RU2495663C1 - Solid dosage form of taurine with improved pharmacological properties - Google Patents

Abstract

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine and pharmacology, and concerns solid dosage forms of taurine. The dosage forms are applicable in treating type I and II diabetes mellitus, cardiovascular insufficiency and hepatobilliary systems. The dosage forms of taurine contain pharmaceutically acceptable carriers, excipients and additives differing by the fact that such forms have an external coating; as taurine promotors, they contain potassium chloride and N-vinylpyrrolidone copolymer.

EFFECT: solid dosage forms possess the improved pharmacological properties and improved efficacy in cardiovascular insufficiency, diabetes mellitus and hepatobilliary systems.

5 cl, 6 tbl, 6 ex

Description

FIELD OF THE INVENTION

The invention relates to medicine and pharmacology. More specifically, the invention provides solid dosage forms of taurine with improved pharmacological properties, in particular, forms for use in cardiovascular failure, diabetes mellitus and diseases of the hepatobiliary system, which have increased effectiveness.

State of the art

In the monograph Nefedov L.I. "Taurine: biochemistry, pharmacology, medical use." Grodno, 1999 .-- 145 s. with links to literature data and the results of his own research, the author convincingly proves that taurine has membrane-stabilizing and antioxidant effects, has antiatherogenic, cardio, radio, and hepatoprotective properties.

The membrane-stabilizing function of taurine determines its neuroeffective effect, which is presumably associated with modulation of ion fluxes, changes in the activity of pyruvate dehydrogenase in the brain, glutamate concentration, as well as suppression of the release of exciting neurotransmitters.

The anti-atherogenic effect was confirmed on a model of experimental atherosclerosis in male rats of the Wistar CRL strain, kept for 45 days on an atherogenic diet. The adequacy of the experimental model is confirmed by the pathomorphological characteristic of specific changes in the vascular endothelium.

The hepatoprotective effects of taurine and the mechanisms of their implementation in liver lesions have been proven and characterized in a model of toxic hepatitis in male Wistar CRL rats induced by 3-fold intraperitoneal administration of CCl ₄ according to a spectrum of metabolic control indicators that are informative for liver damage. The revealed patterns of their change indicate the activation of gluconeogenesis processes, the catabolism of aromatic compounds in the liver, and the stabilizing effect of taurine on hepatocellular membranes.

In experiments on isolated hearts of rabbits and cats in situ, taurine has a positive inotropic effect, and is also beneficial in congestive heart failure in rabbits, since it prevents the progression of aortic insufficiency. On various models of arrhythmia, it was shown that in rats and dogs, taurine at a dose of 100 mg / kg (intravenously) exerts a pronounced antiarrhythmic effect, prevents the development of necrotic changes in the myocardium, normalizes heart function in rats with hypoxia and hemodynamic insufficiency. Based on experimental data, the drug is used in a clinic for the treatment of patients with chronic congestive heart failure and cardiomyopathy, the appointment of which taurine at a dose of 3 g per day for 6 weeks improves the work of the left ventricle.

It was also shown that taurine, when administered orally to rats (1% of the feed weight), lowers blood pressure during spontaneous hypertension and hypertension. Moreover, in animals, in addition to lowering blood pressure (mainly systolic), the heart rate and plasma catecholamines decrease. In normotensive rats, blood pressure does not change under the action of taurine.

In accordance with ICD-10, taurine is prescribed as an instillation for ophthalmic diseases (H18.4 corneal degeneration, H25 senile cataract, H26.1 traumatic cataract, H28.0 diabetic cataract, H26.8 other specified cataracts, S05 Eye and eye socket injury, H35.3 degeneration of the macula and posterior pole) and inward in diabetes mellitus (EH insulin-dependent diabetes mellitus, E11 non-insulin-dependent diabetes mellitus), unspecified heart failure (150.9), as well as in case of poisoning with cardiac glycosides and similar deis Via (T46.0). When introduced into the dosage regimen is set individually, but usually 0.25-0.5 g 2 times a day. If necessary, the dose can be increased to 2-3 g / day.

Contraindications to the appointment of taurine are individual intolerance and hypersensitivity. In publications of Goyer R.A., Yin M.W. and Bowden D.N. Proc. Soc. Exp. Biol. Med. Vol. 116 (1964). P.534 and Roe D.A. J. Invest. Dermatology Vol. 46 (1966). P.420-430 noted that taking taurine in patients with psoriasis provokes an exacerbation of the disease, with a case of severe pruritis. Daily doses of 2 g, administered during the month, cause clinical manifestations of psoriasis in its latent course.

With increased secretion of gastric juice, as well as persons under the age of majority, taurine is prescribed with caution. Hypersecretion of gastric juice, usually accompanied by an increase in acidity of the juice and the amount of pepsinogen in it, is observed in such common gastrointestinal diseases as gastric ulcer (mainly localized in the duodenal bulb and pyloric), hypertrophic or erosive gastritis, as well as in the initial stage of thyrotoxicosis and in organic and functional changes in the central and peripheral parts of the autonomic nervous system with hyperactivation of the food center of the brain. As a result, the administration of taurine to cardiological patients with the listed concomitant gastrointestinal diseases can be a problem, especially if it is necessary to increase its daily dose.

Various solid dosage forms containing taurine as an active substance are known in the art. In the patent RU 2001616 (publ. 30.10.1993) disclosed an agent for the treatment of cardiovascular failure, containing (in wt.%):

Taufon: 87.2-84.09 Potato starch: 4.59-4.72 Gelatin: 1.77-2.2 Microcrystalline cellulose: 8.2-8.48 Aerosil: 0.353-0.95 Calcium stearic acid: 0.71-1.3.

The effect of the use of such a drug (taucard) in patients with dilated cardiomyopathy and circulatory failure of the I-III stages is assessed as satisfactory only in 20% of cases, which is expressed mainly in the improvement of the patient's condition, assessed subjectively.

The patent RU 2024256 (publ. 15.12.1994) discloses the use of taukard as an agent for the treatment of chronic diffuse diseases of the liver, in particular chronic persistent or active hepatitis and biliary cirrhosis. From the results of clinical use it follows that the drug is effective in a dose of more than 1.5 g / day, which may be intolerable during the treatment time of more than 3 weeks.

The patent RU 2054936 (publ. 27.02.1996) discloses the use of taurine as a membrane-stabilizing agent for the treatment of patients with insulin-dependent and non-insulin-dependent diabetes mellitus. However, with insulin-dependent diabetes, there is no significant decrease in the daily dose of insulin, and only half of the patients show compensation for the disease, which is manifested in normoglycemia and aglycosuria. The introduction of taurine (oral, 0.5 g 2 times a day for a month) showed that the effect of therapy extends exclusively to the content of triglycerides of total cholesterol and does not affect the phospholipid content of the erythrocyte membrane. Therefore, there is a need for taurine preparations that are more effective.

As the closest analogue of the present invention, the authors consider the drug “Dibicor®” containing 250 mg of taurine (83.33 wt.%), 23 mg of microcrystalline cellulose (7.67 wt.%), 18 mg of potato starch in one tablet (6, 00 wt.%), 6 mg of gelatin (2.00 wt.%), 0.3 mg of aerosil (0.10 wt.%) And 2.7 mg of calcium stearate (0.90 wt.%), Indications for use which are cardiovascular failure of various etiologies, intoxication with cardiac glycosides, type 1 diabetes mellitus and type 2 diabetes mellitus, including with moderate hypercholesterolemia nemiey.

Disclosure of invention

As a result of the studies, the inventors have found that the disadvantage of the prior art can be overcome by creating a solid dosage form of taurine for use in the treatment of type I and II diabetes mellitus, cardiovascular insufficiency and diseases of the hepatobiliary system containing pharmaceutically acceptable carriers, excipients and excipients characterized in that the solid dosage form has an outer coating, and as promoters of the action of taurine, it includes chloride chloride Ia and copolymer based on N-vinylpyrrolidone, represented by the general formula (I):

,

,

where the monomer unit M represents a fragment of 2-methyl-5-vinyltetrazole (MBT) or 2-methyl-5-vinylpyridine (MVP):

,

,

the content of monomer units n is 25-90 mol.%, and the average viscosity molecular weight M _{µ of the} copolymer depends on the nature of M: if M represents MW, then M _µ = 100-250 kDa; if M represents the profit center, then M _µ = 46-150 kDa.

In one embodiment, the invention provides a solid dosage form of taurine in tablet form. Preferably, such a tablet contains 200-400 mg of taurine, microcrystalline cellulose as a carrier, aerosil as a filler and starch, gelatin and calcium stearate as excipients. Preferably, such a tablet contains (in wt.%):

Taurine 58.8-60.6 Potassium chloride 23.5-22.7 The copolymer of the formula (I) 1.5-1.4 Microcrystalline cellulose 5.9-6.1 Starch 4.7-4.6 Gelatin 1.8-1.5 Aerosil 0.09-0.08 Calcium stearate 0, 8-0,4 Opadry II Coating Compound 2.9-2.7

More preferably, the tablet is coated with a polyvinyl alcohol and polyethylene glycol film coating such as Opadry II with the addition of a mineral pigment such as red iron oxide (Opadry II Orange).

In another embodiment, the invention provides a solid dosage form of taurine in capsule form. Preferably, such a capsule contains 350 mg (63.1 wt.%) Taurine, 23.4 wt.% Potassium chloride, 1.3 wt.% Copolymer of formula (I), 5.4 wt.% Microcrystalline cellulose as a carrier, 0 , 09 wt.% Aerosil as a filler, 4.5 wt.% Starch, 1.5 wt.% Gelatin and 0.7 wt.% Calcium stearate as excipients. The outer coating is the shell of a hard gelatin capsule.

In all embodiments of the invention, the starch is preferably potato starch.

The implementation of the invention

The invention will now be illustrated by examples of its preferred implementation.

Examples 1-2. Tablets containing 200 or 400 mg of taurine

The gelatin is mixed with distilled water to obtain a 5% solution used as a humectant to increase the adhesion between the particles of the components of the tabletting mixture, to which finely ground potassium chloride is then added.

Separate screening of taurine, a copolymer of formula (I), microcrystalline cellulose and potato starch is carried out through sieves with a hole size of 0.15 mm Aerosil is added to the sifted components and mixed for 30 minutes in a mixer with sigmoid-shaped blades. The resulting mass in the same mixer is moistened with a solution of gelatin and potassium chloride with constant stirring until a uniform distribution of moisture. The moistened mass is granulated by passing through a granulator with a hole size of 1.0 mm.

Wet granules are dried in an oven at a temperature of 40 ° C until a residual moisture content of 2.0-4.5% is reached. The dried granules are then subjected to dry granulation, for which they are passed through a granulator with a hole size of 1.0 mm, and then powdered with calcium stearic acid for 10 minutes to improve the fluidity of the granules and reduce their adhesion.

The granules obtained are pressed into tablets of 200 or 400 mg on a Korsch tablet press equipped with spherical punches. The resulting tablets are dedusted on a metal sieve with a hole size of 3-4 mm.

Coating on tablet cores begins with the preparation of a 20% suspension of an integrated coating system based on polyvinyl acetate (trademark Opadry II, registered by BPSI Holdings, LLC). The coating suspension is stirred for 15-20 minutes, and then filtered through a nylon sieve No. 23. The tablet cores are coated in a drum-type apparatus under the conditions indicated below. Inlet air temperature: 30 ± 2 ° C, outlet air temperature: 28 ± 1 ° C, pressure: 2.5 ± 0.5 bar, coating slurry through the nozzle: 8 ± 1 ml / min, core preheating: 10 min to 45-50 ° C, suspension spraying time: 30-40 min, final drying of the cores - 10 min. The coating process is carried out to obtain a mass gain of 3-5%.

The finished coated tablets are packed in blisters (10 pieces each) or in polymer jars with a screw neck and a screw-on lid for medicines and vitamins (30 pieces each). The packaging is labeled to identify the drug and directions for use are applied.

Table 1 shows the absolute and relative composition of the tablet.

Table 1 Name of components Content in one tablet Example 1 Example 2 mg mass% mg mass% Taurine 200 58.82% 400 60.61% Potassium chloride 80 23.53% 150 22.73% The copolymer of the formula (I) 5 1.47% 9 1.36% Microcrystalline cellulose twenty 5.88% 40 6.06% Starch 16 4.71% thirty 4,55% Gelatin 6 1.76% 10 1.52% Aerosil 0.3 0.09% 0.5 0.08% Calcium stearate 2.7 0.79% 2,5 0.38% Opadry II Coating Compound 10 2.94% eighteen 2.73% Tablet weight mg 340 100.00 660 100.00

Example 3. Gelatin capsules containing 350 mg of taurine. Gelatin is mixed with distilled water to obtain a 5% solution used as a humectant to increase the adhesion between the particles of the components of the tabletting mixture, to which finely ground potassium chloride is then added.

Separate screening of taurine, a copolymer of formula (I), microcrystalline cellulose and potato starch is carried out through sieves with a hole size of 0.15 mm. Aerosil is added to the sifted components and mixed for 30 minutes in a mixer with sigmoid-shaped blades. The resulting mass in the same mixer is moistened with a solution of gelatin and potassium chloride with constant stirring until a uniform distribution of moisture. The moistened mass is granulated by passing through a granulator with a hole size of 1.0 mm.

Wet granules are dried in an oven at a temperature of 40 ° C until a residual moisture content of 2.0-4.5% is reached. The dried granules are then subjected to dry granulation, for which they are passed through a granulator with a hole size of 1.0 mm, and then powdered with calcium stearic acid for 10 minutes to improve the fluidity of the granules and reduce their adhesion. The granules are re-crushed, the resulting powder is sieved and filled with No. 2 gelatin capsules.

Table 2 shows the absolute and relative composition of the capsule.

table 2 Name of components Content in one capsule mg mass% Taurine 350 63.06% Potassium chloride 130 23.42% The copolymer of the formula (I) 7 1.26% Microcrystalline cellulose thirty 5.41% Starch 25 4.50% Gelatin 8.5 1.53% Aerosil 0.5 0.09% Calcium stearate four 0.72% The mass of the contents of the capsule, mg 555 100.00%

Example 4. Hepatoprotective effect of the drug in accordance with the invention

Male rabbits of the breed "Gray Giant" with a body weight of 4.3-4.6 kg are divided into three groups of 5 animals each. Before the start of the study, animals in the control group (“control (0)”) take a blood sample and determine the activity of enzymes and the level of bilirubin as described below. All animals were injected subcutaneously with a 50% solution of hepatotoxin (carbon tetrachloride, CCl ₄ ) in sterile sunflower oil at a rate of 0.4 ml / 100 g body weight for 4 days.

Animals of all three groups once a day for 10 days receive the appropriate preparations. The animals of the first group (“control”) are given placebo tablets orally (forcibly with a small amount of water from a syringe). The animals of the second group ("taurine") are injected with a special gastric tube suspension of taurine at the rate of 45 mg / kg body weight. Animals of the third group (“preparation”) receive tablets in accordance with the invention containing 200 mg of taurine (dose at a level of 45 mg / kg body weight), which are administered in the same way as animals of the first group.

At the end of the experiment, serum is isolated from the blood of sacrificed animals by conventional methods. The activity of alanine aminotransferase (AlAT), aspartate aminotransferase (AcAT), alkaline phosphatase (ALP) is determined in blood serum using Bio-1a-test kits (manufactured by Pliva-Lachem Diagnostika S.R.O). Bilirubin is determined spectrophotometrically. The results are presented in table 3.

Table 3 Group Indicator, mmol / l AlAT AsAT Alkaline phosphatase Common bilirubin Indirect bilirubin Control (0) 1.17 ± 0.20 1.31 ± 0.15 8.2 ± 0.8 10.63 ± 0.80 4.40 ± 0.93 The control 4.10 ± 0.23 3.22 ± 0.11 13.2 ± 0.5 19.75 ± 1.42 10.31 ± 1.95 Taurine 3.37 ± 0.52 2.00 ± 1.52 9.5 ± 0.3 16.65 ± 2.10 8.81 ± 2.20 A drug 2.90 ± 0.47 1.66 ± 1.61 7.9 ± 0.2 13.63 ± 1.98 7.49 ± 1.89

Toxic liver damage in rabbits caused by carbon tetrachloride leads to a significant increase in the plasma activity of animals of the enzymes AlAT, AcAT and alkaline phosphatase, an increase in the content of total and indirect bilirubin. The hepatoprotective effect of taurine is manifested in the normalization of the activity of the main enzymes that characterize the state of catabolism of the protein structures of hepatocytes. Moreover, the protective effect of the drug in accordance with the invention significantly exceeds the effectiveness of a suspension of taurine by approximately 15%, which confirms the achievement of the technical result of the invention.

Example 5. Cardioprotective effect

The cardioprotective effect of the preparation according to the invention and taurine is evaluated in experiments on male Wistar rats weighing 330-370 g, kept under 12/12 hour light conditions and treated with standard food and drinking ad libitum water. Animals are divided into three groups of 9 animals each. The first group serves as a control group. In it, animals receive placebo capsules. The second group of animals (“taurine”) receives hard gelatin capsules with taurine powder (100 mg). The animals of the third group (“preparation”) are given capsules made in accordance with the invention, but for experimental purposes containing only 100 mg of taurine (dose at a level of 350 mg / kg body weight).

An occluder is formed as a model for creating reversible myocardial ischemia and assessing a heart attack zone: the ends of the ligature, covering the coronary artery, are drawn into the lumen of a polyethylene tube with a diameter of 1 mm and a length of 5-6 cm (PE 40), after which occlusion is achieved by moving the tube to the heart. left coronary artery, and in the opposite direction - reperfusion. During the experiment, the animals are kept on a thermostatic operating table, maintaining the animal's body temperature within 37.0 ± 0.5 ° C.

The dimensions of the anatomical risk zone and infarction zone are estimated using the double staining method with Evans blue dye and triphenyltetrazolium chloride (TTC) (MP Biomed., USA). After visualizing the border between the blood supply and ischemic sections, the heart is quickly removed and cut in the transverse direction into five fragments of the same thickness (2 mm). Images of the basal surfaces of the five fragments are photographed with an Olimpus 2020 digital camera connected to a microphotographic microscope device for subsequent determination of the area of the anatomical risk zone (Evans-negative areas) and non-ischemic myocardium (Evans-positive areas). The calculation of the area is carried out on a computer using the program Adobe Photoshop 4.0. The total volume of the risk zone for each heart is calculated by multiplying the area of the Evans-negative section of each slice by its thickness and summing the values obtained from four slices. Then calculate the total volume of the infarction zone for a given heart in the same way. Data on the size of the risk zone and heart attack are presented as the ratio of the volume of the risk zone to the total heart volume, as well as the ratio of the volume of the heart attack zone and the volume of the risk zone (in percent). The results are shown in table 4.

Table 4 Group Indicator The size of the risk zone,% The size of the heart attack zone,% The control 46 ± 3.7 61 ± 4.3 Taurine 39 ± 2.8 30 ± 9.2 A drug 43 ± 2,3 27 ± 8.6

The absence of differences in the size of the risk zone indicates a standard level of ligation of the left coronary artery and equal initial conditions of ischemia in all groups of animals. The protective effect of the drug in accordance with the invention exceeds the effectiveness of a suspension of taurine by approximately 10%, which confirms the achievement of the technical result of the invention.

Example 6. The effect of the drug in diabetes

Outbred white rats weighing 270-350 g are divided into 4 groups of 6 individuals. The first group (“control (0)”) is composed of intact animals, which are injected intraperitoneally with 1 ml / 100 g of body weight of pyrogen-free water. The animals of the second group ("control") are injected intraperitoneally with alloxan at a dose of 135 mg / kg. The third group of animals ("taurine") receives hard gelatin capsules with taurine powder (100 mg). The animals of the fourth group (“preparation”) are given capsules made in accordance with the invention, but for experimental purposes containing only 100 mg of taurine (dose at a level of 350 mg / kg body weight).

Subsequently, animals are observed for four weeks. The general condition, body weight, food and water intake are recorded. Therapy of experimental animals in the third and fourth groups is carried out for four weeks with a daily single oral administration of taurine. A control group of patients with diabetes and intact animals were given placebo capsules.

At the end of the experiment, the coefficient of increase in body weight of animals and the mass coefficients of internal organs are evaluated. In homogenates of internal organs and in blood serum, the content of lipid peroxidation products is determined: diene conjugates (DC) and malondialdehyde (MD). The results are shown in table 5.

Table 5 Indicator Group of animals on the 18th day of the experiment Intact The control Taurine A drug DC spleen, mmol / kg 72.2 ± 5.1 130.3 ± 12.8 95.3 ± 8.6 81.1 ± 7.9 DC liver, µmol / kg 256.1 ± 18.1 420.3 ± 21.5 345.1 ± 31.5 296.3 ± 32.1 DC brain, µmol / kg 176.2 ± 10.1 294.6 ± 21.7 181.3 ± 9.9 178.4 ± 9.2 Kidney DC, μmol / kg 59.7 ± 5.6 85.7 ± 11.1 57.7 ± 6.4 52.8 ± 7.4 MD serum, µmol / kg 4.08 ± 0.2 4.3 ± 0.1 4.4 ± 0.1 4.2 ± 0.1 MD brain, µmol / kg 56.7 ± 5.5 111.8 ± 13.4 49.7 ± 8.4 45.7 ± 8.8 MD spleen, mmol / kg 50.5 ± 1.3 101.9 ± 20.4 58.5 ± 14.5 51.2 ± 15.1 MD kidney, μmol / kg 69.9 ± 5.1 78.7 ± 13.3 75.8 ± 11.8 72.6 ± 12.7 MD liver, µmol / kg 236.2 ± 22.7 530.1 ± 80.6 232.4 ± 36.5 227.9 ± 35.7

According to the results of rat autopsy in all 4 groups, the indices of the masses of the internal organs - targets of the diabetic lesion, which are given in table 6, are calculated.

Table 6 Organs Mass ratio Intact The control Taurine A drug Pituitary 3.63 ± 0.24 5.07 ± 0.52 4.30 ± 0.35 3.92 ± 0.26 Heart 3.94 ± 0.04 4.62 ± 0.21 4.52 ± 0.19 4.38 ± 0.21 Liver 3.08 ± 0.08 4.41 ± 0.18 3.50 ± 0.21 3.46 ± 0.19 Brain 5.40 ± 0.19 5.80 ± 0.20 6.54 ± 0.25 6.01 ± 0.27 Adrenal glands 1.48 ± 0.10 2.48 ± 0.20 2.20 ± 0.36 1.98 ± 0.25 Spleen 3.54 ± 0.21 4.68 ± 0.38 3.70 ± 0.14 3.63 ± 0.17 Thymus 0.99 ± 0.13 0.80 ± 0.06 0.50 ± 0.12 0.66 ± 0.09

The initial level of blood glucose in intact animals was 2.68 ± 0.09 mmol / L, and in patients with diabetes - 27.28 ± 1.03 mmol / L (p <0.001). The drug in accordance with the invention in the treatment of diabetic rats significantly reduced blood sugar levels on the 3rd, 16th and 29th day of the experiment by 20.5%, 29% and 50%, respectively.

The results showed that the drug in accordance with the invention at a dose of 350 mg / kg with a two-week course of administration has a normalizing effect on the mass coefficients of the diabetes targets: heart, spleen, adrenal glands, which confirms the achievement of the technical result of the invention.

Claims (5)

1. A solid dosage form of taurine for use in the treatment of diabetes mellitus type I and II, cardiovascular failure and diseases of the hepatobiliary system containing pharmaceutically acceptable carriers, excipients and excipients, characterized in that the solid dosage form has an outer coating, and as promoters of the action of taurine, it includes potassium chloride and a copolymer based on N-vinylpyrrolidone, represented by the general formula (I):

,
where the monomer unit M represents a fragment of 2-methyl-5-vinyltetrazole (MBT) or 2-methyl-5-vinylpyridine (MVP):

,
the content of monomer units n leaves 25-90 mol%, and the average viscosity molecular weight M _{µ of the} copolymer depends on or the nature of M: if M represents MBT, then M _µ = 100-250 kDa; if M represents the profit center, then M _µ = 46-150 kDa. 2. The drug dosage form according to claim 1, characterized in that it is presented in tablet form with the following content of components, in wt.%:
Taurine 58.8-60.6 Potassium chloride 23.5-22.7 The copolymer of the formula (I) 1.5-1.4 Microcrystalline cellulose 5.9-6.1 Starch 4.7-4.6 Gelatin 1.8-1.5 Aerosil 0.09-0.08 Calcium stearate 0.8-0.4 Opaclry II Coating Compound 2.9-2.7 3. The dosage form according to claim 2, characterized in that the content of taurine is 200-400 mg, and the tablet is coated with a film coating based on polyvinyl alcohol and poly (ethylene glycol), such as Opadry II, with the addition of a mineral pigment such as red iron oxide. 4. The dosage form according to claim 1, characterized in that it is presented in the form of a capsule with the following content of components, in wt.%:
Taurine 63.06 Potassium chloride 23.42 The copolymer of the formula (I) 1.26 Microcrystalline cellulose 5.41 Starch 4,50 Gelatin 1,53 Aerosil 0.09 Calcium stearate 0.73 5. The dosage form according to claim 4, characterized in that the capsule contains 350 mg of taurine, and the outer coating is a hard gelatin capsule.