MA55417B1 - Forme posologique parentérale stable d'acétate de cétrorélix - Google Patents

Forme posologique parentérale stable d'acétate de cétrorélix

Info

Publication number
MA55417B1
MA55417B1 MA55417A MA55417A MA55417B1 MA 55417 B1 MA55417 B1 MA 55417B1 MA 55417 A MA55417 A MA 55417A MA 55417 A MA55417 A MA 55417A MA 55417 B1 MA55417 B1 MA 55417B1
Authority
MA
Morocco
Prior art keywords
dosage form
parenteral dosage
cetrorelix acetate
stable
ready
Prior art date
Application number
MA55417A
Other languages
English (en)
Other versions
MA55417A (fr
Inventor
Rajamannar Thennati
Jaydip Joshi
Rakesh Thummar
Sudeep Agrawal
Subhas Balaram Bhowmick
Arunkumar Yadav
Original Assignee
Sun Pharmaceutical Ind Ltd
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=69784288&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MA55417(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sun Pharmaceutical Ind Ltd filed Critical Sun Pharmaceutical Ind Ltd
Publication of MA55417A publication Critical patent/MA55417A/fr
Publication of MA55417B1 publication Critical patent/MA55417B1/fr

Links

Classifications

    • 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
    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • 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
    • A61K9/0029—Parenteral nutrition; Parenteral nutrition compositions as drug carriers
    • 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
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/59—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/04—Preparation or injection of sample to be analysed
    • G01N30/16—Injection
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N2030/022—Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027—Liquid chromatography

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Nutrition Science (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Molecular Biology (AREA)
  • Gynecology & Obstetrics (AREA)
  • General Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La présente invention concerne une forme posologique parentérale stable avec une solution aqueuse stable stérile prête à l'injection d'acétate de cétrorélix. L'invention concerne également un dispositif d'injection pré-rempli avec la solution aqueuse stable stérile prête à l'injection d'acétate de cétrorélix. La présente invention concerne un procédé d'inhibition des pics d'hormone lutéinisante prématurés chez des femmes soumises à une stimulation ovarienne contrôlée, faisant intervenir une forme posologique parentérale stable avec une solution aqueuse stable stérile prête à l'injection d'acétate de cétrorélix.
MA55417A 2019-10-24 2020-03-10 Forme posologique parentérale stable d'acétate de cétrorélix MA55417B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN201921043355 2019-10-24

Publications (2)

Publication Number Publication Date
MA55417A MA55417A (fr) 2021-04-28
MA55417B1 true MA55417B1 (fr) 2022-02-28

Family

ID=69784288

Family Applications (2)

Application Number Title Priority Date Filing Date
MA55417A MA55417B1 (fr) 2019-10-24 2020-03-10 Forme posologique parentérale stable d'acétate de cétrorélix
MA054713A MA54713A (fr) 2019-10-24 2020-10-23 Forme posologique parentérale stable d'acétate de cétrorélix

Family Applications After (1)

Application Number Title Priority Date Filing Date
MA054713A MA54713A (fr) 2019-10-24 2020-10-23 Forme posologique parentérale stable d'acétate de cétrorélix

Country Status (29)

Country Link
US (2) US20210121517A1 (fr)
EP (2) EP3811927B8 (fr)
JP (1) JP2023501902A (fr)
KR (1) KR20220114533A (fr)
CN (1) CN114599384A (fr)
AR (1) AR120290A1 (fr)
AU (1) AU2020369236A1 (fr)
BR (1) BR112022007746A2 (fr)
CA (1) CA3155348A1 (fr)
CL (1) CL2022001021A1 (fr)
CO (1) CO2022006820A2 (fr)
DK (1) DK3811927T3 (fr)
ES (1) ES2902784T3 (fr)
HR (1) HRP20211890T1 (fr)
HU (1) HUE058963T2 (fr)
IL (1) IL293908A (fr)
JO (1) JOP20220094A1 (fr)
LT (1) LT3811927T (fr)
MA (2) MA55417B1 (fr)
MD (1) MD3811927T2 (fr)
MX (1) MX2022004859A (fr)
PL (1) PL3811927T3 (fr)
PT (1) PT3811927T (fr)
RS (1) RS62754B1 (fr)
SA (1) SA522432367B1 (fr)
SI (1) SI3811927T1 (fr)
TW (1) TW202128210A (fr)
WO (1) WO2021079339A1 (fr)
ZA (1) ZA202204282B (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
LT3811927T (lt) 2019-10-24 2022-01-10 Sun Pharmaceutical Industries Ltd Cetrorelikso acetato stabili parenteralinės dozuotės forma
EP4164608A1 (fr) 2021-06-25 2023-04-19 Extrovis AG Compositions pharmaceutiques
CN115541733B (zh) * 2022-07-14 2024-08-09 南京锐志生物医药有限公司 一种反相色谱法测定保护氨基酸对映异构体的方法
CN115184507B (zh) * 2022-07-27 2024-07-05 南京锐志生物医药有限公司 一种多肽中n,n-二异丙基碳二亚胺和哌啶的检测方法

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10024451A1 (de) 2000-05-18 2001-11-29 Asta Medica Ag Pharmazeutische Darreichungsform für Peptide, Verfahren zu deren Herstellung und Verwendung
DE10157628A1 (de) 2001-11-26 2003-06-12 Zentaris Ag Injektionslösung eines LHRH-Antagonisten
US7214662B2 (en) 2001-11-27 2007-05-08 Zentaris Gmbh Injectable solution of an LHRH antagonist
WO2003097080A1 (fr) 2002-05-15 2003-11-27 Sun Pharmaceutical Industries Limited Composition aqueuse stable de peptide
CA2817941A1 (fr) 2010-12-06 2012-06-14 Astron Research Limited Injectable de cetrorelix pret a l'usage stable
EP2659902A1 (fr) 2012-04-30 2013-11-06 Sun Pharmaceutical Industries Limited Injection de leuprolide
US20130303453A1 (en) 2012-05-09 2013-11-14 Sun Pharmaceutical Industries Ltd. Octreotide injection
EP2823808A1 (fr) 2013-07-09 2015-01-14 Ipsen Pharma S.A.S. Composition pharmaceutique de lanréotide à libération prolongée
US20180325993A1 (en) 2017-05-15 2018-11-15 Sun Pharmaceutical Industries Limited Octreotide injection
CN109467591B (zh) * 2018-12-27 2020-11-03 苏州天马医药集团天吉生物制药有限公司 一种西曲瑞克的纯化方法
LT3811927T (lt) 2019-10-24 2022-01-10 Sun Pharmaceutical Industries Ltd Cetrorelikso acetato stabili parenteralinės dozuotės forma

Also Published As

Publication number Publication date
DK3811927T3 (da) 2021-12-13
US20210121517A1 (en) 2021-04-29
JOP20220094A1 (ar) 2023-01-30
SA522432367B1 (ar) 2024-08-05
WO2021079339A1 (fr) 2021-04-29
PL3811927T3 (pl) 2022-02-07
MA55417A (fr) 2021-04-28
HUE058963T2 (hu) 2022-10-28
JP2023501902A (ja) 2023-01-20
ZA202204282B (en) 2024-01-31
MD3811927T2 (ro) 2022-03-31
CO2022006820A2 (es) 2022-06-10
US20220153802A1 (en) 2022-05-19
AU2020369236A1 (en) 2022-05-19
MA54713A (fr) 2021-11-17
MX2022004859A (es) 2022-05-19
EP3908259A1 (fr) 2021-11-17
ES2902784T3 (es) 2022-03-29
CL2022001021A1 (es) 2023-02-03
AR120290A1 (es) 2022-02-09
TW202128210A (zh) 2021-08-01
LT3811927T (lt) 2022-01-10
SI3811927T1 (sl) 2022-03-31
PT3811927T (pt) 2021-12-14
EP3811927B1 (fr) 2021-11-17
RS62754B1 (sr) 2022-01-31
BR112022007746A2 (pt) 2022-07-05
EP3811927B8 (fr) 2022-02-23
IL293908A (en) 2022-08-01
CN114599384A (zh) 2022-06-07
CA3155348A1 (fr) 2021-04-29
EP3811927A1 (fr) 2021-04-28
KR20220114533A (ko) 2022-08-17
HRP20211890T1 (hr) 2022-03-04

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