AU2004251481B2 - Multiparticulates - Google Patents
Multiparticulates Download PDFInfo
- Publication number
- AU2004251481B2 AU2004251481B2 AU2004251481A AU2004251481A AU2004251481B2 AU 2004251481 B2 AU2004251481 B2 AU 2004251481B2 AU 2004251481 A AU2004251481 A AU 2004251481A AU 2004251481 A AU2004251481 A AU 2004251481A AU 2004251481 B2 AU2004251481 B2 AU 2004251481B2
- Authority
- AU
- Australia
- Prior art keywords
- oxycodone
- multiparticulates
- pharmaceutical composition
- release
- plasticiser
- 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.)
- Ceased
Links
- 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 145
- 229960002085 oxycodone Drugs 0.000 claims description 140
- 239000000203 mixture Substances 0.000 claims description 58
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 53
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 claims description 36
- 230000035699 permeability Effects 0.000 claims description 36
- 238000000034 method Methods 0.000 claims description 34
- 239000003814 drug Substances 0.000 claims description 33
- 229920001577 copolymer Polymers 0.000 claims description 31
- 239000002775 capsule Substances 0.000 claims description 28
- 239000003607 modifier Substances 0.000 claims description 27
- 239000004014 plasticizer Substances 0.000 claims description 26
- 229940105606 oxycontin Drugs 0.000 claims description 25
- 239000000314 lubricant Substances 0.000 claims description 23
- BQNSLJQRJAJITR-UHFFFAOYSA-N 1,1,2-trichloro-1,2-difluoroethane Chemical compound FC(Cl)C(F)(Cl)Cl BQNSLJQRJAJITR-UHFFFAOYSA-N 0.000 claims description 19
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 19
- 229960003617 oxycodone hydrochloride Drugs 0.000 claims description 19
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 18
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 18
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 18
- GOQYKNQRPGWPLP-UHFFFAOYSA-N n-heptadecyl alcohol Natural products CCCCCCCCCCCCCCCCCO GOQYKNQRPGWPLP-UHFFFAOYSA-N 0.000 claims description 17
- 239000008194 pharmaceutical composition Substances 0.000 claims description 17
- 229920003156 Eudragit® RL PO Polymers 0.000 claims description 14
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical group CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 13
- 229920003160 Eudragit® RS PO Polymers 0.000 claims description 12
- 235000021355 Stearic acid Nutrition 0.000 claims description 12
- 238000013270 controlled release Methods 0.000 claims description 12
- 239000004615 ingredient Substances 0.000 claims description 12
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 12
- 239000008117 stearic acid Substances 0.000 claims description 12
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims description 10
- 229940049654 glyceryl behenate Drugs 0.000 claims description 10
- 230000008569 process Effects 0.000 claims description 10
- 238000004519 manufacturing process Methods 0.000 claims description 9
- 150000003839 salts Chemical class 0.000 claims description 9
- 230000036407 pain Effects 0.000 claims description 8
- 230000036592 analgesia Effects 0.000 claims description 7
- 229920001223 polyethylene glycol Polymers 0.000 claims description 7
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 6
- 239000004705 High-molecular-weight polyethylene Substances 0.000 claims description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 5
- 239000005557 antagonist Substances 0.000 claims description 5
- 230000000052 comparative effect Effects 0.000 claims description 5
- ZFOZVQLOBQUTQQ-UHFFFAOYSA-N Tributyl citrate Chemical compound CCCCOC(=O)CC(O)(C(=O)OCCCC)CC(=O)OCCCC ZFOZVQLOBQUTQQ-UHFFFAOYSA-N 0.000 claims description 4
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 claims description 4
- 239000000454 talc Substances 0.000 claims description 4
- 229910052623 talc Inorganic materials 0.000 claims description 4
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 3
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims description 3
- 239000001069 triethyl citrate Substances 0.000 claims description 3
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims description 3
- 235000013769 triethyl citrate Nutrition 0.000 claims description 3
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 2
- PYGXAGIECVVIOZ-UHFFFAOYSA-N Dibutyl decanedioate Chemical compound CCCCOC(=O)CCCCCCCCC(=O)OCCCC PYGXAGIECVVIOZ-UHFFFAOYSA-N 0.000 claims description 2
- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 2
- 229940082500 cetostearyl alcohol Drugs 0.000 claims description 2
- 229960000541 cetyl alcohol Drugs 0.000 claims description 2
- 239000007903 gelatin capsule Substances 0.000 claims description 2
- 239000000600 sorbitol Substances 0.000 claims description 2
- 229940012831 stearyl alcohol Drugs 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- 229960004793 sucrose Drugs 0.000 claims description 2
- OULAJFUGPPVRBK-UHFFFAOYSA-N tetratriacontyl alcohol Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO OULAJFUGPPVRBK-UHFFFAOYSA-N 0.000 claims description 2
- 229960002920 sorbitol Drugs 0.000 claims 1
- 229940079593 drug Drugs 0.000 description 30
- 238000009472 formulation Methods 0.000 description 27
- 238000001125 extrusion Methods 0.000 description 24
- 238000004090 dissolution Methods 0.000 description 16
- 238000000338 in vitro Methods 0.000 description 14
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- 239000008108 microcrystalline cellulose Substances 0.000 description 13
- 239000012530 fluid Substances 0.000 description 12
- 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 description 12
- 229960003086 naltrexone Drugs 0.000 description 12
- 229920000642 polymer Polymers 0.000 description 12
- 230000000694 effects Effects 0.000 description 10
- 239000000047 product Substances 0.000 description 10
- 239000002552 dosage form Substances 0.000 description 9
- 239000013543 active substance Substances 0.000 description 8
- 230000002496 gastric effect Effects 0.000 description 7
- 238000002156 mixing Methods 0.000 description 7
- 230000000968 intestinal effect Effects 0.000 description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 6
- 239000000843 powder Substances 0.000 description 6
- 238000010521 absorption reaction Methods 0.000 description 5
- 239000003795 chemical substances by application Substances 0.000 description 5
- 238000001727 in vivo Methods 0.000 description 5
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- 102000004190 Enzymes Human genes 0.000 description 4
- 108090000790 Enzymes Proteins 0.000 description 4
- 238000005520 cutting process Methods 0.000 description 4
- 238000005429 filling process Methods 0.000 description 4
- MUZQPDBAOYKNLO-RKXJKUSZSA-N oxycodone hydrochloride Chemical compound [H+].[Cl-].O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C MUZQPDBAOYKNLO-RKXJKUSZSA-N 0.000 description 4
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- 238000013268 sustained release Methods 0.000 description 4
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- 239000008118 PEG 6000 Substances 0.000 description 3
- 229920002584 Polyethylene Glycol 6000 Polymers 0.000 description 3
- 239000000654 additive Substances 0.000 description 3
- 239000011248 coating agent Substances 0.000 description 3
- 238000000576 coating method Methods 0.000 description 3
- 239000013065 commercial product Substances 0.000 description 3
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- 239000000499 gel Substances 0.000 description 3
- 230000009477 glass transition Effects 0.000 description 3
- 239000012729 immediate-release (IR) formulation Substances 0.000 description 3
- 238000004898 kneading Methods 0.000 description 3
- 238000011068 loading method Methods 0.000 description 3
- 235000019359 magnesium stearate Nutrition 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- 230000036470 plasma concentration Effects 0.000 description 3
- -1 poly(ethylene oxide) Polymers 0.000 description 3
- 125000001453 quaternary ammonium group Chemical group 0.000 description 3
- 235000012222 talc Nutrition 0.000 description 3
- RSSHKMSIEMOBQX-KFIKYVJASA-N (4r,4as,7ar,12bs)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C.O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C RSSHKMSIEMOBQX-KFIKYVJASA-N 0.000 description 2
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 2
- QCQCHGYLTSGIGX-GHXANHINSA-N 4-[[(3ar,5ar,5br,7ar,9s,11ar,11br,13as)-5a,5b,8,8,11a-pentamethyl-3a-[(5-methylpyridine-3-carbonyl)amino]-2-oxo-1-propan-2-yl-4,5,6,7,7a,9,10,11,11b,12,13,13a-dodecahydro-3h-cyclopenta[a]chrysen-9-yl]oxy]-2,2-dimethyl-4-oxobutanoic acid Chemical compound N([C@@]12CC[C@@]3(C)[C@]4(C)CC[C@H]5C(C)(C)[C@@H](OC(=O)CC(C)(C)C(O)=O)CC[C@]5(C)[C@H]4CC[C@@H]3C1=C(C(C2)=O)C(C)C)C(=O)C1=CN=CC(C)=C1 QCQCHGYLTSGIGX-GHXANHINSA-N 0.000 description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 2
- 229920003134 Eudragit® polymer Polymers 0.000 description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 2
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 description 2
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 2
- AFCARXCZXQIEQB-UHFFFAOYSA-N N-[3-oxo-3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propyl]-2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidine-5-carboxamide Chemical compound O=C(CCNC(=O)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F)N1CC2=C(CC1)NN=N2 AFCARXCZXQIEQB-UHFFFAOYSA-N 0.000 description 2
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- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 229940069328 povidone Drugs 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000000979 retarding effect Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 229940080313 sodium starch Drugs 0.000 description 1
- 238000007711 solidification Methods 0.000 description 1
- 230000008023 solidification Effects 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 239000000829 suppository Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- FQXXSQDCDRQNQE-VMDGZTHMSA-N thebaine Chemical compound C([C@@H](N(CC1)C)C2=CC=C3OC)C4=CC=C(OC)C5=C4[C@@]21[C@H]3O5 FQXXSQDCDRQNQE-VMDGZTHMSA-N 0.000 description 1
- 229930003945 thebaine Natural products 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
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- 239000012815 thermoplastic material Substances 0.000 description 1
- 229960002622 triacetin Drugs 0.000 description 1
- 239000012976 trial formulation Substances 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
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Classifications
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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
-
- 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
- A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
- A61K31/385—Heterocyclic compounds having sulfur as a ring hetero atom having two or more sulfur atoms in the same ring
-
- 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
- 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
-
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Pain & Pain Management (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Rheumatology (AREA)
- Emergency Medicine (AREA)
- Molecular Biology (AREA)
- Neurology (AREA)
- Biophysics (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Compositions Of Macromolecular Compounds (AREA)
- Processes Of Treating Macromolecular Substances (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Manufacturing Of Micro-Capsules (AREA)
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB0315137A GB0315137D0 (en) | 2003-06-27 | 2003-06-27 | Multiparticulates |
| GB0315137.0 | 2003-06-27 | ||
| GB0403102A GB0403102D0 (en) | 2004-02-12 | 2004-02-12 | Multiparticulates |
| GB0403102.7 | 2004-02-12 | ||
| GB0413454A GB0413454D0 (en) | 2004-06-16 | 2004-06-16 | Multiparticulates |
| GB0413454.0 | 2004-06-16 | ||
| PCT/GB2004/002705 WO2005000310A1 (en) | 2003-06-27 | 2004-06-23 | Multiparticulates |
Publications (2)
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| AU2004251481A1 AU2004251481A1 (en) | 2005-01-06 |
| AU2004251481B2 true AU2004251481B2 (en) | 2010-01-28 |
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Country Status (25)
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| EP (2) | EP1644002B1 (https=) |
| JP (2) | JP5348841B2 (https=) |
| KR (1) | KR101116518B1 (https=) |
| AR (1) | AR044935A1 (https=) |
| AT (1) | ATE453394T1 (https=) |
| AU (1) | AU2004251481B2 (https=) |
| BR (1) | BRPI0411901B1 (https=) |
| CA (1) | CA2530385C (https=) |
| CY (2) | CY1109917T1 (https=) |
| DE (1) | DE602004024888D1 (https=) |
| DK (2) | DK1644002T3 (https=) |
| EA (1) | EA013424B1 (https=) |
| ES (2) | ES2490598T3 (https=) |
| HR (2) | HRP20100127T1 (https=) |
| IL (1) | IL172730A (https=) |
| MX (1) | MXPA05013799A (https=) |
| MY (1) | MY176831A (https=) |
| NO (1) | NO20060443L (https=) |
| NZ (1) | NZ544181A (https=) |
| PE (1) | PE20050286A1 (https=) |
| PL (2) | PL1889621T3 (https=) |
| PT (2) | PT1644002E (https=) |
| SI (2) | SI1644002T1 (https=) |
| TW (1) | TWI357815B (https=) |
| WO (1) | WO2005000310A1 (https=) |
Families Citing this family (38)
| Publication number | Priority date | Publication date | Assignee | Title |
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| JP2001526228A (ja) | 1997-12-22 | 2001-12-18 | ユーロ−セルティーク，エス．エイ． | オピオイド作動薬／拮抗薬の併用 |
| US6375957B1 (en) | 1997-12-22 | 2002-04-23 | Euro-Celtique, S.A. | Opioid agonist/opioid antagonist/acetaminophen combinations |
| CN1525851A (zh) | 2001-05-11 | 2004-09-01 | ������ҩ������˾ | 抗滥用阿片样物质控释剂型 |
| US20040234602A1 (en) | 2001-09-21 | 2004-11-25 | Gina Fischer | Polymer release system |
| EP1429744A1 (en) | 2001-09-21 | 2004-06-23 | Egalet A/S | Morphine polymer release system |
| EP1492505B1 (en) | 2002-04-05 | 2015-06-03 | Euro-Celtique S.A. | Pharmaceutical preparation containing oxycodone and naloxone |
| WO2004084868A1 (en) | 2003-03-26 | 2004-10-07 | Egalet A/S | Morphine controlled release system |
| TWI357815B (en) * | 2003-06-27 | 2012-02-11 | Euro Celtique Sa | Multiparticulates |
| GB0501638D0 (en) * | 2005-01-28 | 2005-03-02 | Euro Celtique Sa | Particulates |
| GB0403098D0 (en) | 2004-02-12 | 2004-03-17 | Euro Celtique Sa | Extrusion |
| TWI350762B (en) * | 2004-02-12 | 2011-10-21 | Euro Celtique Sa | Particulates |
| EP1604666A1 (en) | 2004-06-08 | 2005-12-14 | Euro-Celtique S.A. | Opioids for the treatment of the Chronic Obstructive Pulmonary Disease (COPD) |
| GB2418854B (en) | 2004-08-31 | 2009-12-23 | Euro Celtique Sa | Multiparticulates |
| EP1702558A1 (en) | 2005-02-28 | 2006-09-20 | Euro-Celtique S.A. | Method and device for the assessment of bowel function |
| US8852638B2 (en) | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
| KR20080089653A (ko) * | 2006-01-21 | 2008-10-07 | 애보트 게엠베하 운트 콤파니 카게 | 남용 약물의 전달을 위한 투여형 및 방법 |
| SA07280459B1 (ar) | 2006-08-25 | 2011-07-20 | بيورديو فارما إل. بي. | أشكال جرعة صيدلانية للتناول عن طريق الفم مقاومة للعبث تشتمل على مسكن شبه أفيوني |
| ATE476176T1 (de) * | 2007-03-02 | 2010-08-15 | Farnam Co Inc | Wachsähnliches material enthaltende tabletten mit verzögerter freisetzung |
| ES2562878T3 (es) | 2007-05-25 | 2016-03-08 | Indivior Uk Limited | Formulaciones de liberación sostenida de compuestos de risperidona |
| EP2155167A2 (en) | 2007-06-04 | 2010-02-24 | Egalet A/S | Controlled release pharmaceutical compositions for prolonged effect |
| US9072670B2 (en) | 2007-10-19 | 2015-07-07 | Otsuka Pharmaceutical Co., Ltd. | Matrix-type pharmaceutical solid preparation |
| US9226907B2 (en) | 2008-02-01 | 2016-01-05 | Abbvie Inc. | Extended release hydrocodone acetaminophen and related methods and uses thereof |
| BRPI0913724B8 (pt) * | 2008-09-18 | 2021-05-25 | Purdue Pharma Lp | formas farmacêuticas de liberação prolongada compreendendo naltrexona e poli (e-caprolactona) e seu preparo |
| NZ594207A (en) | 2009-02-06 | 2013-03-28 | Egalet Ltd | Immediate release composition resistant to abuse by intake of alcohol |
| MY152279A (en) | 2009-03-10 | 2014-09-15 | Euro Celtique Sa | Immediate release pharmaceutical compositions comprising oxycodone and naloxone |
| NZ597283A (en) | 2009-06-24 | 2013-07-26 | Egalet Ltd | Controlled release formulations |
| EP2534478A1 (en) * | 2010-02-11 | 2012-12-19 | Harry Leider | Methods of normalizing measured drug concentrations and testing for non-compliance with a drug treatment regimen |
| US9272044B2 (en) | 2010-06-08 | 2016-03-01 | Indivior Uk Limited | Injectable flowable composition buprenorphine |
| GB2513060B (en) | 2010-06-08 | 2015-01-07 | Rb Pharmaceuticals Ltd | Microparticle buprenorphine suspension |
| BR112015000150A2 (pt) | 2012-07-06 | 2017-06-27 | Egalet Ltd | composições farmacêuticas dissuasoras de abuso de liberação controlada |
| US10071089B2 (en) | 2013-07-23 | 2018-09-11 | Euro-Celtique S.A. | Combination of oxycodone and naloxone for use in treating pain in patients suffering from pain and a disease resulting in intestinal dysbiosis and/or increasing the risk for intestinal bacterial translocation |
| CA3042642A1 (en) | 2013-08-12 | 2015-02-19 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| US10172797B2 (en) | 2013-12-17 | 2019-01-08 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| US9492444B2 (en) | 2013-12-17 | 2016-11-15 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| GB201404139D0 (en) | 2014-03-10 | 2014-04-23 | Rb Pharmaceuticals Ltd | Sustained release buprenorphine solution formulations |
| CA2955229C (en) | 2014-07-17 | 2020-03-10 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
| US9132096B1 (en) | 2014-09-12 | 2015-09-15 | Alkermes Pharma Ireland Limited | Abuse resistant pharmaceutical compositions |
| AU2015336065A1 (en) | 2014-10-20 | 2017-05-04 | Pharmaceutical Manufacturing Research Services, Inc. | Extended release abuse deterrent liquid fill dosage form |
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| EP0253104A1 (en) * | 1986-07-18 | 1988-01-20 | Euro-Celtique S.A. | Controlled release bases for pharmaceuticals |
| WO1993010765A1 (en) * | 1991-11-27 | 1993-06-10 | Euroceltique S.A. | Controlled release oxycodone compositions |
| EP0553392A1 (en) * | 1992-01-27 | 1993-08-04 | Euro-Celtique S.A. | Stabilized controlled release formulations having acrylic polymer coating |
| US5958452A (en) * | 1994-11-04 | 1999-09-28 | Euro-Celtique, S.A. | Extruded orally administrable opioid formulations |
| WO2001058447A1 (en) * | 2000-02-08 | 2001-08-16 | Euro-Celtique, S.A. | Controlled-release compositions containing opioid agonist and antagonist |
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|---|---|---|---|---|
| JPH11508224A (ja) * | 1990-08-09 | 1999-07-21 | エンドコン・インコーポレーテッド | 多重ドラッグデリバリーシステム |
| MX9603480A (es) * | 1994-02-16 | 1997-12-31 | Abbott Lab | Procedimiento para preparar formulaciones farmaceuticas en particulas finas. |
| WO1996034634A1 (en) * | 1995-05-01 | 1996-11-07 | Sam Yang Co. Ltd. | Implantable bioresorbable membrane and method for the preparation thereof |
| SE505146C2 (sv) * | 1995-10-19 | 1997-06-30 | Biogram Ab | Partiklar för fördröjd frisättning |
| AU3404997A (en) * | 1996-05-31 | 1998-01-05 | Euro-Celtique S.A. | Sustained release oxycodone formulations with no fed/fast effect |
| US6022554A (en) * | 1997-12-15 | 2000-02-08 | American Home Products Corporation | Polymeric microporous film coated subcutaneous implant |
| IT1304152B1 (it) * | 1998-12-10 | 2001-03-08 | Mediolanum Farmaceutici Srl | Composizioni comprendenti un peptide ed acido polilattico-glicolicoatte alla preparazione di impianti sottocutanei aventi un prolungato |
| FR2795326B1 (fr) * | 1999-06-28 | 2001-08-31 | Adir | Composition pharmaceutique solide thermoformable a liberation controlee |
| KR100889069B1 (ko) * | 1999-10-29 | 2009-03-17 | 유로-셀티크 소시에떼 아노뉨 | 서방성 하이드로코돈 제형 |
| FR2818552B1 (fr) * | 2000-12-26 | 2003-02-07 | Servier Lab | Compositions pharmaceutique solide thermoformable pour la liberation controlee d'ivabradine |
| BR0309844A (pt) * | 2002-05-07 | 2005-02-15 | Control Delivery Sys Inc | Processos para formação de um dispositivo para a distribuição de droga |
| MXPA05007717A (es) * | 2003-01-24 | 2005-09-30 | Control Delivery Sys Inc | Liberacion controlada de agentes altamente solubles. |
| TWI357815B (en) * | 2003-06-27 | 2012-02-11 | Euro Celtique Sa | Multiparticulates |
-
2004
- 2004-06-18 TW TW093117618A patent/TWI357815B/zh not_active IP Right Cessation
- 2004-06-23 DE DE602004024888T patent/DE602004024888D1/de not_active Expired - Lifetime
- 2004-06-23 DK DK04743056.6T patent/DK1644002T3/da active
- 2004-06-23 JP JP2006516468A patent/JP5348841B2/ja not_active Expired - Fee Related
- 2004-06-23 MX MXPA05013799A patent/MXPA05013799A/es active IP Right Grant
- 2004-06-23 CA CA2530385A patent/CA2530385C/en not_active Expired - Fee Related
- 2004-06-23 AT AT04743056T patent/ATE453394T1/de active
- 2004-06-23 EA EA200600111A patent/EA013424B1/ru not_active IP Right Cessation
- 2004-06-23 WO PCT/GB2004/002705 patent/WO2005000310A1/en not_active Ceased
- 2004-06-23 BR BRPI0411901-0A patent/BRPI0411901B1/pt not_active IP Right Cessation
- 2004-06-23 EP EP04743056A patent/EP1644002B1/en not_active Expired - Lifetime
- 2004-06-23 EP EP07013702.1A patent/EP1889621B1/en not_active Expired - Lifetime
- 2004-06-23 ES ES07013702.1T patent/ES2490598T3/es not_active Expired - Lifetime
- 2004-06-23 PL PL07013702T patent/PL1889621T3/pl unknown
- 2004-06-23 DK DK07013702.1T patent/DK1889621T3/da active
- 2004-06-23 SI SI200431330T patent/SI1644002T1/sl unknown
- 2004-06-23 NZ NZ544181A patent/NZ544181A/en not_active IP Right Cessation
- 2004-06-23 PL PL04743056T patent/PL1644002T3/pl unknown
- 2004-06-23 SI SI200432174T patent/SI1889621T1/sl unknown
- 2004-06-23 PT PT04743056T patent/PT1644002E/pt unknown
- 2004-06-23 HR HR20100127T patent/HRP20100127T1/hr unknown
- 2004-06-23 ES ES04743056T patent/ES2337468T3/es not_active Expired - Lifetime
- 2004-06-23 PT PT70137021T patent/PT1889621E/pt unknown
- 2004-06-23 AU AU2004251481A patent/AU2004251481B2/en not_active Ceased
- 2004-06-23 KR KR1020057024940A patent/KR101116518B1/ko not_active Expired - Fee Related
- 2004-06-24 PE PE2004000617A patent/PE20050286A1/es not_active Application Discontinuation
- 2004-06-25 AR ARP040102264A patent/AR044935A1/es not_active Application Discontinuation
- 2004-06-25 MY MYPI20042516A patent/MY176831A/en unknown
-
2005
- 2005-12-21 IL IL172730A patent/IL172730A/en active IP Right Grant
-
2006
- 2006-01-27 NO NO20060443A patent/NO20060443L/no not_active IP Right Cessation
-
2010
- 2010-03-19 CY CY20101100259T patent/CY1109917T1/el unknown
-
2013
- 2013-05-08 JP JP2013098685A patent/JP5960089B2/ja not_active Expired - Fee Related
-
2014
- 2014-07-04 HR HRP20140635TT patent/HRP20140635T1/hr unknown
- 2014-07-31 CY CY20141100577T patent/CY1115415T1/el unknown
Patent Citations (6)
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|---|---|---|---|---|
| EP0253104A1 (en) * | 1986-07-18 | 1988-01-20 | Euro-Celtique S.A. | Controlled release bases for pharmaceuticals |
| WO1993010765A1 (en) * | 1991-11-27 | 1993-06-10 | Euroceltique S.A. | Controlled release oxycodone compositions |
| EP0553392A1 (en) * | 1992-01-27 | 1993-08-04 | Euro-Celtique S.A. | Stabilized controlled release formulations having acrylic polymer coating |
| US5958452A (en) * | 1994-11-04 | 1999-09-28 | Euro-Celtique, S.A. | Extruded orally administrable opioid formulations |
| US5965161A (en) * | 1994-11-04 | 1999-10-12 | Euro-Celtique, S.A. | Extruded multi-particulates |
| WO2001058447A1 (en) * | 2000-02-08 | 2001-08-16 | Euro-Celtique, S.A. | Controlled-release compositions containing opioid agonist and antagonist |
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