Pharmaceutical composition for preventing and treating infectious-inflammatory diseases of various origins by oromucosal administration

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, and concerns a pharmaceutical composition in the form of tablets for oromucosal administration in treating infectious-inflammatory oropharyngeal diseases. The composition contains recombinant interferon specified in a group: recombinant interferon alpha, recombinant interferon beta, recombinant interferon gamma; amino acid specified in a group: arginine, histidine, glycine, glutathione, lysine, methionine, cysteine; an antiseptic, a preserving agent, flavours specified in a group: tea tree oil, eucalyptus leaf oil, mint leaf oil and a consistence base.

EFFECT: invention makes the composition applicable in fragile and frequently ill patients for reducing a disease recurrence.

7 cl, 1 ex

 

The invention relates to the field of medicine and for the prevention and treatment of infectious and inflammatory diseases of different etiology of upper respiratory tract, oral cavity and pharynx in children and adults by oromucosal the introduction of tablets.

The treatment of infectious-inflammatory diseases of the oral cavity and pharynx is a topical issue due to the wide spread of this disease in both adults and children.

The urgency of the problem determines a large assortment of drugs for local and General steps used in the treatment of these conditions (SU 1659054, EN 93041374, US 5248503).

One of the areas of search for such drugs is the creation of dosage forms for oromucosal route of administration that allows to increase the duration of the effects of medicinal substances on mucous membranes of the oropharynx due to slow dissolution in the mouth - dissolving tablets, drops, syrup. In the majority of antimicrobial agents local actions are antiseptics that may be a possible cause of adverse reactions, especially in children and patients with chronic diseases. In this regard, the widespread medicines, including herbal components (eucalyptus, mint, sage, St. John's wort, and others). Such as Sinupret, Tonsillar N, the Tone is iprit, Bronchipret (medi.ru, "Bionorica" in Ukraine "Herbal medicines for the treatment of colds"). Herbal remedies contain complexes of biologically active substances, similar to the metabolites of an organism, biologically compatible and have a normalizing influence on the modified functions of the body. These features allow virtually eliminate toxic and side effects.

The disadvantage of most common drugs of plant materials is that they have only local effect. Such treatment should be supplemented with total therapy, a large number of other anti-inflammatory drugs, antihistamines, vitamins and other

Infectious-inflammatory diseases, along with local antimicrobial and anti-inflammatory action, there is a need to restore homeostasis and mobilization adaptogenic abilities of the body and its immune responses. This purpose can be used multicomponent drugs, providing a comprehensive therapeutic effect.

In addition, there is a problem of reducing recurrence of the disease, since, as a rule, with the weakening of nonspecific resistance of the organism, as well as local immunity celebrated the re-development of acute respiratory infections, stomatitis, pharyngitis, tonsillitis, etc.,

Us our tasks is not only the treatment of acute infectious-inflammatory process, which is achieved is known for these purposes, antiviral and antiseptic, but also prevent recurrence of the disease due to the stimulation of local immunity.

You know the tool Inhalt containing streptocid soluble norsulfazol, thymol, eucalyptus and peppermint, alcohol, sugar, glycerol, tween-80 and water. Inhalt has antiseptic and anti-inflammatory effect and is used to tonsillitis, pharyngitis, laryngitis, and ulcer aphthous stomatitis (M. D. Mashkovsky "Drugs" Vilnius, 1993, H. 2, S. 245-246).

The closest in technical essence and the achieved result for the proposed tool can be considered as a tool for oromucosal injection in the treatment of infectious-inflammatory diseases of the oropharynx, containing interferon (US 2010/0111902 A1, 06.05.2010). However, this tool does not solve the problem of preventing recurrence of the disease due to the stimulation of local immunity.

Solved by the invention of the task and the expected technical result are the development of medicines for oromucosal route of administration in the form of absorbable tablets not only for treatment of acute infectious-inflammatory diseases of different etiology of upper respiratory tract, oral cavity and pharynx complex is ondastan on the body, but for prevention of repeated cases of these diseases, especially in immunocompromised patients due to the stimulation of nonspecific resistance of the organism, as well as local immunity.

To achieve the technical result of the pharmaceutical composition in tablet form for oromucosal injection in the treatment of infectious-inflammatory diseases of the oropharynx, according to the invention, contains recombinant interferon selected from the group: recombinant interferon-alpha, interferon-beta, interferon-gamma; amino acid selected from the group: arginine, histidine, glycine, glutathione, lysine, methionine, cysteine; antiseptic, a preservative, an aromatic substance selected from the group of: tea tree oil, oil of leaves of eucalyptus, oil of peppermint, and consistentread the basis of the following ratio of components, in g per 1 g of a mixture of:

recombinant interferon IU100-10000000
amino acidwithin 0.00001 to 0.5
antisepticwithin 0.00001 to 0.5
preservativewithin 0.00001 to 0.5
aromatic substances within 0.00001 to 0.5
consistentread baserest

This pharmaceutical composition comprises a preservative selected from the group: lysozyme, bilateral, fusafungine, Amazon, benzyldimethyl-myristoylation-Propylamine, co-trimoxazole, amylmetacresol, dichlorobenzoyl alcohol, cetylpyridinium chloride, benzocaine chloride, chlorhexidine.

Optionally, the pharmaceutical composition may contain glycyrrhizinic acid or its salts in a quantity within 0.00001-0.5 g, and lecithin in an amount within 0.00001-0.5 g or dextran 60000 in number within 0.00001 to 0.5,

Optionally, the pharmaceutical composition may contain vitamins selected from the group of: beta-carotene, vitamin C, vitamin E, b vitamins: B1, B2, B5, B9, B13 in number within 0.00001 to 0.5,

As the preservative used is selected from the group of: benzalkonium chloride, parabens, boric acid in the amount of 0.0001-0.1 g, benzyldimethyl-myristoylation-Propylamine, benzoic acid, sodium benzoate.

As consistentarea framework contains components selected from the group: thiomersal, lactose monohydrate, mannitol, povidone, citric acid (anhydrous), magnesium stearate, microcrystalline cellulose, carmellose, talc.

The claimed means in the form of tablets intended for the prevention and treatment of nfection-inflammatory diseases of different etiology (angina, pharyngitis, chronic tonsillitis, acute respiratory diseases) by oromucosal introduction.

The dose for adults is 1 tablet 4-6 times a day.

The dose for children is 1 tablet 2-3 times a day.

Spent an analysis of the prior art, including searching by the patent and scientific and technical information sources, and identify sources that contain information about the equivalents of the claimed pharmaceutical compositions, has allowed to establish that the petitioners have not found a similar, characterized by signs, identical to all the essential features of the claimed pharmaceutical compositions.

The present invention is illustrated with specific examples of implementation, which, however, are not only possible, but clearly demonstrate the possibility of achieving the desired technical result.

Example 1. Getting a tablet form. Take interferon selected from the group of recombinant interferon-alpha, interferon-beta, interferon-gamma, amino acid selected from the group: arginine, histidine, glycine, glutathione, lysine, methionine, cysteine, antiseptics selected from the group: bilateral, fusafungine, Amazon, benzyldimethyl-myristoylation-Propylamine, cotrimoxazole, amylmetacresol, dichlorobenzyl the new alcohol, cetylpyridinium chloride, menoxenia chloride, chlorhexidine and aromatic substances selected from the group of: tea tree oil, oil of leaves of eucalyptus, oil of mint leaves. Mix these components with acceptable for this form consistentarea basis and tabletirujut mixture in a known manner.

These components take the following ratio of components in g per 1 g of a mixture of:

option 1option 2option 3
recombinant interferon, ME1001000010000000
amino acid100100001000000
antiseptic0,0010,000010,5
preservative0,0010,010,5
aromatic substances0,000010,0010,5
the con is stenobrachius base the rest is up to 1 g

Example 2. Carried out analogously to example 1. Additionally, the composition of the claimed compositions include glycyrrhizinic acid or its salts in a quantity within 0.00001 to 0.5,

Example 3. Carried out analogously to example 1. Additionally, the composition of the claimed compositions include lecithin in the amount within 0.00001 to 0.5,

Example 4. Carried out analogously to example 1. Additionally, the composition of the claimed compositions comprise dextran 60000 in number within 0.00001 to 0.5,

Example 5. Carried out analogously to example 1. Additionally, the composition of the claimed compositions include vitamins selected from the group of: beta-carotene, vitamin C, vitamin E, b vitamins: B1, B2, B5, B9, B13 in number within 0.00001 to 0.5,

Treatment and prevention of infectious-inflammatory diseases of the oropharynx conducted in 50 patients aged 12 to 60 years. Included patients with various diseases of the oropharynx: stomatitis viral and bacterial etiology, pharyngitis, tonsillitis, acute respiratory infections. In the acute period of the disease in the treatment included the proposed tablets at a dose of 4-6 times a day. As a rule, acute symptoms were relieved in 3-4 days. However, in immunocompromised patients with frequent recurrences of acute respiratory infections, stomatitis, tonsillitis history treatment tablets continued for 10-14 days. 32 people were under observation during the course the e year, disease recurrence was not. In 23 of them, treated these tablets, the estimation of local immunity.

By radial immunodiffusion in gel was determined by the concentration of immunoglobulins A, G and lysozyme activity values method. Given that the most important gateway for the penetration of pathogenic microorganisms in the human body are the upper respiratory tract, in particular the mucous membrane, the estimation of local immunity prognostically significant. Indicators of lysozyme in the mucous averaged 6,83 µg/ml, sIgA - 549 mg/l, AsIgA - 0,089, suggesting a low degree of immune stress. After treatment these figures gradually came to normative values. To assess the state of local immunity was also used method smears, fingerprints from the mucous membrane of the nose.

Known studies confirm the effector function of neutrophils, which were the first to enter an inflammatory response, thereby making protection against bacterial agents. In this regard, to assess the state of local immunity we also used the method of smears, fingerprints from the mucous membrane of the nose. For the studied patients were characterized by destructive changes in the epithelial cells that determine adaptive reserve of local immunity in viral and other intracellular infections. Dynamic observation showed that during treatment with tablets and inflammation the number of modified neutrophils and epithelial cells was decreased, increased the percentage of cells with normal morphology.

Example 1. Patient, 30 years. Diagnosis: tonsillitis, pharyngitis, rhinitis. Complaint: pain in the fauces, headache, weakness, fever. History of frequent colds, acute tonsillitis.

When the examination is marked hyperemia and infiltration of heaven and palatal arches, signs of rhinitis, purulent follicles and caseous plugs in the gaps, increasing the submandibular lymph nodes. In addition to General symptomatic treatment, the patient was treated by the proposed tablets 1 tablet 5 times a day for 14 days. Each tablet firmly fixed on the sky and disappeared within 1.5 hours.

After treatment of the stated means of subjectively noted the rapid disappearance of unpleasant sensations in the oropharynx in the form of pain, burning and sore after an average of 3 days. Disappeared hoarseness, at the same time noted improvement in General condition disappeared weakness, headache, appetite improved. Objectively (pharyngoscope) noted the disappearance of hyperemia and infiltration of the Palatine arches (average 2 days) and the disappearance of purulent follicles and caseous plugs in Amanah (average 2 days). Disappeared hyperemia and granularity of the mucosa of the posterior pharyngeal wall, infiltrative changes and swelling of the granules. Positive dynamics from submandibular lymph nodes. For 4-5 hours application of funds marked reduction in size and reduction of morbidity. During the year of colds was not.

Thus, a pharmaceutical composition in the form of the dissolving tablets, expanding Arsenal of known means, has effective properties of complex effects on the body, including the processes of local immunity, providing conditions for rapid relief of acute inflammatory process and prevent recurrence of the disease by increasing the immunological reactivity and non-specific resistance of the organism of the sick.

1. Pharmaceutical composition in tablet form for oromucosal injection in the treatment of infectious-inflammatory diseases of the oropharynx, characterized in that it contains recombinant interferon selected from the group: recombinant interferon-alpha, interferon-beta, interferon-gamma; amino acid selected from the group: arginine, histidine, glycine, glutathione, lysine, methionine, cysteine; antiseptic, a preservative, an aromatic substance selected from the group what s: tea tree oil, the oil of the leaves of eucalyptus, oil of peppermint, and consistentread the basis of the following ratio of components in g per 1 g of a mixture of:

recombinant interferon IU100-10000000
amino acidwithin 0.00001 to 0.5
antisepticwithin 0.00001 to 0.5
preservativewithin 0.00001 to 0.5
aromatic substanceswithin 0.00001 to 0.5
consistentread baserest

2. The pharmaceutical composition under item 1, characterized in that as an antiseptic contains selected from the group lysozyme, bilateral, fusafungine, Amazon, benzyldimethyl-myristoylation-Propylamine, cotrimoxazole, amylmetacresol, dichlorobenzoyl alcohol, cetylpyridinium chloride, benzocaine chloride, chlorhexidine.

3. The pharmaceutical composition under item 1, characterized in that as preservative contains selected from the group of: benzalkonium chloride, parabens, boric acid in the amount of 0.0001-0.1 g, benzyldimethyl-myristoylation-Propylamine, benzoic acid, sodium benzoate.

4. The pharmaceutical composition is I p. 1, characterized in that it further contains glycyrrhizinic acid or its salts in a quantity within 0.00001 to 0.5,

5. The pharmaceutical composition under item 1, characterized in that it further comprises lecithin in the amount within 0.00001 to 0.5,

6. The pharmaceutical composition under item 1, characterized in that it further comprises dextran 60000 in number within 0.00001 to 0.5,

7. The pharmaceutical composition under item 1, characterized in that it further contains vitamins selected from the group of: beta-carotene, vitamin C, vitamin E, b vitamins: B1, B2, B5, B9, B13 in number within 0.00001 to 0.5,



 

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