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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
disintegrating tablet
acid
water
enteric coated
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
Application filed by Takeda Pharmaceutical Company Limited filed Critical Takeda Pharmaceutical Company Limited
Publication of WO2009022670A1 publication Critical patent/WO2009022670A1/en

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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5073—Microcapsules 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)

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)

Applications Claiming Priority (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 (12)

* 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 Methods of manufacturing solid dosage forms
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 tablets containing low dose drugs
US9511028B2 (en) 2012-05-01 2016-12-06 Johnson & Johnson Consumer Inc. Orally disintegrating tablet
JP2018536707A (en) * 2015-10-30 2018-12-13 キャンサー プリベンション ファーマシューティカルズ，インコーポレイテッド Fixed-dose combination of efflornitine and sulindac
US10493026B2 (en) 2017-03-20 2019-12-03 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles
US10835488B2 (en) 2016-06-16 2020-11-17 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
US11077055B2 (en) 2015-04-29 2021-08-03 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions

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 アボツト　ラボラトリーズ Tablet composition
JPS63198625A (en) * 1986-12-12 1988-08-17 ノーウィッチ、イートン、ファーマスーティカルズ、インコーポレーテッド 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 アボツト　ラボラトリーズ Tablet composition
JPS63198625A (en) * 1986-12-12 1988-08-17 ノーウィッチ、イートン、ファーマスーティカルズ、インコーポレーテッド 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 (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
US9107807B2 (en) 2009-09-24 2015-08-18 Mcneil-Ppc, Inc. Machine for the manufacture of dosage forms utilizing radiofrequency energy
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
US9511028B2 (en) 2012-05-01 2016-12-06 Johnson & Johnson Consumer Inc. Orally disintegrating tablet
CN104271339A (en) * 2012-05-01 2015-01-07 麦克内尔-Ppc股份有限公司 Methods of manufacturing solid dosage forms
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
JP2014040379A (en) * 2012-08-21 2014-03-06 Shin Etsu Chem Co Ltd Production method of tablet containing hydrophobic drug
US9789066B2 (en) 2014-01-10 2017-10-17 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles
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 Tablet manufacturing process using high frequency and lossy coated particles
US11077055B2 (en) 2015-04-29 2021-08-03 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
US11986554B2 (en) 2015-04-29 2024-05-21 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
JP6002870B1 (en) * 2015-10-16 2016-10-05 持田製薬株式会社 Orally disintegrating tablets containing low dose drugs
WO2017064815A1 (en) * 2015-10-16 2017-04-20 持田製薬株式会社 Orally disintegrating tablet containing small-dose drug
US11529326B2 (en) 2015-10-30 2022-12-20 Cancer Prevention Pharmaceuticals, Inc. Eflornithine and sulindac, fixed dose combination formulation
JP2022028814A (en) * 2015-10-30 2022-02-16 キャンサー プリベンション ファーマシューティカルズ，インコーポレイテッド Fixed dose combination formulation of eflornithine and sulindac
US11925613B2 (en) 2015-10-30 2024-03-12 Cancer Prevention Pharmaceuticals, Inc. Eflornithine and sulindac, fixed dose combination formulation
JP2018536707A (en) * 2015-10-30 2018-12-13 キャンサー プリベンション ファーマシューティカルズ，インコーポレイテッド Fixed-dose combination of efflornitine and sulindac
JP7592001B2 (en) 2015-10-30 2024-11-29 キャンサー プリベンション ファーマシューティカルズ，インコーポレイテッド Eflornithine and sulindac fixed-dose combination formulation
US10835488B2 (en) 2016-06-16 2020-11-17 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
US10493026B2 (en) 2017-03-20 2019-12-03 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles

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