OraDisc™A (amlexanox 2mg)
Erodible muco-adhesive disc for aphthous ulcers
ULURU Inc. 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.
About OraDisc™ B (benzocaine 15mg)
For treatment of oral pain
OraDisc™ B is a mucoadhesive erodible disc containing 15 mg of benzocaine which has been developed for the treatment of oral pain. The following charts demonstrate the dissolution profile of benzocaine in the OraDisc™ technology:
In addition, the collective assay results for both aged and fresh samples, prototype and preproduction, show no significant differences and remain well within specification.
A benzocaine disc represents a major advance in the treatment of oral pain, by providing a controlled amount of local anesthetic to the covered area without numbing the tongue and other parts of the oral cavity. This product will seek OTC regulatory status.
About OraDisc™ W
Erodible whitening strip for teeth
ULURU Inc. has developed an innovative, patented delivery strip for whitening teeth which completely erodes. ULURU’s proprietary tooth whitening product consists of a laminated bilayer strip that utilizes the OraDisc™ technology. The layer which is applied to the teeth contains hydrophilic polymers and the active whitening ingredient, while the outer layer consists of a blend of hydrophilic and hydrophobic polymers. The residence time of the strip on the teeth is controlled through the formulation. The outer layer serves to resist leakage of the active whitening agent into the oral cavity.
ULURU’s teeth whitening strip is designed to be more user friendly in terms of ease of application with improved aesthetic qualities. In controlled in vitro testing on extracted bovine teeth, the erodible whitening strip provided both superior and rapid speed of whitening compared to the market leader. When applied to the teeth and moisture is absorbed, the ULURU whitening strip completely erodes so that consumers do not have to remove the whitening strip after use. ULURU’s erodible whitening strip is designed to provide an exact amount of whitening agent to the tooth surface for a specific length of time, thus minimizing one of the major safety concerns associated with whitening agents.