JP5721635B2 - 一定して高い曝露レベルを有するオクトレオチドのデポー製剤 - Google Patents

一定して高い曝露レベルを有するオクトレオチドのデポー製剤 Download PDF

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JP5721635B2
JP5721635B2 JP2011540134A JP2011540134A JP5721635B2 JP 5721635 B2 JP5721635 B2 JP 5721635B2 JP 2011540134 A JP2011540134 A JP 2011540134A JP 2011540134 A JP2011540134 A JP 2011540134A JP 5721635 B2 JP5721635 B2 JP 5721635B2
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depot
microparticles
tumors
octreotide
preparation according
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JP2012512147A5 (enExample
JP2012512147A (ja
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アルヘイム，マークス
ぺターソン，ホルゲー
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ノバルティス アーゲー
ノバルティス アーゲー
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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
    • 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
    • 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
    • A61K9/14—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)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (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)
JP2011540134A 2008-12-15 2009-12-14 一定して高い曝露レベルを有するオクトレオチドのデポー製剤 Active JP5721635B2 (ja)

Applications Claiming Priority (3)

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

Publications (3)

Publication Number Publication Date
JP2012512147A JP2012512147A (ja) 2012-05-31
JP2012512147A5 JP2012512147A5 (enExample) 2013-02-07
JP5721635B2 true JP5721635B2 (ja) 2015-05-20

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ID=40520410

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Application Number Title Priority Date Filing Date
JP2011540134A Active JP5721635B2 (ja) 2008-12-15 2009-12-14 一定して高い曝露レベルを有するオクトレオチドのデポー製剤

Country Status (25)

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

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HRP20170929T1 (hr) 2008-09-17 2017-09-22 Chiasma Inc. Farmaceutski pripravci i odgovarajući postupci za isporuku
BR112014028443B1 (pt) * 2012-05-14 2021-01-19 Teijin Limited composição estéril esterilizada com radiação
EP3125871B1 (en) * 2014-03-31 2020-10-21 Pharmathen S.A. Preparation of peptide loaded plga microspheres with controlled release characteristics
AU2015360485B2 (en) 2014-12-10 2020-06-25 Amryt Endo, Inc. Oral octreotide administered in combination with other therapeutic agents
AU2016215350B2 (en) * 2015-02-03 2021-11-25 Amryt Endo, Inc. Method of treating diseases
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
EP3681471B1 (en) 2017-09-15 2025-03-05 Oxular Limited Ophthalmic delivery device
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

Family Cites Families (9)

* Cited by examiner, † Cited by third party
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.
GB9513224D0 (en) * 1995-06-29 1995-09-06 Sandoz Ltd Organic compounds
BR0315304A (pt) * 2002-11-06 2005-08-16 Alza Corp Formulações com depósito para liberação controlada
US20040097419A1 (en) * 2002-11-19 2004-05-20 Holger Petersen Organic compounds
MY158342A (en) * 2003-11-14 2016-09-30 Novartis Ag Pharmaceutical composition
GB0326602D0 (en) * 2003-11-14 2003-12-17 Novartis Ag Organic compounds
US7456254B2 (en) * 2004-04-15 2008-11-25 Alkermes, Inc. Polymer-based sustained release device
US20090092650A1 (en) * 2004-12-15 2009-04-09 Warren Stephen L Sustained Delivery Formulations of Octreotide Compounds
EP1968549B1 (en) * 2005-12-22 2014-05-14 Novartis AG Sustained release formulation comprising octreotide and two or more polylactide-co-glycolide polymers

Also Published As

Publication number Publication date
AU2009336718B2 (en) 2014-01-30
PE20110876A1 (es) 2011-12-21
AU2009336718B9 (en) 2014-04-03
WO2010079047A2 (en) 2010-07-15
US20140363513A1 (en) 2014-12-11
US20170143791A1 (en) 2017-05-25
US20160089336A1 (en) 2016-03-31
RU2011128538A (ru) 2013-01-20
CA2746968C (en) 2016-10-04
BRPI0922607A2 (pt) 2015-12-22
US20250205147A1 (en) 2025-06-26
US20180036230A1 (en) 2018-02-08
US20100151033A1 (en) 2010-06-17
AR074603A1 (es) 2011-01-26
IL213034A0 (en) 2011-07-31
PL2376070T3 (pl) 2017-04-28
TN2011000261A1 (en) 2012-12-17
ES2602614T3 (es) 2017-02-21
US20240082148A1 (en) 2024-03-14
ECSP11011199A (es) 2011-08-31
MY159789A (en) 2017-01-31
BRPI0922607B1 (pt) 2019-11-05
US20110262545A1 (en) 2011-10-27
SG171255A1 (en) 2011-07-28
RU2526822C2 (ru) 2014-08-27
CO6382109A2 (es) 2012-02-15
PT2376070T (pt) 2016-11-16
AU2009336718A1 (en) 2011-06-30
CN105233251A (zh) 2016-01-13
CA2746968A1 (en) 2010-07-15
CL2011001438A1 (es) 2011-11-04
JP2012512147A (ja) 2012-05-31
MA32964B1 (fr) 2012-01-02
US20210161806A1 (en) 2021-06-03
EP2376070B1 (en) 2016-08-10
KR20110104042A (ko) 2011-09-21
CN105031607A (zh) 2015-11-11
HK1159505A1 (zh) 2012-08-03
US20190209462A1 (en) 2019-07-11
CN102245210A (zh) 2011-11-16
EP2376070A2 (en) 2011-10-19
NZ592998A (en) 2013-02-22
MX2011006335A (es) 2011-07-13
KR101708517B1 (ko) 2017-02-20
IL213034A (en) 2017-04-30
WO2010079047A3 (en) 2010-09-16

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