WO2009022670A1 - Quickly disintegrating tablet - Google Patents

Quickly disintegrating tablet Download PDF

Info

Publication number
WO2009022670A1
WO2009022670A1 PCT/JP2008/064367 JP2008064367W WO2009022670A1 WO 2009022670 A1 WO2009022670 A1 WO 2009022670A1 JP 2008064367 W JP2008064367 W JP 2008064367W WO 2009022670 A1 WO2009022670 A1 WO 2009022670A1
Authority
WO
WIPO (PCT)
Prior art keywords
tablet
acid
water
enteric coated
comprises
Prior art date
Application number
PCT/JP2008/064367
Other languages
French (fr)
Japanese (ja)
Inventor
Yutaka Ebisawa
Toshihiro Shimizu
Original Assignee
Takeda Pharmaceutical Company Limited
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
Priority to JP2007-209578 priority Critical
Priority to JP2007209578 priority
Application filed by Takeda Pharmaceutical Company Limited filed Critical Takeda Pharmaceutical Company Limited
Publication of WO2009022670A1 publication Critical patent/WO2009022670A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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
    • A61K9/1611Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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 TOILET 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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
    • A61K9/5015Organic compounds, e.g. fats, sugars
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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

Abstract

Disclosed is a tablet which comprises an acid-unstable physiologically active substance as an active ingredient, which has the same level of hardness as that of a conventional tablet, and which can exhibit an excellent quick-disintegrating property even in the presence of a small quantity of water. Specifically disclosed is a tablet which can be suspended in water upon use. The tablet comprises an enteric coated fine granule comprising an acid-unstable physiologically active substance and an additive, wherein the enteric coated fine granule is contained in an amount of about 10 to 38 wt% per one tablet.
PCT/JP2008/064367 2007-08-10 2008-08-08 Quickly disintegrating tablet WO2009022670A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2007-209578 2007-08-10
JP2007209578 2007-08-10

Publications (1)

Publication Number Publication Date
WO2009022670A1 true WO2009022670A1 (en) 2009-02-19

Family

ID=40350724

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2008/064367 WO2009022670A1 (en) 2007-08-10 2008-08-08 Quickly disintegrating tablet

Country Status (1)

Country Link
WO (1) WO2009022670A1 (en)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2210591A2 (en) 2009-01-26 2010-07-28 Shin-Etsu Chemical Co., Ltd. Wet granulation tableting method using aqueous dispersion of low-substituted hydroxypropyl cellulose
JP2014040379A (en) * 2012-08-21 2014-03-06 Shin Etsu Chem Co Ltd Production method of tablet containing hydrophobic drug
CN104271339A (en) * 2012-05-01 2015-01-07 麦克内尔-Ppc股份有限公司 Method of manufacturing solid dosage form
WO2015105992A1 (en) * 2014-01-10 2015-07-16 Mcneil-Ppc, Inc. Process for making tablet using radiofrequency and lossy coated particles
US9107807B2 (en) 2009-09-24 2015-08-18 Mcneil-Ppc, Inc. Machine for the manufacture of dosage forms utilizing radiofrequency energy
US9233491B2 (en) 2012-05-01 2016-01-12 Johnson & Johnson Consumer Inc. Machine for production of solid dosage forms
JP6002870B1 (en) * 2015-10-16 2016-10-05 持田製薬株式会社 Orally disintegrating tablet containing a low-dose drug
US9511028B2 (en) 2012-05-01 2016-12-06 Johnson & Johnson Consumer Inc. Orally disintegrating tablet

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61221116A (en) * 1985-03-25 1986-10-01 Abbott Lab Tablet composition
JPS63198625A (en) * 1986-12-12 1988-08-17 Norwich Eaton Pharma Azumolene vehicle
JPS63301816A (en) * 1987-01-29 1988-12-08 Takeda Chem Ind Ltd Core-containing granule and production thereof
JPH02174931A (en) * 1988-09-27 1990-07-06 Takeda Chem Ind Ltd Nucleate granule and its preparation
JPH0971523A (en) * 1995-09-07 1997-03-18 Riyuukakusan:Kk Tablet quickly disintegrating in oral cavity
WO1998002185A1 (en) * 1996-07-12 1998-01-22 Daiichi Pharmaceutical Co., Ltd. Quickly disintegrable compression-molded materials and process for producing the same
JPH1143429A (en) * 1997-05-27 1999-02-16 Takeda Chem Ind Ltd Solid preparation
JP2000103731A (en) * 1998-07-28 2000-04-11 Takeda Chem Ind Ltd Rapid disintegrative solid preparation

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61221116A (en) * 1985-03-25 1986-10-01 Abbott Lab Tablet composition
JPS63198625A (en) * 1986-12-12 1988-08-17 Norwich Eaton Pharma Azumolene vehicle
JPS63301816A (en) * 1987-01-29 1988-12-08 Takeda Chem Ind Ltd Core-containing granule and production thereof
JPH02174931A (en) * 1988-09-27 1990-07-06 Takeda Chem Ind Ltd Nucleate granule and its preparation
JPH0971523A (en) * 1995-09-07 1997-03-18 Riyuukakusan:Kk Tablet quickly disintegrating in oral cavity
WO1998002185A1 (en) * 1996-07-12 1998-01-22 Daiichi Pharmaceutical Co., Ltd. Quickly disintegrable compression-molded materials and process for producing the same
JPH1143429A (en) * 1997-05-27 1999-02-16 Takeda Chem Ind Ltd Solid preparation
JP2000103731A (en) * 1998-07-28 2000-04-11 Takeda Chem Ind Ltd Rapid disintegrative solid preparation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HOSHI N. ET AL.: "Hydroxypropylcellulouse no Ko", IYAKUHIN TENKAZAI YORAN, JIHO INC., 1992, pages 26 - 27 *

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2210591A2 (en) 2009-01-26 2010-07-28 Shin-Etsu Chemical Co., Ltd. Wet granulation tableting method using aqueous dispersion of low-substituted hydroxypropyl cellulose
JP2010189384A (en) * 2009-01-26 2010-09-02 Shin-Etsu Chemical Co Ltd Wet granulation tableting method using aqueous dispersion of low-substituted hydroxypropyl cellulose
EP2210591A3 (en) * 2009-01-26 2011-01-19 Shin-Etsu Chemical Co., Ltd. Wet granulation tableting method using aqueous dispersion of low-substituted hydroxypropyl cellulose
US8303868B2 (en) 2009-01-26 2012-11-06 Shin-Etsu Chemical Co., Ltd. Wet granulation tableting method using aqueous dispersion of low-substituted hydroxypropyl cellulose
JP2014133766A (en) * 2009-01-26 2014-07-24 Shin Etsu Chem Co Ltd Wet granulation tableting method using aqueous dispersion of low-substituted hydroxypropyl cellulose
US9610224B2 (en) 2009-09-24 2017-04-04 Johnson & Johnson Consumer Inc. Manufacture of tablet in a die utilizing powder blend containing water-containing material
US9107807B2 (en) 2009-09-24 2015-08-18 Mcneil-Ppc, Inc. Machine for the manufacture of dosage forms utilizing radiofrequency energy
CN104271339A (en) * 2012-05-01 2015-01-07 麦克内尔-Ppc股份有限公司 Method of manufacturing solid dosage form
US9233491B2 (en) 2012-05-01 2016-01-12 Johnson & Johnson Consumer Inc. Machine for production of solid dosage forms
US9445971B2 (en) 2012-05-01 2016-09-20 Johnson & Johnson Consumer Inc. Method of manufacturing solid dosage form
US9511028B2 (en) 2012-05-01 2016-12-06 Johnson & Johnson Consumer Inc. Orally disintegrating tablet
JP2014040379A (en) * 2012-08-21 2014-03-06 Shin Etsu Chem Co Ltd Production method of tablet containing hydrophobic drug
WO2015105992A1 (en) * 2014-01-10 2015-07-16 Mcneil-Ppc, Inc. Process for making tablet using radiofrequency and lossy coated particles
JP2017502060A (en) * 2014-01-10 2017-01-19 ジョンソン・アンド・ジョンソン・コンシューマー・インコーポレイテッド Manufacturing process of tablets using a high frequency and lossy coated particles
US9789066B2 (en) 2014-01-10 2017-10-17 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles
JP6002870B1 (en) * 2015-10-16 2016-10-05 持田製薬株式会社 Orally disintegrating tablet containing a low-dose drug
WO2017064815A1 (en) * 2015-10-16 2017-04-20 持田製薬株式会社 Orally disintegrating tablet containing small-dose drug

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