Dissolvable backing layer for use with a transmucosal delivery device
First Claim
1. A dissolvable backing layer for use with a transmucosal delivery device adapted for placement against mucosa, comprising:
- a hydrophilic region comprising at least one hydrophilic polymer that is adapted to dissolve over time when exposed to moisture; and
a non-hydrophilic region at least partially encapsulated within said hydrophilic region and that is adapted to at least partially inhibit migration of water, active agents or other molecules through the backing layer and that is adapted to disperse when no longer encapsulated within said hydrophilic region.
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Accused Products
Abstract
A dissolvable backing layer for use with transmucosal drug delivery devices includes a dissolvable hydrophilic region and a non-hydrophilic region that inhibits or slows migration of water, drugs, other active agents, or other molecules through the backing layer. The non-hydrophilic region can be a disperse phase of gaseous voids, droplets of a hydrophobic liquid, solid particles of a hydrophobic material, or water insoluble particles that are not necessarily hydrophobic. In the alternative, the non-hydrophilic region may comprise a continuous layer or component that is readily dispersible upon dissolving of the hydrophilic region. The backing layers may be used within any transmucosal delivery device used to delivery drugs or other active agents across a mucosal surface.
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Citations
60 Claims
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1. A dissolvable backing layer for use with a transmucosal delivery device adapted for placement against mucosa, comprising:
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a hydrophilic region comprising at least one hydrophilic polymer that is adapted to dissolve over time when exposed to moisture; and a non-hydrophilic region at least partially encapsulated within said hydrophilic region and that is adapted to at least partially inhibit migration of water, active agents or other molecules through the backing layer and that is adapted to disperse when no longer encapsulated within said hydrophilic region. - 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, 28, 29, 30, 31, 32, 33, 34, 35)
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36. A dissolvable backing layer for use with a transmucosal delivery device adapted for placement against mucosa, comprising:
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a hydrophilic region comprising gelatin and glycerin and that is adapted to dissolve over time when exposed to saliva; and gaseous voids comprising a disperse phase encapsulated within said hydrophilic region in a manner so as to at least partially inhibit migration of water, active agents or other molecules through said backing layer, said backing layer comprising a sheet or film having a thickness in a range of about 0.1 mm to about 5 mm. - View Dependent Claims (37, 38, 39, 40, 41)
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42. A dosage form adapted for transmucosal delivery of an active agent comprising:
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an active layer comprising at least one active agent; and a dissolvable backing layer sized and configured so as to cover a side of said active region, said backing layer comprising; a hydrophilic region comprising at least one hydrophilic polymer that is adapted to dissolve over time when exposed to moisture; and a non-hydrophilic region at least partially encapsulated within said hydrophilic region that is adapted to at least partially inhibit migration of said active agent through said backing layer and that is adapted to disperse when no longer encapsulated within said hydrophilic region. - View Dependent Claims (43, 44, 45, 46, 47, 48, 49, 50, 51)
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52. A method for delivering an active agent across mucosa, comprising:
placing a transmucosal delivery against a mucosal surface, said transmucosal delivery device comprising; an active layer comprising at least one active agent; and a dissolvable backing layer sized and configured so as to cover a side of said active region, said backing layer comprising; a hydrophilic region comprising at least one hydrophilic polymer that is adapted to dissolve over time when exposed to saliva; and a non-hydrophilic region at least partially encapsulated within said hydrophilic region that is adapted to at least partially inhibit migration of said active agent through said backing layer and that is adapted to disperse when no longer encapsulated within said hydrophilic region; and allowing said transmucosal delivery device to remain against said mucosal surface so as to provide a desired treatment. - View Dependent Claims (53, 54, 55, 56, 57, 58, 59, 60)
Specification