CA2524300A1 - Modified-release tablet of bupropion hydrochloride - Google Patents

Modified-release tablet of bupropion hydrochloride Download PDF

Info

Publication number
CA2524300A1
CA2524300A1 CA002524300A CA2524300A CA2524300A1 CA 2524300 A1 CA2524300 A1 CA 2524300A1 CA 002524300 A CA002524300 A CA 002524300A CA 2524300 A CA2524300 A CA 2524300A CA 2524300 A1 CA2524300 A1 CA 2524300A1
Authority
CA
Canada
Prior art keywords
modified
release tablet
bupropion hydrochloride
wellbutrin
core
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.)
Granted
Application number
CA002524300A
Other languages
French (fr)
Other versions
CA2524300C (en
Inventor
Werner Oberegger
Okpo Eradiri
Fang Zhou
Paul J. Maes
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.)
Valeant Pharmaceuticals Luxembourg SARL
Original Assignee
Individual
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=34192557&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2524300(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Publication of CA2524300A1 publication Critical patent/CA2524300A1/en
Application granted granted Critical
Publication of CA2524300C publication Critical patent/CA2524300C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • 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
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

A modified-release tablet of bupropion hydrochloride comprising (i) a core comprising an effective amount of bupropion hydrochloride, a binder, a lubricant; and (ii) a control releasing coat surrounding said core; and (iii) a moisture barrier surrounding said control releasing coat, wherein the modified-release tablet is bioequivalent to Wellbutrin© or Zyban®/Wellbutrin®SR tablets.
CA002524300A 2003-08-08 2003-08-08 Modified-release tablet of bupropion hydrochloride Expired - Lifetime CA2524300C (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2003/024700 WO2005016318A1 (en) 2003-08-08 2003-08-08 Modified-release tablet of bupropion hydrochloride

Publications (2)

Publication Number Publication Date
CA2524300A1 true CA2524300A1 (en) 2005-02-24
CA2524300C CA2524300C (en) 2008-10-28

Family

ID=34192557

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002524300A Expired - Lifetime CA2524300C (en) 2003-08-08 2003-08-08 Modified-release tablet of bupropion hydrochloride

Country Status (30)

Country Link
US (2) US20050238718A1 (en)
EP (1) EP1575565B1 (en)
JP (1) JP2007521231A (en)
KR (1) KR101087464B1 (en)
CN (1) CN1819821B (en)
AP (1) AP1899A (en)
AT (1) ATE454138T1 (en)
AU (1) AU2003264002B2 (en)
BR (1) BRPI0318456B8 (en)
CA (1) CA2524300C (en)
CR (1) CR8056A (en)
CY (1) CY1109955T1 (en)
DE (1) DE60330909D1 (en)
DK (1) DK1575565T3 (en)
EA (1) EA013737B1 (en)
ES (1) ES2336913T3 (en)
HK (1) HK1083193A1 (en)
HR (1) HRP20050625B1 (en)
IL (1) IL171870A (en)
IS (1) IS2779B (en)
ME (2) MEP3608A (en)
MX (1) MXPA05012637A (en)
NO (2) NO335271B1 (en)
NZ (1) NZ544281A (en)
PL (1) PL196544B1 (en)
PT (1) PT1575565E (en)
RS (2) RS20060132A (en)
SI (1) SI1575565T1 (en)
TN (1) TNSN06016A1 (en)
WO (1) WO2005016318A1 (en)

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