VITA-HYAL oral mucosa protector

Lesions of the oral mucosa due to radiation or chemotherapy of malignant tumors (radiation mucositis or stomatitis) are quite painful for the patient – since eating becomes a very painful process. Oral mucositis also negatively affects the results of therapy – the patient 5-year survival rate, since radiation or chemotherapy must be interrupted for a period sufficient for the healing of the damaged oral mucosa. Therapy interruption, even for one day, significantly worsens its results, i.e. patient survival. Preparations of artificial saliva ("Caphosol") or hyaluronic acid ("Mucosamin", "Gelclair") are actively used abroad for the protection and restoration of the oral mucosa. In Russia, these medicinal product are either unavailable or very expensive. Therefore, we decided to develop and release a Russian product for the protection and restoration of the oral mucosa based on hyaluronic acid. We fundamentally refused to silent copy and create an analogue of "Mucosamin", since "RIVIERA BIOTECH" has more than 10 years of experience in developing epithelial protectors and we know well how best to restore and protect various types of epithelium of the human body.

The logic behind the development of our oral mucosa protector, which received the name "VITA-HYAL", was based on the following postulates:

1. Radiation or chemotherapy destroys the protective barrier of the oral mucosa, which consists of high molecular weight hyaluronic acid and chondroitin sulfate
2. Radiation or chemotherapy destroys the so-called intercellular matrix, which fills the spaces between the cells of the epithelium of the oral cavity and which protects the so-called tight contacts connecting the cells of the epithelium of the oral cavity. The intercellular matrix consists of low molecular hyaluronic acid.
3. The destruction of these protective barriers leads to the penetration of substances from the oral cavity into the submucous layer and to the exposure on the nerve endings – that is, to the pain.
4. The constant exposure to substances from the oral cavity on the nerve endings causes chronic non-infectious inflammation, which is then associated with an infection caused by bacteria from the oral cavity.
5. Radiation therapy causes damage to the salivary glands with the development of hyposalivation. This means that saliva stops "flushing" the pathogenic contents of the oral cavity, as well as bacteria.

The composition of "VITA-HYAL" is specially formulated for solving these problems:

• Hyaluronic acid from the well-known manufacturer Bloomagefreda Biopharm with a molecular weight of 1.8 MDa is used to restore the surface protective layer of the oral mucosa
• Low molecular super active Micro – HA: 5,000 Da – to restore the extracellular matrix and reduce inflammation of the oral mucosa
• Cationic hyaluronic acid: a complex of hyaluronic acid and the Polyquaternium cation – 10 is used to prolong the action of VITA-HYAL (since cationic hyaluronic acid "attaches" to the oral mucosa due to different polarities). In addition cationic hyaluronic acid moisturizes the oral mucosa and has an anti-inflammatory effect.

VITA-HYAL has demonstrated its efficacy in patients with radiation and chemotherapeutic lesions of the oral cavity:

• Reduced pain syndrome
• Regeneration of oral cavity ulcerative lesions accelerates
• Decreased dry mouth

In patients with radiation therapy who receive VITA-HYAL, the percentage of those who need to temporarily stop radiation therapy due to its complications is significantly lower. Currently, RIVIERA BIOTECH is developing VITA-HYAL for the protection and restoration of the oral mucosa based on hyaluronic acid and chondroitin sulfate, as well as on the basis of hyaluronic acid and sodium alginate.