BR112018074655A2 - formulação injetável de fosnetupitant e método de fabricação de uma formulação - Google Patents

formulação injetável de fosnetupitant e método de fabricação de uma formulação

Info

Publication number
BR112018074655A2
BR112018074655A2 BR112018074655-0A BR112018074655A BR112018074655A2 BR 112018074655 A2 BR112018074655 A2 BR 112018074655A2 BR 112018074655 A BR112018074655 A BR 112018074655A BR 112018074655 A2 BR112018074655 A2 BR 112018074655A2
Authority
BR
Brazil
Prior art keywords
formulation
fosnetupitant
manufacturing
injectable
injectable formulation
Prior art date
Application number
BR112018074655-0A
Other languages
English (en)
Other versions
BR112018074655B1 (pt
Inventor
Venturini Alessio
Cannella Roberta
Original Assignee
Helsinn Healthcare Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=59055193&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112018074655(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Helsinn Healthcare Sa filed Critical Helsinn Healthcare Sa
Publication of BR112018074655A2 publication Critical patent/BR112018074655A2/pt
Publication of BR112018074655B1 publication Critical patent/BR112018074655B1/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/473Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/675Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures 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)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Hospice & Palliative Care (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

dosagens injetáveis e formulações de fosnetupitant e sais farmaceuticamente aceitáveis dos mesmos são fornecidas que sejam eficazes, quimicamente estáveis e fisiologicamente equilibradas para segurança e eficácia.
BR112018074655-0A 2016-06-06 2017-06-01 Formulação injetável de fosnetupitanto, método de fabricação de uma formulação e uso de uma formulação injetável BR112018074655B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662345942P 2016-06-06 2016-06-06
US62/345,942 2016-06-06
PCT/EP2017/063268 WO2017211663A1 (en) 2016-06-06 2017-06-01 Physiologically balanced injectable formulations of fosnetupitant

Publications (2)

Publication Number Publication Date
BR112018074655A2 true BR112018074655A2 (pt) 2019-03-06
BR112018074655B1 BR112018074655B1 (pt) 2024-02-15

Family

ID=59055193

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018074655-0A BR112018074655B1 (pt) 2016-06-06 2017-06-01 Formulação injetável de fosnetupitanto, método de fabricação de uma formulação e uso de uma formulação injetável

Country Status (36)

Country Link
US (3) US10624911B2 (pt)
EP (2) EP3435980B1 (pt)
JP (2) JP6936817B2 (pt)
KR (1) KR102459416B1 (pt)
CN (1) CN109310627B (pt)
AR (1) AR108676A1 (pt)
AU (1) AU2017276588B2 (pt)
BR (1) BR112018074655B1 (pt)
CA (1) CA3025837C (pt)
CL (1) CL2018003338A1 (pt)
CO (1) CO2018011686A2 (pt)
CY (1) CY1122755T1 (pt)
DK (1) DK3435980T3 (pt)
EA (1) EA036605B1 (pt)
EC (1) ECSP19000169A (pt)
ES (1) ES2771226T3 (pt)
HR (1) HRP20200196T1 (pt)
IL (1) IL263126B (pt)
JO (1) JOP20170137B1 (pt)
LT (1) LT3435980T (pt)
MA (1) MA44513B1 (pt)
MD (1) MD3435980T2 (pt)
MX (1) MX2018015036A (pt)
MY (1) MY194081A (pt)
PE (1) PE20190347A1 (pt)
PH (1) PH12018502524A1 (pt)
PL (1) PL3435980T3 (pt)
PT (1) PT3435980T (pt)
RS (1) RS59852B1 (pt)
SG (1) SG11201809708PA (pt)
SI (1) SI3435980T1 (pt)
TW (1) TWI725191B (pt)
UA (1) UA122285C2 (pt)
UY (1) UY37273A (pt)
WO (1) WO2017211663A1 (pt)
ZA (1) ZA201807932B (pt)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
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
WO2023182388A1 (ja) * 2022-03-23 2023-09-28 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

Family Cites Families (8)

* Cited by examiner, † Cited by third party
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
EP1462450B1 (en) 1993-12-29 2007-06-13 MERCK SHARP & DOHME LTD. Substituted morpholine derivatives and their use as therapeutic agents
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
SI2866797T1 (sl) * 2012-07-06 2020-08-31 Pharmathen S.A. Stabilni injekcijski farmacevtski sestavek antagonista neurokinin 1 receptorja in postopek za njegovo pripravo

Also Published As

Publication number Publication date
US20170348335A1 (en) 2017-12-07
DK3435980T3 (da) 2020-02-24
EA201892837A1 (ru) 2019-06-28
CN109310627A (zh) 2019-02-05
PE20190347A1 (es) 2019-03-07
KR102459416B1 (ko) 2022-10-27
UA122285C2 (uk) 2020-10-12
RS59852B1 (sr) 2020-02-28
AU2017276588A1 (en) 2018-11-22
LT3435980T (lt) 2020-02-25
EA036605B1 (ru) 2020-11-27
ECSP19000169A (es) 2019-01-31
IL263126B (en) 2021-04-29
UY37273A (es) 2018-01-31
CY1122755T1 (el) 2021-03-12
JP7223084B2 (ja) 2023-02-15
US20200206249A1 (en) 2020-07-02
JP6936817B2 (ja) 2021-09-22
US20230172953A1 (en) 2023-06-08
ZA201807932B (en) 2019-08-28
ES2771226T3 (es) 2020-07-06
MX2018015036A (es) 2019-04-11
WO2017211663A1 (en) 2017-12-14
EP3435980B1 (en) 2019-11-13
PL3435980T3 (pl) 2020-05-18
SG11201809708PA (en) 2018-11-29
CO2018011686A2 (es) 2019-02-08
CL2018003338A1 (es) 2019-02-22
JOP20170137B1 (ar) 2021-08-17
MD3435980T2 (ro) 2020-03-31
CN109310627B (zh) 2021-12-14
CA3025837A1 (en) 2017-12-14
TWI725191B (zh) 2021-04-21
PH12018502524A1 (en) 2019-10-14
HRP20200196T1 (hr) 2020-05-01
AR108676A1 (es) 2018-09-12
MA44513B1 (fr) 2020-02-28
AU2017276588B2 (en) 2022-06-02
KR20190015276A (ko) 2019-02-13
EP3435980A1 (en) 2019-02-06
US11529362B2 (en) 2022-12-20
JP2021183639A (ja) 2021-12-02
CA3025837C (en) 2024-02-13
MY194081A (en) 2022-11-11
SI3435980T1 (sl) 2020-03-31
BR112018074655B1 (pt) 2024-02-15
US10624911B2 (en) 2020-04-21
JP2019521102A (ja) 2019-07-25
EP3626231A1 (en) 2020-03-25
IL263126A (en) 2018-12-31
TW201801727A (zh) 2018-01-16
PT3435980T (pt) 2020-02-21

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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]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B09X Republication of the decision to grant [chapter 9.1.3 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 01/06/2017, OBSERVADAS AS CONDICOES LEGAIS