PL2987484T3 - Kompozycja farmaceutyczna mikrosfery o przedłużonym uwalnianiu gosereliny - Google Patents

Kompozycja farmaceutyczna mikrosfery o przedłużonym uwalnianiu gosereliny

Info

Publication number
PL2987484T3
PL2987484T3 PL14785916T PL14785916T PL2987484T3 PL 2987484 T3 PL2987484 T3 PL 2987484T3 PL 14785916 T PL14785916 T PL 14785916T PL 14785916 T PL14785916 T PL 14785916T PL 2987484 T3 PL2987484 T3 PL 2987484T3
Authority
PL
Poland
Prior art keywords
pharmaceutical composition
sustained release
release microsphere
goserelin
microsphere pharmaceutical
Prior art date
Application number
PL14785916T
Other languages
English (en)
Inventor
Wei Sun
Xuemei Zhang
Tao Wang
Guangyi LENG
Kaoxiang Sun
Youxin Li
Wanhui Liu
Original Assignee
Shandong Luye Pharmaceutical 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 Shandong Luye Pharmaceutical Co., Ltd. filed Critical Shandong Luye Pharmaceutical Co., Ltd.
Publication of PL2987484T3 publication Critical patent/PL2987484T3/pl

Links

Classifications

    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • 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
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Reproductive Health (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
PL14785916T 2013-04-18 2014-04-16 Kompozycja farmaceutyczna mikrosfery o przedłużonym uwalnianiu gosereliny PL2987484T3 (pl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201310136505 2013-04-18
EP14785916.9A EP2987484B1 (en) 2013-04-18 2014-04-16 Goserelin sustained release microsphere pharmaceutical composition
PCT/CN2014/075441 WO2014169816A1 (zh) 2013-04-18 2014-04-16 戈舍瑞林缓释微球药物组合物

Publications (1)

Publication Number Publication Date
PL2987484T3 true PL2987484T3 (pl) 2019-07-31

Family

ID=51704550

Family Applications (1)

Application Number Title Priority Date Filing Date
PL14785916T PL2987484T3 (pl) 2013-04-18 2014-04-16 Kompozycja farmaceutyczna mikrosfery o przedłużonym uwalnianiu gosereliny

Country Status (8)

Country Link
US (2) US20160022584A1 (pl)
EP (1) EP2987484B1 (pl)
JP (1) JP6151848B2 (pl)
CN (1) CN104107434B (pl)
ES (1) ES2716384T3 (pl)
PL (1) PL2987484T3 (pl)
RU (1) RU2694901C2 (pl)
WO (1) WO2014169816A1 (pl)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201805191D0 (en) * 2018-03-29 2018-05-16 Camurus Ab Compositions
KR20200051916A (ko) * 2018-11-05 2020-05-14 주식회사 메디포럼제약 고세렐린을 포함하는 실리카 하이드로겔 조성물
JP2023151957A (ja) * 2022-04-01 2023-10-16 理研ビタミン株式会社 薬物含有粒子の製造方法
CN119139240B (zh) * 2024-10-08 2026-03-03 北京博恩特药业有限公司 一种戈舍瑞林微球的制备方法及其产品

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IE52535B1 (en) * 1981-02-16 1987-12-09 Ici Plc Continuous release pharmaceutical compositions
AR012448A1 (es) * 1997-04-18 2000-10-18 Ipsen Pharma Biotech Composicion en forma de microcapsulas o de implantes que comprende un excipiente biodegradable, polimero o co-polimero, o una mezcla de talesexcipientes, y una sustancia activa o una mezcla de sustancias activas, procedimiento para la preparacion de una sustancia soluble en agua de elevada
IE980115A1 (en) 1998-02-16 2000-02-09 Biovail Internat Ltd Solubilizing delivery systems and method of manufacture
AU3323902A (en) * 2000-12-13 2002-06-24 Merckle Gmbh Microparticles with an improved release profile and method for the production thereof
WO2006123361A2 (en) * 2005-03-01 2006-11-23 Sun Pharmaceutical Industries Limited Microspheres containing goserelin or a pharmaceutically acceptable salt thereof
JP5350620B2 (ja) * 2006-11-24 2013-11-27 キヤノン株式会社 粒子の製造方法、及び粒子
US8293819B2 (en) 2006-11-24 2012-10-23 Canon Kabushiki Kaisha Method for producing particles and particles
KR100816065B1 (ko) * 2006-11-27 2008-03-24 동국제약 주식회사 초기 방출억제 특성이 우수한 서방출성 마이크로캡슐의제조방법 및 이에 의해 제조되는 마이크로캡슐
JP5158835B2 (ja) * 2006-12-06 2013-03-06 独立行政法人産業技術総合研究所 生分解性高分子リン酸カルシウム複合ナノ粒子及びその製造方法
GB0625322D0 (en) * 2006-12-19 2007-01-24 Pharmakodex Ltd Pharmaceutical compositions
CA2730760A1 (en) * 2008-07-16 2010-01-21 Surmodics Pharmaceuticals, Inc. Process for preparing microparticles containing bioactive peptides
KR101113044B1 (ko) * 2008-08-29 2012-02-27 동국제약 주식회사 용매교류증발법에 의한 서방출성 미립구의 제조방법
CN101721370A (zh) * 2008-10-10 2010-06-09 深圳清华大学研究院 戈舍瑞林缓释微球制剂及其制备方法、检测方法
CA2742680C (en) * 2008-11-07 2013-12-31 Samyang Corporation Pharmaceutical compositions for release control of methylphenidate
CN101461786A (zh) * 2009-01-08 2009-06-24 上海交通大学 用水包油-油包固体制备的pla/plga壳-核微球及其制备方法
GB201110601D0 (en) * 2011-06-23 2011-08-03 Controlled Therapeutics Scotland Ltd Improved bioresorbable
UA112192C2 (uk) * 2011-07-22 2016-08-10 Іннокор Текнолоджис Б.В. Здатні до біорозкладання напівкристалічні термопластичні мультиблокові співполімери з розділеними фазами для контрольованого вивільнення біологічно активних сполук

Also Published As

Publication number Publication date
RU2015149431A (ru) 2017-05-24
CN104107434B (zh) 2017-02-01
EP2987484B1 (en) 2018-12-19
EP2987484A4 (en) 2017-03-08
CN104107434A (zh) 2014-10-22
EP2987484A1 (en) 2016-02-24
US20180036246A1 (en) 2018-02-08
US20160022584A1 (en) 2016-01-28
ES2716384T3 (es) 2019-06-12
WO2014169816A1 (zh) 2014-10-23
JP2016516785A (ja) 2016-06-09
RU2694901C2 (ru) 2019-07-18
US10258572B2 (en) 2019-04-16
JP6151848B2 (ja) 2017-06-21

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