CA2400567A1 - Tamper-resistant oral opioid agonist formulations - Google Patents
Tamper-resistant oral opioid agonist formulations Download PDFInfo
- 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
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- 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
- A61K9/5084—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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- A61K31/33—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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- A61K9/0043—Nose
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
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- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
- A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- 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
- A61K9/1676—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 having a drug-free core with discrete complete coating layer containing drug
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- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
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- 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
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- 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
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- 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
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- A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
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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.
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) | EP2092936B1 (en) |
JP (10) | JP2003522144A (en) |
KR (2) | KR20020071032A (en) |
CN (3) | CN101703777B (en) |
AP (1) | AP1665A (en) |
AT (1) | ATE431145T1 (en) |
AU (2) | AU776666B2 (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) | DK2092936T3 (en) |
EA (1) | EA004876B1 (en) |
EE (1) | EE05171B1 (en) |
ES (5) | ES2539904T3 (en) |
GE (1) | GEP20053614B (en) |
HK (3) | HK1051487A1 (en) |
HU (2) | HUP0204163A2 (en) |
IL (5) | IL151057A0 (en) |
ME (1) | MEP48308A (en) |
MX (2) | MXPA02007690A (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) | SI2283842T1 (en) |
SK (1) | SK287107B6 (en) |
TW (1) | TWI292317B (en) |
UA (1) | UA79069C2 (en) |
WO (2) | WO2001058447A1 (en) |
Families Citing this family (329)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2314896C (en) * | 1997-12-22 | 2005-09-13 | Euro-Celtique, S.A. | A method of preventing abuse of opioid dosage forms |
PT1685839E (en) | 1997-12-22 | 2013-07-08 | Euro Celtique Sa | Pharmaceutical oral dosage form comprising a combination of an opioid agonist and opioid antagonist |
US6375957B1 (en) | 1997-12-22 | 2002-04-23 | Euro-Celtique, S.A. | Opioid agonist/opioid antagonist/acetaminophen combinations |
EP2269587A1 (en) | 1999-10-29 | 2011-01-05 | Euro-Celtique S.A. | Controlled release hydrocodone formulations |
US10179130B2 (en) | 1999-10-29 | 2019-01-15 | Purdue Pharma L.P. | Controlled release hydrocodone formulations |
HUP0204163A2 (en) | 2000-02-08 | 2003-04-28 | Euro-Celtique S.A. | Controlled-release composition containing opioid agonist and antagonist and process for its preparation |
AU2738302A (en) | 2000-10-30 | 2002-05-15 | Euro Celtique Sa | Controlled release hydrocodone formulations |
US7858118B2 (en) * | 2001-04-11 | 2010-12-28 | Galephar Pharmaceutical Research, Inc. | Extended release composition containing Tramadol |
US20030065002A1 (en) * | 2001-05-11 | 2003-04-03 | Endo Pharmaceuticals, Inc. | Abuse-resistant controlled-release opioid dosage form |
DE60216078T2 (en) * | 2001-05-11 | 2007-07-05 | Endo Pharmaceuticals Inc. | OPIOID CONTAINING ARZNEIFORM AGAINST MISUSE |
US7968119B2 (en) * | 2001-06-26 | 2011-06-28 | Farrell John J | Tamper-proof narcotic delivery system |
PL207748B1 (en) * | 2001-07-06 | 2011-01-31 | Penwest Pharmaceuticals Company | Sustained release formulations of oxymorphone |
CA2452874A1 (en) * | 2001-07-06 | 2003-01-16 | Endo Pharmaceuticals, Inc. | Oral administration of 6-hydroxy-oxymorphone for use as an analgesic |
US8329216B2 (en) | 2001-07-06 | 2012-12-11 | Endo Pharmaceuticals Inc. | Oxymorphone controlled release formulations |
PT1416842E (en) * | 2001-07-18 | 2009-03-31 | Euro Celtique Sa | Pharmaceutical combinations of oxycodone and naloxone |
US20030068375A1 (en) | 2001-08-06 | 2003-04-10 | Curtis Wright | Pharmaceutical formulation containing gelling agent |
US7842307B2 (en) | 2001-08-06 | 2010-11-30 | Purdue Pharma L.P. | Pharmaceutical formulation containing opioid agonist, opioid antagonist and gelling agent |
US7332182B2 (en) | 2001-08-06 | 2008-02-19 | Purdue Pharma L.P. | Pharmaceutical formulation containing opioid agonist, opioid antagonist and irritant |
US7144587B2 (en) * | 2001-08-06 | 2006-12-05 | Euro-Celtique S.A. | Pharmaceutical formulation containing opioid agonist, opioid antagonist and bittering agent |
US20030157168A1 (en) | 2001-08-06 | 2003-08-21 | Christopher Breder | Sequestered antagonist formulations |
PL367427A1 (en) | 2001-08-06 | 2005-02-21 | Euro-Celtique S.A. | Opioid agonist formulations with releasable and sequestered antagonist |
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