RU2526822C2 - Содежащий октреотид состав с замедленным высвобождением со стабильно высоким уровнем воздействия - Google Patents

Содежащий октреотид состав с замедленным высвобождением со стабильно высоким уровнем воздействия Download PDF

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RU2526822C2
RU2526822C2 RU2011128538/15A RU2011128538A RU2526822C2 RU 2526822 C2 RU2526822 C2 RU 2526822C2 RU 2011128538/15 A RU2011128538/15 A RU 2011128538/15A RU 2011128538 A RU2011128538 A RU 2011128538A RU 2526822 C2 RU2526822 C2 RU 2526822C2
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pharmaceutical composition
sustained release
microparticles
octreotide
present
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RU2011128538/15A
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English (en)
Russian (ru)
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RU2011128538A (ru
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АЛЬХАЙМ Маркус
ПЕТЕРЗЕН Хольгер
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Новартис Аг
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    • 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
    • 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
    • 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
    • A61K47/34—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
    • 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
    • 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
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • 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
    • 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
    • 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
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
RU2011128538/15A 2008-12-15 2009-12-14 Содежащий октреотид состав с замедленным высвобождением со стабильно высоким уровнем воздействия RU2526822C2 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP08171712 2008-12-15
EP08171712.6 2008-12-15
PCT/EP2009/067049 WO2010079047A2 (en) 2008-12-15 2009-12-14 Octreotide depot formulation with constantly high exposure levels

Publications (2)

Publication Number Publication Date
RU2011128538A RU2011128538A (ru) 2013-01-20
RU2526822C2 true RU2526822C2 (ru) 2014-08-27

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RU2011128538/15A RU2526822C2 (ru) 2008-12-15 2009-12-14 Содежащий октреотид состав с замедленным высвобождением со стабильно высоким уровнем воздействия

Country Status (25)

Country Link
US (10) US20100151033A1 (cg-RX-API-DMAC7.html)
EP (1) EP2376070B1 (cg-RX-API-DMAC7.html)
JP (1) JP5721635B2 (cg-RX-API-DMAC7.html)
KR (1) KR101708517B1 (cg-RX-API-DMAC7.html)
CN (3) CN105233251A (cg-RX-API-DMAC7.html)
AR (1) AR074603A1 (cg-RX-API-DMAC7.html)
AU (1) AU2009336718B9 (cg-RX-API-DMAC7.html)
BR (1) BRPI0922607B1 (cg-RX-API-DMAC7.html)
CA (1) CA2746968C (cg-RX-API-DMAC7.html)
CL (1) CL2011001438A1 (cg-RX-API-DMAC7.html)
CO (1) CO6382109A2 (cg-RX-API-DMAC7.html)
EC (1) ECSP11011199A (cg-RX-API-DMAC7.html)
ES (1) ES2602614T3 (cg-RX-API-DMAC7.html)
IL (1) IL213034A (cg-RX-API-DMAC7.html)
MA (1) MA32964B1 (cg-RX-API-DMAC7.html)
MX (1) MX2011006335A (cg-RX-API-DMAC7.html)
MY (1) MY159789A (cg-RX-API-DMAC7.html)
NZ (1) NZ592998A (cg-RX-API-DMAC7.html)
PE (1) PE20110876A1 (cg-RX-API-DMAC7.html)
PL (1) PL2376070T3 (cg-RX-API-DMAC7.html)
PT (1) PT2376070T (cg-RX-API-DMAC7.html)
RU (1) RU2526822C2 (cg-RX-API-DMAC7.html)
SG (1) SG171255A1 (cg-RX-API-DMAC7.html)
TN (1) TN2011000261A1 (cg-RX-API-DMAC7.html)
WO (1) WO2010079047A2 (cg-RX-API-DMAC7.html)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ591810A (en) 2008-09-17 2012-12-21 Chiasma Inc Pharmaceutical compositions and related methods of delivery the composition comprises a medium chain fatty acid
RU2695522C2 (ru) * 2012-05-14 2019-07-23 Тейдзин Лимитед Стерильная композиция
PT3125871T (pt) * 2014-03-31 2021-01-06 Pharmathen Sa Preparação de microsferas de plga carregadas com péptido com características de libertação controlada
IL285440B1 (en) 2014-12-10 2025-09-01 Amryt Endo Inc Oral preparations containing octreotide in combination with other medicinal substances for the treatment of acromegaly
EP4527456A3 (en) 2015-02-03 2025-05-21 Amryt Endo, Inc. Treating acromegaly with oral octreotide
CN105963258B (zh) 2016-04-26 2021-01-22 广州帝奇医药技术有限公司 一种缓释微粒的制备方法
KR102142026B1 (ko) * 2017-05-31 2020-08-06 주식회사 대웅제약 방출제어가 용이한 서방성 약물 미립자의 제조방법
KR20250004925A (ko) 2017-09-15 2025-01-08 옥슬러 리미티드 안과용 약물 조성물
JP7704740B2 (ja) 2019-09-16 2025-07-08 アムジエン・インコーポレーテツド 薬物送達デバイスの外部滅菌の方法
US11141457B1 (en) 2020-12-28 2021-10-12 Amryt Endo, Inc. Oral octreotide therapy and contraceptive methods

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2160741C2 (ru) * 1995-06-29 2000-12-20 Новартис Аг Соматостатиновые пептиды
US20040151753A1 (en) * 2002-11-06 2004-08-05 Guohua Chen Controlled release depot formulations
WO2005046645A1 (en) * 2003-11-14 2005-05-26 Novartis Ag Microparticles comprising somatostatin analogues
EA200601905A1 (ru) * 2004-04-15 2007-08-31 Амилин Фармасьютикалз, Инк. Микрокапсулы с замедленным высвобождением, основанные на сополимере лактида и гликолида, включающие полипептид и сахар

Family Cites Families (5)

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Publication number Priority date Publication date Assignee Title
PH30995A (en) * 1989-07-07 1997-12-23 Novartis Inc Sustained release formulations of water soluble peptides.
US20040097419A1 (en) * 2002-11-19 2004-05-20 Holger Petersen Organic compounds
GB0326602D0 (en) * 2003-11-14 2003-12-17 Novartis Ag Organic compounds
JP2008524235A (ja) * 2004-12-15 2008-07-10 キューエルティー ユーエスエー，インコーポレイテッド． オクトレオチド化合物の徐放性送達処方物
ES2492641T3 (es) * 2005-12-22 2014-09-10 Novartis Ag Formulación de liberación sostenida que comprende octreótida y dos o más polímeros de poliláctida-co-glicólido

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2160741C2 (ru) * 1995-06-29 2000-12-20 Новартис Аг Соматостатиновые пептиды
US20040151753A1 (en) * 2002-11-06 2004-08-05 Guohua Chen Controlled release depot formulations
WO2005046645A1 (en) * 2003-11-14 2005-05-26 Novartis Ag Microparticles comprising somatostatin analogues
EA200601905A1 (ru) * 2004-04-15 2007-08-31 Амилин Фармасьютикалз, Инк. Микрокапсулы с замедленным высвобождением, основанные на сополимере лактида и гликолида, включающие полипептид и сахар

Non-Patent Citations (1)

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Title
0. *

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US20100151033A1 (en) 2010-06-17
BRPI0922607A2 (pt) 2015-12-22
TN2011000261A1 (en) 2012-12-17
US20240082148A1 (en) 2024-03-14
PE20110876A1 (es) 2011-12-21
MA32964B1 (fr) 2012-01-02
RU2011128538A (ru) 2013-01-20
EP2376070A2 (en) 2011-10-19
US20160089336A1 (en) 2016-03-31
BRPI0922607B1 (pt) 2019-11-05
PL2376070T3 (pl) 2017-04-28
SG171255A1 (en) 2011-07-28
JP2012512147A (ja) 2012-05-31
AU2009336718B2 (en) 2014-01-30
IL213034A0 (en) 2011-07-31
US20210161806A1 (en) 2021-06-03
US20250205147A1 (en) 2025-06-26
WO2010079047A2 (en) 2010-07-15
CN102245210A (zh) 2011-11-16
AU2009336718A1 (en) 2011-06-30
US20110262545A1 (en) 2011-10-27
CO6382109A2 (es) 2012-02-15
CL2011001438A1 (es) 2011-11-04
WO2010079047A3 (en) 2010-09-16
KR101708517B1 (ko) 2017-02-20
MX2011006335A (es) 2011-07-13
US20170143791A1 (en) 2017-05-25
CA2746968A1 (en) 2010-07-15
CN105031607A (zh) 2015-11-11
HK1159505A1 (zh) 2012-08-03
ECSP11011199A (es) 2011-08-31
MY159789A (en) 2017-01-31
PT2376070T (pt) 2016-11-16
US20140363513A1 (en) 2014-12-11
US20180036230A1 (en) 2018-02-08
ES2602614T3 (es) 2017-02-21
US20190209462A1 (en) 2019-07-11
AR074603A1 (es) 2011-01-26
NZ592998A (en) 2013-02-22
KR20110104042A (ko) 2011-09-21
IL213034A (en) 2017-04-30
AU2009336718B9 (en) 2014-04-03
EP2376070B1 (en) 2016-08-10
CA2746968C (en) 2016-10-04
JP5721635B2 (ja) 2015-05-20
CN105233251A (zh) 2016-01-13

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