BR112013030093B1 - comprimido revestido seco de desintegração oral contendo tegafur, gimeracilo e oteracilo potássico - Google Patents

comprimido revestido seco de desintegração oral contendo tegafur, gimeracilo e oteracilo potássico Download PDF

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Publication number
BR112013030093B1
BR112013030093B1 BR112013030093A BR112013030093A BR112013030093B1 BR 112013030093 B1 BR112013030093 B1 BR 112013030093B1 BR 112013030093 A BR112013030093 A BR 112013030093A BR 112013030093 A BR112013030093 A BR 112013030093A BR 112013030093 B1 BR112013030093 B1 BR 112013030093B1
Authority
BR
Brazil
Prior art keywords
dry coated
coated tablet
outer coating
tablet according
tablet
Prior art date
Application number
BR112013030093A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112013030093A2 (pt
Inventor
Yoshizawa Takashi
Okamoto Takumi
Ohnishi Yoshito
Original Assignee
Taiho Pharmaceutical Co Ltd
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 Taiho Pharmaceutical Co Ltd filed Critical Taiho Pharmaceutical Co Ltd
Publication of BR112013030093A2 publication Critical patent/BR112013030093A2/pt
Publication of BR112013030093B1 publication Critical patent/BR112013030093B1/pt

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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
    • A61K9/20—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K31/4412—Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • 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
    • A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • 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
    • A61K47/36—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
    • A61K9/0012—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
BR112013030093A 2011-05-25 2012-05-24 comprimido revestido seco de desintegração oral contendo tegafur, gimeracilo e oteracilo potássico BR112013030093B1 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2011116884 2011-05-25
PCT/JP2012/063260 WO2012161240A1 (ja) 2011-05-25 2012-05-24 テガフール、ギメラシル、オテラシルカリウム含有有核錠

Publications (2)

Publication Number Publication Date
BR112013030093A2 BR112013030093A2 (pt) 2016-09-20
BR112013030093B1 true BR112013030093B1 (pt) 2019-12-10

Family

ID=47217314

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013030093A BR112013030093B1 (pt) 2011-05-25 2012-05-24 comprimido revestido seco de desintegração oral contendo tegafur, gimeracilo e oteracilo potássico

Country Status (16)

Country Link
US (1) US20140335174A1 (enExample)
EP (1) EP2716290B1 (enExample)
JP (2) JP5689173B2 (enExample)
KR (2) KR20170072959A (enExample)
AU (1) AU2012259803B2 (enExample)
BR (1) BR112013030093B1 (enExample)
CA (1) CA2836865C (enExample)
ES (1) ES2671926T3 (enExample)
IL (1) IL229372B (enExample)
MX (1) MX353289B (enExample)
MY (1) MY167883A (enExample)
PH (1) PH12013502323A1 (enExample)
RU (1) RU2601620C2 (enExample)
SG (2) SG194922A1 (enExample)
TW (2) TWI566787B (enExample)
WO (1) WO2012161240A1 (enExample)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY167883A (en) * 2011-05-25 2018-09-26 Taiho Pharmaceutical Co Ltd Dry-coated tablet containing tegafur, gimeracil and oteracil potassium
CN107837273A (zh) * 2016-09-18 2018-03-27 江苏金甙生物技术有限公司 一种肠溶替吉奥缓释制剂及其制备方法
CN107865871B (zh) * 2016-09-23 2021-09-03 江苏恒瑞医药股份有限公司 一种替吉奥组合物及其制备方法
CN106619689B (zh) * 2016-12-30 2018-05-01 陈晓华 一种用于治疗癌症的药物组合物、试剂盒及其应用
AU2020347662A1 (en) * 2019-09-13 2022-03-31 Meiji Co., Ltd. Solid food and solid milk
US20250312280A1 (en) * 2022-06-10 2025-10-09 Taiho Pharmaceutical Co., Ltd. Pharmaceutical composition containing pimitespib

Family Cites Families (21)

* Cited by examiner, † Cited by third party
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JP2614164B2 (ja) * 1991-05-27 1997-05-28 大鵬薬品工業株式会社 抗腫瘍効果増強のための及び腫瘍治療のための組成物
CA2322315C (en) * 1998-03-06 2008-09-16 Eurand International S.P.A. Fast disintegrating tablets
WO2001087272A2 (en) * 2000-05-18 2001-11-22 Therics, Inc. Encapsulating a toxic core within a non-toxic region in an oral dosage form
WO2003028706A1 (fr) * 2001-09-28 2003-04-10 Sanwa Kagaku Kenkyusho Co.,Ltd Double comprime a desintegration rapide
PT1443917E (pt) * 2001-11-07 2006-06-30 Synthon Bv Comprimidos de tamsulosina
US6723348B2 (en) * 2001-11-16 2004-04-20 Ethypharm Orodispersible tablets containing fexofenadine
WO2003080023A2 (en) * 2002-03-20 2003-10-02 Elan Pharma International Limited Fast dissolving dosage forms having reduced friability
US9611227B2 (en) * 2003-03-14 2017-04-04 Taiho Pharmaceutical Co., Ltd. Antitumor effect potentiator and antitumor agent
CA2540488A1 (en) * 2003-09-29 2005-04-07 Cipla Limited Pharmaceutical formulation with improved stability
CN100333726C (zh) 2004-12-23 2007-08-29 鲁南制药集团股份有限公司 含有替加氟、吉莫斯特和氧嗪酸钾的口腔崩解片
CN101155600B (zh) * 2005-04-01 2011-05-04 大鹏药品工业株式会社 放射线治疗增强剂
JP4994618B2 (ja) * 2005-08-11 2012-08-08 学校法人北里研究所 Ｔｓ−１／カンプトテシン類による化学放射線療法
EP2223683B1 (en) * 2007-12-27 2014-06-18 Taiho Pharmaceutical Co., Ltd. Oral particulate antitumor preparation
TWI468188B (zh) * 2008-01-30 2015-01-11 Univ Tokushima Anti-cancer effect enhancers consisting of oxaliplatin liposomal preparations and anticancer agents comprising the formulation
KR100934876B1 (ko) 2008-01-31 2010-01-06 성균관대학교산학협력단 Ｌｉｇａ공정의 도금방법
CN101380327B (zh) * 2008-10-09 2011-01-26 北京恒瑞康达医药科技发展有限公司 抗癌复合缓释组合物及制备
JP5553522B2 (ja) 2009-03-31 2014-07-16 大鵬薬品工業株式会社 経口投与用医薬組成物
WO2010131460A1 (ja) * 2009-05-12 2010-11-18 大鵬薬品工業株式会社 テガフール・ギメラシル・オテラシルカリウム配合剤及びオキサリプラチンを含有する抗腫瘍剤
CN101711765B (zh) * 2009-10-31 2011-03-23 山东新时代药业有限公司 一种含有替加氟、吉美嘧啶和奥替拉西钾的分散片
MY167883A (en) * 2011-05-25 2018-09-26 Taiho Pharmaceutical Co Ltd Dry-coated tablet containing tegafur, gimeracil and oteracil potassium
CN102614183B (zh) * 2012-03-05 2013-10-30 齐鲁制药(海南)有限公司 一种替吉奥的口服制剂

Also Published As

Publication number Publication date
JP5689173B2 (ja) 2015-03-25
KR20140037879A (ko) 2014-03-27
WO2012161240A1 (ja) 2012-11-29
TW201300141A (zh) 2013-01-01
EP2716290B1 (en) 2018-03-14
RU2601620C2 (ru) 2016-11-10
TWI566787B (zh) 2017-01-21
NZ617625A (en) 2015-10-30
IL229372A0 (en) 2014-01-30
MY167883A (en) 2018-09-26
JP5769853B2 (ja) 2015-08-26
IL229372B (en) 2018-12-31
JP2014218523A (ja) 2014-11-20
AU2012259803B2 (en) 2016-03-17
TWI488659B (zh) 2015-06-21
SG194922A1 (en) 2013-12-30
KR101869127B1 (ko) 2018-06-19
JPWO2012161240A1 (ja) 2014-07-31
PH12013502323A1 (en) 2014-01-06
CA2836865A1 (en) 2012-11-29
CA2836865C (en) 2018-02-27
MX2013013563A (es) 2013-12-16
SG10201505503WA (en) 2015-09-29
TW201529100A (zh) 2015-08-01
KR20170072959A (ko) 2017-06-27
MX353289B (es) 2018-01-05
US20140335174A1 (en) 2014-11-13
EP2716290A4 (en) 2014-11-26
EP2716290A1 (en) 2014-04-09
BR112013030093A2 (pt) 2016-09-20
RU2013157528A (ru) 2015-06-27
ES2671926T3 (es) 2018-06-11

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Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06T Formal requirements before examination [chapter 6.20 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 24/05/2012, OBSERVADAS AS CONDICOES LEGAIS. (CO) 20 (VINTE) ANOS CONTADOS A PARTIR DE 24/05/2012, OBSERVADAS AS CONDICOES LEGAIS

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

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B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2828 DE 18-03-2025 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.