CA2440884A1 - Transdermal patch for administering fentanyl - Google Patents

Transdermal patch for administering fentanyl Download PDF

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Publication number
CA2440884A1
CA2440884A1 CA002440884A CA2440884A CA2440884A1 CA 2440884 A1 CA2440884 A1 CA 2440884A1 CA 002440884 A CA002440884 A CA 002440884A CA 2440884 A CA2440884 A CA 2440884A CA 2440884 A1 CA2440884 A1 CA 2440884A1
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CA
Canada
Prior art keywords
patch
reservoir
fentanyl
sufentanil
adhesive
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Granted
Application number
CA002440884A
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French (fr)
Other versions
CA2440884C (en
Inventor
Subramanian S. Venkatraman
Shaoling Li
Robert M. Gale
Jane Stepic
William W. Van Osdol
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Alza Corp
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Individual
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Publication of CA2440884A1 publication Critical patent/CA2440884A1/en
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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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4535—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • A61K9/7061—Polyacrylates
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

Abstract

A method and a non-rate controlled, monolithic, subsaturated patch for transdermally administering fentanyl and analogs thereof, for analgetic purposes, to a subject through skin over an extended period of time are disclosed.

Claims (93)

1. A transdermal patch for administering fentanyl or an analog thereof through the skin comprising:
(a) a backing layer;
(b) a reservoir disposed on the backing layer, at least the skin contacting surface of said reservoir being adhesive; said reservoir comprising a single phase polymeric composition free of undissolved components containing an amount of fentanyl or an analog thereof sufficient to induce and maintain analgesia in a human for at least three days.
2. The patch of claim 1 which is bioequivalent to DURAGESIC®
transdermal fentanyl system.
3. The patch of claim 1 wherein said reservoir is formed from an adhesive polymer.
4. The patch of claim 1 or claim 3 wherein said patch exhibits a normalized C max of about 3.3 to about 82.5 ng/ml-(mg/h).
5. The patch of claim 4 wherein the patch exhibits a steady state drug flux of about 0.1 to about 20 µg/cm2/hr.
6. The patch of claim 1 or claim 3 wherein said patch exhibits a standardized C max of about 0.001 to about 0.2 ng/ml-cm2.
7. The patch of claim 6 wherein the patch exhibits a steady state drug flux of about 0.1 to about 20 µg/cm2/hr.
8. The patch of claim 1 wherein said reservoir comprises an amount of dissolved fentanyl or analog thereof sufficient to induce and maintain analgesia for 3-7 days.
9. The patch of claim 8 wherein fentanyl analog is selected from the group consisting of alfentanil, lofentanil, remifentanil and sufentanil.
10. The patch of claim 8 wherein said reservoir comprises a polymer having a solubility for fentanyl and analogs thereof of about 1 wt% to about wt%.
11. The patch of claim 8 wherein the reservoir comprises about 0.05 to about 1.75 mg/cm2 of fentanyl or analogs thereof.
12. The patch of claim 8 wherein the reservoir has a thickness of about 0.0125 mm (0.5 mil) to about 0.1 mm (4 mil).
13. The patch of claim 3 wherein said adhesive is a polyacrylate adhesive.
14. The patch of claim 8 or claim 13 wherein the reservoir further comprises an enhancer.
15. The patch of claim 1 wherein the backing layer comprises a polymer selected from the group consisting of polyurethane, polyvinyl acetate, polyvinylidene chloride, polyethylene, polyethylene terephthalate (PET), PET-polyolefin laminates, and polybutylene terephthalate.
16. The patch of claim 15 wherein the backing layer has a thickness of about 0.012 mm (0.5 mil) to about 0.125 mm (5 mil).
17. A transdermal patch for administering fentanyl through the skin comprising:

(a) a backing layer;

(b) a reservoir disposed on the backing layer, at least the skin contacting surface of said reservoir being adhesive; said reservoir comprising a single phase polymeric composition free of undissolved components containing an amount of fentanyl sufficient to induce and maintain analgesia in a human for at least three days.
18. The patch of claim 17 which is bioequivalent to DURAGESIC®
transdermal fentanyl system.
19. The patch of claim 17 wherein said reservoir is formed from an adhesive.
20. The patch of claim 17 or 19 wherein said patch exhibits a normalized C max of about 3.3 to about 82.5 ng/ml-(mg/h).
21. The patch of claim 17 or 19 wherein said patch exhibits a standardized C max of about 0.01 to about 0.2 ng/ml-cm2.
22. The patch of claim 19 wherein the patch exhibits a steady state drug flux of about 1 to about 10 µg/cm2/hr.
23. The patch of claim 17 wherein said reservoir comprises an amount of dissolved fentanyl sufficient to induce and maintain analgesia for about 3 to about 7 days.
24. The patch of claim 17 wherein fentanyl has a solubility of 7 wt% to 12 wt% in said reservoir.
25. The patch of claim 23 wherein the reservoir comprises about 0.05 to about 1.75 mg/cm2 of fentanyl base.
26. The patch of claim 25 wherein the reservoir comprises about 0.08 to about 1.25 mg/cm2 of fentanyl base.
27. The patch of claim 26 wherein the reservoir comprises about 0.1 to about 0.75 mg/cm2 of fentanyl base.
28. The patch of claim 27 wherein the reservoir comprises about 0.12 to about 0.5 mg/cm2 of fentanyl base
29. The patch of claim 23 wherein the reservoir has a thickness of about 0.0125 mm (0.5 mil) to about 0.1 mm (4 mil).
30. The patch of claim 19 wherein said adhesive is a polyacrylate adhesive.
31. The patch of claim 30 wherein said polyacrylate adhesive has a T g less than -10 °C.
32. The patch of claim 30 wherein the reservoir comprises about 0.05 to about 1.75 mg/cm2 of fentanyl base.
33. The patch of claim 32 wherein the reservoir comprises about 0.08 to about 1.25 mg/cm2 of fentanyl base.
34. The patch of claim 33 wherein the reservoir comprises about 0.1 to about 0.75 mg/cm2 of fentanyl base.
35. The patch of claim 34 wherein the reservoir comprises about 0.12 to about 0.5 mg/cm2 of fentanyl base.
36. The patch of claim 30 wherein the reservoir has a thickness of about 0.0125 mm (0.5 mil) to about 0.1 mm (4 mil).
37. The patch of claim 23 or claim 30 wherein the reservoir further comprises an enhancer.
38. The patch of any one of claims 17, 23 or 30, wherein the backing layer comprises a polymer selected from the group consisting of polyurethane, polyvinyl acetate, polyvinylidene chloride, polyethylene, polyethylene terephthalate (PET), PET-polyolefin laminates, and polybutylene terephthalate.
39 39. The patch of claim 38, wherein the backing layer comprises low density polyethylene (LDPE) materials, medium density polyethylene (MDPE) materials or high density polyethylene (HDPE) materials.
40. The patch of claim 39, wherein the backing layer comprises low density polyethylene (LDPE) materials.
41. The patch of claim 38 wherein the backing layer has a thickness of about 0.012 mm (0.5 mil) to about 0.125 mm (5 mil).
42. A transdermal patch for administering fentanyl, comprising an adhesive fentanyl reservoir on a backing layer; said reservoir comprising a single phase polymeric composition free of undissolved components containing a polyacrylate adhesive having sufficient solubility for fentanyl to contain dissolved fentanyl in an amount sufficient to induce and maintain analgesia in a human for at least three days, said patch exhibiting a normalized C max of about 3.3 to about 82.5 ng/ml-(mg/h).
43. A transdermal patch for administering fentanyl, comprising an adhesive fentanyl reservoir on a backing layer; said reservoir comprising a single phase polymeric composition free of undissolved components containing a polyacrylate adhesive having sufficient solubility for fentanyl to contain dissolved fentanyl in an amount sufficient to induce and maintain analgesia in a human for at least three days, said patch exhibiting a standardized C max of about 0.01 to about 0.2 ng/ml-cm2.
44. The patch of claim 42 or 43 wherein the patch exhibits a steady state drug flux of about 1 to about 10 µg/cm2/hr.
45. The patch of claim 42 or 43 wherein said reservoir comprises an amount of dissolved fentanyl sufficient to induce and maintain analgesia for about 3 to about 7 days.
46. The patch of claim 45 wherein said adhesive is a polyacrylate adhesive having a T g less than -10 °C; and fentanyl has a solubility of at least 4 wt% in said reservoir.
47. The patch of claim 46 wherein the adhesive reservoir has a thickness of about 0.0125 mm (0.5 mil) to about 0.1 mm (4 mil).
48. The patch of claim 47 wherein the reservoir comprises about 0.05 to about 1.75 mg/cm2 of fentanyl base.
49. The patch of claim 48 wherein the reservoir comprises about 0.08 to about 1.25 mg/cm2 of fentanyl base.
50. The patch of claim 49 wherein the reservoir comprises about 0.1 to about 0.5 mg/cm2 of fentanyl base.
51. A monolithic transdermal patch for administering fentanyl, comprising an adhesive fentanyl reservoir on a backing layer, said reservoir comprising a single phase polymeric composition free of undissolved components containing a polyacrylate adhesive having sufficient solubility for fentanyl to contain dissolved fentanyl in an amount sufficient to induce and maintain analgesia in a human for at least three days, said patch being completely free from a rate controlling membrane, said patch exhibiting a normalized C max of about 3.3 to about 82.5 ng/ml-(mg/h).
52. A monolithic transdermal patch for administering fentanyl, comprising an adhesive fentanyl reservoir on a backing layer, said reservoir comprising a single phase polymeric composition free of undissolved components containing a polyacrylate adhesive having sufficient solubility for fentanyl to contain dissolved fentanyl in an amount sufficient to induce and maintain analgesia in a human for at least three days, said patch being completely free from a rate controlling membrane, said patch exhibiting a standardized C max of about 0.01 to about 0.2 ng/ml-cm2.
53. The patch of claim 51 or 52 wherein said reservoir comprises an amount of dissolved fentanyl sufficient to induce and maintain analgesia for about 3 to about 7 days wherein fentanyl has a solubility of at least 4 wt% in said reservoir; the reservoir has a thickness of about 0.0125 mm (0.5 mil) to about 0.1 mm (4 mil); and said patch exhibits a steady state drug flux of about 1-10 µg/cm2/hr.
54. The patch of claim 51 or 52 wherein the reservoir comprises about 0.05 to about 1.75 mg/cm2 of fentanyl base.
55. A transdermal patch for administering sufentanil through the skin comprising:

(a) a backing layer;

(b) a reservoir disposed on the backing layer, at least the skin contacting surface of said reservoir being adhesive; said reservoir comprising a single phase polymeric composition free of undissolved components containing an amount of sufentanil sufficient to induce and maintain analgesia in a human for at least three days.
56. The patch of claim 55 wherein said reservoir is formed from an adhesive.
57. The patch of claim 56 wherein said patch exhibits a normalized C max of about 0.04 to about 10 ng/ml-(mg/h).
58. The patch of claim 56 wherein said patch exhibits a standardized C max of about 0.001 to about 0.05 ng/ml-cm2.
59. The patch of claim 57 or 58 wherein the patch exhibits a steady state drug flux of about 0.1 to about 10 µg/cm2/hr.
60. The patch of claim 55 wherein said reservoir comprises an amount of dissolved sufentanil sufficient to induce and maintain analgesia for about 3 to about 7 days.
61. The patch of claim 55 wherein sufentanil has a solubility of 1 wt% to 25 wt% in said reservoir.
62. The patch of claim 61 wherein the reservoir comprises about 0.05 to about 1.75 mg/cm2 of sufentanil base.
63. The patch of claim 62 wherein the reservoir comprises about 0.08 to about 1.25 mg/cm2 of sufentanil base.
64. The patch of claim 63 wherein the reservoir comprises about 0.1 to about 0.75 mg/cm2 of sufentanil base.
65. The patch of claim 64 wherein the reservoir comprises about 0.12 to about 0.5 mg/cm2 of sufentanil base.
66. The patch of claim 60 wherein the reservoir has a thickness of about 0.0125 mm (0.5 mil) to about 0.1 mm (4 mil).
67. The patch of claim 56 wherein said adhesive is a polyacrylate adhesive.
68. The patch of claim 67 wherein said polyacrylate adhesive has a T9 less than -10 °C.
69. The patch of claim 66 wherein the reservoir comprises about 0.05 to about 1.75 mg/cm2 of sufentanil base.
70. The patch of claim 69 wherein the reservoir comprises about 0.08 to about 1.25 mg/cm2 of sufentanil base.
71. The patch of claim 70 wherein the reservoir comprises about 0.1 to about 0.75 mg/cm2 of sufentanil base.
72. The patch of claim 70 wherein the reservoir comprises about 0.12 to about 0.5 mg/cm2 of sufentanil base.
73. The patch of claim 67 wherein the reservoir has a thickness of about 0.0125 mm (0.5 mil) to about 0.1 mm (4 mil).
74. The patch of claim 60 or 66 wherein the reservoir further comprises an enhancer.
75. The patch of any one of claims 55, 60 or 64 wherein the backing layer comprises a polymer selected from the group consisting of polyurethane, polyvinyl acetate, polyvinylidene chloride, polyethylene, polyethylene terephthalate (PET), PET-polyolefin laminates, and polybutylene terephthalate.
76. The patch of claim 75, wherein the backing layer comprises low density polyethylene (LDPE) materials, medium density polyethylene (MDPE) materials or high density polyethylene (HDPE) materials.
77. The patch of claim 76, wherein the backing layer comprises low density polyethylene (LDPE) materials.
78. The patch of claim 75 wherein the backing layer has a thickness of about 0.012 mm (0.5 mil) to about 0.125 mm (5 mil).
79. A transdermal patch for administering sufentanil, comprising an adhesive sufentanil reservoir on a backing layer; said reservoir comprising a single phase polymeric composition free of undissolved components containing a polyacrylate adhesive having sufficient solubility for sufentanil to contain dissolved sufentanil in an amount sufficient to induce and maintain analgesia in a human for at least three days, said patch exhibiting a normalized C max of about 0.04 to about 10 ng/ml-(mg/h).
80. A transdermal patch for administering sufentanil, comprising an adhesive sufentanil reservoir on a backing layer; said reservoir comprising a single phase polymeric composition free of undissolved components containing a polyacrylate adhesive having sufficient solubility for sufentanil to contain dissolved sufentanil in an amount sufficient to induce and maintain analgesia in a human for at least three days, said patch exhibiting a standardized C max of about 0.001 to about 0.05 ng/ml-cm2.
81. The patch of claim 79 or 80 wherein the patch exhibits a steady state drug flux of about 0.1 to about 10 µg/cm2/hr.
82. The patch of claim 79 or 80 wherein said reservoir comprises an amount of dissolved sufentanil sufficient to induce and maintain analgesia for about 3 to about 7 days.
83. The patch of claim 82 wherein said adhesive is a polyacrylate adhesive having a T g less than -10 °C; and sufentanil has a solubility of at least 1 wt% in said reservoir.
84. The patch of claim 83 wherein the adhesive reservoir has a thickness of about 0.0125 mm (0.5 mil) to about 0.1 mm (4 mil).
85. The patch of claim 84 wherein the reservoir comprises about 0.05 to about 1.75 mg/cm2 of sufentanil base.
86. The patch of claim 85 wherein the reservoir comprises about 0.08 to about 1.25 mg/cm2 of sufentanil base.
87. The patch of claim 86 wherein the reservoir comprises about 0.1 to about 0.5 mg/cm2 of sufentanil base.
88. A monolithic transdermal patch for administering sufentanil, comprising an adhesive sufentanil reservoir on a backing layer, said reservoir comprising a single phase polymeric composition free of undissolved components containing a polyacrylate adhesive having sufficient solubility for sufentanil to contain dissolved sufentanil in an amount sufficient to induce and maintain analgesia in a human for at least three days, said patch being completely free from a rate controlling membrane, said patch exhibiting a normalized C max of about 0.04 to about 10 ng/ml-(mg/h).
89. A monolithic transdermal patch for administering sufentanil, comprising an adhesive sufentanil reservoir on a backing layer, said reservoir comprising a single phase polymeric composition free of undissolved components containing a polyacrylate adhesive having sufficient solubility for sufentanil to contain dissolved sufentanil in an amount sufficient to induce and maintain analgesia in a human for at least three days, said patch being completely free from a rate controlling membrane, said patch exhibiting a standardized C max of about 0.001 to about 0.05 ng/ml-cm2.
90. The patch of claim 88 or 89 wherein said reservoir comprises an amount of dissolved sufentanil sufficient to induce and maintain analgesia for about 3 to about 7 days wherein sufentanil has a solubility of at least 1 wt%
in said reservoir; the reservoir has a thickness of about 0.0125 mm (0.5 mil) to about 0.1 mm (4 mil); and said patch exhibits a steady state drug flux of about 0.1 to about 10 µg/cm2/hr.
91. The patch of claim 90 wherein the reservoir comprises about 0.05 to about 1.75 mg/cm2 of sufentanil base.
92. The patch of claim 1 which is pharmacologically equivalent to DURAGESIC® transdermal fentanyl system.
93. The patch of claim 55 which is pharmacologically equivalent to DURAGESIC® transdermal fentanyl system.
CA2440884A 2001-03-16 2002-03-15 Transdermal patch for administering fentanyl Expired - Lifetime CA2440884C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US27683701P 2001-03-16 2001-03-16
US60/276,837 2001-03-16
PCT/US2002/007701 WO2002074286A1 (en) 2001-03-16 2002-03-15 Transdermal patch for administering fentanyl

Publications (2)

Publication Number Publication Date
CA2440884A1 true CA2440884A1 (en) 2002-09-26
CA2440884C CA2440884C (en) 2012-05-22

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ID=23058257

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2440884A Expired - Lifetime CA2440884C (en) 2001-03-16 2002-03-15 Transdermal patch for administering fentanyl

Country Status (22)

Country Link
US (11) US20030026829A1 (en)
EP (1) EP1381352B1 (en)
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