Antiseptic pharmaceutical composition for oral hygiene and treatment of microbial oral diseases

FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions refers to an antiseptic pharmaceutical composition applicable for oral hygiene and treatment of microbial oral diseases, to a method for producing and using it. The composition contains from 0.05 to 0.3 wt % of hydrogen peroxide or its equivalent amount in the form of carbamide peroxide, from 0.001 to 0.03 wt % of eugenol, from 0.001 to 0.01 wt % of camphor, from 0.001 to 0.5 wt % of a salt of zinc or other heavy metals, such as silver, mercury, copper or a mixture thereof; from 1 to 1.2 wt % of sodium fluoride; from 2% to 7 wt % of xylitol, from 0.002 to 0.05 wt % of cetylpyridinium chloride and excipients in an amount sufficient to reduce the composition to 100%. The composition possesses a wide spectrum of action. What is also presented is a method for producing the composition and using it for producing a therapeutic agent effective for odour elimination, suppression and relief of an oral inflammation, dental tartar inhibition; for treating oral diseases; for rinsing and treating orthodontic damages; for preventing oral diseases during orthodontic treatment after oral operations and in the patients using fixed and temporary dentures; for relieving, treating or preventing oral diseases in different categories of patients, such as the patients receiving radiation therapy or chemotherapy, hospital patients and terminally ill patients, patients suffering from eating disorders, endocrine, haematological, cardiovascular and psychosomatic disorders, and besides physically or mentally deprived patients, patients with genetic or inherited changes.

EFFECT: preparing the antiseptic pharmaceutical composition.

22 cl, 3 ex

 

Field of the invention

The present invention relates to pharmaceutical compositions for oral use, antiseptic action, broad-spectrum, in the form of a liquid for rinsing of a mouth or in other forms, which are useful for the prevention or treatment of oral diseases caused by microorganisms.

The vast majority of oral diseases caused by microorganisms present in the oral cavity. The most common are, among other things, dental caries, gum disease and halitosis, and to a lesser extent the inflammation of the mucous membrane candidiasis, thrush. These infectious diseases can be the condition of the oral cavity 80% or more of the world's population, and recent studies have revealed that the cost of their treatment is more than 10% of per capita income.

Given the scale and global impact of these diseases, especially dental caries and gingivitis, it is highly discouraging that more effective therapeutic ways and means to control and eliminate these diseases has not yet been found.

Prior art

Dentistry mainly focuses on the correction, restoration, rehabilitation caused damage. As for prevention, apply actions aimed at improving the sustainability of the teeth deystviy bacteria through consumption of fluoridated water or by topical application in a dental clinic. In addition, apply a controlled intake of carbohydrates in the diet and the daily removal of bacterial plaque by means of a liquid mouthwash, containing, among other things, chlorhexidine gluconate, cetylpyridinium chloride, thymol. Even though the effect of these methods obviously, the optimal levels of the control subjects was not achieved, and remain at high risk.

Currently, more modern approaches have focused on finding safer antimicrobial drugs aimed at treatment of the causes of pathologies of the oral cavity, and not their effects, which gives this type of therapy is of great importance.

Making a review of existing pharmaceutical drugs in dentistry, it is possible to mention a number of drugs in the form of a liquid mouthwash, gels, toothpaste, etc. that include several active agents. Among the best known drugs is Listerine®, the widely used liquid mouthwash, containing thymol and other essential oils, such as menthol and eucalyptus, as the active substances. Other liquids, mouthwash use triclosan or cetylpyridinium chloride as the active substances and large quantities of alcohol, from 25 to 30 vol.%. The alcohol is used as a carrier and as a solvent for active�beings and as excipients to homogenize. However, a large amount of alcohol contained in the liquid mouthwash, largely remains in question.

The vast majority of dental materials contains fluoride, the function of which is to strengthen tooth enamel against acid effects of bacteria described as anti-bacterial properties.

Other pastes, gels or liquids mouthwash include chlorhexidine gluconate, a substance with antibacterial actions used in the treatment of periodontitis.

Briefly, the means of hygiene of an oral cavity, and more specifically liquid mouthwash, can be classified into two types: cosmetic products designed to freshen breath and suppress bad taste, not having a specific function against microorganisms, and pharmaceuticals that help to control pathogenic microorganisms of the oral cavity due to the inclusion of antibacterial active substances, such as derivatives of phenol, chlorophenol, such as chlorhexidine, and agents against dental plaque, such as sodium benzoate.

Among related patents in the US patent US 6348187 authors Pan et al. describes the drug in the form of a liquid for rinsing the mouth, useful for the prevention and reduction of bad breath, plaque and gum disease, contain�of ASI combination of thymol and one or more than one active essential oils optionally containing ethanol in an amount above 30 vol.%; from 0.1 to 8% hydrogen peroxide mass./about.; at least one surface-active substance in sufficient quantity to solubilize essential oils and water. This product is offered in two separate solutions to be mixed before application.

In the patent US 5104644 describes the drug in the form of a liquid mouthwash, containing from 0.5 to 3% wt./about. hydrogen peroxide, at least 0.02% wt./about. of zinc chloride, at least 0.04% of the mass./about. sodium lauryl sulfate, at least about 0.08% wt./about. sodium citrate and from 2 to 3.5% wt./about. ethanol. Peppermint oil and menthol is used as corrigentov. In this patent claimed the ability to destroy bacteria, preventing dental disease.

In European patent 0161899 authors Saxton et al. described nicotianae antibacterial agent and agent against dental plaque, containing hydroxydiphenyl ether, triclosan in combination with zinc citrate.

Chilean patent No. 44471 describes the drug in the form of a liquid for rinsing of a mouth and other forms that are useful for the treatment of periodontitis and halitosis, which consists of a mixture of from 0.01 to 0.5 wt.% hydrogen peroxide, 0.001 to 0.5 mass.% eugenol, from 0.001 to 0.5 wt.% prolactinoma, from 0.001 to 0.3 wt.% camphor, among other ingredients. This product does not contain, which contains chamazulene�, and stated as a treatment of periodontitis, as well as prevent the formation of plaque, reduce the development of cavities and inhibiting the development of Tartar.

In the field of dental therapy and preventive dentistry, thus, would be more desirable for a drug that could be effective in the treatment of microbial diseases of the oral cavity, would be effective in the prevention of the above diseases, the control of halitosis, ensure a high degree of oral health without changing microbiotics balance of the oral cavity and without prejudice to the application as a result of staining of the teeth, changes in taste or irritation of the mucous membranes of the oral cavity.

Description of the invention

The inventors found that the prior art mainly described a mixture of active substances with the origin of essential oils, together with phenolic compounds and oxidizing agents. This study demonstrates some concerns regarding biocompatibility, even in reduced concentrations of compounds, originating from phenol or chlorophenols, exemplified by the limitations of the sensory type to prolactinoma imposed by the Department of environmental protection (USA), which limit the content of this compound is not to Bo�her than 0.1 µg/l in water for human consumption. However, the known technical limitations resulting from the use of "organoleptic" criteria when determining quantitative parameters.

On the other hand, in the USA, means of hygiene of an oral cavity containing chlorhexidine gluconate, one of the main compounds used for the treatment of serious diseases of the gums due to bacterial in nature, regulated, and, consequently, their commercial implementation is not permitted without a doctor's prescription, and their use is restricted and allowed only on medical prescription, because some patients may meet some permanent colour of the teeth or other areas of the mouth, changes in taste, as well as varying degrees of irritation of the oral cavity.

To create a tool sold without a prescription, without limitation applications, such as chlorhexidine where chlorophenolic compounds will be replaced and to carry out special antibacterial drug therapy against the microorganisms such as Streptococcus mutans and lactobacillus, the main causative agents of dental caries; Porphyromonas gingivalis, which causes varying degrees of gingivitis, and Solobacterium moorei, which causes halitosis proposed this antiseptic composition of broad-spectrum, which mainly consists of mixtures of two volatile oils in the presence of oxidized lignite through extraction�enforcement agents and other active substances, designed to combat these diseases.

This drug is in the form of a liquid mouthwash, gel, toothpaste or other forms of application, alcohol-free, contains the following ingredients.

1. Hydrogen peroxide is present in the range of 0.05 to 0.3 mass%, preferably from 0.05 to 0.2 mass%, and more preferably 0.05 to 0.1 mass%. This connection, weak acid bactericidal action, which inhibits the development of Streptococcus mutans, is a chemical inhibitor of bacterial plaque and specific effect on anaerobic microorganisms due to its ability to generate oxygen free radicals. In the present invention the hydrogen peroxide is preferably used in aqueous solution, directly added to the composition, where it is also possible to add in the form of carbamide peroxide, combinations of hydrogen peroxide and urea, which is soluble in water containing about 36 wt.% active hydrogen peroxide, which is released upon contact with the enzyme catalase, found in the saliva.

2. Eugenol, an essential oil that is present in the range from 0.001 to 0.03 mass%, preferably from 0.001 to 0.02 wt.% and more preferably from 0.005 to 0.01 mass%.

This component is an antiseptic and disinfectant, which also shows protivovospalitel�tion and analgesic effect.

3. Camphor, an aromatic terpenoid compound found in the essential oil camphor Laurel and present in the drug in the range from 0.001 to 0.01 wt.% and preferably from 0.001 to 0.007 wt.%. It has anti-inflammatory and antiseptic properties and acts as a mild local anesthetic agent that provides a cooling sensation like menthol.

4. Zinc salt or other ingredients, formed of zinc, or, alternatively, formed from heavy metals such as silver, mercury, copper, tin or mixtures thereof, used in a wide number of tools relevant to the health of a person, known as having antiseptic properties. Zinc, a natural mineral, is widely used in products for human consumption, recognized by the American quality supervision food and drug administration (FDA) safe (GRAS), which means "generally recognized safe", it is very important for growth, development and health of the human body; this drug is present in the range from 0.001 to 0.5 mass%, preferably from 0.005 to 0.2 mass%, and more preferably from 0.009 to 0.1 mass%. It has antiviral activity and is used for the treatment of herpes simplex, improves wound healing, mainly caused by burns or surgical incisions, cuts, and warned�t the development of bacterial plaque and neoplasms of supragingival calculus. Preliminary studies demonstrate the effect of the reduction in respect of halitosis and some degree of action on aphthous ulcers of the oral cavity and recurrent aphthous stomatitis, mucositis and candidiasis, particularly in patients with reduced immunity or radiation therapy. In the present invention preferably use zinc sulfate.

5. Fluorine in the form of sodium fluoride, sodium monofluorophosphate or other salts which release fluoride, has the ability to be included in tooth enamel from eating it, making the teeth more strong to destruction. It includes the drug in the range of 1 to 1.2 mass%. Sodium fluoride either in aqueous solutions or in toothpastes or dental gels apparently reduces the frequency or occurrence of dental caries in children and adults, showing also desensitizing effect in relation to dentin. Antibacterial activity characteristic of fluorine due to its oxidative nature against bacteria.

6. Xylitol, a sweet pentane - Petit, which is a natural ingredient in many fruits and vegetables, widely used as a sweetener for products that do not contain sugar, pharmaceuticals and oral health. Xylitol is characteristic of anti-caries action, because it is not fermented karigasniemi bacteria�mi, and he is charismaticism, because it stops the development of caries and inhibits the proliferation of Streptococcus mutans, thus avoiding the development of new carious lesions. It includes the drug in the range from 2 to 7 mass%.

7. Cetylpyridinium chloride is a Quaternary ammonium compound, non-toxic on the skin and mucous membranes; its antiseptic action is based on the interaction of alkali ions with cetylpyridinium bacterial acid molecules, thereby inhibiting their normal metabolism. Even though it is considered antiseptic first generation (low affinity) and is very inefficient when added to the drug in amounts of from 0.002 to 0.05 mass%, he synergistic increases by antiseptic effect, potentiates the bactericidal effect on microorganisms present in sanaatana region, and prevents the formation of plaque on the tongue for best results in vivo.

8. Excipienti, which are, among other things, approved colourants and corrigentov, sweeteners, demineralized water, on the basis of their presentation (among other things, gel, paste, liquid for rinsing the mouth), in an amount sufficient for completion of the composition to 100%.

Depending on the presentation format, i.e. various forms of matrices to release the active and�of gredients, a method of producing the drug is relatively simple and mainly consists in obtaining a homogeneous solution containing the active ingredients in certain proportions. Then getting a homogeneous solution of each inactive ingredient, such as corriente, dyes and excipiente, it immediately mixed with both previous solutions and add sufficient water to homogeneity. Finally, add the mixture with the carrier, releasing the active ingredient, in accordance with the presentation format.

To counteract a possible decrease of antibacterial activity by removal of the relevant nakatannyh compounds against dental plaque, such as chlorophenol, such a compound will be replaced by a zinc salt, a cationic compound which has highly effective properties against oral bacteria and against the formation of bacterial plaque and which may increase the efficiency. It is widely known that the combination of cationic compounds, such as zinc and other metals, with sectionname antibacterial compounds, such as eugenol produces a very desirable effect against the formation of plaque, thus allowing to avoid gingivitis or dental caries.

Other aspects of the invention include �various applications pharmaceutical compositions according to the invention. In particular, the following applications:

to obtain the drug, useful for odor control, suppress and relieve inflammation of the area of the oral cavity, prevention education and neoplasms of Tartar;

to obtain the medicines useful for the treatment of oral diseases such as periodontitis, dental caries, halitosis, inflammation of the mucous membrane, athlete's foot, canker sores of the mouth, herpes and candidiasis;

to obtain the medicines useful for washing and treating dental injuries such as periodontal bags, fistulas, abscesses, alveolitis, necrosis and gangrene of the pulp;

to obtain the drug, useful for the prevention or prevention of diseases of the oral cavity during orthodontic treatments, surgeries of the oral cavity in patients wearing fixed and removable prostheses;

to obtain the medicines useful to alleviate, reduce, cure or prevent diseases of the mouth in patients receiving radiation therapy or chemotherapy inpatients and chronically ill patients; and

to obtain the medicines useful for alleviating, reducing, treating or preventing diseases of the oral cavity in patients suffering from �archenemy power endocrine, hematological, cardiovascular and psychosomatic disorders, and, in addition, physically or mentally handicapped patients or patients with genetic or hereditary changes.

When testing the effectiveness of in vitro liquid mouthwash, obtained the compounds described in this application, against S. mutans could be observed high efficacy against the development of bacterial colonies.

The test used two series of cups with agar Mueller Hinton, with strains of S. mutans ADS 35668, which were cultured in microaerophilic conditions for 48 hours. In the first series of cups containing a liquid for rinsing of a mouth with the study medication, bacterial growth was observed. Control cups with agar MN without liquid mouthwash showed a high growth of S. mutans ADS 35668.

Examples

The following describes examples of preparation of pharmaceutical compositions.

These ingredients are mixed in demineralized water with continuous stirring to achieve a completely homogeneous solution.

The ingredients are mixed to homogeneity with the formation of white toothpaste and put it in an aluminum or plastic tubes.

These ingredients form a toothpaste in the form of a clear gel that is injected into aluminum or plastic tubes.

1. Antiseptic pharmaceutical composition suitable for oral hygiene and treatment of oral diseases of microbial origin, which contains from 0.05 to 0.3 wt.% hydrogen peroxide or its equivalent amount in the form of carbamide peroxide, 0.001 to 0.03 wt.% eugenol, from 0.001 to 0.01 wt.% camphor, from 0.001 to 0.5 wt.% salts of zinc or other heavy metals, such as silver, mercury, copper, tin, or a mixture thereof; from 1 to 1.2 wt.% sodium fluoride; from 2% to 7 wt.% xylitol, from 0.002 to 0.05 wt.% cetylpyridinium chloride and excipient in an amount sufficient to bring the composition to 100%.

2. Pharmaceutical composition according to claim 1, containing preferably from 0.05 to 0.2 wt.% peroxide of hydrogen.

3. Pharmaceutical composition according to claim 2, containing more preferably from 0.05 to 0.1 wt.% peroxide of hydrogen.

4. Pharmaceutical composition according to claim 2, containing hydrogen peroxide, which may be formed of carbamide peroxide in appropriate concentrations to form from 0.05 to 0.2 wt.% peroxide of hydrogen.

5. Pharmaceutical composition according to claim 3, containing hydrogen peroxide, which may be formed of carbamide peroxide in appropriate concentrations to images�you from 0.05 to 0.1 wt.% peroxide of hydrogen.

6. Pharmaceutical composition according to claim 1, containing preferably from 0.001 to 0.02 wt.% eugenol.

7. Pharmaceutical composition according to claim 4, containing more preferably from 0.005 to 0.01 wt.% eugenol.

8. Pharmaceutical composition according to claim 1, containing preferably from 0.001 to 0.007 wt.% camphor.

9. Pharmaceutical composition according to claim 1, containing preferably from 0.005 to 0.2 wt.% of zinc sulfate.

10. Pharmaceutical composition according to claim 1, containing more preferably from 0.009 to 0.1 wt.% of zinc sulfate.

11. Pharmaceutical composition according to claim 1, containing preferably 0.1 wt.% hydrogen peroxide, 0.01 wt.% eugenol, 0.005 wt.% camphor, 0.01 wt.% of zinc sulfate, 5 wt.% xylitol, 0,003 wt.% cetylpyridinium chloride and excipient in an amount sufficient to bring the composition to 100%.

12. Pharmaceutical composition according to claim 8, which instead of zinc sulfate may contain other pharmaceutically acceptable zinc compounds, such as, among other things, lactate, carbonate, citrate, oxide, borate, benzoate, salicylate.

13. Pharmaceutical composition according to claim 8, which instead of zinc sulfate may contain other pharmaceutically acceptable heavy metals, such as, among others, silver, mercury, copper, tin.

14. Pharmaceutical composition according to claim 1, containing preferably from 0.01 to 0.05 wt.% cetylpyridinium chloride.

1. Pharmaceutical composition according to claim 1, which is in the form of a liquid mouthwash, gel, toothpaste or other oral administration forms.

16. A method of obtaining a pharmaceutical composition according to claims.1-12, consisting of:
a) obtaining a homogeneous solution containing the active ingredients in definite proportions;
b) obtaining a homogeneous solution of each inactive ingredient, such as corriente, dyes and excipient;
b) mixing both previous solutions and add enough water to make a homogeneous;
d) adding the mixture to the carrier to release the active ingredient in accordance with the form submission.

17. Use of pharmaceutical composition according to claim 1 for obtaining a medicinal product, useful for odor control, suppress and relieve inflammation of the area of the oral cavity, prevention education and neoplasms of Tartar.

18. Use of pharmaceutical compositions according to claims.1-12 to obtain the medicines useful for the treatment of oral diseases such as periodontitis, dental caries, halitosis, inflammation of the mucous membrane, athlete's foot, canker sores of the mouth, herpes and candidiasis.

19. Use of pharmaceutical compositions according to claims.1-12 to obtain medicines, useful �La rinsing and treatment of dental injuries such as periodontal bags, fistulas, abscesses, alveolitis, necrosis and gangrene of the pulp.

20. Use of pharmaceutical compositions according to claims.1-12 to obtain the drug, useful for the prevention or prevention of diseases of the oral cavity during orthodontic treatments, surgeries of the oral cavity in patients wearing fixed and removable prostheses.

21. Use of pharmaceutical compositions according to claims.1-12 to obtain medicines useful to alleviate, reduce, cure or prevent diseases of the mouth in patients receiving radiation therapy or chemotherapy, in-patients and terminally ill patients.

22. Use of pharmaceutical compositions according to claims.1-12 to obtain medicines useful to alleviate, reduce, cure or prevent diseases of the oral cavity in patients suffering from eating disorders, endocrine, hematological, cardiovascular and psychosomatic disorders, and, in addition, physically or mentally handicapped patients or patients with genetic or hereditary changes.



 

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3 cl, 5 tbl, 1 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to pharmaceutical composition, containing compound of formula or for prevention or treatment of diseases, associated with oxidative stress, selected from group, consisting of MELAS (mitochondrial myopathy, encephalopathy, lactic acidosis and stroke episodes), MERRF syndrome (myoclonic epilepsy with ragged red fibres) or Kearns-Sayre syndrome, arrhythmia, cardioplegia or myocardium infarction. in formula (1) na stands for 1 or 2, Aa represents 5-membered heteroaryl or heterocycle, each of which has 2 heteroatoms, selected from N, O and S, Rla represents R5a-Xa-Ba-X′a-, Ba represents direct bond, Xa and X′a independently on each other represent direct bond or -OC(O)-, R5a represents hydrogen or 6-9-membered monocyclic or condensed cyclic heterocycle or heteroaryl, each of which has from 1 to 3 heteroatoms, selected from N, O and S, and is optionally substituted with oxo or C1-C6-alkyl, R2a represents -(CR8aR9a)pa-Ya-R7a, pa stands for number from 0 or 1, Ya represents direct bond or -O-, R7a represents hydrogen or phenyl, R3a, R8a, R9a, R10a represent hydrogen, R4a represents -(CH2)pa-Da-R10a-, Da represents C5-cycloalkyl or 6-membered heterocycle, which has 1 heteroatom, selected from N, S and O. Radical values for formula (2) are give in invention formula.

EFFECT: obtaining compositions for prevention or treatment of diseases, associated with oxidative stress.

19 dwg, 5 tbl, 3 ex

FIELD: medicine.

SUBSTANCE: opening of a carious cavity, ablation of overhanging enamel edges on the entire circumference, necrectomy and drug treatment with a 0.06% chlorhexidine solution are performed. The preparation "Lemifaren" is applied on walls and bottom of the carious cavity in a uniform 1 mm thick layer, which is left for 1 day under temporary filling. After the removal of the preparation irradiation in a pulse mode with the power of 5 W and frequency of 2000-3000 Hz is carried out for 5 min with the application of the laser apparatus ALST-01. After that, the cavity is restored with an account of functional and aesthetic parameters of the particular tooth.

EFFECT: effective treatment of deep caries prevents caries recurrences and pulp inflammation.

1 ex

FIELD: medicine.

SUBSTANCE: method involves administering an anthelminthic agent in the period of stationary process stage; the anthelminthic treatment is preceded by administering chophytol 200 mg 3 times a day before meals for 14 days; the anthelminthic treatment involves administering Osinol food supplement 2 tablets 3 times a day during meals for 14 days; thereafter, chophytol is taken in a dose of 200 mg 3 times a day before meals for 14 days; 7 days later, the repeated course of the anthelminthic treatment with Osinol food supplement 2 tablets 3 times a day during meals is prescribed to be administered for 14 days; the entire therapeutic course involves washing the face with the Setaphyldermocontrol foaming facial cleanser 2 times a day followed by applying an SPF30 product on the face once after the morning wash.

EFFECT: reducing the number of complications and the high efficacy of the anthelminthic treatment.

1 ex

FIELD: medicine, oncology, amino acids.

SUBSTANCE: invention relates, in particular, to the development of an antitumor preparation based on natural substances. Invention relates to an amino acid preparation comprising at least one modified essential amino acid obtained by treatment of amino acid by ultraviolet radiation (UV) at wavelength 250-350 nm for 12-80 h at temperature 15-30oC or with ozone at temperature 15-25oC. The modified amino acid has no toxicity for health cells. Also, invention relates to a method for preparing such preparation. Invention provides the development of an antitumor preparation based on modified amino acids and expanded assortment of antitumor preparations being without cytotoxicity for normal cells.

EFFECT: valuable medicinal antitumor properties of preparation.

8 cl, 4 tbl, 2 dwg, 4 ex

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