CN102245210A - 有恒定高暴露水平的奥曲肽贮库制剂 - Google Patents

有恒定高暴露水平的奥曲肽贮库制剂 Download PDF

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Publication number
CN102245210A
CN102245210A CN2009801503147A CN200980150314A CN102245210A CN 102245210 A CN102245210 A CN 102245210A CN 2009801503147 A CN2009801503147 A CN 2009801503147A CN 200980150314 A CN200980150314 A CN 200980150314A CN 102245210 A CN102245210 A CN 102245210A
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CN
China
Prior art keywords
pharmaceutical composition
plga
octreotide
microgranule
sustained release
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN2009801503147A
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English (en)
Chinese (zh)
Inventor
M·阿尔海姆
H·彼得森
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Novartis AG
Original Assignee
Novartis AG
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40520410&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN102245210(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis AG filed Critical Novartis AG
Priority to CN201510542720.5A priority Critical patent/CN105233251A/zh
Priority to CN201510542237.7A priority patent/CN105031607A/zh
Publication of CN102245210A publication Critical patent/CN102245210A/zh
Pending legal-status Critical Current

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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
    • 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 cartridges, 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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (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)
CN2009801503147A 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂 Pending CN102245210A (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201510542720.5A CN105233251A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂
CN201510542237.7A CN105031607A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂

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

Related Child Applications (2)

Application Number Title Priority Date Filing Date
CN201510542237.7A Division CN105031607A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂
CN201510542720.5A Division CN105233251A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂

Publications (1)

Publication Number Publication Date
CN102245210A true CN102245210A (zh) 2011-11-16

Family

ID=40520410

Family Applications (3)

Application Number Title Priority Date Filing Date
CN2009801503147A Pending CN102245210A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂
CN201510542237.7A Pending CN105031607A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂
CN201510542720.5A Pending CN105233251A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂

Family Applications After (2)

Application Number Title Priority Date Filing Date
CN201510542237.7A Pending CN105031607A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂
CN201510542720.5A Pending CN105233251A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂

Country Status (25)

Country Link
US (10) US20100151033A1 (enExample)
EP (1) EP2376070B1 (enExample)
JP (1) JP5721635B2 (enExample)
KR (1) KR101708517B1 (enExample)
CN (3) CN102245210A (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 (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017186077A1 (zh) 2016-04-26 2017-11-02 广州帝奇医药技术有限公司 一种缓释微粒的制备方法
CN111712228A (zh) * 2017-09-15 2020-09-25 奥叙拉尔有限公司 眼科药物组合物

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2678833C2 (ru) 2008-09-17 2019-02-04 Киазма Инк. Фармацевтические композиции и соответствующие способы доставки
KR102037555B1 (ko) * 2012-05-14 2019-10-28 데이진 가부시키가이샤 멸균 조성물
PT3125871T (pt) * 2014-03-31 2021-01-06 Pharmathen Sa Preparação de microsferas de plga carregadas com péptido com características de libertação controlada
EP3229824A4 (en) 2014-12-10 2018-07-11 Chiasma Inc. Oral octreotide administered in combination with other therapeutic agents
SI3253401T1 (sl) 2015-02-03 2025-07-31 Amryt Endo, Inc. Zdravljenje akromegalije z oralnim oktreotidom
KR102142026B1 (ko) * 2017-05-31 2020-08-06 주식회사 대웅제약 방출제어가 용이한 서방성 약물 미립자의 제조방법
MX2022002980A (es) 2019-09-16 2022-04-06 Amgen Inc Metodo para la esterilizacion externa de un dispositivo de suministro de farmacos.
US11141457B1 (en) 2020-12-28 2021-10-12 Amryt Endo, Inc. Oral octreotide therapy and contraceptive methods
US20240197646A1 (en) * 2022-12-20 2024-06-20 Axogen Corporation Drug delivery system and methods of using the same

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
US7368126B2 (en) * 2002-11-06 2008-05-06 Guohua Chen Controlled release depot formulations
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
WO2006065951A2 (en) * 2004-12-15 2006-06-22 Qlt Usa, Inc. Sustained delivery formulations of octreotide compounds
KR20130024988A (ko) * 2005-12-22 2013-03-08 노파르티스 아게 옥트레오티드 및 ２종 이상의 폴리락티드-코-글리콜리드 중합체를 포함하는 서방형 제제

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017186077A1 (zh) 2016-04-26 2017-11-02 广州帝奇医药技术有限公司 一种缓释微粒的制备方法
CN111712228A (zh) * 2017-09-15 2020-09-25 奥叙拉尔有限公司 眼科药物组合物
CN111712228B (zh) * 2017-09-15 2024-05-07 奥叙拉尔有限公司 眼科药物组合物

Also Published As

Publication number Publication date
BRPI0922607B1 (pt) 2019-11-05
SG171255A1 (en) 2011-07-28
US20170143791A1 (en) 2017-05-25
US20100151033A1 (en) 2010-06-17
CL2011001438A1 (es) 2011-11-04
PE20110876A1 (es) 2011-12-21
ECSP11011199A (es) 2011-08-31
NZ592998A (en) 2013-02-22
CA2746968A1 (en) 2010-07-15
CA2746968C (en) 2016-10-04
MY159789A (en) 2017-01-31
HK1159505A1 (zh) 2012-08-03
RU2526822C2 (ru) 2014-08-27
IL213034A0 (en) 2011-07-31
WO2010079047A2 (en) 2010-07-15
CN105233251A (zh) 2016-01-13
EP2376070B1 (en) 2016-08-10
PL2376070T3 (pl) 2017-04-28
JP2012512147A (ja) 2012-05-31
AR074603A1 (es) 2011-01-26
ES2602614T3 (es) 2017-02-21
KR20110104042A (ko) 2011-09-21
TN2011000261A1 (en) 2012-12-17
JP5721635B2 (ja) 2015-05-20
US20240082148A1 (en) 2024-03-14
WO2010079047A3 (en) 2010-09-16
US20140363513A1 (en) 2014-12-11
BRPI0922607A2 (pt) 2015-12-22
US20250205147A1 (en) 2025-06-26
MX2011006335A (es) 2011-07-13
AU2009336718B9 (en) 2014-04-03
CN105031607A (zh) 2015-11-11
AU2009336718A1 (en) 2011-06-30
AU2009336718B2 (en) 2014-01-30
EP2376070A2 (en) 2011-10-19
US20160089336A1 (en) 2016-03-31
US20190209462A1 (en) 2019-07-11
KR101708517B1 (ko) 2017-02-20
MA32964B1 (fr) 2012-01-02
IL213034A (en) 2017-04-30
US20210161806A1 (en) 2021-06-03
US20180036230A1 (en) 2018-02-08
US20110262545A1 (en) 2011-10-27
PT2376070T (pt) 2016-11-16
RU2011128538A (ru) 2013-01-20
CO6382109A2 (es) 2012-02-15

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Application publication date: 20111116