AR108676A1 - Formulaciones inyectables fisiológicamente balanceadas de fosnetupitant - Google Patents
Formulaciones inyectables fisiológicamente balanceadas de fosnetupitantInfo
- Publication number
- AR108676A1 AR108676A1 ARP170101521A ARP170101521A AR108676A1 AR 108676 A1 AR108676 A1 AR 108676A1 AR P170101521 A ARP170101521 A AR P170101521A AR P170101521 A ARP170101521 A AR P170101521A AR 108676 A1 AR108676 A1 AR 108676A1
- Authority
- AR
- Argentina
- Prior art keywords
- fosnetupitant
- pharmaceutically acceptable
- acceptable salt
- optionally
- formulation
- Prior art date
Links
- HZIYEEMJNBKMJH-UHFFFAOYSA-N [4-[5-[[2-[3,5-bis(trifluoromethyl)phenyl]-2-methylpropanoyl]-methylamino]-4-(2-methylphenyl)pyridin-2-yl]-1-methylpiperazin-1-ium-1-yl]methyl hydrogen phosphate Chemical compound C=1N=C(N2CC[N+](C)(COP(O)([O-])=O)CC2)C=C(C=2C(=CC=CC=2)C)C=1N(C)C(=O)C(C)(C)C1=CC(C(F)(F)F)=CC(C(F)(F)F)=C1 HZIYEEMJNBKMJH-UHFFFAOYSA-N 0.000 title abstract 4
- 229950010727 fosnetupitant Drugs 0.000 title abstract 4
- 239000007972 injectable composition Substances 0.000 title abstract 2
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 abstract 6
- 150000003839 salts Chemical class 0.000 abstract 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 abstract 4
- 238000009472 formulation Methods 0.000 abstract 3
- 239000000203 mixture Substances 0.000 abstract 3
- 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 2
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 abstract 2
- 229930195725 Mannitol Natural products 0.000 abstract 2
- 239000012458 free base Substances 0.000 abstract 2
- 235000010355 mannitol Nutrition 0.000 abstract 2
- 239000000594 mannitol Substances 0.000 abstract 2
- CPZBLNMUGSZIPR-NVXWUHKLSA-N palonosetron Chemical compound C1N(CC2)CCC2[C@@H]1N1C(=O)C(C=CC=C2CCC3)=C2[C@H]3C1 CPZBLNMUGSZIPR-NVXWUHKLSA-N 0.000 abstract 2
- 229960002131 palonosetron Drugs 0.000 abstract 2
- 239000007864 aqueous solution Substances 0.000 abstract 1
- IXCSERBJSXMMFS-UHFFFAOYSA-N hcl hcl Chemical compound Cl.Cl IXCSERBJSXMMFS-UHFFFAOYSA-N 0.000 abstract 1
- 239000007788 liquid Substances 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- 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
- A61K31/66—Phosphorus compounds
- A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K9/0012—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
- 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
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Otolaryngology (AREA)
- Hospice & Palliative Care (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Dosificaciones y formulaciones inyectables de fosnetupitant y sales farmacéuticamente aceptables del mismo que son eficaces, químicamente estables y fisiológicamente balanceadas para seguridad y eficacia. Reivindicación 1: Una formulación inyectable de fosnetupitant, liquida o liofilizada, que comprende: a) fosnetupitant o una sal farmacéuticamente aceptable del mismo; b) opcionalmente palonosetrón o una sal farmacéuticamente aceptable del mismo; c) hidróxido de sodio; d) edetato de disodio; e) opcionalmente ácido clorhídrico; y f) manitol. Reivindicación 7: La formulación de cualquiera de las reivindicaciones precedentes como una solución acuosa, que comprende: a) desde 2,3 a 30 mg/ml de fosnetupitant o una sal farmacéuticamente aceptable del mismo, en base al peso de la base libre; y b) opcionalmente, desde 5 a 50 mg/ml de palonosetrón o una sal farmacéuticamente aceptable del mismo, en base al peso de la base libre; c) hidróxido de sodio; d) edetato de disodio; e) opcionalmente ácido clorhídrico; y f) manitol. Reivindicación 18: La formulación de cualquiera de las reivindicaciones precedentes, que comprende aproximadamente 260 mg de la sal cloruro clorhidrato de fosnetupitant.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662345942P | 2016-06-06 | 2016-06-06 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR108676A1 true AR108676A1 (es) | 2018-09-12 |
Family
ID=59055193
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP170101521A AR108676A1 (es) | 2016-06-06 | 2017-06-02 | Formulaciones inyectables fisiológicamente balanceadas de fosnetupitant |
Country Status (37)
| Country | Link |
|---|---|
| US (4) | US10624911B2 (es) |
| EP (2) | EP3435980B1 (es) |
| JP (2) | JP6936817B2 (es) |
| KR (1) | KR102459416B1 (es) |
| CN (1) | CN109310627B (es) |
| AR (1) | AR108676A1 (es) |
| AU (1) | AU2017276588B2 (es) |
| BR (1) | BR112018074655B1 (es) |
| CA (1) | CA3025837C (es) |
| CL (1) | CL2018003338A1 (es) |
| CO (1) | CO2018011686A2 (es) |
| CY (1) | CY1122755T1 (es) |
| DK (1) | DK3435980T3 (es) |
| EA (1) | EA036605B1 (es) |
| EC (1) | ECSP19000169A (es) |
| ES (1) | ES2771226T3 (es) |
| GE (1) | GEP20207189B (es) |
| HR (1) | HRP20200196T1 (es) |
| IL (1) | IL263126B (es) |
| JO (1) | JOP20170137B1 (es) |
| LT (1) | LT3435980T (es) |
| MA (1) | MA44513B1 (es) |
| MD (1) | MD3435980T2 (es) |
| MX (1) | MX376118B (es) |
| MY (1) | MY194081A (es) |
| PE (1) | PE20190347A1 (es) |
| PH (1) | PH12018502524B1 (es) |
| PL (1) | PL3435980T3 (es) |
| PT (1) | PT3435980T (es) |
| RS (1) | RS59852B1 (es) |
| SG (1) | SG11201809708PA (es) |
| SI (1) | SI3435980T1 (es) |
| TW (1) | TWI725191B (es) |
| UA (1) | UA122285C2 (es) |
| UY (1) | UY37273A (es) |
| WO (1) | WO2017211663A1 (es) |
| ZA (1) | ZA201807932B (es) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11654154B2 (en) | 2019-01-29 | 2023-05-23 | Navinta Iii Inc | Process for preparing injectable Fosaprepitant Dimeglumine compositions having improved storage stability |
| US12097197B2 (en) | 2021-12-21 | 2024-09-24 | Slayback Pharma Llc | Stable liquid compositions of netupitant and palonosetron |
| JP7783403B2 (ja) * | 2022-03-23 | 2025-12-09 | 大鵬薬品工業株式会社 | ホスネツピタント又はその医薬上許容される塩の安定化製剤およびその製造方法 |
| WO2025036703A1 (en) * | 2023-08-13 | 2025-02-20 | Helsinn Healthcare Sa | Fosnetupitant for administration via intravenous bolus |
| WO2025056094A1 (zh) * | 2023-09-15 | 2025-03-20 | 广州帝奇医药技术有限公司 | 一种冻干制剂和注射液及其制备方法 |
| WO2026002808A1 (en) | 2024-06-24 | 2026-01-02 | Helsinn Healthcare Sa | Prevention of nausea and vomiting from antibody-drug conjugates and other long-acting emetogenics |
| CN119185243A (zh) * | 2024-11-28 | 2024-12-27 | 山东齐都药业有限公司 | 福奈妥匹坦帕洛诺司琼口服掩味颗粒剂及其制备方法与应用 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL111960A (en) | 1993-12-17 | 1999-12-22 | Merck & Co Inc | Morpholines and thiomorpholines their preparation and pharmaceutical compositions containing them |
| ATE278687T1 (de) | 1993-12-29 | 2004-10-15 | Merck Sharp & Dohme | Substituierte morpholinderivate und ihre verwendung als therapeutische mittel |
| TW385308B (en) | 1994-03-04 | 2000-03-21 | Merck & Co Inc | Prodrugs of morpholine tachykinin receptor antagonists |
| JO2735B1 (en) * | 2003-01-30 | 2013-09-15 | هيلسين هيلث كير أس ايه. | Liquid pharmaceutical formations of balloonosterone |
| US20060167072A1 (en) * | 2004-01-30 | 2006-07-27 | Helsinn Healthcare Sa | Liquid pharmaceutical formulations of palonosetron |
| US20100048607A1 (en) * | 2008-08-25 | 2010-02-25 | Chandrashekhar Kocherlakota | Formulations comprising palonosetron |
| US8426450B1 (en) | 2011-11-29 | 2013-04-23 | Helsinn Healthcare Sa | Substituted 4-phenyl pyridines having anti-emetic effect |
| SMT202000385T1 (it) * | 2012-07-06 | 2020-11-10 | Pharmathen Sa | Composizione farmaceutica iniettabile stabile di un antagonizta dei recettori della neurochinina 1 e processo per la sua preparazione |
-
2017
- 2017-06-01 MY MYPI2018001970A patent/MY194081A/en unknown
- 2017-06-01 EA EA201892837A patent/EA036605B1/ru unknown
- 2017-06-01 EP EP17729822.1A patent/EP3435980B1/en active Active
- 2017-06-01 MX MX2018015036A patent/MX376118B/es active IP Right Grant
- 2017-06-01 DK DK17729822.1T patent/DK3435980T3/da active
- 2017-06-01 CA CA3025837A patent/CA3025837C/en active Active
- 2017-06-01 SG SG11201809708PA patent/SG11201809708PA/en unknown
- 2017-06-01 JP JP2018563684A patent/JP6936817B2/ja active Active
- 2017-06-01 AU AU2017276588A patent/AU2017276588B2/en active Active
- 2017-06-01 WO PCT/EP2017/063268 patent/WO2017211663A1/en not_active Ceased
- 2017-06-01 KR KR1020187034943A patent/KR102459416B1/ko active Active
- 2017-06-01 ES ES17729822T patent/ES2771226T3/es active Active
- 2017-06-01 GE GEAP202014974A patent/GEP20207189B/en unknown
- 2017-06-01 MD MDE20190164T patent/MD3435980T2/ro unknown
- 2017-06-01 RS RS20200100A patent/RS59852B1/sr unknown
- 2017-06-01 MA MA44513A patent/MA44513B1/fr unknown
- 2017-06-01 UA UAA201812842A patent/UA122285C2/uk unknown
- 2017-06-01 HR HRP20200196TT patent/HRP20200196T1/hr unknown
- 2017-06-01 PE PE2018003074A patent/PE20190347A1/es unknown
- 2017-06-01 LT LTEP17729822.1T patent/LT3435980T/lt unknown
- 2017-06-01 PH PH1/2018/502524A patent/PH12018502524B1/en unknown
- 2017-06-01 CN CN201780034681.5A patent/CN109310627B/zh active Active
- 2017-06-01 SI SI201730178T patent/SI3435980T1/sl unknown
- 2017-06-01 PL PL17729822T patent/PL3435980T3/pl unknown
- 2017-06-01 EP EP19200383.8A patent/EP3626231A1/en not_active Withdrawn
- 2017-06-01 BR BR112018074655-0A patent/BR112018074655B1/pt active IP Right Grant
- 2017-06-01 PT PT177298221T patent/PT3435980T/pt unknown
- 2017-06-02 US US15/611,785 patent/US10624911B2/en active Active
- 2017-06-02 UY UY0001037273A patent/UY37273A/es active IP Right Grant
- 2017-06-02 AR ARP170101521A patent/AR108676A1/es unknown
- 2017-06-06 JO JOP/2017/0137A patent/JOP20170137B1/ar active
- 2017-06-06 TW TW106118613A patent/TWI725191B/zh active
-
2018
- 2018-11-09 CO CONC2018/0011686A patent/CO2018011686A2/es unknown
- 2018-11-19 IL IL263126A patent/IL263126B/en active IP Right Grant
- 2018-11-22 CL CL2018003338A patent/CL2018003338A1/es unknown
- 2018-11-23 ZA ZA2018/07932A patent/ZA201807932B/en unknown
-
2019
- 2019-01-02 EC ECSENADI2019169A patent/ECSP19000169A/es unknown
-
2020
- 2020-02-10 CY CY20201100123T patent/CY1122755T1/el unknown
- 2020-03-13 US US16/817,683 patent/US11529362B2/en active Active
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2021
- 2021-08-27 JP JP2021138576A patent/JP7223084B2/ja active Active
-
2022
- 2022-11-15 US US17/986,934 patent/US12208109B2/en active Active
-
2024
- 2024-12-23 US US18/999,533 patent/US20250235473A1/en active Pending
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FB | Suspension of granting procedure |