EA201290637A1 - Способ получения фармацевтических композиций с замедленным высвобождением аналогов соматостатина - Google Patents

Способ получения фармацевтических композиций с замедленным высвобождением аналогов соматостатина

Info

Publication number
EA201290637A1
EA201290637A1 EA201290637A EA201290637A EA201290637A1 EA 201290637 A1 EA201290637 A1 EA 201290637A1 EA 201290637 A EA201290637 A EA 201290637A EA 201290637 A EA201290637 A EA 201290637A EA 201290637 A1 EA201290637 A1 EA 201290637A1
Authority
EA
Eurasian Patent Office
Prior art keywords
pharmaceutical compositions
somatostatin
analogs
slow release
producing pharmaceutical
Prior art date
Application number
EA201290637A
Other languages
English (en)
Other versions
EA023128B1 (ru
Inventor
Мартин Монтес
Томас Сиаран Лафман
Шанталь Рум
Ролан ШЕРИФ-ШЕЙК
Original Assignee
Ипсен Фарма С.А.С.
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 Ипсен Фарма С.А.С. filed Critical Ипсен Фарма С.А.С.
Publication of EA201290637A1 publication Critical patent/EA201290637A1/ru
Publication of EA023128B1 publication Critical patent/EA023128B1/ru

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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
    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • A61K38/31—Somatostatins
    • 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
    • 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
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
    • 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
    • A61P5/08—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH for decreasing, blocking or antagonising the activity of the anterior pituitary hormones
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04—Linear peptides containing only normal peptide links
    • C07K7/06—Linear peptides containing only normal peptide links having 5 to 11 amino acids

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

Abstract

Изобретение относится к способу получения инъекционных фармацевтических композиций с замедленным высвобождением аналогов соматостатина и к фармацевтическим композициям, полученным в соответствии со способом. В предпочтительном аспекте способ включает стадии смешивания ланреотида ацетата и уксусной кислоты, лиофилизации полученной смеси только один раз и гидратации лиофилизата. Уксусная кислота может быть добавлена до необходимого рН на последнем этапе способа.
EA201290637A 2010-01-13 2011-01-11 Способ получения инъекционной фармацевтической композиции с замедленным высвобождением ланреотида EA023128B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US29464410P 2010-01-13 2010-01-13
PCT/EP2011/000069 WO2011085957A2 (en) 2010-01-13 2011-01-11 Process for the preparation of pharmaceutical compositions for the sustained release of somatostatin analogs

Publications (2)

Publication Number Publication Date
EA201290637A1 true EA201290637A1 (ru) 2013-01-30
EA023128B1 EA023128B1 (ru) 2016-04-29

Family

ID=43743499

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201290637A EA023128B1 (ru) 2010-01-13 2011-01-11 Способ получения инъекционной фармацевтической композиции с замедленным высвобождением ланреотида

Country Status (25)

Country Link
US (3) US9352012B2 (ru)
EP (2) EP3378468A1 (ru)
JP (1) JP6029472B2 (ru)
KR (1) KR101915820B1 (ru)
CN (2) CN102711728B (ru)
AR (1) AR079896A1 (ru)
AU (1) AU2011206728B2 (ru)
BR (1) BR112012017435A2 (ru)
CA (1) CA2786181C (ru)
DK (1) DK2523653T3 (ru)
EA (1) EA023128B1 (ru)
ES (1) ES2677012T3 (ru)
HK (1) HK1222807A1 (ru)
HU (1) HUE038200T2 (ru)
IL (2) IL220538A (ru)
MX (1) MX343112B (ru)
NZ (1) NZ600891A (ru)
PL (1) PL2523653T3 (ru)
PT (1) PT2523653T (ru)
SG (1) SG182548A1 (ru)
TR (1) TR201809874T4 (ru)
TW (2) TWI536999B (ru)
UA (1) UA108872C2 (ru)
WO (1) WO2011085957A2 (ru)
ZA (1) ZA201205160B (ru)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011085957A2 (en) * 2010-01-13 2011-07-21 Ipsen Pharma S.A.S. Process for the preparation of pharmaceutical compositions for the sustained release of somatostatin analogs
EP2823808A1 (en) * 2013-07-09 2015-01-14 Ipsen Pharma S.A.S. Pharmaceutical composition for a sustained release of lanreotide
TW201605488A (zh) 2013-10-15 2016-02-16 大塚製藥股份有限公司 用以預防及／或治療多囊腎病之藥物
CA2928407A1 (en) * 2013-10-22 2015-04-30 Prolynx Llc Conjugates of somatostatin and its analogs
FR3079421A1 (fr) * 2018-03-28 2019-10-04 Edix Sa Presentations injectables, seringues et compositions a liberation prolongee et/ou controlee de lanreotide
GR1009814B (el) * 2019-07-29 2020-09-11 Φαρματεν Α.Β.Ε.Ε. Φαρμακευτικο σκευασμα που περιλαμβανει ενα πεπτιδιο αναλογο σωματοστατινης
RU2742196C1 (ru) * 2019-09-11 2021-02-03 Общество с ограниченной ответственностью "Медицинские нанотехнологии" Фармацевтическая композиция для приготовления инъекционного раствора при использовании в лечении магнитной гипертермии и способ ее получения
CN112791177B (zh) * 2019-10-28 2023-06-20 深圳翰宇药业股份有限公司 注射用生长抑素冻干组合物及其制备方法
EP4192427A1 (en) 2020-08-07 2023-06-14 Pharmathen S.A. Process and apparatus for preparing viscous pharmaceutical formulations
GR1010059B (el) * 2020-08-10 2021-08-13 Φαρματεν Α.Β.Ε.Ε. Διαδικασια και συσκευη για την παρασκευη παχυρευστων φαρμακοτεχνικων μορφων
LU101974B1 (en) 2020-08-07 2022-02-07 Pharmathen Sa Process and apparatus for preparing viscous pharmaceutical formulations

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JPH085913B2 (ja) 1985-09-12 1996-01-24 ザ・アドミニストレ−タ−ズ・オブ・ザ・ツ−レイン・エデユケイシヨナル・フアンド 治療用ソマトスタチン同族体
CA2168113C (en) 1993-08-09 2002-10-01 Sun Hyuk Kim Therapeutic peptide derivatives
US5595760A (en) 1994-09-02 1997-01-21 Delab Sustained release of peptides from pharmaceutical compositions
FR2762319A1 (fr) * 1997-04-18 1998-10-23 Pharma Biotech Microcapsules presentant une liberation prolongee et leur procede de preparation
FR2776520B1 (fr) * 1998-03-25 2000-05-05 Sod Conseils Rech Applic Nouvelles compositions pharmaceutiques destinees a la liberation prolongee de peptides et leur procede de preparation
KR100658476B1 (ko) * 1999-09-02 2006-12-18 후지쯔 가부시끼가이샤 네가티브형 레지스트 조성물 및 레지스트 패턴의 형성방법
IT1318539B1 (it) 2000-05-26 2003-08-27 Italfarmaco Spa Composizioni farmaceutiche a rilascio prolungato per lasomministrazione parenterale di sostanze idrofile biologicamente
US7098305B2 (en) 2001-09-06 2006-08-29 Ardana Bioscience Limited Sustained release of microcrystalline peptide suspensions
CN100509053C (zh) 2002-09-27 2009-07-08 赞塔里斯有限公司 持续释放的药物活性肽施用形式及其制备方法
US6953447B2 (en) 2002-10-22 2005-10-11 Societe De Conseils De Recherches Et D'applications Scientifiques (S.C.R.A.S) Pre-filled safety injection device with integrated waste collector
CN1415378A (zh) * 2002-10-22 2003-05-07 南京长澳医药科技有限公司 生长抑素冻干粉针及其制备工艺
GB0428151D0 (en) 2004-12-22 2005-01-26 Novartis Ag Organic compounds
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WO2011085957A2 (en) * 2010-01-13 2011-07-21 Ipsen Pharma S.A.S. Process for the preparation of pharmaceutical compositions for the sustained release of somatostatin analogs

Also Published As

Publication number Publication date
CN105456206B (zh) 2018-12-14
PL2523653T3 (pl) 2018-09-28
US20130079282A1 (en) 2013-03-28
AU2011206728A1 (en) 2012-08-30
BR112012017435A2 (pt) 2020-08-25
SG182548A1 (en) 2012-08-30
MX343112B (es) 2016-10-25
NZ600891A (en) 2014-05-30
JP6029472B2 (ja) 2016-11-24
TW201129371A (en) 2011-09-01
KR101915820B1 (ko) 2018-11-06
CN102711728B (zh) 2016-01-20
TW201600108A (zh) 2016-01-01
HK1222807A1 (zh) 2017-07-14
CN105456206A (zh) 2016-04-06
WO2011085957A2 (en) 2011-07-21
DK2523653T3 (en) 2018-07-16
UA108872C2 (uk) 2015-06-25
IL248510A0 (en) 2016-12-29
EP2523653B1 (en) 2018-04-11
ZA201205160B (en) 2013-03-27
US9352012B2 (en) 2016-05-31
US20190167754A1 (en) 2019-06-06
EP3378468A1 (en) 2018-09-26
HUE038200T2 (hu) 2018-09-28
MX2012007802A (es) 2012-08-31
ES2677012T3 (es) 2018-07-27
CA2786181A1 (en) 2011-07-21
WO2011085957A3 (en) 2012-05-03
EA023128B1 (ru) 2016-04-29
IL220538A (en) 2016-12-29
JP2013517228A (ja) 2013-05-16
CN102711728A (zh) 2012-10-03
EP2523653A2 (en) 2012-11-21
US20160339075A1 (en) 2016-11-24
US10206968B2 (en) 2019-02-19
TR201809874T4 (tr) 2018-07-23
IL220538A0 (en) 2012-08-30
TWI536999B (zh) 2016-06-11
AR079896A1 (es) 2012-02-29
PT2523653T (pt) 2018-06-28
AU2011206728B2 (en) 2016-02-04
CA2786181C (en) 2017-12-12
KR20120125576A (ko) 2012-11-15

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MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM AZ KG MD TJ TM