CN105816437B - 一种帕布昔利布的药物制剂及其制备方法 - Google Patents

一种帕布昔利布的药物制剂及其制备方法 Download PDF

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Publication number
CN105816437B
CN105816437B CN201610187046.8A CN201610187046A CN105816437B CN 105816437 B CN105816437 B CN 105816437B CN 201610187046 A CN201610187046 A CN 201610187046A CN 105816437 B CN105816437 B CN 105816437B
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CN
China
Prior art keywords
acid
palbociclib
preparation
former times
pharmaceutically acceptable
Prior art date
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Active
Application number
CN201610187046.8A
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English (en)
Chinese (zh)
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CN105816437A (zh
Inventor
王泽人
曲龙
徐俊
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shenzhen Pharmaceutical Biotechnology Co Ltd
Original Assignee
Hlk Pharmaceuticals Co ltd
Shenzhen Pharmacin Co Ltd
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
Priority to CN201610187046.8A priority Critical patent/CN105816437B/zh
Application filed by Hlk Pharmaceuticals Co ltd, Shenzhen Pharmacin Co Ltd filed Critical Hlk Pharmaceuticals Co ltd
Priority to CN201810902418.XA priority patent/CN109078006B/zh
Priority to GB1817116.5A priority patent/GB2564793B/en
Priority to IL261989A priority patent/IL261989B2/en
Priority to GB2010241.4A priority patent/GB2583425B/en
Priority to AU2016400468A priority patent/AU2016400468B2/en
Priority to BR112018070198-0A priority patent/BR112018070198B1/pt
Priority to CA3019257A priority patent/CA3019257C/en
Priority to PCT/CN2016/086546 priority patent/WO2017166451A1/zh
Priority to JP2018551287A priority patent/JP6799612B2/ja
Priority to EA201892173A priority patent/EA201892173A1/ru
Priority to KR1020187031357A priority patent/KR102386665B1/ko
Priority to ES16896224T priority patent/ES2968132T3/es
Priority to EP16896224.9A priority patent/EP3437637B1/en
Publication of CN105816437A publication Critical patent/CN105816437A/zh
Priority to US15/613,853 priority patent/US10449195B2/en
Application granted granted Critical
Publication of CN105816437B publication Critical patent/CN105816437B/zh
Priority to US16/554,103 priority patent/US10894049B2/en
Priority to US16/554,112 priority patent/US10813937B2/en
Priority to US17/024,389 priority patent/US11464779B2/en
Priority to JP2020191821A priority patent/JP2021046410A/ja
Priority to US17/954,421 priority patent/US20230226063A1/en
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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
    • 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
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    • 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
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    • 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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    • 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
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    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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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
    • A61K9/146—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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    • A61K9/16—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
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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
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
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    • A61K9/2004—Excipients; Inactive ingredients
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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    • 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
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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • 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)
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  • Medicinal Chemistry (AREA)
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  • Dispersion Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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CN201610187046.8A 2016-03-29 2016-03-29 一种帕布昔利布的药物制剂及其制备方法 Active CN105816437B (zh)

Priority Applications (20)

Application Number Priority Date Filing Date Title
CN201810902418.XA CN109078006B (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
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
EP16896224.9A EP3437637B1 (en) 2016-03-29 2016-06-21 Pharmaceutical preparation of palbociclib and medical use thereof
GB2010241.4A GB2583425B (en) 2016-03-29 2016-06-21 A pharmaceutical formulation of palbociclib and a preparation method thereof
AU2016400468A AU2016400468B2 (en) 2016-03-29 2016-06-21 Pharmaceutical preparation of palbociclib and preparation method thereof
BR112018070198-0A BR112018070198B1 (pt) 2016-03-29 2016-06-21 Dispersão sólida amorfa única e seu uso
CA3019257A CA3019257C (en) 2016-03-29 2016-06-21 A pharmaceutical formulation of palbociclib and a preparation method thereof
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
JP2018551287A JP6799612B2 (ja) 2016-03-29 2016-06-21 パルボシクリブの医薬製剤およびその調製方法
EA201892173A EA201892173A1 (ru) 2016-03-29 2016-06-21 Фармацевтический состав палбоциклиба и способ его получения
GB1817116.5A GB2564793B (en) 2016-03-29 2016-06-21 A pharmaceutical formulation of palbociclib and a preparation method thereof
ES16896224T ES2968132T3 (es) 2016-03-29 2016-06-21 Preparación farmacéutica de palbociclib y uso médico de la misma
IL261989A IL261989B2 (en) 2016-03-29 2016-06-21 A pharmaceutical preparation of flavociclib and a method for its preparation
KR1020187031357A KR102386665B1 (ko) 2016-03-29 2016-06-21 팔보시클립의 약학 제제 및 그 제조 방법
US15/613,853 US10449195B2 (en) 2016-03-29 2017-06-05 Pharmaceutical formulation of palbociclib and a preparation method thereof
US16/554,103 US10894049B2 (en) 2016-03-29 2019-08-28 Pharmaceutical formulation of palbociclib and a preparation method thereof
US16/554,112 US10813937B2 (en) 2016-03-29 2019-08-28 Pharmaceutical formulation of palbociclib and a preparation method thereof
US17/024,389 US11464779B2 (en) 2016-03-29 2020-09-17 Pharmaceutical formulation of palbociclib and a preparation method thereof
JP2020191821A JP2021046410A (ja) 2016-03-29 2020-11-18 パルボシクリブの医薬製剤およびその調製方法
US17/954,421 US20230226063A1 (en) 2016-03-29 2022-09-28 Pharmaceutical formulation of palbociclib and a preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
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

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CN105816437B true CN105816437B (zh) 2018-08-03

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CN201610187046.8A Active 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

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Country Link
US (1) US20230226063A1 (enExample)
EP (1) EP3437637B1 (enExample)
JP (2) JP6799612B2 (enExample)
KR (1) KR102386665B1 (enExample)
CN (2) CN109078006B (enExample)
AU (1) AU2016400468B2 (enExample)
CA (1) CA3019257C (enExample)
EA (1) EA201892173A1 (enExample)
ES (1) ES2968132T3 (enExample)
GB (2) GB2564793B (enExample)
IL (1) IL261989B2 (enExample)
WO (1) WO2017166451A1 (enExample)

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CN113616606A (zh) 2015-06-04 2021-11-09 辉瑞公司 帕博西尼的固体剂型
US10449195B2 (en) 2016-03-29 2019-10-22 Shenzhen Pharmacin Co., Ltd. Pharmaceutical formulation of palbociclib and a preparation method thereof
CN109078006B (zh) * 2016-03-29 2021-04-20 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
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
KR20230034207A (ko) * 2020-07-02 2023-03-09 아사무 세라퓨틱스 가부시키가이샤 경구용 의약 조성물 및 그 제조 방법
WO2022063119A1 (zh) * 2020-09-24 2022-03-31 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
TW202345842A (zh) 2022-03-25 2023-12-01 大陸商深圳市藥欣生物科技有限公司 Ｐｒｏｔａｃ化合物之醫藥組合物及其用途
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