Amorphous drug transdermal systems, manufacturing methods, and stabilization
First Claim
Patent Images
1. A transdermal delivery device comprising:
- a) a backing layer,b) an adhesive matrix layer comprising a supersaturated concentration of at least one active agent substantially in amorphous form within said adhesive matrix, andc) a release liner.
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Abstract
The present invention refers to a transdermal delivery device comprising a backing layer, an adhesive matrix layer comprising a supersaturated concentration of an active agent substantially in amorphous form within the adhesive matrix, and a release liner. The present invention also refers to a method of preparing an adhesive matrix containing at least one supersaturated active agent substantially in amorphous form. Further, the present invention refers to a method to stabilize and a method to reestablish the meta-stable amorphous-drug transdermal system during its manufacturing, storing, shipping and handling process.
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Citations
118 Claims
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1. A transdermal delivery device comprising:
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a) a backing layer, b) an adhesive matrix layer comprising a supersaturated concentration of at least one active agent substantially in amorphous form within said adhesive matrix, and c) a release liner. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A transdermal delivery device comprising:
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a) a backing layer, b) an adhesive matrix layer comprising a supersaturated concentration of oxybutynin substantially in amorphous form within said adhesive matrix, and c) a release liner. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54)
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55. A transdermal delivery device comprising:
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a) a backing layer, b) an adhesive matrix layer comprising a supersaturated concentration of an active agent substantially in amorphous form within said adhesive matrix, and c) a release liner, wherein said active agent is selected from the group consisting of piroxicam, fentanyl, naltrexone, scopolamine and a steroid. - View Dependent Claims (56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82)
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83. A method of preparing an adhesive matrix containing at least one active agent that is supersaturated and present in amorphous form comprising:
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a) dissolving said at least one active agent and an adhesive material in a solvent in an amount so as to provide said at least one active agent at a subsaturated concentration in an adhesive matrix solution, b) casting said subsaturated active agent in said adhesive matrix solution to one of a release liner and a backing layer, c) removing said solvent at a temperature which is at, below, or above the melting point of said at least one active agent to form a dry adhesive matrix in which said at least one active agent is in a supersaturated concentration, and d) laminating the other of said release liner and said backing film to said supersaturated active agent in said dry adhesive matrix, so that said supersaturated active agent in said dry adhesive matrix is between said release liner and said backing layer. - View Dependent Claims (84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95)
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96. A method of preparing an adhesive matrix containing at least one active agent that is supersaturated and present in amorphous form comprising:
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a) admixing said at least one active agent with an adhesive matrix at a supersaturated concentration, b) heating said supersaturated concentration of said at least one active agent in said adhesive matrix to a temperature which allows said at least one active agent to be completely dissolved and uniformly dispersed in said adhesive matrix to create a hot melt, c) casting said hot melt to one of a release liner and a backing layer, at a predetermined temperature, and d) laminating the other of said release liner and said backing layer to said hot melt, so that said hot melt is between said release liner and said backing layer. - View Dependent Claims (97, 98, 99, 100, 101, 102, 103, 104, 105, 106)
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- 107. A method of removing crystallization nuclei and reestablishing the favored internal adhesive matrix environment of a transdermal drug delivery device having a backing layer, an adhesive matrix layer having a supersaturated concentration of an active agent substantially in the amorphous form within said adhesive matrix layer, and a release liner, said method comprising curing said transdermal delivery device.
- 114. A method of storing and protecting a transdermal delivery device having a backing layer, an adhesive matrix layer comprising a supersaturated concentration of at least one active agent substantially in amorphous form within said adhesive matrix, and a release liner said method comprising packaging said transdermal delivery device in a pouch.
Specification