
| AU2004243531B2 (en) | 2003-06-03 | 2009-11-05 | Novo Nordisk A/S | Stabilized pharmaceutical peptide compositions |
| KR101308912B1 (ko) * | 2003-06-03 | 2013-09-23 | 노보 노르디스크 에이/에스 | 안정화된 약학적 펩티드 조성물 |
| US7265092B2 (en) | 2004-09-30 | 2007-09-04 | Kai Pharmaceuticals, Inc. | Pharmaceutical formulation |
| JP5645408B2 (ja) * | 2006-11-16 | 2014-12-24 | カイ ファーマシューティカルズ インコーポレーティッド | 副甲状腺機能亢進症および高カルシウム血症性障害の治療のためのポリカチオン性カルシウムモジュレーターペプチド |
| US8067532B2 (en) * | 2007-01-19 | 2011-11-29 | Kai Pharmaceuticals, Inc. | Modifications of peptide compositions to increase stability and delivery efficiency |
| EP2264138B2 (en) | 2009-06-19 | 2023-03-08 | The Procter & Gamble Company | Liquid hand dishwashing detergent composition |
| EP2459208B1 (en) * | 2009-07-29 | 2016-09-28 | Kai Pharmaceuticals, Inc. | Therapeutic agents for reducing parathyroid hormone levels |
| EP2399604A1 (en) | 2010-06-25 | 2011-12-28 | F. Hoffmann-La Roche AG | Novel antibody formulation |
| WO2012075375A1 (en) * | 2010-12-02 | 2012-06-07 | Lanco Biosciences, Inc. | Delivery of parathyroid hormones by microinjection systems |
| PT2717896T (pt) | 2011-06-08 | 2016-12-23 | Kai Pharmaceuticals Inc | Agentes terapêuticos para a regulação do fósforo sérico |
| MX355063B (es) | 2011-11-10 | 2018-04-04 | Kai Pharmaceuticals Inc | Calcimiméticos y métodos para su uso. |
| PE20160549A1 (es) | 2013-06-28 | 2016-06-15 | Amgen Inc | Formulacion liquida estable de etelcalcetida (amg 416) |
| WO2015154031A1 (en) * | 2014-04-03 | 2015-10-08 | Amgen Inc. | Method for preparing amg 416 |
-
2014
- 2014-06-27 PE PE2015002666A patent/PE20160549A1/es unknown
- 2014-06-27 TW TW103122433A patent/TWI635874B/zh active
- 2014-06-27 AU AU2014302122A patent/AU2014302122B2/en active Active
- 2014-06-27 EA EA201690099A patent/EA030220B1/ru not_active IP Right Cessation
- 2014-06-27 SI SI201430290T patent/SI3013318T1/sl unknown
- 2014-06-27 MY MYPI2015003044A patent/MY180276A/en unknown
- 2014-06-27 UA UAA201600641A patent/UA115373C2/uk unknown
- 2014-06-27 ME MEP-2017-150A patent/ME02818B/me unknown
- 2014-06-27 PE PE2020001772A patent/PE20210413A1/es unknown
- 2014-06-27 MX MX2015017952A patent/MX2015017952A/es active IP Right Grant
- 2014-06-27 CA CA2916222A patent/CA2916222C/en active Active
- 2014-06-27 KR KR1020167002370A patent/KR102231957B1/ko active Active
- 2014-06-27 US US14/908,481 patent/US9820938B2/en active Active
- 2014-06-27 HU HUE14742093A patent/HUE034209T2/en unknown
- 2014-06-27 JP JP2016524250A patent/JP6027708B2/ja active Active
- 2014-06-27 WO PCT/US2014/044622 patent/WO2014210489A1/en not_active Ceased
- 2014-06-27 EP EP21156687.2A patent/EP3878433A1/en active Pending
- 2014-06-27 SG SG11201510647TA patent/SG11201510647TA/en unknown
- 2014-06-27 SM SM20170401T patent/SMT201700401T1/it unknown
- 2014-06-27 CN CN202111597304.7A patent/CN114376970A/zh active Pending
- 2014-06-27 CR CR20160002A patent/CR20160002A/es unknown
- 2014-06-27 AP AP2015008936A patent/AP2015008936A0/xx unknown
- 2014-06-27 CN CN201480047399.7A patent/CN105764487A/zh active Pending
- 2014-06-27 ES ES14742093.9T patent/ES2633989T3/es active Active
- 2014-06-27 PL PL14742093T patent/PL3013318T3/pl unknown
- 2014-06-27 EP EP17160312.9A patent/EP3246017B1/en active Active
- 2014-06-27 DK DK14742093.9T patent/DK3013318T3/en active
- 2014-06-27 LT LTEP14742093.9T patent/LT3013318T/lt unknown
- 2014-06-27 PT PT147420939T patent/PT3013318T/pt unknown
- 2014-06-27 RS RS20170704A patent/RS56238B1/sr unknown
- 2014-06-27 EP EP14742093.9A patent/EP3013318B1/en active Active
- 2014-06-27 MA MA38724A patent/MA38724B1/fr unknown
- 2014-06-27 HR HRP20171092TT patent/HRP20171092T1/hr unknown
- 2014-06-27 TN TN2015000569A patent/TN2015000569A1/en unknown
- 2014-06-27 CR CR20160061A patent/CR20160061A/es unknown
- 2014-06-29 JO JOP/2014/0204A patent/JO3817B1/ar active
- 2014-06-30 AR ARP140102450A patent/AR096773A1/es not_active Application Discontinuation
- 2014-06-30 UY UY0001035636A patent/UY35636A/es not_active Application Discontinuation
-
2015
- 2015-12-17 IL IL243210A patent/IL243210B/en active IP Right Grant
- 2015-12-17 PH PH12015502816A patent/PH12015502816B1/en unknown
- 2015-12-28 CL CL2015003738A patent/CL2015003738A1/es unknown
-
2016
- 2016-01-12 ZA ZA2016/00238A patent/ZA201600238B/en unknown
-
2017
- 2017-07-19 CY CY171100771T patent/CY1120811T1/el unknown
- 2017-11-02 US US15/802,390 patent/US10344765B2/en active Active
-
2019
- 2019-06-03 US US16/430,322 patent/US11162500B2/en active Active
-
2021
- 2021-08-11 US US17/400,044 patent/US11959486B2/en active Active
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