MA55417A - Forme posologique parentérale stable d'acétate de cétrorélix - Google Patents

Forme posologique parentérale stable d'acétate de cétrorélix

Info

Publication number
MA55417A
MA55417A MA055417A MA55417A MA55417A MA 55417 A MA55417 A MA 55417A MA 055417 A MA055417 A MA 055417A MA 55417 A MA55417 A MA 55417A MA 55417 A MA55417 A MA 55417A
Authority
MA
Morocco
Prior art keywords
dosage form
parenteral dosage
cetrorelix acetate
stable
ready
Prior art date
Application number
MA055417A
Other languages
English (en)
Other versions
MA55417B1 (fr
Inventor
Sudeep Agrawal
Subhas Balaram Bhowmick
Jaydip Joshi
Rajamannar Thennati
Rakesh Thummar
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(A) "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

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08Peptides having 5 to 11 amino acids
    • 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
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08Peptides having 5 to 11 amino acids
    • A61K38/09Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0029Parenteral nutrition; Parenteral nutrition compositions as drug carriers
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • C07K14/59Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/04Preparation or injection of sample to be analysed
    • G01N30/16Injection
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N2030/022Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027Liquid 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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • General Physics & Mathematics (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 true MA55417A (fr) 2021-04-28
MA55417B1 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 (32)

Country Link
US (2) US20210121517A1 (fr)
EP (2) EP3811927B8 (fr)
JP (1) JP7682869B2 (fr)
KR (1) KR20220114533A (fr)
CN (1) CN114599384A (fr)
AR (1) AR120290A1 (fr)
AU (1) AU2020369236B2 (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) IL293908B1 (fr)
JO (1) JOP20220094A1 (fr)
LT (1) LT3811927T (fr)
MA (2) MA55417B1 (fr)
MD (1) MD3811927T2 (fr)
MX (1) MX2022004859A (fr)
PH (1) PH12022550967A1 (fr)
PL (1) PL3811927T3 (fr)
PT (1) PT3811927T (fr)
RS (1) RS62754B1 (fr)
SA (1) SA522432367B1 (fr)
SI (1) SI3811927T1 (fr)
TN (1) TN2022000111A1 (fr)
TW (1) TWI885001B (fr)
UA (1) UA128877C2 (fr)
WO (1) WO2021079339A1 (fr)
ZA (1) ZA202204282B (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HRP20211890T1 (hr) * 2019-10-24 2022-03-04 Sun Pharmaceutical Industries Ltd Stabilan parenteralni dozni oblik cetroreliks acetata
US20240123021A1 (en) 2021-06-25 2024-04-18 Extrovis Ag Pharmaceutical compositions
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
CN115792011B (zh) * 2022-11-30 2025-04-22 四川汇宇制药股份有限公司 N-乙酰基保护氨基酸与其光学异构体的分离检测方法

Family Cites Families (13)

* 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
AU2003269747A1 (en) 2002-05-15 2003-12-02 Sun Pharmaceutical Industries Limited A stable aqueous composition of a peptide
KR20140091652A (ko) * 2010-12-06 2014-07-22 아스트론 리서치 리미티드 안정적이며 바로 사용 가능한 세트로레릭스 주사액
JP2013231030A (ja) 2012-04-30 2013-11-14 Sun Pharmaceutical Industries Ltd リュープロリド注射剤
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
CN110678194B (zh) 2017-05-15 2024-08-06 太阳制药有限公司 奥曲肽注射液
CN107312073A (zh) * 2017-06-20 2017-11-03 浙江湃肽生物有限公司 一种纯化分离西曲瑞克的方法
CN107664666B (zh) * 2017-09-23 2019-04-23 海南中和药业股份有限公司 一种醋酸西曲瑞克及其制剂的有关物质测定方法
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
HRP20211890T1 (hr) 2019-10-24 2022-03-04 Sun Pharmaceutical Industries Ltd Stabilan parenteralni dozni oblik cetroreliks acetata

Also Published As

Publication number Publication date
EP3811927B1 (fr) 2021-11-17
MA55417B1 (fr) 2022-02-28
RS62754B1 (sr) 2022-01-31
HUE058963T2 (hu) 2022-10-28
JP7682869B2 (ja) 2025-05-26
UA128877C2 (uk) 2024-11-13
EP3908259A1 (fr) 2021-11-17
IL293908A (en) 2022-08-01
BR112022007746A2 (pt) 2022-07-05
US20220153802A1 (en) 2022-05-19
MA54713A (fr) 2021-11-17
ES2902784T3 (es) 2022-03-29
SI3811927T1 (sl) 2022-03-31
DK3811927T3 (da) 2021-12-13
KR20220114533A (ko) 2022-08-17
MD3811927T2 (ro) 2022-03-31
HRP20211890T1 (hr) 2022-03-04
LT3811927T (lt) 2022-01-10
AR120290A1 (es) 2022-02-09
TWI885001B (zh) 2025-06-01
CN114599384A (zh) 2022-06-07
PL3811927T3 (pl) 2022-02-07
TN2022000111A1 (en) 2024-01-02
AU2020369236A1 (en) 2022-05-19
PT3811927T (pt) 2021-12-14
EP3811927B8 (fr) 2022-02-23
PH12022550967A1 (en) 2023-09-25
CA3155348A1 (fr) 2021-04-29
SA522432367B1 (ar) 2024-08-05
IL293908B1 (en) 2026-01-01
TW202128210A (zh) 2021-08-01
CL2022001021A1 (es) 2023-02-03
WO2021079339A1 (fr) 2021-04-29
US20210121517A1 (en) 2021-04-29
JOP20220094A1 (ar) 2023-01-30
EP3811927A1 (fr) 2021-04-28
AU2020369236B2 (en) 2025-09-11
MX2022004859A (es) 2022-05-19
ZA202204282B (en) 2024-01-31
JP2023501902A (ja) 2023-01-20
CO2022006820A2 (es) 2022-06-10

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