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WO2008150080A1 - Solutions injectables prêtes à l'emploi contenant de la gonadotrophine chorionique - Google Patents

Solutions injectables prêtes à l'emploi contenant de la gonadotrophine chorionique Download PDF

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Publication number
WO2008150080A1
WO2008150080A1 PCT/KR2008/002971 KR2008002971W WO2008150080A1 WO 2008150080 A1 WO2008150080 A1 WO 2008150080A1 KR 2008002971 W KR2008002971 W KR 2008002971W WO 2008150080 A1 WO2008150080 A1 WO 2008150080A1
Authority
WO
WIPO (PCT)
Prior art keywords
hcg
chorionic gonadotropin
human chorionic
injectable ready
injectable
Prior art date
Application number
PCT/KR2008/002971
Other languages
English (en)
Inventor
Beom-Soo Park
Ho-Young Yi
Kyu-Heum Na
Sung-Hee Lee
Soo-Hyung Kang
Original Assignee
Dong-A Pharm. Co., 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
Application filed by Dong-A Pharm. Co., Ltd. filed Critical Dong-A Pharm. Co., Ltd.
Priority to EP08765941A priority Critical patent/EP2152296A1/fr
Publication of WO2008150080A1 publication Critical patent/WO2008150080A1/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
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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

Definitions

  • International Publication No. WO 88Ol 0270 discloses a freeze-dried formulation in which urine-derived follicle stimulating hormones (FSH) are stabilized with lactose and human serum albumin
  • European Patent No. EP 448146 discloses a freeze- dried gonadotropin formulation which is stabilized with dicarboxylic acid such as citric acid.
  • International Publication No. WO 93011788 discloses a method for stabilizing a freeze-dried gonadotropin formulation using sucrose and ⁇ r glycine.
  • sucrose has been proposed as a desirable vehicle so as to maintain the stability of hCG
  • a freeze-dried pharmaceutical composition including sucrose has a superior stability to a freeze-dried pharmaceutical composition including lactose or mannitol.
  • U.S. Patent Publication No. 5929028 discloses a liquid gonadotropin- stabilized formulation comprising 25-100 mM citric acid (pH 6.5-7.2), 1-10 mM methionine, 25-300 mM sucrose, and a non-ionic surfactant.
  • the present invention provides the injectable ready-to-use solution comprising human chorionic gonadotropin (hCG) containing non-reducing sugar such as trehalose and methionine, and the solution which has not been reconstituted from a freeze-dried materials and not containing HSA as an additive may store stably the hCG for an extended time.
  • hCG human chorionic gonadotropin
  • compositions of recombinant hCG solutions Compositions of recombinant hCG solutions

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Reproductive Health (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une solution injectable prête à l'emploi contenant de la gonadotrophine chorionique humaine (hCG) qui peut stocker de manière stable de la hCG. La solution injectable prête à l'emploi contenant de la gonadotrophine chorionique humaine (hCG) selon la présente invention peut être utile pour stocker de manière stable la hCG sans reconstitution à partir de matières lyophilisées étant donné que la solution injectable prête à l'emploi comprend des sucres pharmaceutiques non réducteurs tels que le tréhalose et la méthionine.
PCT/KR2008/002971 2007-06-04 2008-05-28 Solutions injectables prêtes à l'emploi contenant de la gonadotrophine chorionique WO2008150080A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP08765941A EP2152296A1 (fr) 2007-06-04 2008-05-28 Solutions injectables prêtes à l'emploi contenant de la gonadotrophine chorionique

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020070054283A KR20080106636A (ko) 2007-06-04 2007-06-04 사람 융모성 성선자극호르몬 함유 즉시 사용형 주사 용액
KR10-2007-0054283 2007-06-04

Publications (1)

Publication Number Publication Date
WO2008150080A1 true WO2008150080A1 (fr) 2008-12-11

Family

ID=40093856

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2008/002971 WO2008150080A1 (fr) 2007-06-04 2008-05-28 Solutions injectables prêtes à l'emploi contenant de la gonadotrophine chorionique

Country Status (3)

Country Link
EP (1) EP2152296A1 (fr)
KR (1) KR20080106636A (fr)
WO (1) WO2008150080A1 (fr)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107281138A (zh) * 2016-03-31 2017-10-24 重庆润泽医药有限公司 一种注射用的(s)-4-羟基-2氧代-1-吡咯烷乙酰胺无菌粉末及其制备方法
CN107281134A (zh) * 2016-03-31 2017-10-24 重庆润泽医药有限公司 一种稳定性好的左旋奥拉西坦无菌粉末及其制备方法
CN107281132A (zh) * 2016-03-31 2017-10-24 重庆润泽医药有限公司 一种杂质少的（s）-4-羟基-2氧代-1-吡咯烷乙酰胺无菌粉末及其制备方法
CN107281123A (zh) * 2016-03-31 2017-10-24 重庆润泽医药有限公司 一种（s）-4-羟基-2氧代-1-吡咯烷乙酰胺冻干粉针及其制备方法
CN107281128A (zh) * 2016-03-31 2017-10-24 重庆润泽医药有限公司 一种杂质少的左旋奥拉西坦无菌粉末及其制备方法
CN107281126A (zh) * 2016-03-31 2017-10-24 重庆润泽医药有限公司 一种稳定性好的（s）-4-羟基-2氧代-1-吡咯烷乙酰胺冻干粉针及其制备方法
CN107397725A (zh) * 2016-05-20 2017-11-28 重庆润泽医药有限公司 注射用左旋奥拉西坦冻干组合物及其制备方法
CN107397723A (zh) * 2016-05-20 2017-11-28 重庆润泽医药有限公司 左旋奥拉西坦无菌粉末及其制备方法
CN107432864A (zh) * 2016-05-26 2017-12-05 重庆润泽医药有限公司 一种(s)-4-羟基-2-氧代-1-吡咯烷乙酰胺无菌粉末及其制备方法
CN107536811A (zh) * 2016-06-28 2018-01-05 重庆润泽医药有限公司 左旋奥拉西坦无菌粉末
CN107536814A (zh) * 2016-06-29 2018-01-05 重庆润泽医药有限公司 注射用左旋奥拉西坦冻干粉
CN107536810A (zh) * 2016-06-28 2018-01-05 重庆润泽医药有限公司 注射用(s)‑4‑羟基‑2‑氧代‑1‑吡咯烷乙酰胺无菌粉末
CN107536815A (zh) * 2016-06-29 2018-01-05 重庆润泽医药有限公司 注射用左旋奥拉西坦冻干粉针剂的制备方法
CN107536812A (zh) * 2016-06-28 2018-01-05 重庆润泽医药有限公司 注射用左旋奥拉西坦冻干粉
CN113398251A (zh) * 2021-07-30 2021-09-17 宁波人健药业集团股份有限公司 一种重组人绒毛膜促性腺激素冻干粉针剂及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3852422A (en) * 1971-06-26 1974-12-03 Serono Ist Farm Long-active gonadotropins
WO1993022335A1 (fr) * 1992-04-30 1993-11-11 Cor Therapeutics, Inc. Compositions stables a base de polypeptides
JPH05331071A (ja) * 1992-01-17 1993-12-14 Asahi Chem Ind Co Ltd カルシトニン遺伝子関連ペプチド類の凍結乾燥組成物および安定化法
WO1996029095A1 (fr) * 1995-03-21 1996-09-26 Applied Research Systems Ars Holding N.V. Compositions liquides de gonadotrophine chorionique de l'homme
US5929028A (en) * 1997-01-15 1999-07-27 Akzo Nobel, N.V. Liquid gonadotropin containing formulations

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3852422A (en) * 1971-06-26 1974-12-03 Serono Ist Farm Long-active gonadotropins
JPH05331071A (ja) * 1992-01-17 1993-12-14 Asahi Chem Ind Co Ltd カルシトニン遺伝子関連ペプチド類の凍結乾燥組成物および安定化法
WO1993022335A1 (fr) * 1992-04-30 1993-11-11 Cor Therapeutics, Inc. Compositions stables a base de polypeptides
WO1996029095A1 (fr) * 1995-03-21 1996-09-26 Applied Research Systems Ars Holding N.V. Compositions liquides de gonadotrophine chorionique de l'homme
US5929028A (en) * 1997-01-15 1999-07-27 Akzo Nobel, N.V. Liquid gonadotropin containing formulations

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107281138B (zh) * 2016-03-31 2020-08-18 重庆润泽医药有限公司 一种注射用的(s)-4-羟基-2氧代-1-吡咯烷乙酰胺无菌粉末及其制备方法
CN107281134A (zh) * 2016-03-31 2017-10-24 重庆润泽医药有限公司 一种稳定性好的左旋奥拉西坦无菌粉末及其制备方法
CN107281132A (zh) * 2016-03-31 2017-10-24 重庆润泽医药有限公司 一种杂质少的（s）-4-羟基-2氧代-1-吡咯烷乙酰胺无菌粉末及其制备方法
CN107281123A (zh) * 2016-03-31 2017-10-24 重庆润泽医药有限公司 一种（s）-4-羟基-2氧代-1-吡咯烷乙酰胺冻干粉针及其制备方法
CN107281128A (zh) * 2016-03-31 2017-10-24 重庆润泽医药有限公司 一种杂质少的左旋奥拉西坦无菌粉末及其制备方法
CN107281126A (zh) * 2016-03-31 2017-10-24 重庆润泽医药有限公司 一种稳定性好的（s）-4-羟基-2氧代-1-吡咯烷乙酰胺冻干粉针及其制备方法
CN107281138A (zh) * 2016-03-31 2017-10-24 重庆润泽医药有限公司 一种注射用的(s)-4-羟基-2氧代-1-吡咯烷乙酰胺无菌粉末及其制备方法
CN107397725A (zh) * 2016-05-20 2017-11-28 重庆润泽医药有限公司 注射用左旋奥拉西坦冻干组合物及其制备方法
CN107397723A (zh) * 2016-05-20 2017-11-28 重庆润泽医药有限公司 左旋奥拉西坦无菌粉末及其制备方法
CN107432864A (zh) * 2016-05-26 2017-12-05 重庆润泽医药有限公司 一种(s)-4-羟基-2-氧代-1-吡咯烷乙酰胺无菌粉末及其制备方法
CN107536810A (zh) * 2016-06-28 2018-01-05 重庆润泽医药有限公司 注射用(s)‑4‑羟基‑2‑氧代‑1‑吡咯烷乙酰胺无菌粉末
CN107536812A (zh) * 2016-06-28 2018-01-05 重庆润泽医药有限公司 注射用左旋奥拉西坦冻干粉
CN107536811A (zh) * 2016-06-28 2018-01-05 重庆润泽医药有限公司 左旋奥拉西坦无菌粉末
CN107536810B (zh) * 2016-06-28 2020-08-25 重庆润泽医药有限公司 注射用(s)-4-羟基-2-氧代-1-吡咯烷乙酰胺无菌粉末
CN107536814A (zh) * 2016-06-29 2018-01-05 重庆润泽医药有限公司 注射用左旋奥拉西坦冻干粉
CN107536815A (zh) * 2016-06-29 2018-01-05 重庆润泽医药有限公司 注射用左旋奥拉西坦冻干粉针剂的制备方法
CN113398251A (zh) * 2021-07-30 2021-09-17 宁波人健药业集团股份有限公司 一种重组人绒毛膜促性腺激素冻干粉针剂及其制备方法

Also Published As

Publication number Publication date
KR20080106636A (ko) 2008-12-09
EP2152296A1 (fr) 2010-02-17

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