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Transmucosal Drug
Delivery (OraDisc™) |
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Description: |
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ULURU Inc. has
developed a novel, patented, cost-effective,
commercially-viable, water-erodible pharmaceutical carrier
device. The multi-layered device as shown below is applied to
mucosal surfaces, adheres immediately, delivering actives to
treat specific localized diseases/disorders. OraDisc™
technology can deliver drugs systemically across the mucosal
surface or for the release of drugs into the oral cavity. The
device causes minimum discomfort, is easy to apply and capable
of providing tailored erosion rates to deliver therapeutics
over different time intervals. |
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The erosion time,
or “Residence Time”, can be easily regulated, from 15 minutes
to over three hours, by simple compositional changes and/or
coating thicknesses of the backing layer and mucoadhesive
layer. |
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The main features
of the OraDisc™ technology are: |
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Novel, patented,
multi-layered, mucoadhesive, water erodible film
pharmaceutical carrier device.
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Mucoadhesive
film device is applied to the mucosal surface, adheres
immediately, delivering actives systematically to the
mucosal surface, into the oral cavity or the surfaces of the
teeth or gums.
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Film can be
composed of 2-4 layers to provide multiple release profiles.
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Multilayer
erodible film is composed of both hydrophobic and
hydrophilic polymers in the controlled erosion layer and
hydrophilic polymers in the mucoadhesive layer.
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Up to 20mg of an
active substance or flavor can be incorporated in a 50mg
disc, approximately 250 microns in thickness and 9/16” in
diameter.
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Technology has
been validated through the development and FDA approval of
OraDisc™ A, a product for the treatment of aphthous ulcers
(canker sores).
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The relationship
between “Residence Time” and coating thickness and composition of the backing layer are shown in the
following graphs: |
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Active compounds
can be incorporated into any layer for multiple release
profiles. For topical and primarily unidirectional delivery,
the drug is formulated in the adhesive layer. For cavity
delivery, the drug is formulated in the backing layer and/or
the preformed polymer film. |
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