CA2823166C - Orally disintegrating tablet - Google Patents

Orally disintegrating tablet Download PDF

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Publication number
CA2823166C
CA2823166C CA2823166A CA2823166A CA2823166C CA 2823166 C CA2823166 C CA 2823166C CA 2823166 A CA2823166 A CA 2823166A CA 2823166 A CA2823166 A CA 2823166A CA 2823166 C CA2823166 C CA 2823166C
Authority
CA
Canada
Prior art keywords
fine granules
controlled release
coated
active ingredient
pharmaceutically active
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.)
Active
Application number
CA2823166A
Other languages
English (en)
French (fr)
Other versions
CA2823166A1 (en
Inventor
Shiro Ishii
Yutaka Ebisawa
Takayuki Okabe
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=45509604&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2823166(C) "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
Publication of CA2823166A1 publication Critical patent/CA2823166A1/en
Application granted granted Critical
Publication of CA2823166C publication Critical patent/CA2823166C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K9/20—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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • 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
    • A61K9/5078—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 with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA2823166A 2010-12-27 2011-12-26 Orally disintegrating tablet Active CA2823166C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201061427384P 2010-12-27 2010-12-27
US61/427,384 2010-12-27
PCT/JP2011/080568 WO2012091153A2 (en) 2010-12-27 2011-12-26 Orally disintegrating tablet

Publications (2)

Publication Number Publication Date
CA2823166A1 CA2823166A1 (en) 2012-07-05
CA2823166C true CA2823166C (en) 2019-04-09

Family

ID=45509604

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2823166A Active CA2823166C (en) 2010-12-27 2011-12-26 Orally disintegrating tablet

Country Status (24)

Country Link
US (1) US20130273157A1 (enExample)
EP (1) EP2658530A2 (enExample)
JP (1) JP2014501224A (enExample)
KR (1) KR20140007364A (enExample)
CN (1) CN103402500A (enExample)
AR (1) AR084610A1 (enExample)
AU (1) AU2011350396A1 (enExample)
BR (1) BR112013014875A2 (enExample)
CA (1) CA2823166C (enExample)
CL (1) CL2013001793A1 (enExample)
CO (1) CO6731132A2 (enExample)
CR (1) CR20130327A (enExample)
EA (1) EA028217B1 (enExample)
EC (1) ECSP13012718A (enExample)
MA (1) MA34768B1 (enExample)
MX (1) MX2013007588A (enExample)
PE (1) PE20141115A1 (enExample)
PH (1) PH12013501391A1 (enExample)
SG (2) SG10201602311XA (enExample)
TN (1) TN2013000220A1 (enExample)
TW (1) TW201304823A (enExample)
UY (1) UY33841A (enExample)
WO (1) WO2012091153A2 (enExample)
ZA (1) ZA201304617B (enExample)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2254556A2 (en) 2008-03-11 2010-12-01 Takeda Pharmaceutical Company Limited Orally-disintegrating solid preparation
US9012450B2 (en) 2011-12-28 2015-04-21 Global Blood Therapeutics, Inc. Substituted heteroaryl aldehyde compounds and methods for their use in increasing tissue oxygenation
PL2797416T3 (pl) 2011-12-28 2017-12-29 Global Blood Therapeutics, Inc. Podstawione związki benzaldehydowe i sposoby ich zastosowania do zwiększania natlenienia tkanek
GB201303781D0 (en) 2013-03-04 2013-04-17 Gauthier Pierre Pascal Oral timer device and method of using same
EP2968299B1 (en) 2013-03-15 2021-01-20 Global Blood Therapeutics, Inc. Compounds and uses thereof for the modulation of hemoglobin
JP6426694B2 (ja) 2013-03-15 2018-11-21 グローバル ブラッド セラピューティクス インコーポレイテッド ヘモグロビンの修飾のための化合物及びその使用
US9458139B2 (en) 2013-03-15 2016-10-04 Global Blood Therapeutics, Inc. Compounds and uses thereof for the modulation of hemoglobin
US8952171B2 (en) 2013-03-15 2015-02-10 Global Blood Therapeutics, Inc. Compounds and uses thereof for the modulation of hemoglobin
BR112015021982B1 (pt) 2013-03-15 2022-12-13 Global Blood Therapeutics, Inc Compostos e seus usos para a modulação de hemoglobina
EA201992707A1 (ru) 2013-11-18 2020-06-30 Глобал Блад Терапьютикс, Инк. Соединения и их применения для модуляции гемоглобина
AP2016009261A0 (en) 2014-02-07 2016-06-30 Global Blood Therapeutics Inc Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1h-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde
EP3218349A2 (en) 2014-11-14 2017-09-20 Gemphire Therapeutics Inc. Processes and intermediates for preparing , -dicarboxylic acid-terminated dialkane ethers
US20170042806A1 (en) 2015-04-29 2017-02-16 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
PL3383392T3 (pl) 2015-12-04 2025-11-17 Global Blood Therapeutics, Inc. Schematy dawkowania dla 2-hydroksy-6-((2-(1-izopropylo-1H-pirazol-5-ilo)pirydyn3-ylo)metoksy)benzaldehydu
TWI663160B (zh) 2016-05-12 2019-06-21 全球血液治療公司 用於合成2-羥基-6-((2-(1-異丙基-1h-吡唑-5-基)-吡啶-3-基)甲氧基)苯甲醛之方法
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
TW202332423A (zh) * 2016-10-12 2023-08-16 美商全球血液治療公司 包含2-羥基-6-((2-(1-異丙基-1h-吡唑-5-基)吡啶-3-基)甲氧基)-苯甲醛之片劑
EP3612171A4 (en) 2017-04-18 2020-10-21 Gemphire Therapeutics Inc. GEMCABENE, PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, COMPOSITIONS THEREOF AND PROCEDURES FOR THE USE OF THE SAME
WO2018209257A1 (en) * 2017-05-11 2018-11-15 Gemphire Therapeutics Inc. Gemcabene compositions and methods of use thereof
MY200542A (en) * 2017-07-10 2024-01-02 Takeda Pharmaceuticals Co Preparation comprising vonoprazan
CN108576205B (zh) * 2018-03-22 2022-01-04 湖北省农业科学院农产品加工与核农技术研究所 一种草莓联合干燥的处理方法
EP3860975B1 (en) 2018-10-01 2023-10-18 Global Blood Therapeutics, Inc. Modulators of hemoglobin for the treatment of sickle cell disease

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JPS6150978A (ja) 1984-08-16 1986-03-13 Takeda Chem Ind Ltd ピリジン誘導体およびその製造法
JPH072761B2 (ja) 1985-03-20 1995-01-18 不二パウダル株式会社 微結晶セルロ−ス球形顆粒及びその製造法
JPS62277322A (ja) 1986-02-13 1987-12-02 Takeda Chem Ind Ltd 安定化された腸溶性抗潰瘍固形組成物
FR2679451B1 (fr) 1991-07-22 1994-09-09 Prographarm Laboratoires Comprime multiparticulaire a delitement rapide.
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KR20100002278A (ko) 2000-12-01 2010-01-06 다케다 야쿠힌 고교 가부시키가이샤 (ｒ)- 또는 (ｓ)-란소프라졸의 결정
JP4493970B2 (ja) 2002-10-16 2010-06-30 武田薬品工業株式会社 持続性製剤
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JP2009519334A (ja) * 2005-12-20 2009-05-14 テバ ファーマシューティカル インダストリーズ リミティド ランソプラゾール経口崩壊錠剤
US20070141151A1 (en) * 2005-12-20 2007-06-21 Silver David I Lansoprazole orally disintegrating tablets
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US9486446B2 (en) * 2006-12-28 2016-11-08 Takeda Pharmaceutical Company Limited Orally disintegrating solid preparation
EP2254556A2 (en) * 2008-03-11 2010-12-01 Takeda Pharmaceutical Company Limited Orally-disintegrating solid preparation
WO2010008569A1 (en) * 2008-07-17 2010-01-21 Barr Laboratories, Inc. Orally disintegrating solid pharmaceutical dosage forms comprising delayed-release lansoprazole and methods of making and using the same

Also Published As

Publication number Publication date
CA2823166A1 (en) 2012-07-05
ZA201304617B (en) 2014-08-27
AU2011350396A1 (en) 2013-07-11
US20130273157A1 (en) 2013-10-17
WO2012091153A2 (en) 2012-07-05
ECSP13012718A (es) 2013-12-31
EA028217B1 (ru) 2017-10-31
BR112013014875A2 (pt) 2016-10-18
PE20141115A1 (es) 2014-09-12
AR084610A1 (es) 2013-05-29
CO6731132A2 (es) 2013-08-15
MX2013007588A (es) 2013-08-09
CN103402500A (zh) 2013-11-20
WO2012091153A3 (en) 2012-09-07
SG190905A1 (en) 2013-07-31
JP2014501224A (ja) 2014-01-20
CL2013001793A1 (es) 2013-12-06
KR20140007364A (ko) 2014-01-17
TW201304823A (zh) 2013-02-01
CR20130327A (es) 2013-08-22
SG10201602311XA (en) 2016-04-28
PH12013501391A1 (en) 2013-08-28
TN2013000220A1 (en) 2014-11-10
MA34768B1 (fr) 2013-12-03
EA201390981A1 (ru) 2014-07-30
UY33841A (es) 2012-07-31
EP2658530A2 (en) 2013-11-06

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