CN115209877B - 颗粒和使用该颗粒的制剂 - Google Patents

颗粒和使用该颗粒的制剂 Download PDF

Info

Publication number
CN115209877B
CN115209877B CN202180018225.8A CN202180018225A CN115209877B CN 115209877 B CN115209877 B CN 115209877B CN 202180018225 A CN202180018225 A CN 202180018225A CN 115209877 B CN115209877 B CN 115209877B
Authority
CN
China
Prior art keywords
molten component
drug substance
layer
core material
molten
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
CN202180018225.8A
Other languages
English (en)
Chinese (zh)
Other versions
CN115209877A (zh
Inventor
吉原尚辉
桥本翔太
木全崚太
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.)
Sawai Pharmaceutical Co Ltd
Original Assignee
Sawai Pharmaceutical 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
Application filed by Sawai Pharmaceutical Co Ltd filed Critical Sawai Pharmaceutical Co Ltd
Publication of CN115209877A publication Critical patent/CN115209877A/zh
Application granted granted Critical
Publication of CN115209877B publication Critical patent/CN115209877B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K9/1682—Processes
    • 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
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/1635—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Glanulating (AREA)
CN202180018225.8A 2020-03-11 2021-03-09 颗粒和使用该颗粒的制剂 Active CN115209877B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062988077P 2020-03-11 2020-03-11
US62/988,077 2020-03-11
PCT/JP2021/009297 WO2021182469A1 (ja) 2020-03-11 2021-03-09 顆粒及びそれを用いた製剤

Publications (2)

Publication Number Publication Date
CN115209877A CN115209877A (zh) 2022-10-18
CN115209877B true CN115209877B (zh) 2025-02-11

Family

ID=77670626

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180018225.8A Active CN115209877B (zh) 2020-03-11 2021-03-09 颗粒和使用该颗粒的制剂

Country Status (7)

Country Link
US (1) US20230000777A1 (enExample)
EP (1) EP4119130A4 (enExample)
JP (2) JP7467596B2 (enExample)
KR (3) KR20260069752A (enExample)
CN (1) CN115209877B (enExample)
TW (1) TWI859428B (enExample)
WO (1) WO2021182469A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115209877B (zh) * 2020-03-11 2025-02-11 泽井制药株式会社 颗粒和使用该颗粒的制剂
JP7817300B2 (ja) * 2023-02-14 2026-02-18 沢井製薬株式会社 コーティング顆粒、コーティング顆粒を含む製剤及びそれらの製造方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06256169A (ja) * 1993-02-18 1994-09-13 Amano Pharmaceut Co Ltd 顆粒の製造法
JP2015199721A (ja) * 2014-03-31 2015-11-12 富山化学工業株式会社 セファロスポリンエステルを含む粒状固形製剤およびその製造方法
JP2017001999A (ja) * 2015-06-12 2017-01-05 富士フイルム株式会社 薬物含有粒子の製造方法、薬物含有粒子、医薬組成物、及び口腔内崩壊錠

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5290569A (en) * 1990-04-12 1994-03-01 Shionogi & Co., Ltd. Coated composition and its preparation process
ES2096624T3 (es) * 1990-04-12 1997-03-16 Shionogi & Co Composicion revestida y su procedimiento de preparacion.
JP3685625B2 (ja) 1998-09-09 2005-08-24 株式会社パウレック 加熱により溶融する物質を用いた粒子加工方法
JP4521654B2 (ja) 2003-04-24 2010-08-11 株式会社ダルトン 造粒物および造粒方法
JP2005075826A (ja) 2003-08-29 2005-03-24 Boehringer Ingelheim Internatl Gmbh 多孔質シリカ担体を含有する徐放性製剤
CN100528233C (zh) * 2003-10-29 2009-08-19 盐野义制药株式会社 不愉快味道改善了的包覆制剂的制造方法
JP2009541337A (ja) * 2006-06-19 2009-11-26 マクニール−ピーピーシー・インコーポレーテツド 活性成分を含有する腸溶性の被覆された粒子
JP2012087073A (ja) * 2010-10-15 2012-05-10 Pharma Polytech:Kk コーティング粒子の製造方法、及び該製造方法で製造されたコーティング粒子
JP2015071542A (ja) 2012-09-10 2015-04-16 エーザイ・アール・アンド・ディー・マネジメント株式会社 固体分散体の製造方法
FR2999937B1 (fr) * 2012-12-21 2015-01-09 Sanofi Sa Unite solide a haute teneur en fexofenadine et son procede de preparation
KR101553348B1 (ko) 2013-12-18 2015-09-15 김예주 주먹밥 포장 시트와 이를 이용한 스틱 주먹밥의 제조 방법
WO2015152190A1 (ja) * 2014-03-31 2015-10-08 富山化学工業株式会社 セファロスポリンエステルを含む粒状固形製剤およびその製造方法
KR20170001999A (ko) 2015-06-29 2017-01-06 주식회사 엘지유플러스 셋탑 단말, 셋탑 단말을 위한 어플리케이션, 및 서버의 동작 방법
EP3413937A4 (en) * 2016-02-08 2019-10-30 The Johns Hopkins University COMPOSITIONS AND METHODS OF PREPARING COMPOSITE POLYMER COATINGS ON MEDICAL IMPLANTS AND THEIR USE FOR THE CO-ADMINISTRATION OF SEVERAL ANTIMICROBIAL ACTIVITIES
CN115209877B (zh) * 2020-03-11 2025-02-11 泽井制药株式会社 颗粒和使用该颗粒的制剂

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06256169A (ja) * 1993-02-18 1994-09-13 Amano Pharmaceut Co Ltd 顆粒の製造法
JP2015199721A (ja) * 2014-03-31 2015-11-12 富山化学工業株式会社 セファロスポリンエステルを含む粒状固形製剤およびその製造方法
JP2017001999A (ja) * 2015-06-12 2017-01-05 富士フイルム株式会社 薬物含有粒子の製造方法、薬物含有粒子、医薬組成物、及び口腔内崩壊錠

Also Published As

Publication number Publication date
TWI859428B (zh) 2024-10-21
JP7467596B2 (ja) 2024-04-15
JPWO2021182469A1 (enExample) 2021-09-16
EP4119130A1 (en) 2023-01-18
WO2021182469A1 (ja) 2021-09-16
KR20260069752A (ko) 2026-05-15
KR20220124747A (ko) 2022-09-14
CN115209877A (zh) 2022-10-18
TW202200117A (zh) 2022-01-01
EP4119130A4 (en) 2024-01-31
JP2024081778A (ja) 2024-06-18
US20230000777A1 (en) 2023-01-05
JP7738697B2 (ja) 2025-09-12
KR20260059682A (ko) 2026-04-30

Similar Documents

Publication Publication Date Title
US7785630B2 (en) Preparation and administration form comprising an acid-labile active compound
KR0168849B1 (ko) 피목 조성물 및 그의 제조방법
JP7738697B2 (ja) 顆粒及びそれを用いた製剤
CN1249950A (zh) 药学活性颗粒的制备
CN1148171C (zh) 多单元缓释片剂
JPWO2021182469A5 (enExample)
JP2024063111A (ja) 顆粒及びそれを用いた製剤
HK40081736A (en) Granules and preparation using same
JP7854897B2 (ja) フィルムコーティング顆粒、それを含む製剤、及びそれらの製造方法
US20230083072A1 (en) Film-coated granule, pharmaceutical preparation containing the same, and manufacturing methods thereof
HK40082230A (en) Granules and preparation using same
JPH06190267A (ja) マイクロカプセル
HK1036220B (en) Multiple-unit sustained release tablets

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant