Formulation of cough medical composition and method for producing it

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to the pharmaceutical industry, namely to a formulation of a cough medical composition. The formulation of the cough medical composition contains an active substance presented by thermopsis herb powder or a dry extract of thermopsis and sodium hydrocarbonate, as well as an excipient, a granulating agent and a lubricant taken in certain relations (versions).

EFFECT: composition of the cough medical composition possesses improved pharmaceutical (appearance, taste) and technological characteristics (hardness, disintegration).

11 cl, 7 ex

 

The invention relates to pharmaceutical industry, namely to production of finished dosage forms, in particular medicines for cough.

Cough medicine with thermopsis used for many years. And today, despite the availability in pharmacies by more modern means of cough, they are consistently popular. The reason is that they really help. Grass thermopsis lanceolate (misalnya) of the legume family has long been used as an expectorant in various diseases of the bronchopulmonary system. The composition thermopsis herb include alkaloids, compounds containing nitrogen and forming when combined with oxygen and water-soluble salts, often poisonous, but in small quantities used as medicines. Thermopsis contains such alkaloids cytisine, metiltsitizin, sparteine, anagirin, termopsin, termopsidin, as well as some other biologically active substances. Together, these substances have complex effects on the human body. So, cytisine and metiltsitizin excite breathing, sparteine has an inhibitory effect on root ganglion (ganglia) of the autonomic nervous system. But in General, thermopsis has expectorant, and in large doses is emetic effect. The ingestion of cough medicine with thermopsis absorbed in the key�enom tract, into the bloodstream, and from there to the mucous membrane of the bronchi and trachea, rendering it irritating. This causes a reflex secretion of bronchial secretions and coughing. In addition, thermopsis has a stimulating effect on the respiratory and vomiting centers in the brain. Under the action termopsisa also increases motor activity of ciliated epithelium that lines the inside bronchi, and motor activity of the muscular layer of the bronchi. Increased respiration, which is marked by the reception of thermopsis, promotes expectoration and remove mucus. As a result, the cough and the secretion of sputum increases, but also accelerates the process of removing mucus from the bronchi. The composition of cough drops with thermopsis is also sodium bicarbonate, which stimulates the secretion of bronchial glands and reduces the viscosity of sputum. In connection with such mechanism of action thermopsis has been applied in a dry unproductive cough, when you want to translate it into productive, with expectoration of sputum. This may be in acute and chronic bronchitis, pneumonia and some other diseases. Used thermopsis tablets and in inflammatory diseases of the upper respiratory tract, often accompanied by separation of thick viscous sputum. Thermopsis makes the sputum less Vya�coy, increasing its volume and quickly relieve the upper respiratory tract from inflammatory plaque.

Known composition of antitussive drugs (patent RF №2124893, A61K 33/10, 9/20; 20.01.99) [1], namely, the fact that the drug in tablet form for oral administration contains alkaloid of opium - codeine, sodium bicarbonate, terpin hydrate, starch, talc, stearic acid (analogue).

The disadvantages of this composition are its side effects due to the presence of the tablet: codeine - the possibility of narcotic addiction, respiratory depression and gastro-intestinal tract, constipation due to the presence in the composition of codeine (M. D. Mashkovsky "drugs", ed. 14-e, M.: New wave, 2000, vol. 1, p. 149); terpine - exacerbation of gastritis and gastric ulcer and duodenal ulcer (ibid., p. 343) [2]. Also because of this dose of codeine in this medication according to the Instructions on the production of narcotic drugs" [3] given a drug listed in the list of narcotic drugs, therefore produced, stored and released in accordance with the requirements specified Instructions and documents of the Standing Committee on drug control under the Ministry of health and medical products.�tion industry of the Russian Federation, in this connection may not be available to a wide range of patients with bronchitis, cough of different etiology, patients with chronic cough syndrome, etc. This situation creates difficulties not only for patients, but also industrial facilities producing the tool, as well as pharmacies in connection with drug control.

Known drug that possesses antitussive effect (patent RF №2123856, A61K 35/78, 9/20; 27.12.98) [4]. The product contains an alkaloid of opium - codeine, grass thermopsis, sodium bicarbonate, licorice root powder, starch, talc (analogue). The method of obtaining drugs having antitussive effect, includes the preparation of raw materials, obtaining mass for tabletting, wet granulation, drying, tableting, and obtaining mass for tableting is carried out by the sequential mixing of starch powder, sodium bicarbonate, licorice root powder, herbs thermopsis powder, talc powder, and then adding the dissolved codeine and the resulting mass is moistened with this solution, having a temperature of 40-60°C, prepared as 3-7% paste on the basis of the solution of codeine and starch.

A disadvantage of the known tools is also the possibility of narcotic addiction, respiratory depression and gastro-intestinal tract, constipation sun�bedstvie the presence in the composition of codeine [2]. The presence in the composition of the powder of licorice root significantly increases the possibility of introducing microbial contaminants from the soil to the drug.

Known drug - tablets cough [2], containing the grass thermopsis 0.01 g and sodium bicarbonate 0.25 g, providing a soothing effect. The disadvantage of this composition is in the tableting mixture thermopsis herb and sodium bicarbonate without the use of auxiliary substances (moving, linking, etc.). This leads to the sticking of the tablet weight to the punches and dies, as well as losses in production and storage of tablets.

The disadvantage is the appearance of tablets: due to insufficient distribution of thermopsis in the tablet mass tablet work with dark flecks. This also affects quality: understated indicator quantitative determination of total alkaloids thermopsis in terms termopsin.

The closest to the claimed is a medicament having antitussive effect (patent RF №2247556, 10.03.2005, owner of JSC "tatchempharmpreparaty"), which discloses a drug composition in the form of tablets or granules; contains thermopsis, sodium bicarbonate, licorice extract dry or dense, sodium benzoate, ammonium chloride, anise oil, a granulating agent and�alsasua substance.

Disadvantage is the appearance of tablets: due to insufficient distribution of thermopsis in the tablet mass tablet work with dark flecks. This also affects quality: understated indicator quantitative determination of total alkaloids thermopsis in terms termopsin.

Also a big disadvantage is that in this part 6 active substances that are not saved successful combination of active substances - thermopsis herb and sodium bicarbonate. Due to the introduction of the combination of active substances is uderzenie drug.

The aim of the invention is to develop compositions pharmaceutical compositions cough with improved pharmaceutical characteristics with the right combination of active ingredients - thermopsis and sodium bicarbonate.

The technical result of the invention is the production of effective formulations of pharmaceutical compositions cough with a good combination of active substances - thermopsis and sodium bicarbonate in the form of tablets, capsules, in the form of sachets or pellets without spoilage during manufacture and storage.

As well as the efficient production of pharmaceutical compositions compositions cough in the form of tablets, capsules, in the form of sachets or pellets for use in pediatric practice and the production of effervescent forms of composition.

Also stated in the technical�if decision made unexpected effect in the improvement of other pharmaceutical indicators, namely: exterior (tablets without inclusions), quantitative indicators (authenticity) and palatability.

The task is achieved by the fact that a successful combination of active substances - thermopsis and sodium bicarbonate remains unchanged. In the composition is introduced as a major component thermopsis dry extract or powdered herb in powder and sodium bicarbonate and certain relationships and granulating moving substances and optionally the filler is injected. If necessary, are introduced edible organic acid or mixture of acids. Also it is possible to introduce corrective elements disintegrants. It is proposed another method of production of compounds of pharmaceutical compositions for cough, including the use of direct compression method.

Are different dosage forms of compositions compositions cough: tablets, capsules, sachets or pellets, as well as the execution of these dosage forms using corrective substances for use in pediatric practice.

Proposed as a part of the drug composition from cough to introduce additional filler and grass in powder or dry extract thermopsis with the following ratio of components, wt.%:

grass powder or dry� extract thermopsis 1,0-6
sodium bicarbonate4,0-88
pharmaceutically acceptable filler5,0-80
pharmaceutically acceptable granulating agent5,0-70
pharmaceutically acceptable moving substance0,5-15

It is also proposed a method of producing the medicinal composition cough, characterized in that in the preparation of the mass in the mixer initially served the filler, then thermopsis dry extract or powdered herb powder, stirring was performed for 10-15 minutes, then add sodium bicarbonate, stirred for 20-25 minutes and make all necessary operations.

It is also proposed a method of producing the medicinal composition cough; characterized in that the 1/2 of the active substance sodium hydrogen carbonate is used as filler.

Also proposed is a part of the drug composition from cough, further comprising an organic acid or a mixture of organic acids of some food acids: tartaric, citric, succinic, ascorbic, fumaric in the amount of 1-40 wt.%.

Also net�avoided the part of the drug composition from cough, further comprising pharmaceutically acceptable corrective substance in an amount of 0.5-40 wt.%.

It is also proposed the implementation of part of the drug composition from cough by direct compression method.

It is also proposed embodiment of the part of the drug composition from cough by direct extrusion and further comprising pharmaceutically acceptable excipient: lactose monohydrate or microcrystalline cellulose or calcium phosphate dvuhkamernyi, in an amount of from 5 to 20 wt.%.

It is also proposed embodiment of the part of the drug composition from the coughing used as a granulating agent of a 10% solution of low-molecular polyvinylpyrrolidone.

It is also proposed embodiment of the part of the drug composition cough further comprising pharmaceutically acceptable disintegrant from 0.5 to 4 wt%.

It is also proposed embodiment of the part of the drug composition cough using as disintegrant sodium glycolate starch (primogel).

Option 1:

The part of the drug composition from cough in the following ratio of components, wt.%:

grass powder or dry extract thermopsis1,0-6
sodium bicarbonate4,0-88
filler5,0-80
granulating agent5,0-70
moving substance0,5-15

The proposed method of obtaining the composition of the medicinal composition comprises the following steps: medicinal and auxiliary substances are crushed to the required size. Sodium bicarbonate is subjected to further drying at a temperature of 70°C to remove free moisture, in the mixer initially served the filler, then thermopsis dry extract or powdered herb, stirring was performed for 10-15 minutes, then add sodium bicarbonate, stirred for 20-25 min, the plant will produce 10% starch paste or with a 10% solution of polyvinylpyrrolidone with stirring for 20-25 minutes, subjected to wet granulation and dried mass at a temperature of from 45 to 50°C to a residual moisture of 1.2%; next, hold dusting of mass of dry potato starch and talc and conduct dry granulation, the granulate is compressed on a rotary tabletting machine.

Composition and method for producing tablets cough is described below as an example, but is not limited to them.

Example 1

Ingredient Content, wt. % of the tablet weight

grass powder or dry extract thermopsis3,5
sodium bicarbonate84,5
microcrystalline cellulose5,5
potato starch5,5
talc1,0

Example 1 shows one of the optimal formulations specified song.

Composition is prepared as follows: Medicinal and auxiliary substances are crushed to the required size. Sodium bicarbonate is subjected to further drying at a temperature of 70°C to remove free moisture. In the mixer initially served microcrystalline cellulose and 1/2 part of active substance of sodium bicarbonate, stirring for 10-15 minutes. Then put the herb in powder or dry extract thermopsis, stirring for 20-25 minutes until complete distribution of thermopsis. Enter the remaining amount of sodium bicarbonate, stirring for 10-15 minutes. Granulation produces 10% starch paste with stirring for 20-25 minutes. After PE�of emiliania subjected to wet granulation through a sieve with a hole diameter of 3×3 mm and dried mass at a temperature of from 45 to 50°C, to a residual moisture of 1.2%. Next, hold dusting of mass of dry potato starch and talc and spend the dry granulation through a sieve of 3 mm. the Obtained granulate has a good particle size distribution and flowability (more than 10 g/h). Microcrystalline cellulose gives the pellets excellent moldability and improves the release of the active substance, the time of disintegration of tablets, perfectly combined with natural substances (extracts).

Also improves the appearance of tablets, pills greenish-gray color without any inclusions.

The granulate is compressed on a rotary tabletting machine. The tablets obtained meet all regulatory requirements.

The medicinal composition may be in the form of capsules, granules or sachets; in these cases, the method will not stage tabletting. Pellets capaliwoda or are Packed in sachets or other types of packages after dry granulation stage.

Example 2. Example 2 differs from example 1 in that as a granulating agent used 10% solution of low molecular weight polyvinylpyrrolidone. Tablets have low abrasion (less than 0.4%) and high strength (strength of tablets from 12 to 15 kgf/cm2).

Example 2.

Ingredient Content, wt.% from the tablet weight

grass powder or dry extract thermopsis3,5
sodium bicarbonate84,5
microcrystalline cellulose5,5
polyvinylpyrrolidone5,5
talc1,0

The medicinal composition may be in the form of capsules, granules or sachets; in these cases, the method will not stage tabletting. Pellets capaliwoda or are Packed in sachets or other types of packages after dry granulation stage.

Example 3.

Ingredient Content, wt. % of the tablet weight

grass powder or dry extract thermopsis2,31
sodium bicarbonateOf 86.2
polyvinylpyrrolidone or starch9,63
talcTo 1.86

Example 3 differs from example 1 in that 1/2 of the active substance sodium hydrogen carbonate is used as filler. Was charged into the mixer 1/2 part acting�th substance of sodium bicarbonate, then introduced grass powder (or dry extract) thermopsis, stirring for 10-15 minutes. Enter the remaining amount of sodium bicarbonate, stirring for 20-25 minutes. Granulation produces 10% starch paste or a 10% solution of polyvinylpyrrolidone with stirring for 20-25 minutes. After stirring subjected to wet granulation through a sieve with a hole diameter of 3×3 mm and dried mass at a temperature of from 45 to 50°C, to a residual moisture of 1.2%. Next, hold dusting of mass of dry potato starch and talc and spend the dry granulation through a sieve of 3 mm.

The resulting granulate has a good particle size distribution and flowability (more than 10 g/h). Also improved the appearance of tablets, pills greenish-gray color without any inclusions.

The granulate is compressed on a rotary tabletting machine. The tablets obtained meet all regulatory requirements.

The medicinal composition may be in the form of capsules, granules or sachets; in these cases, the method will not stage tabletting. Pellets capaliwoda or are Packed in sachets or other types of packages after dry granulation stage.

Example 4. Example 4 differs from example 1 in that it further comprises a pharmaceutically acceptable disintegrant from 0.5 to 4 wt%. As one of the options as disintegr�NTA use sodium glycolate starch (primogel) in an amount of from 0.5 to 4% (composition per tablet). Primogel ensures quick absorption of water and, as a consequence, a great disintegration of tablets and increase the bioavailability of the active substance.

Ingredient Content, wt.% from the tablet weight

grass powder or dry extract thermopsis3,5
sodium bicarbonate82,0
microcrystalline cellulose5,5
primogel2,5
potato starch5,5
talc1,0

The medicinal composition may be in the form of capsules, granules or sachets; in these cases, the method will not stage tabletting. Pellets capaliwoda or are Packed in sachets or other packaging types.

Example 5. Example 5 differs from example 1 in that it further comprises an organic acid or a mixture of organic acids of some food acids: tartaric, citric, succinic, ascorbic, fumaric in the amount of 1-40 wt. %.

Ingredient Content, wt. % of the tablet weight

grass powder or dry extract thermopsis3,5
sodium bicarbonate63,0
granulating agent starch or PVP5,0
citric acid1,5
acid wine26,0
salt of stearic acid1,0

The introduction of organic acids in the composition allows to pass effervescent reaction with sodium hydrogen when water is added, improves disintegration, solubility and taste properties of the composition.

The medicinal composition may be in the form of capsules, granules or sachets; in these cases, the method will not stage tabletting. Pellets capaliwoda or are Packed in sachets or other packaging types.

Example 6.

Example 6 differs from example 1 in that it further comprises a pharmaceutically acceptable corrective substance in an amount of 0.5-40 wt. % one of the options is milk sugar.

Ingredient Content, wt. % of the tablet weight

grass powder or dry extract thermopsis 3,5
sodium bicarbonate75,5
milk sugar15,0
granulating agent starch or PVP5,0
talc1,0

Introduction to the composition of water-soluble sugar allows to improve organoleptic properties of the composition, camouflaged unpleasant taste sodium bicarbonate, and provides the binding ingredients of the composition in the granules.

Improving taste gives the possibility of applying the composition in pediatric practice.

The medicinal composition may be in the form of capsules, granules or sachets; in these cases, the method will not stage tabletting. Pellets capaliwoda or are Packed in sachets or other packaging types.

Example 7. Example 7 differs from example 1 in that tableting is carried out by the method of direct pressing, which can reduce energy consumption and complexity.

As one of the options when you perform a composition by direct compression method optionally include pharmaceutically acceptable excipients: lactose monohydrate or microcrystalline cellulose or calcium phosphate dvuhkamernyi, in an amount of from 5 to 20 wt. %.

Ingredient Content, wt. % of the tablet weight

grass powder or dry extract thermopsis3,5
sodium bicarbonate70,0
microcrystalline cellulose20,0
potato starch5,5
talc1,0

The tablets obtained meet all regulatory requirements.

The medicinal composition may be in the form of capsules, granules or sachets; in these cases, the method will not stage tabletting. Pellets capaliwoda or are Packed in sachets or other packaging types.

Sources of information

1. RF patent №2124893, A61K 33/10, 9/20; 20.01.99, Antitussive a drug and a method thereof.

2. M. D. Mashkovsky. Medicines, ed. 14-e, M.: New wave, 2000, vol. 1, 539 S.

3. Annex 6 Instructions RD 64-008-97 "the acquisition, calculations, acceptance, release, recording, storage, organization of production and harvesting, transportation of narcotic substances and narcotic medicinal products in enterprises and organizations of the Ministry of IU�izinski and microbiological industry of the USSR", M: Minmedia, 1987.

4. RF patent №2123856, A61K 35/78, 9/20; 27.12.98, Drug, possessing antitussive effect, and a method thereof.

5. RF patent №2247556, 10.03.2005, "a member of the drug from cough", the copyright holder JSC "tatchempharmpreparaty").

1. The part of the drug composition from cough, including grass thermopsis powder or dry extract thermopsis, sodium hydrogen carbonate, granulating agent, a moving substance, characterized in that the active substance it contains a combination of herbs thermopsis powder or dry extract thermopsis and sodium bicarbonate and additionally contains a filler in the following ratio, wt.%:
grass thermopsis powder or dry extract thermopsis - 1,0-6
- sodium bicarbonate, dried at a temperature of 70°C - 4,0-88
- pharmaceutically acceptable filler - 5,0-80
- pharmaceutically acceptable granulating agent - 5,0-70
- pharmaceutically acceptable moving matter - 0.5 to 15.

2. The part of the drug composition cough according to claim 1, characterized in that is made in the form of tablets or sachets, or granules, or capsules.

3. The part of the drug composition cough according to claim 1, characterized in that it further contains an organic acid or a mixture of organic acids of some food acids: tartaric, citric, succinic, ascorbic�, fumaric in the amount of 1-40 wt.%.

4. The part of the drug composition cough according to claim 1, characterized in that it further comprises a pharmaceutically acceptable corrective substance in an amount of 0.5-40 wt.%.

5. The part of the drug composition cough according to claim 1, characterized in that the method of direct compression.

6. The part of the drug composition cough according to claim 5, characterized in that the method of direct pressing and further comprises a pharmaceutically acceptable excipient: lactose monohydrate or microcrystalline cellulose or calcium phosphate dvuhkamernyi in an amount of from 5 to 20 wt.%.

7. The part of the drug composition cough according to claim 1, characterized in that the granulating agent is used 10% starch paste or a 10% solution of low-molecular polyvinylpyrrolidone.

8. The part of the drug composition cough according to claim 1, characterized in that it further comprises a pharmaceutically acceptable disintegrant from 0.5 to 4 wt.%.

9. The part of the drug composition cough according to claim 8, characterized in that as disintegrant use sodium glycolate starch (primogel).

10. The part of the drug composition cough according to claim 1, characterized in that the 1/2 of the active substance sodium hydrogen carbonate is used as filler.

11. Composition l�drug compositions cough, including grass thermopsis powder or dry extract thermopsis, sodium hydrogen carbonate, granulating agent, a moving substance, characterized in that the active substance it contains a combination of herbs thermopsis powder or dry extract thermopsis and sodium bicarbonate and additionally contains a filler in the following ratio, wt.%:
grass powder or dry extract thermopsis - 3,5
- sodium bicarbonate, dried at a temperature of 70°C was 84.5
- microcrystalline cellulose - 5,5
- starch - 5,5
- talc - 1,0,
while preparing a part of the drug composition from coughing as follows: medicinal and auxiliary substances are crushed, sodium bicarbonate is subjected to further drying at a temperature of 70°C to remove free moisture, in the mixer initially served microcrystalline cellulose and 1/2 part of active substance of sodium bicarbonate, stirred for 10-15 minutes, then injected the grass in powder or dry extract thermopsis with stirring for 20-25 minutes until complete distribution of thermopsis, enter the remaining amount of sodium bicarbonate with stirring for 10-15 minutes, granulation produce 10% starch paste with stirring for 20-25 minutes then subjected to wet granulation through a sieve with a diameter of �of twisty 3x3 mm and dried mass at a temperature of from 45 to 50°C to a residual moisture of 1.2%, next, hold dusting of mass of dry potato starch and talc and spend the dry granulation through a sieve of 3 mm.



 

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79 cl, 10 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: present invention refers to a method for producing a tablet by (i) compressing a powder mixture in a mould plate of one device for producing a tabletted form with the powder mixture comprising a pharmaceutically active substance and a fusible binding agent, and (ii) exposing the above tabletted form to radio-frequency radiation generated by the above device over a period of time adequate to soften or melt the binding agent inside the above tabletted form to produce a tablet. Oral absorption of the produced tablet placed on the tongue takes less than approximately 30 s.

EFFECT: more effective method for producing the tablet by (i) compression.

18 cl, 14 dwg, 7 tbl, 9 ex

FIELD: chemistry.

SUBSTANCE: invention provides a composition having antioxidant properties in the form of a tablet, comprising an active agent based on nicotinamide adenine dinucleotide in reduced form (NADH) and inert filling agents, characterised by that the active ingredient is a complex which is a mixture of 10 wt % NADH with 63 wt % vegetable fats, 17 wt % beeswax and 10 wt % chlorophyll, and the inert filling agents are in the form of microcrystalline cellulose, Macrogol 6000, intense sweetener and a food flavourant.

EFFECT: invention provides a new tablet form of NADH.

1 ex

FIELD: chemistry.

SUBSTANCE: as active component pharmaceutical composition contains dihydrochloride of 9-(2-morpholine ethyl)-2-(4-fluorophenyl)imidazo[1,2-α]benzimidasol, and as additional substances - fillers, binding, sliding and film coatings, in quantities, given in the invention formula. Composition can be made in form of solid medication form, mainly in form of tablets and capsules.

EFFECT: obtained solid medication forms satisfy the requirements of the State Pharmacopoeia.

7 cl, 2 dwg, 3 tbl, 14 ex

FIELD: medicine.

SUBSTANCE: invention refers to a pharmaceutical composition with anti-ischemic and antioxidant activity in the form of tablets or capsules, and a method for preparing it. The composition contains 4-((3-oxo-3-ethoxypropanoyl)amino)benzoic acid in an amount of 40 to 80 wt %, an amino-containing compound and pharmaceutically acceptable excipients. The amino-containing compound is specified in a group of trometamol, methyl glucamine and L-lysine; 1 mole of 4-((3-oxo-3-ethoxypropanoyl)amino)benzoic acid is accounted for 0.05 to 0.25 mole of the above amino-containing compound. The composition also contains lactose, microcrystalline cellulose, calcium stearate and other pharmaceutically acceptable excipients. According to the method for preparing the composition, taking 4-((3-oxo-3-ethoxypropanoyl)amino)benzoic acid and amino-containing compound in molar ratio 1:0.05 to 1:0.25, pre-mixing, moisturising with a aqueous or alcohol solution of a binding agent, adding pharmaceutically acceptable excipients in such an amount to provide the content of 4-((3-oxo-3-ethoxypropanoyl)amino)benzoic acid from 40 to 80 wt %, granulating the mixture, drying and producing tablets or capsules according to the known technique.

EFFECT: implementing the above application.

6 cl, 7 tbl, 4 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to pharmaceutics, in particular a pharmaceutical composition in the form of a peroral drug form is described. The composition includes rebamipide as an active ingredient and a pharmaceutically acceptable carrier. Rebamipide is contained in an amount from 0.5 to 50 mg/kg, preferably from 0.6 to 6 mg/kg.

EFFECT: application of the rebamipide-based pharmaceutical composition for the prevention and treatment of arthrosoarthritis.

5 cl, 3 dwg, 1 tbl, 1 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: claimed is immunogenic composition for application in treatment or prevention of disease, associated with Clostridium difficile, method of obtaining said composition by mixing ingredients included into its composition and method of inducing immune response to C. Difficile, which includes introduction of said composition to individual. Claimed composition includes toxin or anatoxin of Clostridium difficile and one or several pharmaceutically acceptable excipients, which contain a) buffer, selected from the group of citrate and phosphate, in concentration from 10-30, 15-25 or 20 mM and b) sugar or sugar alcohol, selected from the group, consisting of sorbitol, trehalose and sucrose in concentration 4-20%.

EFFECT: excipients, which are components of composition, increase stability and/or reduce aggregation of toxins, which makes it possible to obtain compositions more stable in storage with preservation of their conformational integrity.

41 cl, 16 dwg, 13 tbl

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