CA3019257C - A pharmaceutical formulation of palbociclib and a preparation method thereof - Google Patents

A pharmaceutical formulation of palbociclib and a preparation method thereof Download PDF

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Publication number
CA3019257C
CA3019257C CA3019257A CA3019257A CA3019257C CA 3019257 C CA3019257 C CA 3019257C CA 3019257 A CA3019257 A CA 3019257A CA 3019257 A CA3019257 A CA 3019257A CA 3019257 C CA3019257 C CA 3019257C
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Prior art keywords
palbociclib
composition
solid dispersion
pharmaceutically acceptable
breast cancer
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CA3019257A
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English (en)
French (fr)
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CA3019257A1 (en
Inventor
Zeren Wang
Jun Xu
Long Qu
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Shenzhen Pharmacin Co Ltd
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Shenzhen Pharmacin Co Ltd
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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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D471/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00
    • C07D471/02—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00 in which the condensed system contains two hetero rings
    • C07D471/04—Ortho-condensed systems

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CA3019257A 2016-03-29 2016-06-21 A pharmaceutical formulation of palbociclib and a preparation method thereof Active CA3019257C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201610187046.8 2016-03-29
CN201610187046.8A CN105816437B (zh) 2016-03-29 2016-03-29 一种帕布昔利布的药物制剂及其制备方法
PCT/CN2016/086546 WO2017166451A1 (zh) 2016-03-29 2016-06-21 一种帕布昔利布的药物制剂及其制备方法

Publications (2)

Publication Number Publication Date
CA3019257A1 CA3019257A1 (en) 2017-10-05
CA3019257C true CA3019257C (en) 2023-08-22

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CA3019257A Active CA3019257C (en) 2016-03-29 2016-06-21 A pharmaceutical formulation of palbociclib and a preparation method thereof

Country Status (12)

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US (5) US10449195B2 (enExample)
EP (1) EP3437637B1 (enExample)
JP (2) JP6799612B2 (enExample)
KR (1) KR102386665B1 (enExample)
CN (2) CN105816437B (enExample)
AU (1) AU2016400468B2 (enExample)
CA (1) CA3019257C (enExample)
EA (1) EA201892173A1 (enExample)
ES (1) ES2968132T3 (enExample)
GB (2) GB2583425B (enExample)
IL (1) IL261989B2 (enExample)
WO (1) WO2017166451A1 (enExample)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX376083B (es) 2015-06-04 2025-03-07 Pfizer Formas de dosificacion solidas de palbociclib.
CN105816437B (zh) 2016-03-29 2018-08-03 深圳市药欣生物科技有限公司 一种帕布昔利布的药物制剂及其制备方法
CN108017629A (zh) * 2016-11-04 2018-05-11 上海奥博生物医药技术有限公司 一种帕博西尼无定形态
CN108210454A (zh) * 2016-12-14 2018-06-29 深圳市华力康生物医药有限公司 一种帕布昔利布的口服乳剂及其制备方法
US20200054560A1 (en) * 2017-04-21 2020-02-20 Alnova Pharmaceuticals, Ltd. Palbociclib compositions and methods thereof
WO2019056163A1 (zh) * 2017-09-19 2019-03-28 浙江华海药业股份有限公司 N-甲酰基帕博西尼及其制备方法和用途以及帕博西尼制剂及其质量控制方法
CN108014343A (zh) * 2017-12-21 2018-05-11 孟斯琴 一种治疗乳腺癌的药物组合物及其制备方法
CN108066312B (zh) * 2017-12-29 2020-03-20 山东裕欣药业有限公司 一种帕博西尼药物组合物及其制备方法
CN108066303A (zh) * 2017-12-31 2018-05-25 湖南博隽生物医药有限公司 一种抗癌药物组合物及其制备方法
ES2968899T3 (es) * 2018-05-14 2024-05-14 Pfizer Formulación de la solución oral
CN108653222A (zh) * 2018-07-03 2018-10-16 威海贯标信息科技有限公司 一种帕博西尼片剂组合物
CN109288806A (zh) * 2018-08-22 2019-02-01 深圳市华力康生物医药有限公司 一种帕布昔利布的泡腾片及其应用
CN115989022A (zh) * 2020-07-02 2023-04-18 阿瑟姆治疗株式会社 口服用药物组合物及其制备方法
CN114246841B (zh) * 2020-09-24 2024-02-02 南京济群医药科技股份有限公司 一种羟乙磺酸哌柏西利的组合物及药物
CN114306245A (zh) * 2020-09-29 2022-04-12 深圳市药欣生物科技有限公司 无定形固体分散体的药物组合物及其制备方法
CN114748426A (zh) * 2020-12-28 2022-07-15 上海博志研新药物技术有限公司 帕博西尼固体分散体、其制备方法及应用
CN112870166B (zh) * 2021-01-20 2022-04-08 中山大学 一种核丛青霉素固体分散体、制备方法及应用
CN114010604B (zh) * 2021-11-26 2022-12-20 河南省人民医院 一种帕博西尼固体制剂及其制备方法
JP2025512788A (ja) 2022-03-25 2025-04-22 シェンチェン ファーマシン シーオー．，エルティーディー． Ｐｒｏｔａｃ化合物の医薬組成物及びその使用
KR20240170460A (ko) * 2023-05-25 2024-12-03 주식회사 삼양홀딩스 팔보시클립의 경구용 조성물
KR102908668B1 (ko) * 2023-10-11 2026-01-06 경희대학교 산학협력단 화합물과 설폰산 또는 카르복시산의 결정체, 및 이를 포함하는 유방암 치료를 위한 약학적 조성물
KR20250062261A (ko) 2023-10-30 2025-05-08 신풍제약주식회사 향상된 용해도 및 안정성을 가지는 팔보시클립의 제약학적 조성물 및 이의 제조방법
WO2025156193A1 (en) * 2024-01-25 2025-07-31 Zhejiang Qizheng Pharmaceutical Co., Ltd. Palbociclib dosage form

Family Cites Families (90)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US745168A (en) 1903-07-16 1903-11-24 Arthur C Eastwood System for control of electric motors.
US1025860A (en) 1911-02-25 1912-05-07 Santi Caruso Coin-operated hat, coat, and umbrella rack.
US1016075A (en) 1911-10-18 1912-01-30 George Kowalsky Feed-bag.
US6087380A (en) 1949-11-24 2000-07-11 Boehringer Ingelheim Pharma Kg Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions
EP0198395A3 (en) * 1985-04-09 1989-04-12 Mitsubishi Kasei Corporation Separating agent for mixed solution
US4847092A (en) * 1985-11-12 1989-07-11 Eli Lilly And Company Orally administerable sustained release pharmaceutical formulations
DE59808063D1 (de) 1998-06-03 2003-05-28 Gergely Dr & Co Mit Alkali- bzw. Erdalkali-Ionen dotierte Zitronensäure
JP2000309588A (ja) * 1999-04-28 2000-11-07 Taisho Pharmaceut Co Ltd 固体分散体
EA003052B1 (ru) 1999-07-27 2002-12-26 Балканфарма Холдинг АД Антиаритмическое лекарственное средство
SK10772002A3 (sk) 2000-01-27 2004-01-08 Warner-Lambert Company Pyridopyrimidinónové deriváty na liečbu neurodegeneratívnych ochorení
AP2002002643A0 (en) 2000-03-06 2002-12-31 Warner Lambert Co 5-alkylpyrido[2,3-d]pyrimidines tyrosine kinase inhibitors
JP2004519422A (ja) 2000-08-04 2004-07-02 ワーナー−ランバート・カンパニー、リミテッド、ライアビリティ、カンパニー ２−（４−ピリジル）アミノ−６−ジアルコキシフェニルピリド〔２，３−ｄ〕ピリミジン−７−オン
US20050019399A1 (en) * 2001-09-21 2005-01-27 Gina Fischer Controlled release solid dispersions
NZ534069A (en) 2002-01-22 2007-03-30 Warner Lambert Co 2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones to be used to treat neurodegenerative disorders, viruses and cancer
EP1485094B2 (de) 2002-03-07 2020-03-25 Boehringer Ingelheim International GmbH Oral zu applizierende darreichungsform für 3- [(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1h-benzimidazol-5-carbonyl)-pyridin-2-yl-amino] -propionsäure-ethylester oder dessen salze
DE10209985A1 (de) 2002-03-07 2003-09-25 Boehringer Ingelheim Pharma Oral zu applizierende Darreichungsform für 3-[(2-{[4-(Hexyloxycarbonylaminoimino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propinsäure-ethylester und dessen Salze
US20030181488A1 (en) 2002-03-07 2003-09-25 Boehringer Ingelheim Pharma Gmbh & Co. Kg Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionic acid ethyl ester and the salts thereof
US7884127B2 (en) * 2002-07-08 2011-02-08 Pirimal Life Sciences Ltd. Inhibitors of cyclin dependent kinases and their use
DE602004017474D1 (de) 2003-07-11 2008-12-11 Warner Lambert Co Isethionat salz eines selektiven cdk4 inhibitors
GB0317663D0 (en) 2003-07-29 2003-09-03 Astrazeneca Ab Pharmaceutical composition
DE10339862A1 (de) 2003-08-29 2005-03-24 Boehringer Ingelheim Pharma Gmbh & Co. Kg 3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)- phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionsäure-ethylester-Methansulfonat und dessen Verwendung als Arzneimittel
BRPI0509580A (pt) * 2004-03-30 2007-11-27 Pfizer Prod Inc combinações de inibidores de transdução de sinal
DE102004062864A1 (de) 2004-12-21 2006-06-22 Boehringer Ingelheim Pharma Gmbh & Co. Kg Folienbehälter
NZ556673A (en) 2005-02-03 2010-03-26 Gen Hospital Corp Method for treating gefitinib and/or erlotinib resistant cancer with an EGFR inhibitor
EP1871346A4 (en) 2005-04-20 2012-07-18 Ctc Bio Inc PHARMACEUTICAL COMPOSITION WITH FREE BASE FROM SIBUTRAMIN AND MANUFACTURING METHOD THEREFOR
KR100627687B1 (ko) * 2005-04-20 2006-09-25 주식회사 씨티씨바이오 시부트라민 유리염기 함유 조성물 및 이의 제조방법
RU2442574C2 (ru) 2005-08-22 2012-02-20 Новартис Аг ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ pН-ЗАВИСИМОЕ ЛЕКАРСТВЕННОЕ СРЕДСТВО, МОДИФИКАТОР pН И ЗАМЕДЛЯЮЩИЙ АГЕНТ
US20070196491A1 (en) * 2006-01-27 2007-08-23 Eurand, Inc. Drug delivery systems comprising weakly basic drugs and organic acids
WO2009014642A1 (en) 2007-07-19 2009-01-29 Amgen Inc. Combination of a de novo purine biosynthesis inhibitor and a cyclin dependent kinase inhibitor for the treatment of cancer
EP2200613B1 (en) 2007-09-21 2018-09-05 The Johns Hopkins University Phenazine derivatives and uses thereof
US9259399B2 (en) 2007-11-07 2016-02-16 Cornell University Targeting CDK4 and CDK6 in cancer therapy
WO2010039997A2 (en) 2008-10-01 2010-04-08 The University Of North Carolina At Chapel Hill Hematopoietic protection against chemotherapeutic compounds using selective cyclin-dependent kinase 4/6 inhibitors
WO2010055119A2 (en) 2008-11-17 2010-05-20 Novartis Ag Pharmaceutical composition comprising pimobendan
DE102009028354B4 (de) 2009-08-07 2013-05-29 Mtu Friedrichshafen Gmbh Gasführungssystem für eine Peripherie einer Brennkraftmaschine zur Führung von Gas der Brennkraftmaschine, Brennkraftsystem und Verfahren zum Betrieb der Brennkraftmaschine
EP2502078A1 (en) 2009-11-20 2012-09-26 Infinity Pharmaceuticals, Inc. Methods and compositions for treating hedgehog-associated cancers
CN102106806B (zh) * 2009-12-29 2013-04-17 上海中西制药有限公司 一种固体制剂的制备方法及所得固体制剂
CN102106807B (zh) * 2009-12-29 2013-03-27 上海中西制药有限公司 一种固体制剂的制备方法及所得固体制剂
TWI513466B (zh) 2010-01-20 2015-12-21 Boehringer Ingelheim Int 抗凝血劑解毒劑
UY33227A (es) 2010-02-19 2011-09-30 Novartis Ag Compuestos de pirrolopirimidina como inhibidores de la cdk4/6
RU2566716C2 (ru) * 2010-06-09 2015-10-27 Эббви Бахамаз Лтд. Твердые дисперсии, содержащие ингибиторы киназ
AR086913A1 (es) 2011-06-14 2014-01-29 Novartis Ag 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]-amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluoro-metil)-fenil]-benzamida amorfa, forma de dosificacion que la contiene y metodo para prepararlas
CA2856406C (en) * 2011-11-23 2020-06-23 Novartis Ag Pharmaceutical formulations
ES2776365T3 (es) 2012-07-09 2020-07-30 Novartis Ag Biomarcadores asociados con inhibidores de CDK
WO2014121235A2 (en) * 2013-02-01 2014-08-07 Zoneone Pharma, Inc. Transformation of drug cyclodextrin complex compositions into compositions of mixtures of lipid vesicle encapsulated drug and cyclodextrin drug complexes
DK3431475T3 (da) 2013-02-21 2021-05-25 Pfizer Faste former af en selektiv CDK4/6-hæmmer
CA2909683A1 (en) 2013-04-16 2014-10-23 Memorial Sloan-Kettering Cancer Center Companion diagnostic for cdk4 inhibitors
CN104224754A (zh) 2013-06-21 2014-12-24 四川海思科制药有限公司 一种达比加群酯药物组合物及其制备方法
EP4772247A2 (en) 2013-08-14 2026-07-08 Novartis AG Combination therapy comprising ribociclib and fulvestrant for the treatment of cancer
EA201690987A1 (ru) * 2013-11-13 2016-10-31 Новартис Аг Низкодозовые иммуностимулирующие ингибиторы mtor и их применения
US20170067116A1 (en) 2014-03-04 2017-03-09 The Regents Of The University Of California Biomarkers of Response to Cyclin D-CDK4/6 Targeted Therapies in Cancer
US20150320754A1 (en) 2014-04-16 2015-11-12 Infinity Pharmaceuticals, Inc. Combination therapies
WO2015165571A2 (en) 2014-05-01 2015-11-05 Fresenius Medical Care Deutschland Gmbh Solid oral formulations comprising solid melt dispersions of organic acids in xylitol
WO2016015597A1 (en) 2014-07-26 2016-02-04 Sunshine Lake Pharma Co., Ltd. Compounds as cdk small-molecule inhibitors and uses thereof
CN105616418A (zh) 2014-11-07 2016-06-01 江苏豪森药业集团有限公司 含有细胞周期蛋白抑制剂的药物制剂及其制备方法
CN105616419A (zh) 2014-11-07 2016-06-01 江苏豪森药业集团有限公司 含有细胞周期蛋白抑制剂固体分散体的药物组合物及其制备方法
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
DK3255046T3 (da) 2015-02-03 2020-01-20 Jiangsu Hengrui Medicine Co Hydroxyethylsulfonat af cyclin-afhængig proteinkinasehæmmer, krystallinsk form deraf og fremgangsmåde til fremstilling deraf
CZ201589A3 (cs) 2015-02-11 2016-08-24 Zentiva, K.S. Pevné formy soli Palbociclibu
WO2016156070A1 (en) * 2015-04-02 2016-10-06 Sandoz Ag Modified particles of palbociclib
CN104887641B (zh) * 2015-04-08 2017-12-01 上海鲁源医药科技有限公司 帕布昔利布胃漂浮片及其制备方法
MX376083B (es) 2015-06-04 2025-03-07 Pfizer Formas de dosificacion solidas de palbociclib.
WO2017021111A1 (en) * 2015-08-05 2017-02-09 Ratiopharm Gmbh New crystalline form and acetic acid adducts of palbociclib
CN105085517B (zh) 2015-08-06 2016-11-23 天津华洛康生物科技有限公司 一种结晶型帕博西尼游离碱水合物及其制备方法
CN107510847A (zh) 2016-06-16 2017-12-26 常州方楠医药技术有限公司 一种含有无定型帕博西林固体分散体的药用组合物及其制备方法
CN106474129A (zh) * 2015-09-01 2017-03-08 上海方楠生物科技有限公司 一种帕博西林或其药学上可接受的盐与药用辅料的组合物及其制备方法
WO2017036390A1 (zh) * 2015-09-01 2017-03-09 上海方楠生物科技有限公司 帕博西林或其药学上可接受的盐与药用辅料的组合物及其制备方法
CN105213322A (zh) 2015-10-30 2016-01-06 南京正大天晴制药有限公司 一种干法制粒工艺制备的药物组合物
CN106831710A (zh) 2015-12-07 2017-06-13 常州爱诺新睿医药技术有限公司 一种无定型来那替尼或其药学上可接受的盐与药用辅料的固体分散体及其制备方法
WO2017115315A1 (en) * 2015-12-30 2017-07-06 Dr. Reddy's Laboratories Limited Solid forms of palbociclib
CN106967061A (zh) 2016-01-13 2017-07-21 常州方楠医药技术有限公司 帕博西林的盐、晶型及其制备方法
WO2017130219A1 (en) 2016-01-25 2017-08-03 Mylan Laboratories Limited Amorphous solid dispersion of palbociclib
WO2017160990A1 (en) 2016-03-15 2017-09-21 Merrimack Pharmaceuticals, Inc. Methods for treating er+, her2-, hrg+ breast cancer using combination therapies comprising an anti-erbb3 antibody
CN105816437B (zh) * 2016-03-29 2018-08-03 深圳市药欣生物科技有限公司 一种帕布昔利布的药物制剂及其制备方法
US10690673B2 (en) 2016-03-29 2020-06-23 Mayo Foundation For Medical Education And Research Method of treating cancer metastasis by CDK 4/6 inhibitors
CN105748435B (zh) 2016-04-21 2019-03-29 石家庄海瑞药物科技有限公司 一种帕布昔利布药物组合物及其制备方法
US20190345558A1 (en) 2016-05-18 2019-11-14 Université Libre de Bruxelles Method for determining sensitivity to a cdk4/6 inhibitor
EP3255048A1 (en) 2016-06-07 2017-12-13 K.H.S. Pharma Holding GmbH Non-crystalline form of palbociclib
CN110099680B (zh) 2016-10-11 2021-02-05 杜克大学 Er+乳腺癌的拉索昔芬治疗
CN108017629A (zh) 2016-11-04 2018-05-11 上海奥博生物医药技术有限公司 一种帕博西尼无定形态
CN106667952A (zh) 2016-12-12 2017-05-17 河南润弘制药股份有限公司 一种帕布昔利布药物组合物及其制备方法
US20200054560A1 (en) 2017-04-21 2020-02-20 Alnova Pharmaceuticals, Ltd. Palbociclib compositions and methods thereof
CN108864078B (zh) 2017-05-10 2021-10-15 江苏豪森药业集团有限公司 帕博西尼晶型b的制备方法
WO2019056163A1 (zh) 2017-09-19 2019-03-28 浙江华海药业股份有限公司 N-甲酰基帕博西尼及其制备方法和用途以及帕博西尼制剂及其质量控制方法
CN108014343A (zh) 2017-12-21 2018-05-11 孟斯琴 一种治疗乳腺癌的药物组合物及其制备方法
CN108066312B (zh) 2017-12-29 2020-03-20 山东裕欣药业有限公司 一种帕博西尼药物组合物及其制备方法
CN108066303A (zh) 2017-12-31 2018-05-25 湖南博隽生物医药有限公司 一种抗癌药物组合物及其制备方法
CN111867586A (zh) 2018-03-13 2020-10-30 得克萨斯州大学系统董事会 用于治疗具有egfr激活突变的癌症的方法
CN108272754A (zh) 2018-04-11 2018-07-13 吴小戈 一种抗癌药物固体分散体组合物及其制备方法
ES2968899T3 (es) 2018-05-14 2024-05-14 Pfizer Formulación de la solución oral
CN108653222A (zh) 2018-07-03 2018-10-16 威海贯标信息科技有限公司 一种帕博西尼片剂组合物

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