CA2537103A1 - Once daily dosage forms of trospium - Google Patents

Once daily dosage forms of trospium Download PDF

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Publication number
CA2537103A1
CA2537103A1 CA002537103A CA2537103A CA2537103A1 CA 2537103 A1 CA2537103 A1 CA 2537103A1 CA 002537103 A CA002537103 A CA 002537103A CA 2537103 A CA2537103 A CA 2537103A CA 2537103 A1 CA2537103 A1 CA 2537103A1
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Canada
Prior art keywords
trospium chloride
composition
trospium
component
chloride
Prior art date
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Granted
Application number
CA002537103A
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French (fr)
Other versions
CA2537103C (en
Inventor
Argaw Kidane
Henry H. Flanner
Padmanabh Bhatt
Arash Raoufinia
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Supernus Pharmaceuticals Inc
Original Assignee
Shire Laboratories Inc.
Argaw Kidane
Henry H. Flanner
Padmanabh Bhatt
Arash Raoufinia
Supernus Pharmaceuticals, Inc.
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Application filed by Shire Laboratories Inc., Argaw Kidane, Henry H. Flanner, Padmanabh Bhatt, Arash Raoufinia, Supernus Pharmaceuticals, Inc. filed Critical Shire Laboratories Inc.
Publication of CA2537103A1 publication Critical patent/CA2537103A1/en
Application granted granted Critical
Publication of CA2537103C publication Critical patent/CA2537103C/en
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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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2072—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
    • 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
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • A61K9/20—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
    • A61K9/2806—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
    • 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
    • A61K9/4808—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
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/5073—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/06—Anti-spasmodics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder

Abstract

A pharmaceutical composition of a pharmaceutically acceptable trospium salt, with upon administration to a human patient generates an average steady state blood levels of trospium with a minimum (Cmin) and maximum (Cmax) blood levels of about 0.5-2.5 ng/ml and about 2.0-6.0 ng/ml, respectively.

Claims (77)

1. An oral pharmaceutical composition containing trospium, which at a once-daily dosage will give steady state blood levels of trospium of a minimum of about 0.5 ng/ml and a maximum of about 6.0 ng/ml.
2. The composition of claim 1, which at a once-daily dosage will at steady state give minimum blood levels (C min) of trospium of between about 0.5 and about 1.5 ng/ml, and maximum blood levels (C max) of between about 2.0 and about 6.0 ng/ml.
3. The composition of claim 2, wherein the steady state blood levels are between about 1.0 ng/ml and about 5.0 ng/ml.
4. The composition of claim 1, wherein between 25 mg and 80 mg trospium chloride is present.
5. The composition of claim 1, which comprises an immediate release component containing no more than about 20 mg trospium chloride.
6. The composition of claim1, which comprises an extended release component containing between about 25 and about 60 mg trospium chloride.
7. The composition of claim 1, which comprises a delayed release component containing between about 25 and about 80 mg trospium chloride.
8. The composition of claim 1, which is a combination of an IR trospium chloride component and a DR trospium chloride component.
9. The composition of claim 8, wherein the IR component contains no more than about 20 mg trospium chloride and wherein the total dose of trospium chloride is less than about 80 mg.
10. The composition of claim 1, which is a combination of an XR trospium chloride component and a DR trospium chloride component.
11. The composition of claim 10, wherein the XR component contains between about 10 to about 40 mg trospium chloride and the DR component contains between about 10 mg and about 40 mg trospium chloride.
12. The composition of claim 11, wherein the XR component contains about 30 mg trospium chloride and the DR component contains about 30 mg trospium chloride.
13. The composition of claim 1, which is a combination of an IR trospium chloride component and an XR trospium chloride component.
14. The composition of claim 13, wherein the IR component contains no more than about 20 mg and the XR component contains about 20 mg to about 60 mg trospium chloride.
15. The composition of claim 14, wherein the XR component contains about 20 mg to about 40 mg trospium chloride.
16. The composition of claim 1, which is a combination of an IR trospium chloride component, an XR trospium chloride component; and a DR trospium component.
17. The composition of claim 16, wherein the IR component contains no more than about 20 mg trospium chloride, and the XR and DR components combined contain between about 10 mg and 60 mg trospium chloride and are in a ratio of XR:DR of 1:10 to 10:1.
18. The composition of claim 1, which is in the form of a granule, tablet, pellet, powder, sachet, capsule, gel, dispersion, solution or suspension.
19. The composition of claim 1, which is in the form of pellets contained within a capsule.
20. The composition of claim 1, which is in the form of pellets that are compressed into a tablet.
21. The composition of claim 8 - 17, which is a layered tablet, wherein each layer contains one of the components.
22. The composition of claim 8 -17, which is a layered pellet, wherein the DR
and/or XR portion comprises the core of the pellet, and the IR portion surrounds the core.
23. A method for treating a urinary incontinence disease or condition in a mammal, comprising administering a daily dose of a trospium composition according to claim 1 to the mammal, for at least a time sufficient to ameliorate the disease or condition.
24. The method of claim 23, wherein the mammal is a human.
25. The method of claim 23, wherein between 25 and 80 mg trospium chloride is present in the composition.
26. The method of claim 23, wherein about 60 mg trospium chloride is present in the composition.
27. The method of claim 23, which composition comprises an immediate release component containing no more than about 20 mg trospium chloride.
28. The method of claim 23, which composition comprises an extended release component containing between about 25 and about 60 mg trospium chloride.
29. The method of claim 23, which composition comprises a delayed release component containing between about 25 and about 80 mg trospium chloride.
30. The method of claim 23, which composition is a combination of an IR
trospium chloride component and a DR trospium chloride component.
31. The method of claim 30, wherein the IR component contains no more than about 20 mg trospium chloride and wherein the total dose of trospium chloride is less than about 80 mg.
32. The method of claim 23, which composition is a combination of an XR
trospium chloride component and a DR trospium chloride component.
33. The method of claim 32, wherein the XR component contains between about to about 40 mg trospium chloride and the DR component contains between about 10 mg and about 40 mg trospium chloride.
34. The method of claim 33, wherein the XR component contains about 30 mg trospium chloride and the DR component contains about 30 mg trospium chloride.
35. The method of claim 23, which composition is a combination of an IR
trospium chloride component and an XR trospium chloride component.
36. The method of claim 35, wherein the IR component contains no more than about 20 mg and the XR component contains about 20 mg to about 60 mg trospium chloride.
37. The method of claim 36, wherein the XR component contains about 20 mg to about 40 mg trospium chloride.
38. The method of claim 23, which composition is a combination of an IR
trospium chloride component, an XR trospium chloride component, and a DR trospium component.
39. The method of claim 38, wherein the IR component contains no more than about 20 mg trospium chloride, and the XR and DR components combined contain between about 10 mg and 60 mg trospium chloride and are in a ratio of XR:DR of 1:10 to 10:1.
40. A process for preparing an immediate release pharmaceutical composition containing trospium, comprising spraying onto an inert core a drug solution containing trospium chloride to thereby form a layer of drug on the core.
41. The process of claim 40, wherein a binder and anti-tacking agents are also in the drug solution.
42. The process of claim 40, which further comprises applying a protective coat of a polymeric composition to the drug-layered core.
43. A process for preparing an extended release composition of trospium chloride, comprising obtaining a drug layered core or drug loaded granule, and applying a coat on said core or granule of a release controlling polymer.
44. A process for the preparation of a delayed release trospium chloride composition, comprising obtaining a drug layered core or drug loaded granule, and applying a coat on said core or granule of an enteric material.
45. A process for preparing a once daily dosage unit of trospium chloride, which will give steady state blood levels of trospium of a minimum of about 0.5 ng/ml and a maximum of about 6.0 ng/ml, comprising combining immediate release pellets containing no more than about 20 mg trospium chloride with XR pellets containing about 20 mg to about 60 mg trospium chloride into a capsule.
46. The process of claim 45, wherein the XR pellets contain between about 20 mg and about 40 mg trospium chloride.
47. A process for preparing a once daily dosage unit of trospium chloride, which will give steady state blood levels of trospium of a minimum of about 0.5 ng/ml and a maximum of about 6.0 ng/ml, comprising combining immediate release pellets containing no more than about 20 mg trospium chloride with DR pellets, such that the total dose of the combination is less than about 80 mg., into a capsule.
48. A process for preparing a once daily dosage unit of trospium chloride, which will give steady state blood levels of trospium of a minimum of about 0.5 ng/ml and a maximum of about 6.0 ng/ml, comprising combining extended release pellets containing betweeen about 10 and 40 mg trospium chloride with DR
pellets containing between about 10 and 40 mg into a capsule.
49. The process of claim 48, wherein the each of the XR and DR pellets contain about 30 mg trospium chloride.
50. The process of claim 40-49, wherein the blood level at steady state are between about 1.0 ng/ml and about 5.0 ng/ml.
51. The composition of claim 7, wherein about 35 mg of trospium are present, and the DR component is coated with a polymeric substance that will dissolve at pH 5.5 - 6Ø
52. The composition of 15, wherein the release controlling coating gives a 3.5 hour in vivo release profile.
53. The composition of claim 14, wherein the XR component contains about 50 mg trospium chloride, and the release controlling coating gives a 4.5 hour in vivo release profile.
54. A pharmaceutical composition suitable for a once-a-day administration of trospium chloride comprising a plurality of solid, trospium chloride-bearing particulates, said plurality being of an extended release, a delayed release, or a combination thereof or a combination of either with immediate release particulates, such that once-a-day administration of said pharmaceutical composition provides steady state blood levels of trospium that are substantially epuivalent to steady state blood levels of trospium achieved with twice daily administration of 20 mg immediate release trospium chloride tablets.
55. The composition of claim 54, in which once-a-day administration of said controlled release pharmaceutical composition provides steady state blood levels of trospium falling in the range of about 0.5 ng/ml to about 6.0 ng/ml.
56. The composition of claim 55, in which once-a-day administration of said controlled release pharmaceutical composition provides steady state blood levels of trospium falling in the range of about 1.0 ng/ml to about 5.0 ng/ml.
57. The composition of claim 55, in which once-a-day administration of said controlled release pharmaceutical composition provides steady state blood C
max levels of trospium falling in the range of about 2.5 ng/ml to about 4.5 ng/ml and C min levels of trospium falling in the range of about 0.5 ng/ml to about 1.5 ng/ml.
58. The composition of claim 55, in which once-a-day administration of said controlled release pharmaceutical composition provides steady state areas under the curve (AUCs) falling in the range of about 30 to about 60 ng/ml*hr.
59. The composition of claim 58, in which once-a-day administration of said controlled release pharmaceutical composition provides steady state areas under the curve falling in the range of about 35 to about 45 ng/ml*hr.
60. The composition of claim 54, in which once-a-day administration of said controlled release pharmaceutical composition provides single dose %F values falling in the range of about 80 to about 120.
61. The composition of claim 60 in which once-a-day administration of said controlled release pharmaceutical composition provides single dose %F values falling in the range of about 90 to about 110.
62. The composition of claim 54, in which said plurality of particulates are selected from delayed release or extended release, each alone or in combination, or each alone or in combination with an immediate release particulate.
63. The composition of claim 62, in which the particulates are all of a delayed release formulation.
64. The composition of claim 62, in which the particulates are all of an extended release formulation that allows release of about 80% trospium chloride at 3.5 hours post ingestion.
65. The composition of claim 62, in which the particulates are all of an extended release formulation that allows release of about 80% trospium chloride at 4.5 hours post ingestion.
66. The composition of claim 62, which comprises particulates of an extended release formulation that allows release of about 80% trospium chloride at 3.5 hours post ingestion, and delayed release particulates.
67. The composition of claim 66, wherein the delayed release particulates are ones that release trospium chloride when they reach the area of the GI tract where the pH is about 7.
68. A method of treating a mammal suffering-from a condition that would benefit from a once daily administration of an effective amount of trospium chloride, comprising administering to a mammal in need thereof a once-a-day formulation comprising an effective amount of trospium chloride which provides steady state blood levels of trospium substantially equivalent to steady state blood levels of trospium achieved with twice daily administration of 20 mg immediate release trospium chloride tablets and with a lessening of side effects.
69. A once-daily dosage form of trospium chloride, which results in a single dose profile that is equivalent to the corresponding twice-daily regimen.
70. The dosage form of claim 69, wherein the corresponding twice-daily regimen amounts to 40 mg per day.
71. The dosage form of claim 70, wherein the corresponding twice-daily regimen amounts to 20 mg per day.
72. The dosage form of claim 71, wherein the corresponding twice-daily regimen amounts to 80 mg per day.
73. A method of enteral administration of a pharmaceutical composition comprising an effective amount of trospium chloride, the improvement comprising including a delayed release formulation of trospium chloride, which releases trospium chloride at a pH of about 7Ø
74. A method of enteral administration of a pharmaceutical composition comprising an effective amount of trospium chloride, the improvement comprising including a delayed release formulation of trospium chloride, which releases trospium chloride in the lower intestine.
75. A method of enteral administration of a pharmaceutical composition comprising an effective amount of trospium chloride, the improvement comprising including a delayed release formulation of trospium chloride, which releases trospium chloride in the colon.
76. A pharmaceutical composition comprising trospium chloride as at least one active,pharmaceutical ingredient in which at least a portion of said trospium chloride is contained in a delayed release formulation, which releases trospium chloride at a pH of about 7Ø
77. A pharmaceutical composition comprising trospium chloride as at least one active pharmaceutical ingredient in which at least a portion of said trospium chloride is contained in a delayed release formulation, which releases trospium chloride in the lower intestine, colon, or both.
CA002537103A 2003-11-04 2004-11-04 Once daily dosage forms of trospium Expired - Fee Related CA2537103C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US51719803P 2003-11-04 2003-11-04
US60/517,198 2003-11-04
US52396803P 2003-11-21 2003-11-21
US60/523,968 2003-11-21
PCT/US2004/036394 WO2005046684A1 (en) 2003-11-04 2004-11-04 Once daily dosage forms of trospium

Publications (2)

Publication Number Publication Date
CA2537103A1 true CA2537103A1 (en) 2005-05-26
CA2537103C CA2537103C (en) 2010-01-19

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CA002537103A Expired - Fee Related CA2537103C (en) 2003-11-04 2004-11-04 Once daily dosage forms of trospium

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US (12) US7410978B2 (en)
EP (2) EP2210605B1 (en)
JP (2) JP5610663B2 (en)
AT (1) ATE493981T1 (en)
AU (1) AU2004289223B2 (en)
CA (1) CA2537103C (en)
DE (1) DE602004030931D1 (en)
DK (1) DK2210605T3 (en)
ES (1) ES2359375T3 (en)
HK (1) HK1088547A1 (en)
PT (1) PT2210605T (en)
WO (1) WO2005046684A1 (en)

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