KR102386665B1 - 팔보시클립의 약학 제제 및 그 제조 방법 - Google Patents

팔보시클립의 약학 제제 및 그 제조 방법 Download PDF

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KR102386665B1
KR102386665B1 KR1020187031357A KR20187031357A KR102386665B1 KR 102386665 B1 KR102386665 B1 KR 102386665B1 KR 1020187031357 A KR1020187031357 A KR 1020187031357A KR 20187031357 A KR20187031357 A KR 20187031357A KR 102386665 B1 KR102386665 B1 KR 102386665B1
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palbociclib
solid dispersion
acid
amorphous solid
pharmaceutically acceptable
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KR20190013723A (ko
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쩌렌 왕
쥔 쉬
롱 취
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선전 파마신 컴퍼니 리미티드
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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
    • A61K9/20—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
    • 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
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    • 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
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    • 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
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    • 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
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    • 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
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    • 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
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    • 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
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    • 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
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    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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    • A61K9/1629—Organic macromolecular compounds
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    • 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
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    • A—HUMAN NECESSITIES
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    • 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
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    • 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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  • 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)
KR1020187031357A 2016-03-29 2016-06-21 팔보시클립의 약학 제제 및 그 제조 방법 Active KR102386665B1 (ko)

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

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KR20190013723A KR20190013723A (ko) 2019-02-11
KR102386665B1 true KR102386665B1 (ko) 2022-04-13

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US (5) US10449195B2 (https=)
EP (1) EP3437637B1 (https=)
JP (2) JP6799612B2 (https=)
KR (1) KR102386665B1 (https=)
CN (2) CN105816437B (https=)
AU (1) AU2016400468B2 (https=)
CA (1) CA3019257C (https=)
EA (1) EA201892173A1 (https=)
ES (1) ES2968132T3 (https=)
GB (2) GB2564793B (https=)
IL (1) IL261989B2 (https=)
WO (1) WO2017166451A1 (https=)

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KR20250062261A (ko) 2023-10-30 2025-05-08 신풍제약주식회사 향상된 용해도 및 안정성을 가지는 팔보시클립의 제약학적 조성물 및 이의 제조방법

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KR102369405B1 (ko) 2015-06-04 2022-03-02 화이자 인코포레이티드 팔보시클립의 고체 투여 형태
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
CN110573183A (zh) * 2017-04-21 2019-12-13 上海方楠生物科技有限公司 一种帕博西林组合物及其制备方法
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
EP4309656A3 (en) * 2018-05-14 2024-02-28 Pfizer Inc. Oral solution formulation
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
JP7149449B2 (ja) * 2020-07-02 2022-10-06 ＡＲＴｈａｍ Ｔｈｅｒａｐｅｕｔｉｃｓ株式会社 経口用医薬組成物及びその製造方法
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
CN117815184A (zh) * 2020-12-28 2024-04-05 上海云晟研新生物科技有限公司 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
AU2023239642A1 (en) 2022-03-25 2024-11-07 Shenzhen Pharmacin Co., Ltd. Pharmaceutical compositions of protac compounds and uses thereof
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
WO2025156193A1 (en) * 2024-01-25 2025-07-31 Zhejiang Qizheng Pharmaceutical Co., Ltd. Palbociclib dosage form

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