ES2761407T3 - Forma de dosificación rápidamente dispersable de topiramato - Google Patents

Forma de dosificación rápidamente dispersable de topiramato Download PDF

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Publication number
ES2761407T3
ES2761407T3 ES14763925T ES14763925T ES2761407T3 ES 2761407 T3 ES2761407 T3 ES 2761407T3 ES 14763925 T ES14763925 T ES 14763925T ES 14763925 T ES14763925 T ES 14763925T ES 2761407 T3 ES2761407 T3 ES 2761407T3
Authority
ES
Spain
Prior art keywords
dosage form
weight
topiramate
masked
rapidly dispersible
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
ES14763925T
Other languages
English (en)
Spanish (es)
Inventor
Jules Jacob
Lauren Beach
Thomas West
Donald Monkhouse
Henry Surprenant
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.)
Aprecia Pharmaceuticals LLC
Original Assignee
Aprecia Pharmaceuticals LLC
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 Aprecia Pharmaceuticals LLC filed Critical Aprecia Pharmaceuticals LLC
Application granted granted Critical
Publication of ES2761407T3 publication Critical patent/ES2761407T3/es
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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/06—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2027—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
    • A61K9/20—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
    • A61K9/20—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
    • 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
    • A61K9/2095—Tabletting processes
    • 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
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
ES14763925T 2013-03-15 2014-03-14 Forma de dosificación rápidamente dispersable de topiramato Active ES2761407T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361791592P 2013-03-15 2013-03-15
PCT/US2014/029168 WO2014144661A1 (en) 2013-03-15 2014-03-14 Rapidly dispersible dosage form of topiramate

Publications (1)

Publication Number Publication Date
ES2761407T3 true ES2761407T3 (es) 2020-05-19

Family

ID=51537752

Family Applications (1)

Application Number Title Priority Date Filing Date
ES14763925T Active ES2761407T3 (es) 2013-03-15 2014-03-14 Forma de dosificación rápidamente dispersable de topiramato

Country Status (10)

Country Link
US (2) US9492380B2 (enExample)
EP (1) EP2968181B1 (enExample)
JP (1) JP6466399B2 (enExample)
CN (1) CN105050588B (enExample)
AU (2) AU2014228861B2 (enExample)
CA (1) CA2906172C (enExample)
ES (1) ES2761407T3 (enExample)
HK (1) HK1213473A1 (enExample)
MX (1) MX365914B (enExample)
WO (1) WO2014144661A1 (enExample)

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US20160243036A1 (en) * 2015-02-25 2016-08-25 Intelgenx Corp. Film dosage forms containing amorphous active agents
EP3302442B1 (en) 2015-06-03 2024-10-16 Triastek, Inc. Dosage forms and use thereof
JPWO2017175792A1 (ja) * 2016-04-06 2019-02-14 アステラス製薬株式会社 速溶出性三次元造形物、速溶出性三次元造形物用フィラメント及び速溶出性三次元造形物用材料
ES2908220T3 (es) 2016-09-02 2022-04-28 Novo Futura Aps Parrilla desechable y método para fabricar una parrilla desechable
AU2018212273B2 (en) 2017-01-26 2023-12-21 Triastek, Inc. Dosage forms of controlled release at specific gastrointestinal sites
CN107213126B (zh) * 2017-05-17 2020-06-23 西安棣加生物科技有限公司 一种3d打印技术制备治疗高磷血症的口腔速崩片的方法
CN107252418B (zh) * 2017-05-17 2020-06-23 西安棣加生物科技有限公司 一种3d打印技术制备治疗低钾血症的口腔速崩片的方法
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CN111698983B (zh) 2018-01-09 2022-10-18 南京三迭纪医药科技有限公司 一种包含固定剂量adhd非兴奋剂和adhd兴奋剂的复方口服药物剂型
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Also Published As

Publication number Publication date
EP2968181A1 (en) 2016-01-20
JP2016514686A (ja) 2016-05-23
EP2968181B1 (en) 2019-10-16
AU2018220049A1 (en) 2018-09-06
CN105050588B (zh) 2019-01-15
CN105050588A (zh) 2015-11-11
JP6466399B2 (ja) 2019-02-06
CA2906172A1 (en) 2014-09-18
US9492380B2 (en) 2016-11-15
EP2968181A4 (en) 2016-04-13
MX365914B (es) 2019-06-20
HK1214768A1 (en) 2016-08-05
WO2014144661A1 (en) 2014-09-18
AU2014228861B2 (en) 2018-05-24
HK1213473A1 (zh) 2016-07-08
US20160361335A1 (en) 2016-12-15
WO2014144661A4 (en) 2014-11-13
US10420785B2 (en) 2019-09-24
CA2906172C (en) 2021-12-21
AU2014228861A1 (en) 2015-10-08
AU2018220049B2 (en) 2020-07-09
WO2014144661A8 (en) 2015-08-27
US20150366801A1 (en) 2015-12-24
MX2015012135A (es) 2015-11-25

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