WO2014144661A8 - Rapidly dispersible dosage form of topiramate - Google Patents

Rapidly dispersible dosage form of topiramate Download PDF

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Publication number
WO2014144661A8
WO2014144661A8 PCT/US2014/029168 US2014029168W WO2014144661A8 WO 2014144661 A8 WO2014144661 A8 WO 2014144661A8 US 2014029168 W US2014029168 W US 2014029168W WO 2014144661 A8 WO2014144661 A8 WO 2014144661A8
Authority
WO
WIPO (PCT)
Prior art keywords
topiramate
dosage form
rapidly dispersible
dispersible dosage
taste
Prior art date
Application number
PCT/US2014/029168
Other languages
French (fr)
Other versions
WO2014144661A4 (en
WO2014144661A1 (en
Inventor
Jules Jacob
Lauren BEACH
Thomas G. West
Donald C. Monkhouse
Henry L. Surprenant
Original Assignee
Aprecia Pharmaceuticals Company
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
Priority to MX2015012135A priority Critical patent/MX365914B/en
Priority to CN201480015723.7A priority patent/CN105050588B/en
Priority to JP2016503003A priority patent/JP6466399B2/en
Priority to CA2906172A priority patent/CA2906172C/en
Priority to EP14763925.6A priority patent/EP2968181B1/en
Priority to AU2014228861A priority patent/AU2014228861B2/en
Priority to ES14763925T priority patent/ES2761407T3/en
Application filed by Aprecia Pharmaceuticals Company filed Critical Aprecia Pharmaceuticals Company
Publication of WO2014144661A1 publication Critical patent/WO2014144661A1/en
Publication of WO2014144661A4 publication Critical patent/WO2014144661A4/en
Priority to US14/837,354 priority patent/US9492380B2/en
Publication of WO2014144661A8 publication Critical patent/WO2014144661A8/en
Priority to HK16101295.2A priority patent/HK1213473A1/en
Priority to HK16102818.8A priority patent/HK1214768A1/en
Priority to US15/244,563 priority patent/US10420785B2/en
Priority to AU2018220049A priority patent/AU2018220049B2/en

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; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

A taste-masked rapidly dispersible dosage form of topiramate is provided. Wax coated particles of topiramate are included within a porous bound matrix. The topiramate retains its taste-masked form after dispersion in the mouth of a subject even though the particles are not coated with a polymeric material. The dosage form disperses in saliva or water in less than 2 min even though it has a high content of wax. It can be used to treat diseases or disorders that are therapeutically responsive to topiramate or a derivative thereof.
PCT/US2014/029168 2013-03-15 2014-03-14 Rapidly dispersible dosage form of topiramate WO2014144661A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
MX2015012135A MX365914B (en) 2013-03-15 2014-03-14 Rapidly dispersible dosage form of topiramate.
CN201480015723.7A CN105050588B (en) 2013-03-15 2014-03-14 The fast dispersing dosage form of Topiramate
JP2016503003A JP6466399B2 (en) 2013-03-15 2014-03-14 Topiramate rapidly dispersible dosage form
CA2906172A CA2906172C (en) 2013-03-15 2014-03-14 Rapidly dispersible dosage form of topiramate
EP14763925.6A EP2968181B1 (en) 2013-03-15 2014-03-14 Rapidly dispersible dosage form of topiramate
AU2014228861A AU2014228861B2 (en) 2013-03-15 2014-03-14 Rapidly dispersible dosage form of topiramate
ES14763925T ES2761407T3 (en) 2013-03-15 2014-03-14 Quickly dispersible topiramate dosage form
US14/837,354 US9492380B2 (en) 2013-03-15 2015-08-27 Rapidly dispersible dosage form of topiramate
HK16101295.2A HK1213473A1 (en) 2013-03-15 2016-02-04 Rapidly dispersible dosage form of topiramate
HK16102818.8A HK1214768A1 (en) 2013-03-15 2016-03-11 Rapidly dispersible dosage form of topiramate
US15/244,563 US10420785B2 (en) 2013-03-15 2016-08-23 Rapidly dispersible dosage form of topiramate
AU2018220049A AU2018220049B2 (en) 2013-03-15 2018-08-22 Rapidly dispersible dosage form of topiramate

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361791592P 2013-03-15 2013-03-15
US61/791,592 2013-03-15

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US14/837,354 Continuation US9492380B2 (en) 2013-03-15 2015-08-27 Rapidly dispersible dosage form of topiramate

Publications (3)

Publication Number Publication Date
WO2014144661A1 WO2014144661A1 (en) 2014-09-18
WO2014144661A4 WO2014144661A4 (en) 2014-11-13
WO2014144661A8 true WO2014144661A8 (en) 2015-08-27

Family

ID=51537752

Family Applications (1)

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

Country Status (10)

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

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Also Published As

Publication number Publication date
CA2906172C (en) 2021-12-21
WO2014144661A4 (en) 2014-11-13
JP2016514686A (en) 2016-05-23
HK1214768A1 (en) 2016-08-05
MX2015012135A (en) 2015-11-25
US20160361335A1 (en) 2016-12-15
AU2018220049B2 (en) 2020-07-09
CN105050588A (en) 2015-11-11
ES2761407T3 (en) 2020-05-19
AU2018220049A1 (en) 2018-09-06
WO2014144661A1 (en) 2014-09-18
EP2968181B1 (en) 2019-10-16
HK1213473A1 (en) 2016-07-08
US10420785B2 (en) 2019-09-24
CA2906172A1 (en) 2014-09-18
US9492380B2 (en) 2016-11-15
AU2014228861B2 (en) 2018-05-24
JP6466399B2 (en) 2019-02-06
AU2014228861A1 (en) 2015-10-08
US20150366801A1 (en) 2015-12-24
EP2968181A4 (en) 2016-04-13
EP2968181A1 (en) 2016-01-20
MX365914B (en) 2019-06-20
CN105050588B (en) 2019-01-15

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