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.

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.

The main features of the OraDisc™ technology are:

• Novel, patented, multi-layered, mucoadhesive, water erodible film pharmaceutical carrier device.

• 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.

• Film can be composed of 2-4 layers to provide multiple release profiles.

• Multilayer erodible film is composed of both hydrophobic and hydrophilic polymers in the controlled erosion layer and hydrophilic polymers in the mucoadhesive layer.

• Up to 50mg of an active substance or flavor can be incorporated in a 50mg disc, approximately 450 microns in thickness and 11/16 “ (1 75 cm) in diameter.

• Blood levels of active can be achieved more effectively and faster, as the drug enters directly into the blood vessels beneath the mucosa.

• Technology has been validated through the development and FDA approval of OraDisc™ A, a product for the treatment of aphthous ulcers (canker sores).

The relationship between “Residence Time” and coating thickness and composition of the backing layer are shown in the following graph:

The pK profiles for a model drug incorporated in OraDisc™ versus a lactose tablet containing the active is shown in the following table:

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.