OraDisc™A-(amlexanox 2mg) Erodible Mucoadhesive Disc for Aphthous Ulcers

ULURU has developed OraDisc™ A, a novel mucoadhesive, water-erodible disc incorporating 2mg of amlexanox for the treatment and prevention of aphthous ulcers. OraDisc™ is a polymer solid dosage form used to deliver amlexanox to the mucosal tissue. The thin, flexible, biodegradable composite film is composed of a backing layer attached to a layer which contains both the mucosal adhesive polymers and amlexanox. Once OraDisc™ A is in contact with the mucosal tissue, the properties of the mucoadhesive polymers assure the adhesion of the disc to the moist mucosa. While adhering to the mucosal tissue, the polymer absorbs moisture, commences disintegration while delivering the active drug amlexanox into the lesion. Complete erosion and drug release occurs in less than 60 minutes. OraDisc™ A has been FDA approved.

OraDisc™ A dosage form is designed to be more acceptable to the patient in terms of ease of application, retention over the affected site, taste and its aesthetic qualities. The advantages of the OraDisc™ A dosage form are:

• More concentrated delivery of amlexanox to the aphthous ulcer.
• Disc dosage form will limit delivery of amlexanox to a small surface area.
• OraDisc™ backing will help to retain the active drug substance at the site of the aphthous ulcer for a longer period.

Utilizing the OraDisc™ dosage form with amlexanox, it is anticipated that higher concentrations will be achieved at the site of administration and thus, potentially increasing the effectiveness of the product.