About Orafate™
What is Orafate™
Orafate™ is a patented high potency re-formation of sucralfate cleared in August 2013
by the FDA as a medical device to be marketed for the management of oral wounds and
inflammation. Mueller Medical International has determined to promote Orafate™ as
a medicament to treat gingivitis and oral wounds due to tooth extraction.
Orafate's™ high potency sucralfate gel contains standard potency sucralfate that
have been reversibly cross-linked into “sucralfate sheets”. The configuration within
“sucralfate sheets” induces ordinary sucralfate to layer on mucosa as stacked sheets
which enhances sucralfate binding and surface concentration by multiple folds.
Orafate™ - How it Works
When mucosal lining or the gingival surfaces of the mouth are inflamed or infected,
a maintenance system is deployed. This maintenance system is referred to as the
epithelial cytoprotective system, and it is responsible in maintaining the integrity
of the mucosa lining. This system works hard to limit injury, minimize inflammation,
ulcerations and infection. However in certain circumstances of disease it is inadequate.
The key element that govern the process of healing and reversal of inflammation are
growth factors, growth factor receptors and cytokines. Orafate™ engages these
elements by binding to growth factors and driving them to their receptor sites,
activating these sites that in turn coordinate cytokines responsible for
restoration and healing.
Three hours following administration Orafate™ achieves and maintains a surface
concentration of sucralfate that is 800-2400% beyond generic sucralfate.
Disease Target of Orafate™
Primary Target: Oral Post-Surgical Oral Wounds
Oral Periodontitis and Gingivitis in connection with probe, scaling
and root planing
Other Targets: Oral wounds caused by
(a) caustic chemical ingestion
(b) thermal (hot scalding) wound or burn
(c) traumatic injury or laceration
(d) blistering, ulcerations, erosions from virus, bacteria or
fungus
Patient Populations for Orafate™
1. Patients suffering from oral wounds from dental extractions, tonsillectomies or
uvuloplastic surgery.
2. Patients with gingivitis & periodontal disease who have had teeth cleaning,
scaling and root planning.
3. Patients suffering from traumatic oral injury or laceration.
4. Patients suffering from blisters, ulcerations or erosions from infection.
5. Patients with thermal oral burn.
6. Patients with caustic, chemical or acid burns to the mouth.
Clinical Effects of Orafate™ on Mucosa
There are four main effects of Orafate on Oral Wounds:
1. Wound healing.
2. Reversal of Gingival and Periodontal inflammation
3. Hemostasis of venous or capillary bleeding
4. Pain Elimination/Reduction.
Similarities with Other Oral Mucosal Products
Only Orafate™ simultaneously facilitate healing by 366%, reverse gingival and
periodontal inflammation without antibiotics/harsh chemicals, minimize associated
pain, stop venous and capillary bleeding.
