AU2002303718B2 - Abuse-resistant opioid dosage form - Google Patents
Abuse-resistant opioid dosage form Download PDFInfo
- Publication number
- AU2002303718B2 AU2002303718B2 AU2002303718A AU2002303718A AU2002303718B2 AU 2002303718 B2 AU2002303718 B2 AU 2002303718B2 AU 2002303718 A AU2002303718 A AU 2002303718A AU 2002303718 A AU2002303718 A AU 2002303718A AU 2002303718 B2 AU2002303718 B2 AU 2002303718B2
- Authority
- AU
- Australia
- Prior art keywords
- opioid
- tablet
- dosage form
- pharmaceutical dosage
- oral pharmaceutical
- 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.)
- Expired
Links
- 239000002552 dosage form Substances 0.000 title claims abstract description 38
- 239000011159 matrix material Substances 0.000 claims abstract description 66
- 239000003401 opiate antagonist Substances 0.000 claims abstract description 50
- 239000003402 opiate agonist Substances 0.000 claims abstract description 21
- 239000005557 antagonist Substances 0.000 claims description 61
- 229960004127 naloxone Drugs 0.000 claims description 41
- UZHSEJADLWPNLE-GRGSLBFTSA-N naloxone Chemical group O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C UZHSEJADLWPNLE-GRGSLBFTSA-N 0.000 claims description 41
- 238000000576 coating method Methods 0.000 claims description 20
- 239000011248 coating agent Substances 0.000 claims description 19
- 238000004090 dissolution Methods 0.000 claims description 12
- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 claims description 12
- 239000003887 narcotic antagonist Substances 0.000 claims description 11
- BRUQQQPBMZOVGD-XFKAJCMBSA-N Oxycodone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C BRUQQQPBMZOVGD-XFKAJCMBSA-N 0.000 claims description 9
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- OROGSEYTTFOCAN-DNJOTXNNSA-N codeine Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)=C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC OROGSEYTTFOCAN-DNJOTXNNSA-N 0.000 claims description 6
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- 239000012738 dissolution medium Substances 0.000 claims description 6
- PJMPHNIQZUBGLI-UHFFFAOYSA-N fentanyl Chemical compound C=1C=CC=CC=1N(C(=O)CC)C(CC1)CCN1CCC1=CC=CC=C1 PJMPHNIQZUBGLI-UHFFFAOYSA-N 0.000 claims description 6
- OROGSEYTTFOCAN-UHFFFAOYSA-N hydrocodone Natural products C1C(N(CCC234)C)C2C=CC(O)C3OC2=C4C1=CC=C2OC OROGSEYTTFOCAN-UHFFFAOYSA-N 0.000 claims description 6
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- DQCKKXVULJGBQN-XFWGSAIBSA-N naltrexone Chemical compound N1([C@@H]2CC3=CC=C(C=4O[C@@H]5[C@](C3=4)([C@]2(CCC5=O)O)CC1)O)CC1CC1 DQCKKXVULJGBQN-XFWGSAIBSA-N 0.000 claims description 6
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- USSIQXCVUWKGNF-UHFFFAOYSA-N 6-(dimethylamino)-4,4-diphenylheptan-3-one Chemical compound C=1C=CC=CC=1C(CC(C)N(C)C)(C(=O)CC)C1=CC=CC=C1 USSIQXCVUWKGNF-UHFFFAOYSA-N 0.000 claims description 3
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- RBOXVHNMENFORY-DNJOTXNNSA-N dihydrocodeine Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC RBOXVHNMENFORY-DNJOTXNNSA-N 0.000 claims description 3
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- OZYUPQUCAUTOBP-QXAKKESOSA-N Levallorphan Chemical compound C([C@H]12)CCC[C@@]11CCN(CC=C)[C@@H]2CC2=CC=C(O)C=C21 OZYUPQUCAUTOBP-QXAKKESOSA-N 0.000 description 3
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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
- A61K31/33—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
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- A—HUMAN NECESSITIES
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- 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
- A61K9/282—Organic compounds, e.g. fats
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- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
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- A—HUMAN NECESSITIES
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- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
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- 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
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- 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
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Emergency Medicine (AREA)
- Addiction (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Investigating Or Analyzing Materials By The Use Of Fluid Adsorption Or Reactions (AREA)
- Air Bags (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US29043801P | 2001-05-11 | 2001-05-11 | |
| US60/290,438 | 2001-05-11 | ||
| PCT/US2002/015021 WO2002092059A1 (en) | 2001-05-11 | 2002-05-10 | Abuse-resistant opioid dosage form |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU2002303718A1 AU2002303718A1 (en) | 2003-05-01 |
| AU2002303718B2 true AU2002303718B2 (en) | 2008-02-28 |
Family
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2002303718A Expired AU2002303718B2 (en) | 2001-05-11 | 2002-05-10 | Abuse-resistant opioid dosage form |
Country Status (10)
| Country | Link |
|---|---|
| US (6) | US20030004177A1 (enExample) |
| EP (1) | EP1389092B1 (enExample) |
| JP (3) | JP2005515960A (enExample) |
| CN (2) | CN101439024A (enExample) |
| AT (1) | ATE345112T1 (enExample) |
| AU (1) | AU2002303718B2 (enExample) |
| CA (2) | CA2446738C (enExample) |
| DE (1) | DE60216078T2 (enExample) |
| ES (1) | ES2275868T3 (enExample) |
| WO (1) | WO2002092059A1 (enExample) |
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- 2002-05-10 CN CNA2008101667341A patent/CN101439024A/zh active Pending
- 2002-05-10 AT AT02731767T patent/ATE345112T1/de not_active IP Right Cessation
- 2002-05-10 CA CA2778114A patent/CA2778114A1/en not_active Abandoned
- 2002-05-10 EP EP02731767A patent/EP1389092B1/en not_active Expired - Lifetime
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- 2002-05-10 DE DE60216078T patent/DE60216078T2/de not_active Expired - Lifetime
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| US20120237603A1 (en) | 2012-09-20 |
| US20120231075A1 (en) | 2012-09-13 |
| EP1389092A1 (en) | 2004-02-18 |
| DE60216078T2 (de) | 2007-07-05 |
| ATE345112T1 (de) | 2006-12-15 |
| WO2002092059A1 (en) | 2002-11-21 |
| US20110135731A1 (en) | 2011-06-09 |
| CN1592609A (zh) | 2005-03-09 |
| JP2009143964A (ja) | 2009-07-02 |
| US20130209561A1 (en) | 2013-08-15 |
| US20110020444A1 (en) | 2011-01-27 |
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| DE60216078D1 (de) | 2006-12-28 |
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| CA2446738C (en) | 2012-05-29 |
| CN101439024A (zh) | 2009-05-27 |
| JP2005515960A (ja) | 2005-06-02 |
| US20030004177A1 (en) | 2003-01-02 |
| JP2013053165A (ja) | 2013-03-21 |
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