HRP20211890T1 - Stabilan parenteralni dozni oblik cetroreliks acetata - Google Patents
Stabilan parenteralni dozni oblik cetroreliks acetata Download PDFInfo
- Publication number
- HRP20211890T1 HRP20211890T1 HRP20211890TT HRP20211890T HRP20211890T1 HR P20211890 T1 HRP20211890 T1 HR P20211890T1 HR P20211890T T HRP20211890T T HR P20211890TT HR P20211890 T HRP20211890 T HR P20211890T HR P20211890 T1 HRP20211890 T1 HR P20211890T1
- Authority
- HR
- Croatia
- Prior art keywords
- dosage form
- parenteral dosage
- form according
- stable
- sterile
- Prior art date
Links
- 239000006201 parenteral dosage form Substances 0.000 title claims 15
- 108700008462 cetrorelix Proteins 0.000 title claims 3
- 229960001865 cetrorelix acetate Drugs 0.000 title 1
- KFEFLCOCAHJBEA-ANRVCLKPSA-N cetrorelix acetate Chemical compound CC(O)=O.C([C@@H](C(=O)N[C@H](CCCNC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1[C@@H](CCC1)C(=O)N[C@H](C)C(N)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](CC=1C=NC=CC=1)NC(=O)[C@@H](CC=1C=CC(Cl)=CC=1)NC(=O)[C@@H](CC=1C=C2C=CC=CC2=CC=1)NC(C)=O)C1=CC=C(O)C=C1 KFEFLCOCAHJBEA-ANRVCLKPSA-N 0.000 title 1
- 238000002347 injection Methods 0.000 claims 6
- 239000007924 injection Substances 0.000 claims 6
- 239000007864 aqueous solution Substances 0.000 claims 5
- 229940090047 auto-injector Drugs 0.000 claims 2
- SBNPWPIBESPSIF-MHWMIDJBSA-N cetrorelix Chemical compound C([C@@H](C(=O)N[C@H](CCCNC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1[C@@H](CCC1)C(=O)N[C@H](C)C(N)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](CC=1C=NC=CC=1)NC(=O)[C@@H](CC=1C=CC(Cl)=CC=1)NC(=O)[C@@H](CC=1C=C2C=CC=CC2=CC=1)NC(C)=O)C1=CC=C(O)C=C1 SBNPWPIBESPSIF-MHWMIDJBSA-N 0.000 claims 2
- 229960003230 cetrorelix Drugs 0.000 claims 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims 2
- 239000002357 osmotic agent Substances 0.000 claims 2
- 102000009151 Luteinizing Hormone Human genes 0.000 claims 1
- 108010073521 Luteinizing Hormone Proteins 0.000 claims 1
- 239000012535 impurity Substances 0.000 claims 1
- 230000002401 inhibitory effect Effects 0.000 claims 1
- 238000007918 intramuscular administration Methods 0.000 claims 1
- 235000014655 lactic acid Nutrition 0.000 claims 1
- 239000004310 lactic acid Substances 0.000 claims 1
- 229940040129 luteinizing hormone Drugs 0.000 claims 1
- 230000002611 ovarian Effects 0.000 claims 1
- 229940071643 prefilled syringe Drugs 0.000 claims 1
- 230000002028 premature Effects 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000000243 solution Substances 0.000 claims 1
- 230000000638 stimulation Effects 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 239000008215 water for injection Substances 0.000 claims 1
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)
- 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)
Claims (12)
1. Parenteralni dozni oblik naznačen time što sadrži:
sterilnu, stabilnu vodenu otopinu koja je spremna za injektiranje koji sadrži:
(i) cetroreliks ili njegovu farmaceutski prihvatljivu sol, u količini od 0.25 mg/ml,
(ii) mliječnu kiselinu za podešavanje pH u opsegu od 3 do 5,
(iii) nečistoću A, dekapeptid formule I u količini manjoj od 1% tež./zapr. cetroreliks baze,
[image]
(iv) osmotski agens, i
(v) vodu za injekcije.
2. Parenteralni dozni oblik u skladu sa patentnim zahtjevom 1, naznačen time što je osmotski agens prisutan u količini dovoljnoj za osmolalnost otopine u opsegu od 250 do 375 mOsm/kg.
3. Parenteralni dozni oblik u skladu sa patentnim zahtjevom 1, naznačen time što je sterilna, stabilna vodena otopina koja je spremna za injektiranje prisutna u rezervoaru uređaja za injektiranje.
4. Parenteralni dozni oblik u skladu sa patentnim zahtjevom 3, naznačen time što je uređaj za injektiranje prethodno napunjena šprica.
5. Parenteralni dozni oblik u skladu sa patentnim zahtjevom 3, naznačen time što je uređaj za injektiranje autoinjektor.
6. Parenteralni dozni oblik u skladu sa patentnim zahtjevom 5, naznačen time što je uređaj za injektiranje autoinjektor olovka.
7. Parenteralni dozni oblik u skladu sa bilo kojim od patentnih zahtjeva 1-6, naznačen time što je sterilna, vodena otopina stabilna tijekom najmanje 1 mjeseca na temperaturi od 25 °C i 60% relativne vlažnosti.
8. Parenteralni dozni oblik u skladu sa bilo kojim od patentnih zahtjeva 1-6, naznačen time što je sterilna, vodena otopina stabilna tijekom najmanje 3 mjeseca na temperaturi od 25 °C i 60% relativne vlažnosti.
9. Parenteralni dozni oblik u skladu sa bilo kojim od patentnih zahtjeva 1-6, naznačen time što je sterilna, vodena otopina stabilna tijekom najmanje 6 mjeseci na temperaturi od 25 °C i 60% relativne vlažnosti.
10. Parenteralni dozni oblik u skladu sa bilo kojim od patentnih zahtjeva 1-6, naznačen time što je parenteralni dozni oblik pogodan za subkutanu uporabu.
11. Parenteralni dozni oblik u skladu sa bilo kojim od patentnih zahtjeva 1-6, naznačen time što je parenteralni dozni oblik pogodan za intramuskularnu uporabu.
12. Parenteralni dozni oblik u skladu sa patentnim zahtjevom 1, za uporabu u inhibiranju preranog porasta luteinizirajućeg hormona kod žena koje su podvrgnute kontroliranoj stimulaciji jajnika.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN201921043355 | 2019-10-24 | ||
| EP20162018.4A EP3811927B8 (en) | 2019-10-24 | 2020-03-10 | A stable parenteral dosage form of cetrorelix acetate |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20211890T1 true HRP20211890T1 (hr) | 2022-03-04 |
Family
ID=69784288
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20211890TT HRP20211890T1 (hr) | 2019-10-24 | 2020-03-10 | Stabilan parenteralni dozni oblik cetroreliks acetata |
Country Status (28)
| Country | Link |
|---|---|
| US (2) | US20210121517A1 (hr) |
| EP (2) | EP3811927B8 (hr) |
| JP (1) | JP2023501902A (hr) |
| KR (1) | KR20220114533A (hr) |
| CN (1) | CN114599384A (hr) |
| AR (1) | AR120290A1 (hr) |
| AU (1) | AU2020369236A1 (hr) |
| BR (1) | BR112022007746A2 (hr) |
| CA (1) | CA3155348A1 (hr) |
| CL (1) | CL2022001021A1 (hr) |
| CO (1) | CO2022006820A2 (hr) |
| DK (1) | DK3811927T3 (hr) |
| ES (1) | ES2902784T3 (hr) |
| HR (1) | HRP20211890T1 (hr) |
| HU (1) | HUE058963T2 (hr) |
| IL (1) | IL293908A (hr) |
| JO (1) | JOP20220094A1 (hr) |
| LT (1) | LT3811927T (hr) |
| MA (2) | MA55417B1 (hr) |
| MD (1) | MD3811927T2 (hr) |
| MX (1) | MX2022004859A (hr) |
| PL (1) | PL3811927T3 (hr) |
| PT (1) | PT3811927T (hr) |
| RS (1) | RS62754B1 (hr) |
| SI (1) | SI3811927T1 (hr) |
| TW (1) | TW202128210A (hr) |
| WO (1) | WO2021079339A1 (hr) |
| ZA (1) | ZA202204282B (hr) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK3811927T3 (da) | 2019-10-24 | 2021-12-13 | Sun Pharmaceutical Ind Ltd | Stabil, parenteral doseringsform af cetrorelixacetat |
| US20240123021A1 (en) | 2021-06-25 | 2024-04-18 | Extrovis Ag | Pharmaceutical compositions |
| CN115541733A (zh) * | 2022-07-14 | 2022-12-30 | 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 |
| CN115184507A (zh) * | 2022-07-27 | 2022-10-14 | 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 (10)
| 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 |
| US20130303464A1 (en) | 2010-12-06 | 2013-11-14 | Astron Research Limited | Stable ready-to-use cetrorelix injection |
| US20130288968A1 (en) | 2012-04-30 | 2013-10-31 | Sun Pharmaceutical Industries Ltd. | Leuprolide injection |
| US20130303453A1 (en) | 2012-05-09 | 2013-11-14 | Sun Pharmaceutical Industries Ltd. | Octreotide injection |
| EP2823808A1 (en) | 2013-07-09 | 2015-01-14 | Ipsen Pharma S.A.S. | Pharmaceutical composition for a sustained release of lanreotide |
| EP3624829A4 (en) | 2017-05-15 | 2020-10-28 | Sun Pharmaceutical Industries Limited | OCTREOTIDE INJECTION |
| DK3811927T3 (da) * | 2019-10-24 | 2021-12-13 | Sun Pharmaceutical Ind Ltd | Stabil, parenteral doseringsform af cetrorelixacetat |
-
2020
- 2020-03-10 DK DK20162018.4T patent/DK3811927T3/da active
- 2020-03-10 MA MA55417A patent/MA55417B1/fr unknown
- 2020-03-10 HR HRP20211890TT patent/HRP20211890T1/hr unknown
- 2020-03-10 HU HUE20162018A patent/HUE058963T2/hu unknown
- 2020-03-10 US US16/814,447 patent/US20210121517A1/en active Pending
- 2020-03-10 RS RS20211515A patent/RS62754B1/sr unknown
- 2020-03-10 PL PL20162018T patent/PL3811927T3/pl unknown
- 2020-03-10 MD MDE20220046T patent/MD3811927T2/ro unknown
- 2020-03-10 SI SI202030015T patent/SI3811927T1/sl unknown
- 2020-03-10 PT PT201620184T patent/PT3811927T/pt unknown
- 2020-03-10 LT LTEP20162018.4T patent/LT3811927T/lt unknown
- 2020-03-10 ES ES20162018T patent/ES2902784T3/es active Active
- 2020-03-10 EP EP20162018.4A patent/EP3811927B8/en active Active
- 2020-10-23 CN CN202080074551.6A patent/CN114599384A/zh active Pending
- 2020-10-23 AU AU2020369236A patent/AU2020369236A1/en active Pending
- 2020-10-23 KR KR1020227017349A patent/KR20220114533A/ko unknown
- 2020-10-23 JP JP2022523629A patent/JP2023501902A/ja active Pending
- 2020-10-23 US US17/593,512 patent/US20220153802A1/en active Pending
- 2020-10-23 CA CA3155348A patent/CA3155348A1/en active Pending
- 2020-10-23 JO JOP/2022/0094A patent/JOP20220094A1/ar unknown
- 2020-10-23 BR BR112022007746A patent/BR112022007746A2/pt unknown
- 2020-10-23 IL IL293908A patent/IL293908A/en unknown
- 2020-10-23 WO PCT/IB2020/059988 patent/WO2021079339A1/en active Application Filing
- 2020-10-23 EP EP20800340.0A patent/EP3908259A1/en active Pending
- 2020-10-23 AR ARP200102937A patent/AR120290A1/es unknown
- 2020-10-23 MX MX2022004859A patent/MX2022004859A/es unknown
- 2020-10-23 MA MA054713A patent/MA54713A/fr unknown
- 2020-10-23 TW TW109136923A patent/TW202128210A/zh unknown
-
2022
- 2022-04-14 ZA ZA2022/04282A patent/ZA202204282B/en unknown
- 2022-04-22 CL CL2022001021A patent/CL2022001021A1/es unknown
- 2022-05-24 CO CONC2022/0006820A patent/CO2022006820A2/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO2021079339A1 (en) | 2021-04-29 |
| MD3811927T2 (ro) | 2022-03-31 |
| EP3811927B1 (en) | 2021-11-17 |
| EP3811927A1 (en) | 2021-04-28 |
| ES2902784T3 (es) | 2022-03-29 |
| CO2022006820A2 (es) | 2022-06-10 |
| PL3811927T3 (pl) | 2022-02-07 |
| HUE058963T2 (hu) | 2022-10-28 |
| PT3811927T (pt) | 2021-12-14 |
| MA55417A (fr) | 2021-04-28 |
| CL2022001021A1 (es) | 2023-02-03 |
| SI3811927T1 (sl) | 2022-03-31 |
| AU2020369236A1 (en) | 2022-05-19 |
| MA55417B1 (fr) | 2022-02-28 |
| TW202128210A (zh) | 2021-08-01 |
| IL293908A (en) | 2022-08-01 |
| KR20220114533A (ko) | 2022-08-17 |
| CN114599384A (zh) | 2022-06-07 |
| AR120290A1 (es) | 2022-02-09 |
| JOP20220094A1 (ar) | 2023-01-30 |
| US20220153802A1 (en) | 2022-05-19 |
| BR112022007746A2 (pt) | 2022-07-05 |
| JP2023501902A (ja) | 2023-01-20 |
| LT3811927T (lt) | 2022-01-10 |
| EP3811927B8 (en) | 2022-02-23 |
| DK3811927T3 (da) | 2021-12-13 |
| ZA202204282B (en) | 2024-01-31 |
| CA3155348A1 (en) | 2021-04-29 |
| MX2022004859A (es) | 2022-05-19 |
| MA54713A (fr) | 2021-11-17 |
| US20210121517A1 (en) | 2021-04-29 |
| EP3908259A1 (en) | 2021-11-17 |
| RS62754B1 (sr) | 2022-01-31 |
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