CA2400567A1 - Tamper-resistant oral opioid agonist formulations - Google Patents

Tamper-resistant oral opioid agonist formulations Download PDF

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Publication number
CA2400567A1
CA2400567A1 CA002400567A CA2400567A CA2400567A1 CA 2400567 A1 CA2400567 A1 CA 2400567A1 CA 002400567 A CA002400567 A CA 002400567A CA 2400567 A CA2400567 A CA 2400567A CA 2400567 A1 CA2400567 A1 CA 2400567A1
Authority
CA
Canada
Prior art keywords
dosage form
antagonist
tamper
opioid agonist
released
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
CA002400567A
Other languages
French (fr)
Other versions
CA2400567C (en
Inventor
Benjamin Oshlack
Curtis Wright
J. David Haddox
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.)
Euro Celtique SA
Original Assignee
Euro-Celtique S.A.
Benjamin Oshlack
Curtis Wright
J. David Haddox
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=22663996&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2400567(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Euro-Celtique S.A., Benjamin Oshlack, Curtis Wright, J. David Haddox filed Critical Euro-Celtique S.A.
Publication of CA2400567A1 publication Critical patent/CA2400567A1/en
Application granted granted Critical
Publication of CA2400567C publication Critical patent/CA2400567C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
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    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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    • A61K9/1629—Organic macromolecular compounds
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    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
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    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
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    • A61K9/2806—Coating materials
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    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract

Disclosed is an oral dosage form comprising (i) an opioid agonist in releasable form and (ii) a sequestered opioid antagonist which is substantially not released when the dosage form is administered intact, such that the ratio of the amount of antagonist released from said dosage form after tampering to the amount of said antagonist released from said intact dosage form is about 4:1 or greater, based on the in-vitro dissolution at 1 hour of said dosage form in 900 ml of Simulated Gastric Fluid using a USP Type II (paddle) apparatus at 75 rpm at 37 degrees C wherein said agonist and antagonist are interdispersed and are not isolated from each other in two distinct layers.
CA002400567A 2000-02-08 2001-02-08 Tamper-resistant oral opioid agonist formulations Expired - Lifetime CA2400567C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US18136900P 2000-02-08 2000-02-08
US60/181,369 2000-02-08
PCT/US2001/004346 WO2001058451A1 (en) 2000-02-08 2001-02-08 Tamper-resistant oral opioid agonist formulations

Publications (2)

Publication Number Publication Date
CA2400567A1 true CA2400567A1 (en) 2001-08-16
CA2400567C CA2400567C (en) 2008-01-15

Family

ID=22663996

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002400567A Expired - Lifetime CA2400567C (en) 2000-02-08 2001-02-08 Tamper-resistant oral opioid agonist formulations

Country Status (35)

Country Link
US (15) US6696088B2 (en)
EP (6) EP2283842B1 (en)
JP (10) JP2003522146A (en)
KR (2) KR20020071032A (en)
CN (3) CN1423559A (en)
AP (1) AP1665A (en)
AT (1) ATE431145T1 (en)
AU (2) AU776904B2 (en)
BG (1) BG65828B1 (en)
BR (2) BR0108379A (en)
CA (1) CA2400567C (en)
CY (2) CY1109270T1 (en)
CZ (1) CZ299991B6 (en)
DE (1) DE60138706D1 (en)
DK (5) DK2517710T3 (en)
EA (1) EA004876B1 (en)
EE (1) EE05171B1 (en)
ES (5) ES2540103T3 (en)
GE (1) GEP20053614B (en)
HK (3) HK1051487A1 (en)
HU (2) HU229705B1 (en)
IL (5) IL151057A0 (en)
ME (1) ME00398B (en)
MX (2) MXPA02007686A (en)
NO (2) NO324717B1 (en)
NZ (1) NZ520554A (en)
OA (1) OA12215A (en)
PL (1) PL210845B1 (en)
PT (6) PT2283842E (en)
RS (1) RS50407B (en)
SI (5) SI1299104T1 (en)
SK (1) SK287107B6 (en)
TW (1) TWI292317B (en)
UA (1) UA79069C2 (en)
WO (2) WO2001058451A1 (en)

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DK1404331T3 (en) * 2001-07-06 2008-01-28 Penwest Pharmaceuticals Co Sustained release formulations of oxymorphone
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SI2517710T1 (en) 2015-07-31
EA004876B1 (en) 2004-08-26
EA200200840A1 (en) 2003-02-27
JP6403742B2 (en) 2018-10-10
JP5351538B2 (en) 2013-11-27
UA79069C2 (en) 2007-05-25
AP2002002617A0 (en) 2002-09-30
US20190350868A1 (en) 2019-11-21
IL181356A (en) 2011-10-31
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US7718192B2 (en) 2010-05-18
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ME00398B (en) 2011-05-10
US7842311B2 (en) 2010-11-30
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DK2092936T3 (en) 2013-06-17
JP2009138007A (en) 2009-06-25
YU58902A (en) 2005-11-28
SI2277521T1 (en) 2015-07-31
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US20080305167A2 (en) 2008-12-11
NO20023728L (en) 2002-10-04
PT2092936E (en) 2013-06-20
US20050181046A1 (en) 2005-08-18
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KR20020071032A (en) 2002-09-11
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