KR102789488B1 - 의약 제제 및 그 제조 방법 - Google Patents

의약 제제 및 그 제조 방법 Download PDF

Info

Publication number
KR102789488B1
KR102789488B1 KR1020217038479A KR20217038479A KR102789488B1 KR 102789488 B1 KR102789488 B1 KR 102789488B1 KR 1020217038479 A KR1020217038479 A KR 1020217038479A KR 20217038479 A KR20217038479 A KR 20217038479A KR 102789488 B1 KR102789488 B1 KR 102789488B1
Authority
KR
South Korea
Prior art keywords
nuclear particle
particle component
pharmaceutical preparation
nuclear
drug
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
KR1020217038479A
Other languages
English (en)
Korean (ko)
Other versions
KR20220030212A (ko
Inventor
토시유키 이나다
타카키 시모다이라
료세이 카나야마
히로시 오노지
테츠오 야마구치
Original Assignee
후지 파마 컴퍼니 리미티드
가부시키가이샤 키노파마
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 후지 파마 컴퍼니 리미티드, 가부시키가이샤 키노파마 filed Critical 후지 파마 컴퍼니 리미티드
Publication of KR20220030212A publication Critical patent/KR20220030212A/ko
Application granted granted Critical
Publication of KR102789488B1 publication Critical patent/KR102789488B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50

Landscapes

  • 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)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Virology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
KR1020217038479A 2019-04-25 2020-04-24 의약 제제 및 그 제조 방법 Active KR102789488B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JPJP-P-2019-084695 2019-04-25
JP2019084695 2019-04-25
PCT/JP2020/017711 WO2020218518A1 (ja) 2019-04-25 2020-04-24 医薬製剤およびその製造方法

Publications (2)

Publication Number Publication Date
KR20220030212A KR20220030212A (ko) 2022-03-10
KR102789488B1 true KR102789488B1 (ko) 2025-04-01

Family

ID=72942137

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020217038479A Active KR102789488B1 (ko) 2019-04-25 2020-04-24 의약 제제 및 그 제조 방법

Country Status (11)

Country Link
US (1) US20220211688A1 (https=)
EP (1) EP3960240B1 (https=)
JP (1) JP7183403B2 (https=)
KR (1) KR102789488B1 (https=)
CN (1) CN114126590B (https=)
BR (1) BR112021021232A2 (https=)
ES (1) ES2977747T3 (https=)
PL (1) PL3960240T3 (https=)
TW (1) TWI829920B (https=)
WO (1) WO2020218518A1 (https=)
ZA (1) ZA202108670B (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI890738B (zh) * 2020-10-28 2025-07-21 日商基諾製藥股份有限公司 用於預防或治療病毒性陰道周邊部疾病的藥物組成物
CN119497616A (zh) * 2022-05-02 2025-02-21 株式会社基诺制药 含有苯胺衍生物的皮肤用外用剂

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009020198A1 (ja) 2007-08-03 2009-02-12 Kinopharma, Inc. 抗dnaウイルス作用を有するアニリン誘導体
WO2010095494A1 (ja) 2009-02-19 2010-08-26 アサヒビール株式会社 難溶性物質を含有する顆粒、錠剤、及び難溶性物質の可溶化方法
JP2015048315A (ja) 2013-08-30 2015-03-16 旭化成ケミカルズ株式会社 セルロース系核粒子及びその製造方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001081031A (ja) 1999-08-30 2001-03-27 Schering Ag 溶解性および経口吸収性を改善したベンズアミド誘導体含有製剤
CA2427991C (en) * 2000-11-06 2008-01-22 Asahi Kasei Kabushiki Kaisha Cellulose particles for pharmaceuticals
JP2004339162A (ja) * 2003-05-16 2004-12-02 Shin Etsu Chem Co Ltd 難溶性薬物を含む医薬用固形製剤とその製造方法
JP2007517062A (ja) 2003-12-29 2007-06-28 アルザ・コーポレーシヨン 機械的圧縮中に付着抵抗を与える薬物顆粒のコーティング
JP2006016329A (ja) * 2004-06-30 2006-01-19 Lion Corp 粒状医薬品
JP4342426B2 (ja) * 2004-11-24 2009-10-14 科研製薬株式会社 イトラコナゾール経口投与用製剤
MY164765A (en) * 2007-10-10 2018-01-30 Avantor Performance Mat Llc Directly compressible high functionality granular microcrystalline cellulose based excipient, manufacturing process and use thereof
US20100151034A1 (en) * 2008-09-30 2010-06-17 Astellas Pharma Inc. Granular pharmaceutical composition of atorvastatin for oral administration
CA2944727A1 (en) * 2014-04-04 2015-10-08 Memorial Sloan-Kettering Cancer Center Method and kits for identifying of cdk9 inhibitors for the treatment of cancer
JP2019084695A (ja) 2017-11-02 2019-06-06 キヤノンファインテックニスカ株式会社 記録装置

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009020198A1 (ja) 2007-08-03 2009-02-12 Kinopharma, Inc. 抗dnaウイルス作用を有するアニリン誘導体
WO2010095494A1 (ja) 2009-02-19 2010-08-26 アサヒビール株式会社 難溶性物質を含有する顆粒、錠剤、及び難溶性物質の可溶化方法
JP2015048315A (ja) 2013-08-30 2015-03-16 旭化成ケミカルズ株式会社 セルロース系核粒子及びその製造方法

Also Published As

Publication number Publication date
BR112021021232A2 (pt) 2021-12-21
ES2977747T3 (es) 2024-08-29
EP3960240B1 (en) 2024-03-27
CN114126590A (zh) 2022-03-01
EP3960240A1 (en) 2022-03-02
US20220211688A1 (en) 2022-07-07
EP3960240A4 (en) 2023-02-08
CN114126590B (zh) 2024-01-05
JP7183403B2 (ja) 2022-12-05
TWI829920B (zh) 2024-01-21
KR20220030212A (ko) 2022-03-10
PL3960240T3 (pl) 2024-08-19
ZA202108670B (en) 2023-10-25
WO2020218518A1 (ja) 2020-10-29
JPWO2020218518A1 (https=) 2020-10-29
TW202106299A (zh) 2021-02-16

Similar Documents

Publication Publication Date Title
JP7642149B2 (ja) 新たな医薬組成物
JP2008531509A (ja) 医薬品成分の改良された分散性を有する錠剤
WO2014030204A1 (ja) 薬物含有中空粒子
KR102789488B1 (ko) 의약 제제 및 그 제조 방법
TWI721938B (zh) 醫藥劑型
CN101360493A (zh) 左乙拉西坦制剂和制备方法
EP3197438A1 (en) Pharmaceutical composition having improved content uniformity
JP6361925B2 (ja) 固形製剤
JP7133811B2 (ja) 錠剤
JPWO2020218517A5 (https=)
JP6002869B1 (ja) ジエノゲスト含有錠剤
JP7640453B2 (ja) 医薬製剤およびその製造方法
WO2022072099A9 (en) Immediate release dosage forms, methods of making and using
JP2022069437A (ja) 医薬製剤およびその製造方法
JP2017075138A (ja) ジエノゲスト含有錠剤
JP5508311B2 (ja) 低水溶性薬物とともに使用することによく適した圧縮固体状投与形態の製造方法およびそれにより製造された圧縮固体状投与形態
WO2023085300A1 (ja) 優れた溶出性を有する医薬組成物

Legal Events

Date Code Title Description
PA0105 International application

Patent event date: 20211125

Patent event code: PA01051R01D

Comment text: International Patent Application

PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20211125

Comment text: Request for Examination of Application

PG1501 Laying open of application
E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

Comment text: Notification of reason for refusal

Patent event date: 20240105

Patent event code: PE09021S01D

E701 Decision to grant or registration of patent right
PE0701 Decision of registration

Patent event code: PE07011S01D

Comment text: Decision to Grant Registration

Patent event date: 20250113

GRNT Written decision to grant
PR0701 Registration of establishment

Comment text: Registration of Establishment

Patent event date: 20250327

Patent event code: PR07011E01D

PR1002 Payment of registration fee

Payment date: 20250327

End annual number: 3

Start annual number: 1

PG1601 Publication of registration