Development

Science and the Invention of Bocaliner™

Learn about the science behind our product and how Bocaliner could help your oral mucositis

Topical treatments such as mouthwashes and gels are often used to treat patients with oral mucositis. These treatments are used to lessen the pain of oral mucositis, to improve mucosal healing and to help patients to keep up with their nutrition. Unfortunately, topical treatments only stay in the mouth for a very short time. In fact, our studies show that some of these treatments usually remain in the mouth for just a few minutes. Scientific studies that we have performed here at E2Bio Life Sciences have shown that Bocaliner increases the time that topical treatments for oral mucositis stay inside of the mouth. When topical treatments stay longer in the mouth, they will have more contact with the lining of the mouth. The extra time that the medications stay in contact with the oral lining will allow them to work better on those areas that are affected by oral mucositis.

Bocaliner works by two mechanisms. First, Bocaliner provides a cover over some areas that are affected by oral mucositis. Second, Bocaliner blocks saliva from diluting these gels and mouthwashes once they are inside of the mouth. This probably occurs because the mouth is normally bathed by saliva and medications are rapidly washed off by circulating saliva. Using the device, the openings for the parotid duct that drains the parotid gland as well as the openings for the ducts of a number of minor salivary glands are covered, so saliva pools at the lower parts of the mouth simply by the effect of gravity. This reduces bathing of the tongue and other parts of the mouth, including the cheeks. In turn, this lessens the effect of circulating saliva from diluting topical medications that are present in the mouth and used for treatment of oral mucositis. We have shaped the design of our device such that the openings of the ducts of a number of these salivary gland are covered, to enhance this mechanism. Here is a graphic showing the parotid and submandibular glands:

Since more medication stays in contact with the lining of the mouth, these treatments have a chance to work better for pain control, and healing of mouth sores. Bocaliner may also provide patients with more symptom control and a better opportunity to keep up with their nutrient requirements. We did some proof of concept studies with the device and hopefully the information that we obtained will be helpful for you to understand how Bocaliner works.

The graphs below show what happens to a topical gel called alginate when it is placed in the mouths of normal volunteers. Each graph shows how the alginate gel is retained inside of the mouth with and without the use of the Bocaliner. The amount of alginate in the mouth over time is indicated by the lines on the graphs. As can be seen in the graphs, when alginate gel is placed in the mouth, it leaves the mouth very quickly and is gone within 10-14 minutes . When the Bocaliner device is placed in the mouth after the application of alginate gel, the time that the gel stays in the mouth is 2 to 2 ½ times longer. The graphs also show that when Bocaliner is used, twice the amount of alginate gel is retained in the mouth.

How Bocaliner Could Prolong the Effects of Medications for Oral Mucositis

We have data on a normal volunteer that measured the numbing effect of the tongue of viscous lidocaine, a local anesthetic that is commonly used for the pain of oral mucositis. We studied the effect of wearing Bocaliner compared to not using the device on the severity of numbness of the tongue. The device markedly increased the numbing effect of lidocaine on the tongue, even though it does not cover the tongue. Here is a graphic showing the parotid and submandibular glands:

Pharmacokinetic parameters based on curve fitting to two phase equation (plateau followed by exponential decay)