WO2019151405A1 - Comprimés et leur procédé de production - Google Patents

Comprimés et leur procédé de production Download PDF

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Publication number
WO2019151405A1
WO2019151405A1 PCT/JP2019/003412 JP2019003412W WO2019151405A1 WO 2019151405 A1 WO2019151405 A1 WO 2019151405A1 JP 2019003412 W JP2019003412 W JP 2019003412W WO 2019151405 A1 WO2019151405 A1 WO 2019151405A1
Authority
WO
WIPO (PCT)
Prior art keywords
tablet
amorphous
drug
lactone
glucono
Prior art date
Application number
PCT/JP2019/003412
Other languages
English (en)
Japanese (ja)
Inventor
慎 井實
林田　知大
洋平 帆足
中野　善夫
勝久 井上
Original Assignee
ニプロ株式会社
全星薬品工業株式会社
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 ニプロ株式会社, 全星薬品工業株式会社 filed Critical ニプロ株式会社
Priority to JP2019569554A priority Critical patent/JP7336388B2/ja
Publication of WO2019151405A1 publication Critical patent/WO2019151405A1/fr

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Classifications

    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/34—Macromolecular 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
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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

Abstract

L'invention concerne : un procédé de production de comprimés qui peuvent équilibrer la résistance et, de manière facultative, la propriété de désintégration rapide, et qui peuvent contenir un médicament et/ou des microparticules fonctionnelles contenant un médicament à une teneur élevée ; et des comprimés. Le procédé de production de comprimés comprend : une étape de mélange consistant à mélanger au moins un constituant choisi dans le groupe comprenant de l'acide gluconique, un hydrate d'acide gluconique, un sel d'acide gluconique, un hydrate d'un sel d'acide gluconique, de la δ-gluconolactone, un hydrate de δ-gluconolactone, un sel de δ-gluconolactone, un hydrate d'un sel de δ-gluconolactone, du glucuronolactone et de l'acide glucuronique avec un médicament et/ou des microparticules fonctionnelles contenant un médicament pour produire un mélange ; une étape de moulage par compression consistant à mouler par compression le mélange produit dans l'étape de mélange pour produire un article moulé ; une étape de liquéfaction consistant à liquéfier au moins la surface ou l'intérieur de l'article moulé produit par moulage par compression dans l'étape de moulage par compression ; et une étape de solidification consistant à solidifier l'article moulé dont au moins la surface ou l'intérieur a été liquéfié(e) dans l'étape de liquéfaction.
PCT/JP2019/003412 2018-02-02 2019-01-31 Comprimés et leur procédé de production WO2019151405A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2019569554A JP7336388B2 (ja) 2018-02-02 2019-01-31 錠剤及びその製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2018-017036 2018-02-02
JP2018017036 2018-02-02

Publications (1)

Publication Number Publication Date
WO2019151405A1 true WO2019151405A1 (fr) 2019-08-08

Family

ID=67479309

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2019/003412 WO2019151405A1 (fr) 2018-02-02 2019-01-31 Comprimés et leur procédé de production

Country Status (2)

Country Link
JP (1) JP7336388B2 (fr)
WO (1) WO2019151405A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021222739A1 (fr) * 2020-04-30 2021-11-04 Nanocopoeia, Llc Comprimé à désintégration orale comprenant une dispersion solide amorphe de nilotinib
US11389450B2 (en) 2020-01-31 2022-07-19 Nanocopoeia, Llc Amorphous nilotinib microparticles and uses thereof

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5119115A (fr) * 1974-04-11 1976-02-16 Oobaan Risaachi Fuaundeeshon
JPH08291051A (ja) * 1995-04-17 1996-11-05 Sato Seiyaku Kk 速溶解性錠剤の製造方法及び該製造方法により製造した速溶解性錠剤
JPH1112162A (ja) * 1997-06-27 1999-01-19 Taisho Pharmaceut Co Ltd 口腔内速崩錠及びその製造方法
JPH11349475A (ja) * 1998-06-03 1999-12-21 Dainippon Pharmaceut Co Ltd 口腔内崩壊錠及びその製造法
JP2003261440A (ja) * 2001-05-10 2003-09-16 Yamanouchi Pharmaceut Co Ltd 口腔内速崩壊性錠剤およびその製造法
JP2005053792A (ja) * 2003-08-01 2005-03-03 Taiyo Yakuhin Kogyo Kk 圧縮成形製剤およびその製造方法
JP2009137872A (ja) * 2007-12-05 2009-06-25 Lion Corp グルクロノラクトン含有経口用固形製剤
JP2010024181A (ja) * 2008-07-18 2010-02-04 Takeda Chem Ind Ltd 固形製剤及びその製造方法
JP2012162502A (ja) * 2011-02-08 2012-08-30 Fujifilm Corp 口腔内崩壊型錠及びその製造方法
JP2013067611A (ja) * 2011-09-07 2013-04-18 Mitsubishi Shoji Foodtech Co Ltd 硬度を高めた口腔内崩壊錠およびその製造方法
JP2017014155A (ja) * 2015-07-01 2017-01-19 株式会社東洋新薬 網膜保護組成物

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1413294B1 (fr) * 2001-07-27 2010-09-29 Astellas Pharma Inc. Composition contenant des grains fins a libération prolongée pour comprimés à désagrégation rapide dans la cavité buccale

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5119115A (fr) * 1974-04-11 1976-02-16 Oobaan Risaachi Fuaundeeshon
JPH08291051A (ja) * 1995-04-17 1996-11-05 Sato Seiyaku Kk 速溶解性錠剤の製造方法及び該製造方法により製造した速溶解性錠剤
JPH1112162A (ja) * 1997-06-27 1999-01-19 Taisho Pharmaceut Co Ltd 口腔内速崩錠及びその製造方法
JPH11349475A (ja) * 1998-06-03 1999-12-21 Dainippon Pharmaceut Co Ltd 口腔内崩壊錠及びその製造法
JP2003261440A (ja) * 2001-05-10 2003-09-16 Yamanouchi Pharmaceut Co Ltd 口腔内速崩壊性錠剤およびその製造法
JP2005053792A (ja) * 2003-08-01 2005-03-03 Taiyo Yakuhin Kogyo Kk 圧縮成形製剤およびその製造方法
JP2009137872A (ja) * 2007-12-05 2009-06-25 Lion Corp グルクロノラクトン含有経口用固形製剤
JP2010024181A (ja) * 2008-07-18 2010-02-04 Takeda Chem Ind Ltd 固形製剤及びその製造方法
JP2012162502A (ja) * 2011-02-08 2012-08-30 Fujifilm Corp 口腔内崩壊型錠及びその製造方法
JP2013067611A (ja) * 2011-09-07 2013-04-18 Mitsubishi Shoji Foodtech Co Ltd 硬度を高めた口腔内崩壊錠およびその製造方法
JP2017014155A (ja) * 2015-07-01 2017-01-19 株式会社東洋新薬 網膜保護組成物

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11389450B2 (en) 2020-01-31 2022-07-19 Nanocopoeia, Llc Amorphous nilotinib microparticles and uses thereof
WO2021222739A1 (fr) * 2020-04-30 2021-11-04 Nanocopoeia, Llc Comprimé à désintégration orale comprenant une dispersion solide amorphe de nilotinib
US11559485B2 (en) 2020-04-30 2023-01-24 Nanocopoeia, Llc Orally disintegrating tablet comprising amorphous solid dispersion of nilotinib

Also Published As

Publication number Publication date
JP7336388B2 (ja) 2023-08-31
JPWO2019151405A1 (ja) 2021-01-14

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