RU2005119632A - Фармацевтическая композиция, содержащая октреотидные микрочастицы - Google Patents

Фармацевтическая композиция, содержащая октреотидные микрочастицы Download PDF

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RU2005119632A
RU2005119632A RU2005119632/15A RU2005119632A RU2005119632A RU 2005119632 A RU2005119632 A RU 2005119632A RU 2005119632/15 A RU2005119632/15 A RU 2005119632/15A RU 2005119632 A RU2005119632 A RU 2005119632A RU 2005119632 A RU2005119632 A RU 2005119632A
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Prior art keywords
pharmaceutical composition
octreotide acetate
microparticles
glycolide
lactide
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RU2005119632/15A
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English (en)
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RU2404748C2 (ru
Inventor
Оливье ЛАМБЕР (FR)
Оливье Ламбер
Михаэль АУСБОРН (DE)
Михаэль АУСБОРН
Хольгер ПЕТЕРСЕН (DE)
Хольгер ПЕТЕРСЕН
Рольф ЛЕФФЛЕР (DE)
Рольф ЛЕФФЛЕР
Жан-Даньель БОННИ (CH)
Жан-Даньель БОННИ
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Новартис АГ (CH)
Новартис Аг
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Priority claimed from GB0226993A external-priority patent/GB0226993D0/en
Priority claimed from GB0227883A external-priority patent/GB0227883D0/en
Application filed by Новартис АГ (CH), Новартис Аг filed Critical Новартис АГ (CH)
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    • 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
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives 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
    • A61K9/14—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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

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

Claims (10)

1. Фармацевтическая композиция, включающая микрочастицы октреотидацетата, изготовленные из линейного сополимера лактида с гликолидом, в которой полимер содержит менее 1% силиконового масла или гептана, предпочтительно, не содержащего силиконового масла или гептана.
2. Фармацевтическая композиция, включающая микрочастицы октреотидацетата, изготовленные из линейного сополимера лактида с гликолидом, в смеси или в ассоциации с разбавителем, включающим неионогенное поверхностно-активное вещество.
3. Фармацевтическая композиция по п.1 или 2, дополнительно включающая вещество, препятствующее агломерации.
4. Способ получения микрочастиц октреотидацетата, включающий стадии
а) растворения или диспергирования октреотидацетата в метиленхлориде, содержащем растворенный линейный сополимер лактида с гликолидом, с получением дисперсии;
б) объединения указанной дисперсии с эффективным количеством сплошной рабочей среды с получением эмульсии, которая содержит указанную сплошную рабочую среду и микрокапельки, включающие указанный октреотидацетат, указанный растворитель и указанный линейный сополимер лактида с гликолидом; и
в) сразу же после образования указанной эмульсии разового прибавления указанной эмульсии к эффективному количеству экстрагирующей среды для экстрагирования указанного растворителя из указанных микрокапелек с получением указанных микрочастиц.
5. Способ получения микрочастиц октреотидацетата способом многократного эмульгирования, улучшение которого включает стадии
а) растворения октреотидацетата в воде, эмульгирования водного раствора октреотидацетата в метиленхлориде, содержащем растворенный линейный сополимер лактида с гликолидом, с образованием эмульсии вода-в-масле; и
б) эмульгирования указанной эмульсии в воде.
6. Микрочастицы октреотидацетата, изготовленные из линейного сополимера лактида с гликолидом, получаемые способом по п.4 или 5.
7. Фармацевтическая композиция по п.1 или 2, содержащая микрочастицы по п.6 совместно с разбавителем, включающим смачивающее вещество и вещество, увеличивающее вязкость.
8. Фармацевтическая композиция по п.7, в которой смачивающее вещество разбавителя представляет собой Pluronic F 68.
9. Фармацевтическая композиция по п.7, в которой разбавитель дополнительно включает вещество для образования изотонического раствора.
10. Упаковка, предназначенная для продажи, включающая фармацевтическую композицию по п.7.
RU2005119632/15A 2002-11-19 2003-11-18 Фармацевтическая композиция, содержащая октреотидные микрочастицы RU2404748C2 (ru)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB0226993A GB0226993D0 (en) 2002-11-19 2002-11-19 Organic compounds
GB0226993.4 2002-11-19
GB0227883.6 2002-11-29
GB0227883A GB0227883D0 (en) 2002-11-29 2002-11-29 Organic compounds

Related Child Applications (1)

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RU2010144614/15A Division RU2010144614A (ru) 2002-11-19 2010-11-01 Фармацевтическая композиция, содержащая октреотидные микрочастицы

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RU2005119632A true RU2005119632A (ru) 2006-05-10
RU2404748C2 RU2404748C2 (ru) 2010-11-27

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RU2010144614/15A RU2010144614A (ru) 2002-11-19 2010-11-01 Фармацевтическая композиция, содержащая октреотидные микрочастицы

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US (6) US20040097419A1 (ru)
EP (2) EP1565161A2 (ru)
JP (2) JP2006514927A (ru)
KR (2) KR101240071B1 (ru)
AU (3) AU2003293700A1 (ru)
BR (1) BR0316421A (ru)
CA (1) CA2501978C (ru)
CO (1) CO5690533A2 (ru)
EC (1) ECSP055800A (ru)
ES (1) ES2577613T3 (ru)
HK (1) HK1161123A1 (ru)
MX (1) MXPA05005388A (ru)
NO (1) NO20052952L (ru)
PL (1) PL376015A1 (ru)
PT (1) PT2377519E (ru)
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EP1565161A2 (en) 2005-08-24
WO2004045633A3 (en) 2005-01-13
KR20120032537A (ko) 2012-04-05
HK1161123A1 (zh) 2012-08-24
RU2010144614A (ru) 2012-05-10
EP2377519B1 (en) 2016-03-23
EP2377519A2 (en) 2011-10-19
KR101146471B1 (ko) 2012-05-21
AU2011200966B2 (en) 2013-08-01
ECSP055800A (es) 2005-08-11
US20040097419A1 (en) 2004-05-20
NO20052952D0 (no) 2005-06-16
RU2404748C2 (ru) 2010-11-27
US20170281548A1 (en) 2017-10-05
US20200009056A1 (en) 2020-01-09
CA2501978C (en) 2013-12-17
US20220273574A1 (en) 2022-09-01
AU2011200966A1 (en) 2011-03-24
KR20050086708A (ko) 2005-08-30
AU2008200018B2 (en) 2010-12-09
AU2008200018A1 (en) 2008-01-31
ES2577613T3 (es) 2016-07-15
BR0316421A (pt) 2005-10-11
JP2011256185A (ja) 2011-12-22
US20140323415A1 (en) 2014-10-30
PL376015A1 (en) 2005-12-12
PT2377519E (pt) 2016-06-09
KR101240071B1 (ko) 2013-03-06
US20070122485A1 (en) 2007-05-31
CO5690533A2 (es) 2006-10-31
EP2377519A3 (en) 2011-11-23
WO2004045633A2 (en) 2004-06-03
NO20052952L (no) 2005-08-15
AU2003293700A1 (en) 2004-06-15
CA2501978A1 (en) 2004-06-03
MXPA05005388A (es) 2005-08-03
JP2006514927A (ja) 2006-05-18
JP5784402B2 (ja) 2015-09-24

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