CN113508165A - 薄膜包衣组合物和固体制剂 - Google Patents

薄膜包衣组合物和固体制剂 Download PDF

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Publication number
CN113508165A
CN113508165A CN202080016684.8A CN202080016684A CN113508165A CN 113508165 A CN113508165 A CN 113508165A CN 202080016684 A CN202080016684 A CN 202080016684A CN 113508165 A CN113508165 A CN 113508165A
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China
Prior art keywords
film coating
coating composition
tablet
gum
comparative example
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Pending
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CN202080016684.8A
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English (en)
Chinese (zh)
Inventor
伊豆井航
中道克树
松川卓也
菊冈广晃
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Sawai Pharmaceutical Co Ltd
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Sawai Pharmaceutical Co Ltd
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Publication of CN113508165A publication Critical patent/CN113508165A/zh
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    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09DCOATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D7/00Features of coating compositions, not provided for in group C09D5/00; Processes for incorporating ingredients in coating compositions
    • C09D7/40Additives
    • C09D7/65Additives macromolecular
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • 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
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09DCOATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D129/00Coating compositions based on homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by an alcohol, ether, aldehydo, ketonic, acetal, or ketal radical; Coating compositions based on hydrolysed polymers of esters of unsaturated alcohols with saturated carboxylic acids; Coating compositions based on derivatives of such polymers
    • C09D129/02Homopolymers or copolymers of unsaturated alcohols
    • C09D129/04Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09DCOATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D151/00Coating compositions based on graft polymers in which the grafted component is obtained by reactions only involving carbon-to-carbon unsaturated bonds; Coating compositions based on derivatives of such polymers
    • C09D151/08Coating compositions based on graft polymers in which the grafted component is obtained by reactions only involving carbon-to-carbon unsaturated bonds; Coating compositions based on derivatives of such polymers grafted on to macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09DCOATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D171/00Coating compositions based on polyethers obtained by reactions forming an ether link in the main chain; Coating compositions based on derivatives of such polymers
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09DCOATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D7/00Features of coating compositions, not provided for in group C09D5/00; Processes for incorporating ingredients in coating compositions
    • C09D7/40Additives
    • C09D7/43Thickening agents
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09DCOATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D7/00Features of coating compositions, not provided for in group C09D5/00; Processes for incorporating ingredients in coating compositions
    • C09D7/40Additives
    • C09D7/60Additives non-macromolecular
    • C09D7/63Additives non-macromolecular organic

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Materials Engineering (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Paints Or Removers (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CN202080016684.8A 2019-03-04 2020-03-02 薄膜包衣组合物和固体制剂 Pending CN113508165A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2019-038589 2019-03-04
JP2019038589 2019-03-04
PCT/JP2020/008709 WO2020179736A1 (ja) 2019-03-04 2020-03-02 フィルムコーティング組成物及び固形製剤

Publications (1)

Publication Number Publication Date
CN113508165A true CN113508165A (zh) 2021-10-15

Family

ID=72338124

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202080016684.8A Pending CN113508165A (zh) 2019-03-04 2020-03-02 薄膜包衣组合物和固体制剂

Country Status (7)

Country Link
US (2) US20210393534A1 (https=)
EP (1) EP3936581A4 (https=)
JP (1) JP7317940B2 (https=)
KR (1) KR102692871B1 (https=)
CN (1) CN113508165A (https=)
TW (1) TWI791142B (https=)
WO (1) WO2020179736A1 (https=)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7362302B2 (ja) * 2019-05-20 2023-10-17 キョーリンリメディオ株式会社 レベチラセタムを含有する錠剤とその製造方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101208090A (zh) * 2005-04-28 2008-06-25 卫材R&D管理有限公司 稳定化的组合物
CN107252419A (zh) * 2010-12-22 2017-10-17 巴斯夫欧洲公司 快速崩解的固体包衣剂型
WO2018026596A1 (en) * 2016-08-04 2018-02-08 Bpsi Holdings, Llc Easy to swallow coatings and substrates coated therewith

Family Cites Families (7)

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US3967466A (en) 1974-05-01 1976-07-06 The Rovac Corporation Air conditioning system having super-saturation for reduced driving requirement
DE10207427A1 (de) * 2002-02-21 2003-09-04 Basf Ag Schnelllöslicher Filmüberzug basierend auf Polyvinylalkohol-Polyether-Pfropfcopolymeren in Kombination mit Hydroxy-, Amid-, oder Esterfunktionen enthaltenden Komponenten
FR2912915B1 (fr) * 2007-02-28 2012-11-16 Pf Medicament Film a desintegration rapide pour l'administration buccale de substances actives.
RU2010115255A (ru) * 2007-09-17 2011-10-27 МакНЕЙЛ-ППС, ИНК. (US) Составы для нанесения покрытия погружением, содержащие сополимер поливинилового спирта и полиэтиленгликоля и камедь
KR101767288B1 (ko) 2010-03-31 2017-08-10 모찌다 세이야쿠 가부시끼가이샤 복용 용이성 고형 제제
JP2017057147A (ja) 2015-09-14 2017-03-23 柴田 悟 ニンニク等、低塩分濃度の味噌、及びビタミンb1を含有する組成物
US11273129B2 (en) 2015-09-30 2022-03-15 Daicel Corporation Particle composition for easy-to-use solid preparation and easy-to-use solid preparation including said particle composition

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101208090A (zh) * 2005-04-28 2008-06-25 卫材R&D管理有限公司 稳定化的组合物
CN107252419A (zh) * 2010-12-22 2017-10-17 巴斯夫欧洲公司 快速崩解的固体包衣剂型
WO2018026596A1 (en) * 2016-08-04 2018-02-08 Bpsi Holdings, Llc Easy to swallow coatings and substrates coated therewith

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
NIDHAL K MARAIE等: "design and characterization of oroslippery buoyant tablets for ranitidine hydrochloride", 《ASIAN JOURNAL OF PHARMACEUTICAL AND CLINICAL RESEARCH》, vol. 11, no. 1, 30 November 2018 (2018-11-30), pages 143 - 149, XP055736982, DOI: 10.22159/ajpcr.2017.v11i1.21982 *
ZAINAB H. MAHDI: "New Easily Swallowed Tablets with Slippery Coating for the Antihypertensive Drug", 《UK JOURNAL OF PHARMACEUTICAL AND BIOSCIENCES》 *
ZAINAB H. MAHDI: "New Easily Swallowed Tablets with Slippery Coating for the Antihypertensive Drug", 《UK JOURNAL OF PHARMACEUTICAL AND BIOSCIENCES》, vol. 3, no. 5, 31 December 2016 (2016-12-31), pages 9 - 19, XP055737932, DOI: 10.20510/ukjpb/3/i5/89481 *
段红福等: "《药物学基础与临床应用 上》", 吉林科学技术出版社, pages: 148 - 293 *
葛洪: "《新编临床药物学》", 31 May 2017, 吉林科学技术出版社, pages: 169 *

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Publication number Publication date
US20250295595A1 (en) 2025-09-25
TW202033221A (zh) 2020-09-16
EP3936581A1 (en) 2022-01-12
KR102692871B1 (ko) 2024-08-08
KR20210118164A (ko) 2021-09-29
US20210393534A1 (en) 2021-12-23
WO2020179736A1 (ja) 2020-09-10
EP3936581A4 (en) 2022-11-30
TWI791142B (zh) 2023-02-01
JPWO2020179736A1 (https=) 2020-09-10
JP7317940B2 (ja) 2023-07-31

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