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CN110035757A - 一种奥拉帕尼口服缓控释药物组合物及其用途 - Google Patents

一种奥拉帕尼口服缓控释药物组合物及其用途 Download PDF

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Publication number
CN110035757A
CN110035757A CN201780011153.8A CN201780011153A CN110035757A CN 110035757 A CN110035757 A CN 110035757A CN 201780011153 A CN201780011153 A CN 201780011153A CN 110035757 A CN110035757 A CN 110035757A
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olaparib
release
sustained
weight
parts
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CN110035757B (zh
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甘勇
朱全垒
郭仕艳
朱春柳
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Shanghai Institute of Materia Medica of CAS
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Shanghai Institute of Materia Medica of CAS
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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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/50—Pyridazines; Hydrogenated pyridazines
    • A61K31/502—Pyridazines; Hydrogenated pyridazines ortho- or peri-condensed with carbocyclic ring systems, e.g. cinnoline, phthalazine
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

一种奥拉帕尼口服缓控释药物组合物，其包含溶出改善形式的奥拉帕尼和释放速率调节用基质聚合物。所述药物组合物的体内吸收行为、血药浓度和PARP酶抑制水平可控，改进了奥拉帕尼药物载量和/或口服吸收和/或生物利用度和/或血药浓度控制和/或酶抑制水平控制，可作为唯一制剂或与其他疗法联合应用治疗癌症。

Description

PCT国内申请，说明书已公开。

Claims (10)

  1. PCT国内申请，权利要求书已公开。
CN201780011153.8A 2016-12-16 2017-12-15 一种奥拉帕尼口服缓控释药物组合物及其用途 Active CN110035757B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN2016111687971 2016-12-16
CN201611168797.1A CN108201536A (zh) 2016-12-16 2016-12-16 一种奥拉帕尼口服缓控释药物组合物及其用途
PCT/CN2017/116475 WO2018108152A1 (zh) 2016-12-16 2017-12-15 一种奥拉帕尼口服缓控释药物组合物及其用途

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CN110035757A true CN110035757A (zh) 2019-07-19
CN110035757B CN110035757B (zh) 2022-12-23

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CN201780011153.8A Active CN110035757B (zh) 2016-12-16 2017-12-15 一种奥拉帕尼口服缓控释药物组合物及其用途

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US (1) US20200108008A1 (zh)
EP (1) EP3556369B1 (zh)
JP (1) JP6888226B2 (zh)
CN (2) CN108201536A (zh)
ES (1) ES2873389T3 (zh)
WO (1) WO2018108152A1 (zh)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113288859A (zh) * 2020-02-21 2021-08-24 上海宣泰医药科技股份有限公司 奥拉帕尼药物组合物及其制剂、制备方法和用途
CN113350349A (zh) * 2020-03-04 2021-09-07 中国科学院上海药物研究所 奥拉帕尼溶出增强组合物

Families Citing this family (11)

* Cited by examiner, † Cited by third party
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CN109293576A (zh) * 2018-11-08 2019-02-01 威海贯标信息科技有限公司 一种小粒度奥拉帕尼的制备方法
EP3977984A4 (en) * 2019-05-31 2023-01-11 BeiGene, Ltd. PREPARATION OF PARP INHIBITOR TABLET AND METHOD OF PREPARATION THEREOF
CN115175668A (zh) * 2019-12-20 2022-10-11 三养控股公司 具有改善的奥拉帕尼的溶解度和生物利用率的组合物
JP2023511039A (ja) * 2020-01-08 2023-03-16 エージェンシー フォー サイエンス，テクノロジー アンド リサーチ 組み合わせ療法
PL4143182T3 (pl) 2020-04-28 2025-03-31 Rhizen Pharmaceuticals Ag Nowe związki użyteczne jako inhibitory polimerazy poli(adprybozy) (parp)
WO2022090938A1 (en) 2020-10-31 2022-05-05 Rhizen Pharmaceuticals Ag Phthalazinone derivatives useful as parp inhibitors
CN112438954B (zh) * 2020-11-29 2022-09-27 北京康立生医药技术开发有限公司 一种奥拉帕利释放相关的药物组合物
KR102707060B1 (ko) 2020-12-01 2024-09-13 주식회사 삼양홀딩스 안정성 및 생체이용율이 개선된 올라파립 고체 분산체 조성물
CN117321044A (zh) 2021-04-08 2023-12-29 理森制药股份公司 聚(adp-核糖)聚合酶抑制剂
TW202408509A (zh) * 2022-07-14 2024-03-01 大陸商西藏海思科製藥有限公司 雜芳基衍生物的藥物組合物及其在醫藥上的應用
WO2024184927A1 (en) * 2023-03-09 2024-09-12 Bdr Pharmaceuticals International Private Limited Solid oral composition of olaparib and its salts thereof

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CN102238945A (zh) * 2008-10-07 2011-11-09 阿斯利康(英国)有限公司 药物制剂514
WO2015031536A1 (en) * 2013-08-27 2015-03-05 Northeastern University Nanoparticle drug delivery system and method of treating cancer and neurotrauma

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CN104873457A (zh) * 2009-06-02 2015-09-02 陶氏环球技术有限责任公司 缓释剂型
CN102573811A (zh) * 2009-06-02 2012-07-11 陶氏环球技术有限责任公司 缓释剂型
CN103417505B (zh) * 2012-05-24 2016-05-11 中国科学院上海药物研究所 具有双相释药行为的石杉碱甲控释制剂及其制备方法
CN104434809B (zh) 2014-12-10 2018-10-16 北京科莱博医药开发有限责任公司 一种奥拉帕尼固体分散体制剂及其制备方法

Patent Citations (2)

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CN102238945A (zh) * 2008-10-07 2011-11-09 阿斯利康(英国)有限公司 药物制剂514
WO2015031536A1 (en) * 2013-08-27 2015-03-05 Northeastern University Nanoparticle drug delivery system and method of treating cancer and neurotrauma

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113288859A (zh) * 2020-02-21 2021-08-24 上海宣泰医药科技股份有限公司 奥拉帕尼药物组合物及其制剂、制备方法和用途
CN113288859B (zh) * 2020-02-21 2024-11-22 上海宣泰医药科技股份有限公司 奥拉帕尼药物组合物及其制剂、制备方法和用途
CN113350349A (zh) * 2020-03-04 2021-09-07 中国科学院上海药物研究所 奥拉帕尼溶出增强组合物

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Publication number Publication date
JP2020502171A (ja) 2020-01-23
EP3556369A4 (en) 2020-01-01
US20200108008A1 (en) 2020-04-09
JP6888226B2 (ja) 2021-06-16
CN108201536A (zh) 2018-06-26
ES2873389T3 (es) 2021-11-03
WO2018108152A1 (zh) 2018-06-21
EP3556369B1 (en) 2021-04-14
CN110035757B (zh) 2022-12-23
EP3556369A1 (en) 2019-10-23

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