JP2023543814A - 非晶質固体分散体の医薬組成物およびその調製方法 - Google Patents

非晶質固体分散体の医薬組成物およびその調製方法 Download PDF

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JP2023543814A
JP2023543814A JP2023519416A JP2023519416A JP2023543814A JP 2023543814 A JP2023543814 A JP 2023543814A JP 2023519416 A JP2023519416 A JP 2023519416A JP 2023519416 A JP2023519416 A JP 2023519416A JP 2023543814 A JP2023543814 A JP 2023543814A
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acid
amorphous solid
solid dispersion
palbociclib
pharmaceutical composition
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JP2023543814A5 (https=
Inventor
ワン，ゼレン
チェン，シュン
スゥェン，ロンウェイ
ヅァオ，イェンシン
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シェンチェン ファーマシン シーオー．，エルティーディー．
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Publication of JP2023543814A publication Critical patent/JP2023543814A/ja
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    • 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
    • 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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/472—Non-condensed isoquinolines, e.g. papaverine
    • A61K31/4725—Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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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    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
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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
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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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    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
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    • 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
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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
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    • A—HUMAN NECESSITIES
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    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
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    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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  • Animal Behavior & Ethology (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2023519416A 2020-09-29 2021-09-29 非晶質固体分散体の医薬組成物およびその調製方法 Pending JP2023543814A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN202011046895.4 2020-09-29
CN202011046895.4A CN114306245A (zh) 2020-09-29 2020-09-29 无定形固体分散体的药物组合物及其制备方法
PCT/CN2021/121696 WO2022068877A1 (en) 2020-09-29 2021-09-29 Pharmaceutical compositions of amorphous solid dispersions and methods of preperation thereof

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JP2023543814A true JP2023543814A (ja) 2023-10-18
JP2023543814A5 JP2023543814A5 (https=) 2024-10-04

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US (2) US11471418B2 (https=)
EP (1) EP4221691A4 (https=)
JP (1) JP2023543814A (https=)
KR (1) KR20230097027A (https=)
CN (2) CN114306245A (https=)
AU (1) AU2021351818A1 (https=)
CA (1) CA3194010A1 (https=)
MX (1) MX2023003689A (https=)
WO (1) WO2022068877A1 (https=)

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WO2025154730A1 (ja) * 2024-01-18 2025-07-24 沢井製薬株式会社 固体分散体、固体分散体を含む製剤、及び固体分散体の製造方法

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AU2023239642A1 (en) 2022-03-25 2024-11-07 Shenzhen Pharmacin Co., Ltd. Pharmaceutical compositions of protac compounds and uses thereof
TR2022009480A1 (tr) * 2022-06-08 2023-12-21 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Palbosiklib içeren bir farmasötik bileşim.
TR2022009483A2 (tr) * 2022-06-08 2023-12-21 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Palbosiklib içeren bir farmasötik bileşim.
EP4302832A1 (en) * 2022-07-07 2024-01-10 Lotus Pharmaceutical Co., Ltd. Palbociclib formulation containing glucono delta lactone
WO2024186765A1 (en) * 2023-03-03 2024-09-12 Aems Corp. Amorphous solid composition, methods and uses thereof
CN116473923B (zh) * 2023-05-29 2024-05-14 杭州剂泰医药科技有限责任公司 一种奈拉替尼固体分散体组合物及其制备方法和应用
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
WO2025213381A1 (en) * 2024-04-10 2025-10-16 Hangzhou Jitai Pharmaceutical Technology Co., Ltd Neratinib-cyclodextrin composition and method for preparing same

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