CA2452871A1 - Oxymorphone controlled release formulations - Google Patents

Oxymorphone controlled release formulations Download PDF

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Publication number
CA2452871A1
CA2452871A1 CA002452871A CA2452871A CA2452871A1 CA 2452871 A1 CA2452871 A1 CA 2452871A1 CA 002452871 A CA002452871 A CA 002452871A CA 2452871 A CA2452871 A CA 2452871A CA 2452871 A1 CA2452871 A1 CA 2452871A1
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Canada
Prior art keywords
oxymorphone
formulation
controlled release
subject
oral administration
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Granted
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CA002452871A
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French (fr)
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CA2452871C (en
Inventor
Huai-Hung Kao
Anand R. Baichwal
Troy Mccall
David Lee
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Endo Pharmaceuticals Inc
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Endo Pharmaceuticals, Inc.
Huai-Hung Kao
Anand R. Baichwal
Troy Mccall
David Lee
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Application filed by Endo Pharmaceuticals, Inc., Huai-Hung Kao, Anand R. Baichwal, Troy Mccall, David Lee filed Critical Endo Pharmaceuticals, Inc.
Publication of CA2452871A1 publication Critical patent/CA2452871A1/en
Application granted granted Critical
Publication of CA2452871C publication Critical patent/CA2452871C/en
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    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—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
    • A61K9/20—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
    • 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
    • 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]

Abstract

The invention pertains to a method of relieving pain by administering a controlled release pharmaceutical tablet containing oxymorphone which produces a mean minimum blood plasma level 12 to 24 hours after dosing, as well as the tablet producing the sustained pain relief.

Claims (87)

1. A controlled release oxymorphone formulation comprising a controlled release matrix and from about 5 mg to about 80 mg oxymorphone wherein said formulation provides a maximum blood concentration of oxymorphone of between about 0.1 ng/ml and about 7.5 ng/ml upon oral administration of a single dose to a subject.
2. The controlled release oxymorphone formulation of claim 1 wherein said formulation comprises from about 5 mg to about 10 mg oxymorphone and said formulation provides a maximum blood concentration of oxymorphone of between about 0.12 ng/ml and about 1.0 ng/ml upon oral administration of a single dose to a subject.
3. The controlled release oxymorphone formulation of claim 1 wherein said formulation comprises from about 10 mg to about 20 mg oxymorphone and said formulation provides a maximum blood concentration of oxymorphone of between about 0.3 ng/ml and about 1.6 ng/ml upon oral administration of a single dose to a subject
4. The controlled release oxyrmorphone formulation of claim 1 wherein said formulation comprises from about 20 mg to about 40 mg oxymorphone and said formulation provides a maximum blood concentration of oxymorphone of between about 0.5 ng/ml and about 3.5 ng/ml upon oral administration of a single dose to a subject.
5. The controlled release oxymorphone formulation of claim 1 wherein said formulation comprises from about 40 mg to about 80 mg oxymorphone and said formulation provides a maximum blood concentration of oxymorphone of between about 1.5 ng/ml and about 7.5 ng/ml upon oral administration of a single dose to a subject.
6. The controlled release oxymorphone formulation of claim 2 wherein said formulation provides a maximum blood concentration of oxymorphone of between about 0.17 ng/ml and about 0.75 ng/ml upon oral administration of a single dose to a subject.
7. The controlled release oxymorphone formulation of claim 3 wherein said formulation provides a maximum blood concentration of oxymorphone of between about 0.4 ng/ml and about 1.4 ng/ml upon oral administration of a single dose to a subject.
8. The controlled release oxymorphone formulation of claim 4 wherein said formulation provides a maximum blood concentration of oxymorphone of between about 0.9 ng/ml and about 3.0 ng/ml upon oral administration of a single dose to a subject.
9. The controlled release oxymorphone formulation of claim 5 wherein said formulation provides a maximum blood concentration of oxymorphone of between about 1.9 ng/ml and about 6.0 ng/ml upon oral administration of a single dose to a subject.
10. A controlled release oxyrnorphone formulation according to claim 2 wherein said formulation contains about 5 mg oxyrnorphone and wherein said formulation provides a maximum blood concentration of oxymorphone of between about 0.12 ng/ml and about 0.4 ng/ml upon oral administration of a single dose to a subject.
11. A controlled release oxymorphone formulation according to claim 3 wherein said formulation contains about 10 mg oxymorphone and wherein said formulation provides a maximum blood concentration of oxymorphone of between about 0.3 ng/ml and about 0.9 ng/ml upon oral administration of a single dose to a subject.
12. A controlled release oxymorphone formulation according to claim 4 wherein said formulation contains about 20 mg oxymorphone and wherein said formulation provides a maximum blood concentration of oxymorphone of between about 0.5 ng/ml and about 1.6 ng/ml upon oral administration of a single dose to a subject.
13. A controlled release oxymorphone formulation according to claim 5 wherein said formulation contains about 40 mg oxymorphone and wherein said formulation provides a maximum blood concentration of oxymorphone of between about 1.5 ng/ml and about 3.5 ng/ml upon oral administration of a single dose to a subject.
14. A controlled release oxymorphone formulation according to claim 5 wherein said formulation contains about 80 mg oxyrnorphone and wherein said formulation provides a maximum blood concentration of oxymorphone of between about 3.5 ng/ml and about 7.5 ng/ml upon oral administration of a single dose to a subject.
15. A controlled release oxymorphone formulation according to claim 10 wherein said formulation provides a maximum blood concentration of oxymorphone of between about 0.15 ng/ml and about 0.35 ng/ml upon oral administration of a single dose to a subject.
16. A controlled release oxymorphone formulation according to claim 11 wherein said formulation provides a maximum blood concentration of oxymorphone of between about 0.5 ng/ml and about 0.75 ng/ml upon oral administration of a single dose to a subject.
17. A controlled release oxymorphone formulation according to claim 12 wherein said formulation provides a maximum blood concentration of oxymorphone of between about 0.75 ng/ml and about 1.4 ng/ml upon oral administration of a single dose to a subject.
18. A controlled release oxymorphone formulation according to claim 13 wherein said formulation provides a maximum blood concentration of oxymorphone of between about 2.0 ng/ml and about 3.0 ng/ml upon oral administration of a single dose to a subject.
19. A controlled release oxymorphone formulation according to claim 14 wherein said formulation provides a maximum blood concentration of oxymorphone of between about 4.0 ng/ml and about 6.5 ng/ml upon oral administration of a single dose to a subject.
20. A controlled release oxymorphone formulation comprising a controlled release matrix and from about 5 mg to about 10 mg oxymorphone wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.05 ng/ml and about 5.0 ng/ml upon oral administration of a single dose to a subject.
21. The controlled release oxymorphone formulation of claim 20 wherein said formulation comprises from about 5 mg to about 10 mg oxyrnorphone and said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.05 ng/ml and about 0.6 ng/ml upon oral administration of a single dose to a subject.
22. The controlled release oxymorphone formulation of claim 20 wherein said formulation comprises from about 10 mg to about 20 mg oxymorphone and said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.1 nglml and about 1.25 ng/ml upon oral administration of a single dose to a subject.
23. The controlled release oxymorphone formulation of claim 20 wherein said formulation comprises from about 20 mg to about 40 mg oxymorphone and said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.2 ng/ml and about 2.5 ng/ml upon oral administration of a single dose to a subject.
24. The controlled release oxymorphone formulation of claim 20 wherein said formulation comprises from about 40 mg to about 80 mg oxymorphone and said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.4 ng/ml and about 5.0 ng/ml upon oral administration of a single dose to a subject.
25. The controlled release oxymorphone formulation of claim 21 wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.1 ng/ml and about 0.4 ng/ml upon oral administration of a single dose to a subject.
26. The controlled release oxymorphone formulation of claim 22 wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.2 ng/ml and about 0.8 ng/ml upon oral administration of a single dose to a subject.
27. The controlled release oxymorphone formulation of claim 23 wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.4 ng/ml and about 1.6 ng/ml upon oral administration of a single dose to a subject.
28. The controlled release oxymorphone formulation of claim 24 wherein and said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.8 ng/ml and about 3.2 ng/ml upon oral administration of a single dose to a subject.
29. A controlled release oxymorphone formulation according to claim 21 wherein said formulation contains about 5 mg oxymorphone and wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.05 ng/ml and about 0.3 ng/ml upon oral administration of a single dose to a subject.
30. A controlled release oxymorphone formulation according to claim 21 wherein said formulation contains about 10 mg oxymorphone and wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.1 ng/ml and about 0.6 ng/ml upon oral administration of a single dose to a subject.
31. A controlled release oxymorphone formulation according to claim 22 wherein said formulation contains about 20 mg oxymorphone and wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.2 ng/ml and about 1.2 ng/ml upon oral administration of a single dose to a subject.
32. A controlled release oxymorphone formulation according to claim 23 wherein said formulation contains about 40 mg oxymorphone and wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.4 ng/ml and about 2.4 ng/ml upon oral administration of a single dose to a subject.
33. A controlled release oxymorphone formulation according to claim 24 wherein said formulation contains about 80 mg oxymorphone and wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.8 ng/ml and about 4.8 ng/ml upon oral administration of a single dose to a subject.
34. A controlled release oxymorphone formulation according to claim 29 wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.1 ng/ml and about 0.25 ng/ml upon oral administration of a single dose to a subject.
35. A controlled release oxymorphone formulation according to claim 30 wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.2 ng/ml and about 0.5 ng/ml upon oral administration of a single dose to a subject.
36. A controlled release oxymorphone formulation according to claim 31 wherein formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.4 ng/ml and about 1.0 ng/ml upon oral administration of a single dose to a subject.
37. A controlled release oxymorphone formulation according to claim 32 wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 0.8 ng/ml and about 2.0 ng/ml upon oral administration of a single dose to a subject.
38. A controlled release oxymorphone formulation according to claim 33 wherein said formulation provides a maximum blood concentration of 6-OH oxymorphone of between about 1.6 ng/ml and about 4.0 ng/ml upon oral administration of a single dose to a subject.
39. A controlled release oxymorphone formulation comprising a controlled release matrix and from about 5 mg to about 80 mg oxymorphone wherein said formulation provides a minimum blood concentration of oxymorphone of at least about 0.02 ng/mg-ml at about 12 hours after oral administration of a single dose to a subject.
40 The controlled release oxymorphone formulation of claim 39 wherein said formulation contains about 5 mg oxymorphone.
41. The controlled release oxymorphone formulation of claim 39 wherein said formulation contains about 10 mg oxymorphone.
42. The controlled release oxymorphone formulation of claim 39 wherein said formulation contains about 20 mg oxymorphone.
43. The controlled release oxymorphone formulation of claim 39 wherein said formulation contains about 40 mg oxymorphone.
44. The controlled release oxymorphone formulation of claim 39 wherein said formulation contains about 80 mg oxymorphone.
45. The controlled release oxymorphone formulation of claim 40 wherein said formulation provides a minimum blood concentration of oxymorphone of at least about 0.13 ng/ml at about 12 hours after oral administration of a single dose to a subject.
46. The controlled release oxymorphone formulation of claim 41 wherein said formulation provides a minimum blood concentration of oxymorphone of at least about 0.25 ng/ml at about 12 hours after oral administration of a single dose to a subject.
47. The controlled release oxymorphone formulation of claim 42 wherein said formulation provides a minimum blood concentration of oxymorphone of at least about 0.5 ng/ml at about 12 hours after oral administration of a single dose to a subject.
48. The controlled release oxymorphone formulation of claim 43 wherein said formulation provides a minimum blood concentration of oxymorphone of at least about 1.0 ng/ml at about 12 hours after oral administration of a single dose to a subject.
49. The controlled release oxymorphone formulation of claim 44 wherein said formulation provides a minimum blood concentration of oxymorphone of at least about 2.0 ng/ml at about 12 hours after oral administration of a single dose to a subject.
50. A controlled release oxymorphone formulation comprising a controlled release matrix and from about 5 mg to about 80 mg oxymorphone wherein said formulation provides a minimum blood concentration of 6-OH oxymorphone of at least about 0.010 ng/mg-ml at about 12 hours after oral administration of a single dose to a subject.
51. The controlled release oxymorphone formulation of claim 50 wherein said formulation contains about 5 mg oxymorphone.
52. The controlled release oxymorphone formulation of claim 50 wherein said formulation contains about 10 mg oxymorphone.
53. The controlled release oxymorphone formulation of claim 50 wherein said formulation contains about 20 mg oxymorphone.
54. The controlled release oxymorphone formulation of claim 50 wherein said formulation contains about 40 mg oxymorphone.
55. The controlled release oxymorphone formulation of claim 50 wherein said formulation contains about 80 mg oxymorphone.
56. The controlled release oxymorphone formulation of claim 51 wherein said formulation provides a minimum blood concentration of 6-OH oxymorphone of at least about 0.065 ng/ml at about 12 hours after oral administration of a single dose to a subject.
57. The controlled release oxymorphone formulation of claim 52 wherein said formulation provides a minimum blood concentration of 6-OH oxymorphone of at least about 0.13 ng/ml at about 12 hours after oral administration of a single dose to a subject.
58. The controlled release oxymorphone formulation of claim 53 wherein said formulation provides a minimum blood concentration of 6-OH oxymorphone of at least about 0.25 ng/ml at about 12 hours after oral administration of a single dose to a subject.
59. The controlled release oxymorphone formulation of claim 54 wherein said formulation provides a minimum blood concentration of 6-OH oxymorphone of at least about 0.5 ng/ml at about 12 hours after oral administration of a single dose to a subject.
60. The controlled release oxymorphone formulation of claim 55 wherein said formulation provides a minimum blood concentration of 6-OH oxymorphone of at least about 1.0 ng/ml at about 12 hours after oral administration of a single dose to a subject.
61. A controlled release oxymorphone formulation comprising a controlled release matrix and from about 5 mg to about 80 mg oxymorphone wherein upon repeated oral administration of said formulation to a subject every 8 to 12 hours through steady state conditions, said formulation provides a minimum blood concentration of oxymorphone of at least about 0.025 ng/mg-ml at about 12 hours after administration.
62. The controlled release oxymorphone formulation of claim 61 wherein said formulation contains about 5 mg oxymorphone.
63. The controlled release oxymorphone formulation of claim 61 wherein said formulation contains about 10 mg oxymorphone.
64. The controlled release oxymorphone formulation of claim 61 wherein said formulation contains about 20 mg oxymorphone.
65. The controlled release oxymorphone formulation of claim 61 wherein said formulation contains about 40 mg oxymorphone.
66. The controlled release oxymorphone formulation of claim 61 wherein said formulation contains about 80 mg oxymorphone.
67. A controlled release oxymorphone formulation comprising a controlled release matrix and from about 5 mg to about 80 mg oxymorphone wherein upon repeated oral administration of said formulation to a subject every 8 to 12 hours through steady state conditions, said formulation provides a minimum blood concentration of 6-OH
oxymorphone of at least about 0.03 ng/mg-ml at about 12 hours after administration.
68. The controlled release oxymorphone formulation of claim 67 wherein said formulation contains about 5 mg oxymorphone.
69. The controlled release oxymorphone formulation of claim 67 wherein said formulation contains about 10 mg oxymorphone.
70. The controlled release oxymorphone formulation of claim 67 wherein said formulation contains about 20 mg oxymorphone.
71. The controlled release oxymorphone formulation of claim 67 wherein said formulation contains about 40 mg oxymorphone.
72. The controlled release oxymorphone formulation of claim 67 wherein said formulation contains about 80 mg oxymorphone.
73. A method of controlling pain in a patient for 8 hours comprising administering to said patient a single dose of a pharmaceutical preparation comprising from about 5 mg to about 80 mg oxymorphone which induces in the patient a blood plasma concentration of oxymorphone of at least 0.02 ng/mg-ml at least 12 hours after said administration.
74. The method of claim 73 wherein said pharmaceutical preparation contains 5 mg oxymorphone.
75. The method of claim 73 wherein said pharmaceutical preparation contains 10 mg oxymorphone.
76. The method of claim 73 wherein said pharmaceutical preparation contains 20 mg oxymorphone.
77. The method of claim 73 wherein said pharmaceutical preparation contains 40 mg oxymorphone.
78. The method of claim 73 wherein said pharmaceutical preparation contains 80 mg oxymorphone.
79. A method of controlling pain in a patient for 8 hours comprising administering to said patient a single dose of a pharmaceutical preparation comprising from about 5 mg to about 80 mg oxymorphone which induces in the patient a blood plasma concentration of 6-OH oxymorphone of at least 0.014 ng/mg-ml at least 12 hours after said administration.
80. The method of claim 79 wherein said pharmaceutical preparation contains 5 mg oxymorphone.
81. The method of claim 79 wherein said pharmaceutical preparation contains 10 mg oxymorphone.
82. The method of claim 79 wherein said pharmaceutical preparation contains 20 mg oxymorphone.
83. The method of claim 79 wherein said pharmaceutical preparation contains 40 mg oxymorphone.
84. The method of claim 79 wherein said pharmaceutical preparation contains 80 mg oxymorphone.
85. A controlled release pharmaceutical formulation comprising a controlled release matrix and about 5 to about 80 mg oxymorphone wherein the relative bioavailability of oxymorphone to an equal dose of an immediate release formulation of oxymorphone is from about 0.5 to about 1.5 upon oral administration of a single dose to a subject.
86. A controlled release pharmaceutical formulation comprising a controlled release matrix and about 5 to about 80 mg oxymorphone wherein the ratio of the area under the blood plasma concentration versus time curve of 6-OH-oxymorphone to oxymorphone, from time 0 to infinity (AUC)0-inf)) is in the range of about 0.5 to about 1.5 upon oral administration of a single dose of the formulation to a subject.
87. A controlled release pharmaceutical formulation comprising a controlled release matrix and about 5 to about 80 mg oxymorphone wherein upon repeated oral administration of said formulation to a subject every 8 to 12 hours through steady state conditions, the ratio of the area under the blood plasma concentration versus time curve of 6-OH-oxymorphone to oxymorphone, from time 0 to infinity (AUC(0-inf)) is in the range of about 0.5 to about 1.5 upon oral administration a last dose of the formulation to a subject.
CA2452871A 2001-07-06 2002-07-03 Oxymorphone controlled release formulations Expired - Fee Related CA2452871C (en)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US30335701P 2001-07-06 2001-07-06
US60/303,357 2001-07-06
US32944401P 2001-10-15 2001-10-15
US32943201P 2001-10-15 2001-10-15
US32944501P 2001-10-15 2001-10-15
US60/329,444 2001-10-15
US60/329,432 2001-10-15
US60/329,445 2001-10-15
PCT/US2002/021396 WO2003004030A1 (en) 2001-07-06 2002-07-03 Oxymorphone controlled release formulations

Publications (2)

Publication Number Publication Date
CA2452871A1 true CA2452871A1 (en) 2003-01-16
CA2452871C CA2452871C (en) 2011-10-04

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ID=27501826

Family Applications (3)

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CA2452871A Expired - Fee Related CA2452871C (en) 2001-07-06 2002-07-03 Oxymorphone controlled release formulations
CA002452874A Abandoned CA2452874A1 (en) 2001-07-06 2002-07-03 Oral administration of 6-hydroxy-oxymorphone for use as an analgesic
CA002452872A Abandoned CA2452872A1 (en) 2001-07-06 2002-07-03 Parenteral administration of 6-hydroxy-oxymorphone for use as an analgesic

Family Applications After (2)

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CA002452874A Abandoned CA2452874A1 (en) 2001-07-06 2002-07-03 Oral administration of 6-hydroxy-oxymorphone for use as an analgesic
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