AU2012207818B2 - Orally dispersible tablet - Google Patents

Orally dispersible tablet Download PDF

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Publication number
AU2012207818B2
AU2012207818B2 AU2012207818A AU2012207818A AU2012207818B2 AU 2012207818 B2 AU2012207818 B2 AU 2012207818B2 AU 2012207818 A AU2012207818 A AU 2012207818A AU 2012207818 A AU2012207818 A AU 2012207818A AU 2012207818 B2 AU2012207818 B2 AU 2012207818B2
Authority
AU
Australia
Prior art keywords
oral
preparation
indeno
tetrahydro
administration
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
AU2012207818A
Other languages
English (en)
Other versions
AU2012207818A1 (en
Inventor
Tetsuya Matsuura
Naoki Nagahara
Yutaka Tanoue
Yutaka Yamagata
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Takeda 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=45567081&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2012207818(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Takeda Pharmaceutical Co Ltd filed Critical Takeda Pharmaceutical Co Ltd
Priority to AU2013203069A priority Critical patent/AU2013203069A1/en
Publication of AU2012207818A1 publication Critical patent/AU2012207818A1/en
Application granted granted Critical
Publication of AU2012207818B2 publication Critical patent/AU2012207818B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY 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 TOILETRY 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
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY 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
    • 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
    • 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
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic 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 TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2063Proteins, e.g. gelatin
    • 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
    • A61K9/2072Pills, 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 TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D307/00Heterocyclic compounds containing five-membered rings having one oxygen atom as the only ring hetero atom
    • C07D307/77Heterocyclic compounds containing five-membered rings having one oxygen atom as the only ring hetero atom ortho- or peri-condensed with carbocyclic rings or ring systems
    • C07D307/78Benzo [b] furans; Hydrogenated benzo [b] furans
    • C07D307/79Benzo [b] furans; Hydrogenated benzo [b] furans with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached to carbon atoms of the hetero ring
    • C07D307/81Radicals substituted by nitrogen atoms not forming part of a nitro radical

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Zoology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cosmetics (AREA)
AU2012207818A 2011-01-17 2012-01-16 Orally dispersible tablet Ceased AU2012207818B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2013203069A AU2013203069A1 (en) 2011-01-17 2013-04-09 Orally dispersible tablet

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
JP2011-007371 2011-01-17
JP2011007371 2011-01-17
JP2011-227333 2011-10-14
JP2011227333 2011-10-14
PCT/JP2012/051279 WO2012099260A1 (en) 2011-01-17 2012-01-16 Orally dispersible tablet

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2013203069A Division AU2013203069A1 (en) 2011-01-17 2013-04-09 Orally dispersible tablet

Publications (2)

Publication Number Publication Date
AU2012207818A1 AU2012207818A1 (en) 2013-05-02
AU2012207818B2 true AU2012207818B2 (en) 2015-05-14

Family

ID=45567081

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2012207818A Ceased AU2012207818B2 (en) 2011-01-17 2012-01-16 Orally dispersible tablet

Country Status (24)

Country Link
US (6) US20120282191A1 (enExample)
EP (1) EP2665465A1 (enExample)
JP (3) JP5600747B2 (enExample)
KR (1) KR20140014134A (enExample)
CN (1) CN103429223A (enExample)
AR (1) AR084865A1 (enExample)
AU (1) AU2012207818B2 (enExample)
BR (1) BR112013017600A2 (enExample)
CA (1) CA2824430A1 (enExample)
CL (1) CL2013002033A1 (enExample)
CO (1) CO6791611A2 (enExample)
CR (1) CR20130380A (enExample)
EA (1) EA201391053A1 (enExample)
EC (1) ECSP13012825A (enExample)
IL (1) IL227357A0 (enExample)
MA (1) MA34908B1 (enExample)
MX (1) MX2013008314A (enExample)
PE (1) PE20140255A1 (enExample)
PH (1) PH12013501512A1 (enExample)
SG (1) SG191964A1 (enExample)
TW (1) TW201309347A (enExample)
UY (1) UY33869A (enExample)
WO (1) WO2012099260A1 (enExample)
ZA (1) ZA201305567B (enExample)

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WO2012103411A2 (en) 2011-01-28 2012-08-02 Zx Pharma, Llc Controlled-release melatonin composition and related methods
US9532952B2 (en) 2011-01-28 2017-01-03 Physician's Seal, LLC Controlled-release compositions of melatonin combined with sedative and/or analgesic ingredients
JP6245677B2 (ja) * 2012-01-20 2017-12-13 ニプロ株式会社 口腔内崩壊錠
CN103989643B (zh) * 2013-07-26 2018-10-30 武汉先路医药科技有限公司 含有雷美替胺和共聚维酮的片剂
HK1222796A1 (zh) * 2013-07-31 2017-07-14 因特根克斯公司 不含表面活性剂或多元醇的即时可湿性口服薄膜剂型
CN105007904A (zh) * 2014-02-07 2015-10-28 科学实验室药物公司 全天然无毒舌下药物递送系统
CN106389361A (zh) * 2016-03-31 2017-02-15 北京万全德众医药生物技术有限公司 一种含有雷美替胺的口腔崩解片及其制备方法
CN105853379A (zh) * 2016-03-31 2016-08-17 北京万全德众医药生物技术有限公司 一种雷美替胺分散片及其制备工艺
CA3023305C (en) 2016-05-06 2024-07-02 Societe Des Produits Nestle S.A. COMPOSITION OF VALERIAN AND ASSOCIATED PROCESSES
CN106038502A (zh) * 2016-07-01 2016-10-26 北京万全德众医药生物技术有限公司 一种雷美替胺口崩片及其制备方法
US20210113456A1 (en) * 2017-07-13 2021-04-22 Maxinase Life Sciences Limited Pharmaceutical compositions of ramelteon and methods of use thereof
US11648201B2 (en) 2018-05-02 2023-05-16 Ferring B.V. Pharmaceutical formulations
JP7552146B2 (ja) * 2019-08-28 2024-09-18 小野薬品工業株式会社 イバブラジンを含有する錠剤
CN113243444A (zh) * 2020-02-13 2021-08-13 罗盖特公司 作为口香糖中的填充剂的多孔淀粉
JP7611556B2 (ja) * 2020-05-28 2025-01-10 日医工株式会社 服用性、安定性等に優れた医薬組成物
CN115778925A (zh) * 2022-12-26 2023-03-14 湖北广济医药科技有限公司 一种雷美替胺口溶膜剂及其制备方法

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WO1999059544A2 (en) * 1998-05-18 1999-11-25 Takeda Chemical Industries, Ltd. Orally disintegrable tablets
US20070134331A1 (en) * 2005-12-14 2007-06-14 Les Laboratoires Servier Orodispersible pharmaceutical composition for oromucosal or sublingual administration of agomelatine
EP1867641A1 (en) * 2005-04-04 2007-12-19 Takeda Pharmaceutical Company Limited Preventive or remedy for depression or anxiety neurosis
WO2008083204A2 (en) * 2006-12-28 2008-07-10 Braincells, Inc. Modulation of neurogenesis by melatoninergic ligands
US20090105490A1 (en) * 2007-07-12 2009-04-23 Nurit Perlman Polymorphic forms of ramelteon and processes for preparation thereof

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Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0914818A1 (en) * 1996-06-14 1999-05-12 Kyowa Hakko Kogyo Co., Ltd. Intraorally rapidly disintegrable tablet
WO1999059544A2 (en) * 1998-05-18 1999-11-25 Takeda Chemical Industries, Ltd. Orally disintegrable tablets
EP1867641A1 (en) * 2005-04-04 2007-12-19 Takeda Pharmaceutical Company Limited Preventive or remedy for depression or anxiety neurosis
US20070134331A1 (en) * 2005-12-14 2007-06-14 Les Laboratoires Servier Orodispersible pharmaceutical composition for oromucosal or sublingual administration of agomelatine
WO2008083204A2 (en) * 2006-12-28 2008-07-10 Braincells, Inc. Modulation of neurogenesis by melatoninergic ligands
US20090105490A1 (en) * 2007-07-12 2009-04-23 Nurit Perlman Polymorphic forms of ramelteon and processes for preparation thereof

Also Published As

Publication number Publication date
CR20130380A (es) 2013-10-09
US20130035384A1 (en) 2013-02-07
CA2824430A1 (en) 2012-07-26
US20170065553A1 (en) 2017-03-09
JP5600747B2 (ja) 2014-10-01
MA34908B1 (fr) 2014-02-01
PE20140255A1 (es) 2014-03-11
KR20140014134A (ko) 2014-02-05
PH12013501512A1 (en) 2013-09-16
US8642649B2 (en) 2014-02-04
US8642648B2 (en) 2014-02-04
BR112013017600A2 (pt) 2016-10-18
US20120282191A1 (en) 2012-11-08
SG191964A1 (en) 2013-08-30
CN103429223A (zh) 2013-12-04
JP2013544230A (ja) 2013-12-12
CL2013002033A1 (es) 2014-01-03
MX2013008314A (es) 2013-09-26
WO2012099260A1 (en) 2012-07-26
US20130035385A1 (en) 2013-02-07
EA201391053A1 (ru) 2013-12-30
IL227357A0 (en) 2013-09-30
ZA201305567B (en) 2014-10-29
US20140235709A1 (en) 2014-08-21
JP2016053094A (ja) 2016-04-14
CO6791611A2 (es) 2013-11-14
AR084865A1 (es) 2013-07-10
TW201309347A (zh) 2013-03-01
US20140235879A1 (en) 2014-08-21
ECSP13012825A (es) 2013-10-31
AU2012207818A1 (en) 2013-05-02
EP2665465A1 (en) 2013-11-27
JP2014198723A (ja) 2014-10-23
UY33869A (es) 2012-08-31
NZ613265A (en) 2015-08-28

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