New muco-adhesive patch may help treat oral disorders

A newly developed time-released muco-adhesive patch for treating oral health conditions, including the widespread condition of dry mouth (xerostomia), has been shown to be more effective than a leading oral rinse, according to a newly-published study. As increasing segments of the population consume more medications (one of the leading causes of dry mouth), the results of this study could potentially help provide relief for millions of Americans. Chronic dry mouth impacts the quality of life and for some, can be debilitating.

Published in the March 2010 issue of Quintessence International, the study found that chronic dry mouth sufferers can now get a statistically significant reduction of mouth dryness from a new time-released muco-adhesive patch (OraMoist Dry Mouth Patch), compared with the leading oral rinse which has been on the market for nearly two decades.

Overall, patients with xerostomia treated with the muco-adhesive patch reported a statistically significant reduction in mouth dryness sensation with elevated salivary flow rate (150%) after just 30 minutes, which was considered clinically outstanding by the study authors, since the product does not contain any cholinergic agonist, a drug often used to treat dry mouth.

OraMoist, a new time-released, non-drug formula, not only outperformed the mouthwash, one of the most often used delivery formats for treating dry mouth, but unlike dry mouth sprays, rinses or gels, which need to be applied frequently - sometimes every 20 minutes - OraMoist works to increase moisture and help restore a healthy oral environment for hours at a time, day or night, and can even be used by those with dental appliances, such as dentures. It moistens and lubricates the mouth with time-released lipids, citrus oil and sea salt, while simultaneously stimulating saliva production and inhibiting bacterial growth and promoting oral health with enzymes and xylitol.

"Oral disorders such as dry mouth and canker sores require long residence of the active remedy in the mouth or the disease site for effective treatment. Muco-adhesive patches made of safe ingredients that adhere to the oral mucosal tissue and slowly erode while releasing active remedies for two to six hours provide the desired residence time for effective therapy," said Professor Abraham J. Domb, PhD, Institute of Drug Research, School of Pharmacy, Faculty of Medicine at the Hebrew University, co-author of the new published study, inventor of the muco-adhesive time-released patch and world-renowned for his work in biodegradable polymers. "This novel approach of time-released delivery has proven to be a successful and desirable approach to treating chronic conditions that affect millions of people, and can be disruptive to their lifestyle."

The evolution of the muco-adhesive patch has found commercial viability in treating canker sores as well because the patch can also act as a bandage for the sores for eight to twelve hours while releasing active remedial ingredients.

Dry mouth affects upwards of 17% of the population, increasing in older adults (65 years and older) to about 30%. In fact, 34% of people taking three or more medications suffer from dry mouth, which is also a chronic symptom of numerous medical conditions, such as diabetes and Sjogren's Syndrome.

Study Findings
The objective of this study was to evaluate a muco-adhesive lipid-based bioerodable patch as a novel device to decrease signs and symptoms associated with dry mouth, compared to the leading oral rinse. The study consisted of 20 patients who suffered from dry mouth for more than three months as a result of medical conditions, who were divided into two treatment groups - oral rinse and muco-adhesive patch.

•The questionnaires completed prior to treatment showed no statistically significant differences between the groups
•Following treatment, 40% of muco-adhesive patch users reported significantly more moisture and a reduction in the sensation of dry mouth vs. 20% of the leading mouthwash users
•There was a 1.5-fold increase in unstimulated whole saliva flow (UWSF) after 30 minutes in the group using the muco-adhesive patch
•In addition, 70% of patients treated with the muco-adhesive patch reported they would continue using the product in the future, compared to only 30% who would continue using the leading mouthwash