KR101708517B1 - 일정하게 높은 노출 수준을 갖는 옥트레오티드 데포 제제 - Google Patents

일정하게 높은 노출 수준을 갖는 옥트레오티드 데포 제제 Download PDF

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KR101708517B1
KR101708517B1 KR1020117016340A KR20117016340A KR101708517B1 KR 101708517 B1 KR101708517 B1 KR 101708517B1 KR 1020117016340 A KR1020117016340 A KR 1020117016340A KR 20117016340 A KR20117016340 A KR 20117016340A KR 101708517 B1 KR101708517 B1 KR 101708517B1
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depot formulation
microparticles
delete delete
depot
octreotide
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Expired - Fee Related
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Korean (ko)
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KR20110104042A (ko
Inventor
마르쿠스 알헤임
홀게르 페테르센
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노파르티스 아게
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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
    • A61K9/0012—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
    • 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
    • A61K47/34—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)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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)
KR1020117016340A 2008-12-15 2009-12-14 일정하게 높은 노출 수준을 갖는 옥트레오티드 데포 제제 Expired - Fee Related KR101708517B1 (ko)

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 (2)

Publication Number Publication Date
KR20110104042A KR20110104042A (ko) 2011-09-21
KR101708517B1 true KR101708517B1 (ko) 2017-02-20

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ID=40520410

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Application Number Title Priority Date Filing Date
KR1020117016340A Expired - Fee Related KR101708517B1 (ko) 2008-12-15 2009-12-14 일정하게 높은 노출 수준을 갖는 옥트레오티드 데포 제제

Country Status (25)

Country Link
US (10) US20100151033A1 (enExample)
EP (1) EP2376070B1 (enExample)
JP (1) JP5721635B2 (enExample)
KR (1) KR101708517B1 (enExample)
CN (3) CN105031607A (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)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018221884A1 (ko) * 2017-05-31 2018-12-06 주식회사 대웅제약 방출제어가 용이한 서방성 약물 미립자의 제조방법

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010032140A2 (en) 2008-09-17 2010-03-25 Chiasma Inc. Pharmaceutical compositions and related methods of delivery
KR102037555B1 (ko) * 2012-05-14 2019-10-28 데이진 가부시키가이샤 멸균 조성물
DK3125871T3 (da) * 2014-03-31 2020-12-21 Pharmathen Sa Fremstilling af peptidladede plga-mikrosfærer med kontrolleret frigivelse-kendetegn
EP4321213A3 (en) 2014-12-10 2024-05-15 Amryt Endo, Inc. Oral octreotide administered in combination with other therapeutic agents
FI3253401T3 (fi) 2015-02-03 2025-07-09 Amryt Endo Inc Akromegallian hoitaminen suun kautta annettavalla oktreotidilla
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
JP7344197B2 (ja) 2017-09-15 2023-09-13 オクラー リミテッド 眼科用送達装置
CA3150482A1 (en) 2019-09-16 2021-03-25 Amgen Inc. Method for external sterilization of drug delivery device
US11141457B1 (en) 2020-12-28 2021-10-12 Amryt Endo, Inc. Oral octreotide therapy and contraceptive methods

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006514927A (ja) * 2002-11-19 2006-05-18 ノバルティス アクチエンゲゼルシャフト オクトレオチド微粒子を含む医薬組成物

Family Cites Families (8)

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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
WO2004043432A2 (en) * 2002-11-06 2004-05-27 Alza Corporation Controlled release depot formulations
GB0326602D0 (en) * 2003-11-14 2003-12-17 Novartis Ag Organic compounds
MY158342A (en) * 2003-11-14 2016-09-30 Novartis Ag Pharmaceutical composition
US7456254B2 (en) * 2004-04-15 2008-11-25 Alkermes, Inc. Polymer-based sustained release device
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
AU2006328950B2 (en) * 2005-12-22 2010-07-29 Novartis Ag Sustained release formulation comprising octreotide and two or more polylactide-co-glycolide polymers

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006514927A (ja) * 2002-11-19 2006-05-18 ノバルティス アクチエンゲゼルシャフト オクトレオチド微粒子を含む医薬組成物

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018221884A1 (ko) * 2017-05-31 2018-12-06 주식회사 대웅제약 방출제어가 용이한 서방성 약물 미립자의 제조방법

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Publication number Publication date
US20250205147A1 (en) 2025-06-26
AU2009336718B2 (en) 2014-01-30
ES2602614T3 (es) 2017-02-21
IL213034A (en) 2017-04-30
SG171255A1 (en) 2011-07-28
PT2376070T (pt) 2016-11-16
JP2012512147A (ja) 2012-05-31
BRPI0922607B1 (pt) 2019-11-05
AU2009336718A1 (en) 2011-06-30
CA2746968C (en) 2016-10-04
US20100151033A1 (en) 2010-06-17
US20110262545A1 (en) 2011-10-27
PL2376070T3 (pl) 2017-04-28
NZ592998A (en) 2013-02-22
WO2010079047A2 (en) 2010-07-15
EP2376070B1 (en) 2016-08-10
RU2011128538A (ru) 2013-01-20
AR074603A1 (es) 2011-01-26
CL2011001438A1 (es) 2011-11-04
TN2011000261A1 (en) 2012-12-17
MY159789A (en) 2017-01-31
CN105031607A (zh) 2015-11-11
RU2526822C2 (ru) 2014-08-27
PE20110876A1 (es) 2011-12-21
CA2746968A1 (en) 2010-07-15
MX2011006335A (es) 2011-07-13
US20210161806A1 (en) 2021-06-03
CN102245210A (zh) 2011-11-16
US20190209462A1 (en) 2019-07-11
AU2009336718B9 (en) 2014-04-03
US20240082148A1 (en) 2024-03-14
US20170143791A1 (en) 2017-05-25
BRPI0922607A2 (pt) 2015-12-22
CN105233251A (zh) 2016-01-13
MA32964B1 (fr) 2012-01-02
JP5721635B2 (ja) 2015-05-20
IL213034A0 (en) 2011-07-31
HK1159505A1 (zh) 2012-08-03
US20140363513A1 (en) 2014-12-11
CO6382109A2 (es) 2012-02-15
EP2376070A2 (en) 2011-10-19
US20180036230A1 (en) 2018-02-08
ECSP11011199A (es) 2011-08-31
KR20110104042A (ko) 2011-09-21
US20160089336A1 (en) 2016-03-31
WO2010079047A3 (en) 2010-09-16

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