CN114727995A - 优替德隆的固体口服制剂 - Google Patents

优替德隆的固体口服制剂 Download PDF

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Publication number
CN114727995A
CN114727995A CN202180006314.0A CN202180006314A CN114727995A CN 114727995 A CN114727995 A CN 114727995A CN 202180006314 A CN202180006314 A CN 202180006314A CN 114727995 A CN114727995 A CN 114727995A
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solid oral
pellet
oral formulation
preparation
prescription
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CN202180006314.0A
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CN114727995B (zh
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唐莉
张川
邱荣国
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Chengdu Biostar Pharmaceuticals Ltd
Beijing Huahao Zhongtian Biomedical Co ltd
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Chengdu Biostar Pharmaceuticals Ltd
Beijing Huahao Zhongtian Biomedical Co ltd
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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
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/427—Thiazoles not condensed and containing further 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • 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
    • 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
    • A61K9/14—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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • 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
    • A61K9/20—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
    • A61K9/48—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

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

Abstract

一种适用于口服给药的4,8‑二羟基‑5,5,7,9,13‑五甲基‑16‑[1‑甲基‑2‑(2‑甲基‑噻唑‑4‑基)‑乙烯基]‑十六烷氧杂环‑13‑烯‑2,6‑酮内酯(优替德隆)为活性成分的口服药物制剂。所述药物制剂为片剂、胶囊剂等固体制剂，所述药物剂型具有良好的稳定性，体外溶出行为及生物利用度。

Description

PCT国内申请，说明书已公开。

Claims (13)

  1. PCT国内申请，权利要求书已公开。
CN202180006314.0A 2020-09-02 2021-09-02 优替德隆的固体口服制剂 Active CN114727995B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN2020109100725 2020-09-02
CN202010910072 2020-09-02
PCT/CN2021/116194 WO2022048592A1 (zh) 2020-09-02 2021-09-02 优替德隆的固体口服制剂

Publications (2)

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CN114727995A true CN114727995A (zh) 2022-07-08
CN114727995B CN114727995B (zh) 2024-06-11

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ID=80492210

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CN202180006314.0A Active CN114727995B (zh) 2020-09-02 2021-09-02 优替德隆的固体口服制剂

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Country Link
US (1) US20230048901A1 (zh)
EP (1) EP4062913B1 (zh)
JP (1) JP7536098B2 (zh)
KR (1) KR20230024389A (zh)
CN (1) CN114727995B (zh)
AU (1) AU2021337086B2 (zh)
BR (1) BR112023003572A2 (zh)
CA (1) CA3184960A1 (zh)
ES (1) ES2981041T3 (zh)
HU (1) HUE066812T2 (zh)
PL (1) PL4062913T3 (zh)
WO (1) WO2022048592A1 (zh)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024139226A1 (zh) * 2022-12-27 2024-07-04 北京华昊中天生物医药股份有限公司 含白蛋白结合型优替德隆纳米粒的药物组合物及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1099263A (zh) * 1993-06-15 1995-03-01 拜尔公司 伊沙匹隆药物制剂
WO2003084536A1 (en) * 2002-04-04 2003-10-16 Bristol-Myers Squibb Company Oral administration of epothilones
CN1496258A (zh) * 2001-01-25 2004-05-12 ����˹�ж�-����˹˹������˾ 用于治疗癌症的埃博霉素类似物的给药方法
CN101362784A (zh) * 2008-10-06 2009-02-11 山东大学 埃博霉素苷类化合物和以其为活性成分的组合物及其应用
CN104666297A (zh) * 2008-04-24 2015-06-03 百时美施贵宝公司 埃坡霉素D在治疗包括阿尔茨海默病的τ相关疾病中的用途

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20030071853A (ko) 2001-01-25 2003-09-06 브리스톨-마이어스스퀴브컴파니 에포틸론 유사체를 함유한 비경구용 제제
EP1824458A1 (en) 2004-11-18 2007-08-29 Bristol-Myers Squibb Company Enteric coated bead comprising epothilone or an epothilone analog, and preparation and administration thereof
CN107041886A (zh) 2016-02-06 2017-08-15 北京华昊中天生物技术有限公司 脱环氧埃坡霉素衍生物制剂、制备及其治疗肿瘤的应用

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1099263A (zh) * 1993-06-15 1995-03-01 拜尔公司 伊沙匹隆药物制剂
CN1496258A (zh) * 2001-01-25 2004-05-12 ����˹�ж�-����˹˹������˾ 用于治疗癌症的埃博霉素类似物的给药方法
WO2003084536A1 (en) * 2002-04-04 2003-10-16 Bristol-Myers Squibb Company Oral administration of epothilones
CN104666297A (zh) * 2008-04-24 2015-06-03 百时美施贵宝公司 埃坡霉素D在治疗包括阿尔茨海默病的τ相关疾病中的用途
CN101362784A (zh) * 2008-10-06 2009-02-11 山东大学 埃博霉素苷类化合物和以其为活性成分的组合物及其应用

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
ZHANG P. 等: "hase II trial of utidelone as monotherapy or in combination with capecitabine in heavily pretreated metastatic breast cancer patients" *
ZHANG P. 等: "Utidelone plus capecitabine versus capecitabine alone for heavily pretreated metastatic breast cancer refractory to anthracyclines and taxanes: a multicentre, open-label, superiority, phase 3, randomised controlled trial" *
王进欣等: "新型抗肿瘤药物埃坡霉素的研究" *
郭凌云等: "UTD1药物在IV期乳腺癌病人II期试验中的应用观察" *

Also Published As

Publication number Publication date
AU2021337086B2 (en) 2024-02-29
CA3184960A1 (en) 2022-03-10
JP2023508090A (ja) 2023-02-28
EP4062913A4 (en) 2023-01-18
ES2981041T3 (es) 2024-10-07
WO2022048592A1 (zh) 2022-03-10
BR112023003572A2 (pt) 2023-04-04
EP4062913A1 (en) 2022-09-28
KR20230024389A (ko) 2023-02-20
JP7536098B2 (ja) 2024-08-19
CN114727995B (zh) 2024-06-11
HUE066812T2 (hu) 2024-09-28
EP4062913B1 (en) 2024-05-08
US20230048901A1 (en) 2023-02-16
AU2021337086A1 (en) 2023-02-23
EP4062913C0 (en) 2024-05-08
PL4062913T3 (pl) 2024-07-22

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