CN113950327A - 口服胶囊剂及其制备方法 - Google Patents

口服胶囊剂及其制备方法 Download PDF

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Publication number
CN113950327A
CN113950327A CN202080043268.7A CN202080043268A CN113950327A CN 113950327 A CN113950327 A CN 113950327A CN 202080043268 A CN202080043268 A CN 202080043268A CN 113950327 A CN113950327 A CN 113950327A
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China
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oral
capsule
oral capsule
composition
sieving
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CN202080043268.7A
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English (en)
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王亦平
郭远静
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Baiji Shenzhou Switzerland Co ltd
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Baiji Shenzhou Switzerland Co ltd
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Publication of CN113950327A publication Critical patent/CN113950327A/zh
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    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

本发明提供了一种口服胶囊剂和一种采用粉末直接混合后灌装胶囊的方法，该口服胶囊剂包含口服胶囊剂用组合物和胶囊壳，所述口服胶囊剂用组合物包含泽布替尼、填充剂、崩解剂、润湿剂、助流剂、润滑剂以及任选的粘合剂。本发明的胶囊剂用组合物能够获得令人满意的产品稳定性，满足生物利用度标准的溶出度属性，与生产设备一致的制备工艺和合理的生产成本，另外，本发明的方法为无制粒工序，可简化整体工艺步骤并降低制剂工艺对产品生物利用度的影响。

Description

PCT国内申请，说明书已公开。

Claims (17)

  1. PCT国内申请，权利要求书已公开。
CN202080043268.7A 2019-06-10 2020-06-10 口服胶囊剂及其制备方法 Pending CN113950327A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CNPCT/CN2019/090543 2019-06-10
CN2019090543 2019-06-10
PCT/CN2020/095353 WO2020249002A1 (zh) 2019-06-10 2020-06-10 口服胶囊剂及其制备方法

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Publication Number Publication Date
CN113950327A true CN113950327A (zh) 2022-01-18

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CN202080043268.7A Pending CN113950327A (zh) 2019-06-10 2020-06-10 口服胶囊剂及其制备方法

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US (2) US20220241285A1 (zh)
EP (1) EP3981400A4 (zh)
JP (1) JP2022538215A (zh)
CN (1) CN113950327A (zh)
TW (1) TW202112369A (zh)
WO (1) WO2020249002A1 (zh)

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PL3702373T3 (pl) 2013-09-13 2022-12-05 Beigene Switzerland Gmbh Przeciwciała anty-PD1 i ich zastosowanie jako środki terapeutyczne i diagnostyczne
KR102130600B1 (ko) 2014-07-03 2020-07-08 베이진 엘티디 Pd-l1 항체와 이를 이용한 치료 및 진단
CA3033827A1 (en) 2016-08-16 2018-02-22 Beigene, Ltd. Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl )-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide,preparation, and uses thereof
CN110087680B (zh) 2016-08-19 2024-03-19 百济神州有限公司 使用包含btk抑制剂的组合产品治疗癌症
JP2020525411A (ja) 2017-06-26 2020-08-27 ベイジーン リミテッド 肝細胞癌のための免疫療法
WO2019108795A1 (en) 2017-11-29 2019-06-06 Beigene Switzerland Gmbh Treatment of indolent or aggressive b-cell lymphomas using a combination comprising btk inhibitors
CN115212115A (zh) * 2021-09-27 2022-10-21 百济神州(苏州)生物科技有限公司 泽布替尼的鼻饲给药

Citations (3)

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Publication number Priority date Publication date Assignee Title
WO2014173289A1 (en) * 2013-04-25 2014-10-30 Beigene, Ltd. Fused heterocyclic compounds as protein kinase inhibitors
WO2018033853A2 (en) * 2016-08-16 2018-02-22 Beigene, Ltd. Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
WO2019183226A1 (en) * 2018-03-21 2019-09-26 Mei Pharma, Inc. Combination therapy

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US9717745B2 (en) * 2015-03-19 2017-08-01 Zhejiang DTRM Biopharma Co. Ltd. Pharmaceutical compositions and their use for treatment of cancer and autoimmune diseases

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014173289A1 (en) * 2013-04-25 2014-10-30 Beigene, Ltd. Fused heterocyclic compounds as protein kinase inhibitors
WO2018033853A2 (en) * 2016-08-16 2018-02-22 Beigene, Ltd. Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
WO2019183226A1 (en) * 2018-03-21 2019-09-26 Mei Pharma, Inc. Combination therapy

Non-Patent Citations (3)

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Title
20170702: "BEIGENE Efficacy and Safety of BGB-3111 in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma", 《HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03206918》 *
TAM C.S.等: "A Head-to-head Phase III Study Comparing Zanubrutinib Versus Ibrutinib in Patients with Waldenstrom macroglobulinemia", 《FUTURE ONCOLOGY》 *
百济神州（北京）生物科技有限公司: "评估BTK抑制剂BGB-3111在中国B淋巴细胞肿瘤患者的安全性、耐受性以及药代/药效动力学特征的I期临床研究", 《HTTP://WWW.CHINADRUGTRIALS.ORG.CN》 *

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Publication number Publication date
WO2020249002A1 (zh) 2020-12-17
JP2022538215A (ja) 2022-09-01
EP3981400A1 (en) 2022-04-13
US20220241285A1 (en) 2022-08-04
US20230149411A1 (en) 2023-05-18
EP3981400A4 (en) 2023-07-12
TW202112369A (zh) 2021-04-01

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