RU2362552C1 - Preparation for replacement therapy at dry mouth - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention concerns preparations for replacement therapy at dryness in an oral cavity (xerostomia), namely to the preparation of the artificial saliva including 99% of structured water, electrolytes: Na⁺ 0.3 g/l; K⁺ 1 g/l; Ca²⁺ 0.05 g/l; Mg²⁺ 0.01 g/l; Cl^- 0.1 g/l; (PO)₄ ^3- 0.1 g/l and organic substances: 0.5% solution of carboxymethyl cellulose and 0.3-0.5% solution of alginic acid as a thickener, urea in amount of 5 mmol/l. The given preparation is compositionally similar to natural saliva.

EFFECT: improved characteristics.

Description

The invention relates to medicine, specifically to drugs for replacement therapy for dry mouth (xerostomia).

Xerostomia or dry mouth syndrome is a condition that is clinically diagnosed by secretion of unstimulated saliva below 0.2 ml / min. However, many patients complain of xerostomia in the absence of clinically proven dryness, i.e. true and false xerostomia exists. Symptoms of xerostomia may appear in patients with normal saliva secretion as a result of emotional stress, neurosis, and also breathing through the mouth. A patient with dry mouth symptoms may experience varying degrees of inhibition of function: from a slight decrease in saliva secretion with temporary inconvenience to a complete lack of secretion with acute difficulty in speaking, chewing food, swallowing, and digesting. It is likely that patients with xerostomia will experience other problems that are the primary cause of their complaints. These problems are: a burning sensation and tingling sensations, especially in the tongue; cracks, wounds, ulcers on the lips, including the corners of the mouth; ulceration of the oral cavity; need for frequent drinking of water, especially at night; difficulties with wearing dentures; loss of taste; difficulty swallowing. Xerostomia often causes an increase in caries, an increase in injuries of the mucous membranes, swelling of the salivary glands and candidiasis of the oral cavity. Xerostomia can lead to the appearance of conditions such as stomatitis, periodontitis, an increased risk of infections of the oral cavity. Also, patients may experience extraoral symptoms associated with xerostomia and hypofunction of the salivary glands, such as: dry throat; blurred vision, burning sensations, itching, and sand entering the eyes, which leads to regular use of eye drops; dry nasal cavity; dry skin, as well as frequent constipation.

The urgency of solving this problem is great, since dentists very often have to encounter complaints of patients associated with xerostomia at a clinical appointment.

Clinically, xerostomia and hypofunction of the salivary glands can be manifested by the following symptoms:

- loss of luster of the oral mucosa;

- dryness of the oral mucosa;

- a feeling of thinness and pallor of the oral mucosa;

- the appearance of fissures and lobules on the back of the tongue;

- angular cheilitis / cheylosis;

- candidiasis, especially in the tongue and palate;

- dental caries: increased intensity, localization on surfaces that are usually resistant to damage;

- more viscous and viscous mixed saliva;

- the difficulty of obtaining saliva from the ducts of the large salivary glands;

- swelling of the salivary glands.

Symptoms of xerostomia significantly affect the quality of life of this category of patients, and therefore, patients with xerostomia need help and correction of this condition. The percentage of the population suffering from xerostomia, therefore, and the circle of potential consumers of artificial saliva, is large, it includes patients using xerogenous course drugs (among them: analgesics, anticholinergics, anorexigenic and antihistamines, antidepressants, psychotropic and antihypertensive drugs, diuretics and medicines for Parkinsonism treatment), patients exposed to treat oral cancer, and after general exposure. Xerostomia is closely associated with a number of systemic diseases and conditions. Some of them cause progressive destruction of the parenchyma of the glands and this in most cases is already irreversible.

Other systemic diseases can affect the vessels or nerves, which is transient in nature, and the process is reversible. These are rheumatoid conditions (sometimes called collagen vascular, connective tissue or autoimmune disorders), hyposecretory conditions, certain widespread diseases, such as hypertension, diabetes mellitus, cystofibrosis, some neurological conditions, depression and dehydration. The prototype of rheumatoid conditions is Sjögren's syndrome. Decreased chewing or decreased masturbation (liquid diet, soft foods) also lead to atrophy of the salivary glands and a decrease in the rate of salivation.

It should be noted that the treatment of xerostomia varies somewhat depending on the reasons that caused it. Now there are several methods of choice for protecting the oral cavity from the damaging effects of the inadequate functioning of the salivary glands and for relieving the patient's state of discomfort. The decisive consideration in choosing the appropriate treatment is the correct assessment of the degree of violation of the patient's salivary glands. Stimulation of secretion is the optimal approach to a patient who still retains some of the function of the glands. Patients whose residual functions of the salivary glands are insufficient to obtain a positive stimulation effect should receive symptomatic treatment to relieve and relieve dry oral cavity.

In 1981, I.F.Romacheva, L.A. Yudin, T.S. Kondratieva, et al. / Link / created the artificial saliva drug “bensinol”, intended for replacement therapy in patients with dry mouth (xerostomia). The composition of the known drug: potassium chloride, sodium chloride, magnesium sulfate, dimethyldodecylbenzylammonium chloride, methyl cellulose, trimecaine, phosphate buffer. This drug had unsatisfactory consumer properties (too thick and viscous), which caused unpleasant sensations in patients during and after its use, as a result of which "bensinol" was not widely used. Also, during the production of the drug "bensinol", the authors encountered a number of technological problems that did not allow further production of the drug to continue. Currently, the preparation of artificial saliva "bensinol" is not produced and is not available for sale.

There are currently no other similar drugs for replacement therapy in patients with dry mouth in the Russian and foreign markets.

The aim and main objective of the claimed invention is the desire to help patients with symptoms of dry mouth. To achieve our goal, an artificial saliva preparation was developed with a composition, quality properties and price characteristics that are different from previously known drugs. This preparation is similar in composition to natural saliva, and therefore, it is absolutely inert and safe for the microflora of the oral cavity and the body as a whole and can be used for replacement therapy with xerostomia. This preparation of artificial saliva, as well as natural, is 99% water. The remaining 1% is composed of small molecules of organic substances (cellulose derivatives and urea) and electrolytes (mainly potassium, sodium, calcium, chloride and phosphates).

The proposed drug for replacement therapy for dry mouth (xerostomia) Saliva-plus - a preparation of artificial saliva, as well as natural, consists of 99% water. The remaining 1% is composed of small molecules of organic substances (cellulose derivatives and urea) and electrolytes (mainly potassium, sodium, calcium, chloride and phosphates).

The formulation of the artificial saliva preparation:

- 0.5% r-r carboxymethyl cellulose / 0.3-0.5% r-r alginic acid (a natural polysaccharide that provides saliva viscosity) - to the required consistency

- Urea 5 mmol / l - Na ⁺ 0.3 g / l - K ⁺ 1 g / l - Ca ²⁺ 0.05 g / l - Mg ²⁺ 0.01 g / l - Сl ^- 0.1 g / l - (PO) ₄ ^3- 0.1 g / l - Food preservative

The common recognition of Saliva-plus with the artificial saliva preparation “bensinol” is the presence of mineral components: potassium chloride, sodium chloride, phosphate buffer. The main differences between the saliva-plus artificial saliva preparation and the well-known drug are as follows:

1. The composition of the formulation may vary depending on the individual characteristics of the chemical composition and qualitative characteristics of the patient's natural saliva (individual selection of the composition of the drug is possible).

2. Introduction to the composition of urea, which is also found in natural saliva.

3. The use of cellulose derivatives as a thickener to improve the consumer properties of the product (0.5% solution of carboxymethyl cellulose / 0.3-0.5% solution of alginic acid is a natural polysaccharide that provides saliva viscosity).

4. The manufacture of this drug based on structured water, which will improve the quality characteristics and have a beneficial effect on the patient's body as a whole.

5. The use of nanotechnology to obtain a homogenized mixture of the drug, which also affects the consumer characteristics of this drug.

Claims (1)

Artificial saliva preparation, including 99%
structured water, electrolytes:
Na ⁺ 0.3 g / l;
K ⁺ 1 g / l;
Ca ²⁺ 0.05 g / l;
Mg ²⁺ 0.01 g / L;
Cl ^- 0.1 g / l;
(PO) ₄ ^3-1.1 g / l ;
and organic matter:
0.5% solution of carboxymethyl cellulose and 0.3-0.5% solution of alginic acid as a thickener, urea in an amount of 5 mmol / L.