AU2014228861B2 - Rapidly dispersible dosage form of topiramate - Google Patents

Rapidly dispersible dosage form of topiramate Download PDF

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Publication number
AU2014228861B2
AU2014228861B2 AU2014228861A AU2014228861A AU2014228861B2 AU 2014228861 B2 AU2014228861 B2 AU 2014228861B2 AU 2014228861 A AU2014228861 A AU 2014228861A AU 2014228861 A AU2014228861 A AU 2014228861A AU 2014228861 B2 AU2014228861 B2 AU 2014228861B2
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AU
Australia
Prior art keywords
dosage form
drug
wax
matrix
coated particles
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AU2014228861A
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AU2014228861A1 (en
Inventor
Lauren BEACH
Jules Jacob
Donald C. Monkhouse
Henry L. Surprenant
Thomas G. West
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Aprecia Pharmaceuticals LLC
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Aprecia Pharmaceuticals LLC
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Publication of AU2014228861A1 publication Critical patent/AU2014228861A1/en
Assigned to Aprecia Pharmaceuticals LLC reassignment Aprecia Pharmaceuticals LLC Request for Assignment Assignors: APRECIA PHARMACEUTICALS COMPANY
Application granted granted Critical
Publication of AU2014228861B2 publication Critical patent/AU2014228861B2/en
Priority to AU2018220049A priority Critical patent/AU2018220049B2/en
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    • 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

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  • 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)
  • Inorganic Chemistry (AREA)
  • Biophysics (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)
AU2014228861A 2013-03-15 2014-03-14 Rapidly dispersible dosage form of topiramate Active AU2014228861B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2018220049A AU2018220049B2 (en) 2013-03-15 2018-08-22 Rapidly dispersible dosage form of topiramate

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361791592P 2013-03-15 2013-03-15
US61/791,592 2013-03-15
PCT/US2014/029168 WO2014144661A1 (en) 2013-03-15 2014-03-14 Rapidly dispersible dosage form of topiramate

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2018220049A Division AU2018220049B2 (en) 2013-03-15 2018-08-22 Rapidly dispersible dosage form of topiramate

Publications (2)

Publication Number Publication Date
AU2014228861A1 AU2014228861A1 (en) 2015-10-08
AU2014228861B2 true AU2014228861B2 (en) 2018-05-24

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AU2014228861A Active AU2014228861B2 (en) 2013-03-15 2014-03-14 Rapidly dispersible dosage form of topiramate
AU2018220049A Active AU2018220049B2 (en) 2013-03-15 2018-08-22 Rapidly dispersible dosage form of topiramate

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AU2018220049A Active AU2018220049B2 (en) 2013-03-15 2018-08-22 Rapidly dispersible dosage form of topiramate

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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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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Also Published As

Publication number Publication date
CN105050588A (zh) 2015-11-11
WO2014144661A1 (en) 2014-09-18
AU2018220049B2 (en) 2020-07-09
US9492380B2 (en) 2016-11-15
HK1213473A1 (zh) 2016-07-08
AU2014228861A1 (en) 2015-10-08
HK1214768A1 (en) 2016-08-05
JP2016514686A (ja) 2016-05-23
EP2968181A4 (en) 2016-04-13
US20160361335A1 (en) 2016-12-15
CN105050588B (zh) 2019-01-15
WO2014144661A8 (en) 2015-08-27
WO2014144661A4 (en) 2014-11-13
CA2906172A1 (en) 2014-09-18
US10420785B2 (en) 2019-09-24
MX2015012135A (es) 2015-11-25
AU2018220049A1 (en) 2018-09-06
US20150366801A1 (en) 2015-12-24
MX365914B (es) 2019-06-20
EP2968181A1 (en) 2016-01-20
EP2968181B1 (en) 2019-10-16
ES2761407T3 (es) 2020-05-19
CA2906172C (en) 2021-12-21
JP6466399B2 (ja) 2019-02-06

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