SK285964B6 - Medicinal composition comprising fexofenadine hydrochloride and method for the preparation thereof - Google Patents

Abstract

Medicinal preparation comprising fexofenadine hydrochloride as an active substance at amount of 100 mg to 1000 mg, which is 15 to 50 % by weight, at least one ancillary substance from the group of polyols and/or sugars, at least one tabletting mass flow regulator at amount of 0.1 to 10 % by weight, at least one disintegrant at amount of 1 to 25 % by weight, at least one lubricant at amount of 0.1 to 10 % by weight and dry binders at amounts of 10 to 45 % by weight, related to the total weight of the composition. Described is also a method for the preparation of the medicinal preparation.

Description

Technical field

The invention, in the field of pharmacy, provides a composition and a process for the preparation of a tablet containing fexofenadine hydrochloride. The tablet can be used to prepare tablets, coated tablets, microtablets, pellets, micropellets, powders, granules, and as capsules. The preparation is used for the treatment of allergic diseases, especially allergic rhinitis.

BACKGROUND OF THE INVENTION

At present, the dose of fexofenadine hydrochloride in the world of fast-acting oral formulations of the world is in the range of 30 mg to 180 mg. A disadvantage of this active ingredient is its poor water solubility. For this reason, the substance is used for the preparation of solid dosage forms in micronized form, where the surface area is more than 1 m ² / g and the active substance, fexofenadine hydrochloride, is very voluminous. On the basis of the foregoing, the preparation of a tablet by wet granulation seems technologically more appropriate.

WO96 / 26726 describes the preparation of coated tablets and capsules containing fexofenadine hydrochloride. The tablets are compressed from a tablet prepared by wet granulation of the active and excipients. A mixture of excipients and the active ingredient which has been prepared by wet granulation is also used as a capsule filler.

When preparing tablets, respectively. Capsule fillers used in pharmacy are the usual excipients, namely: croscarmellose sodium, lactose, microcrystalline cellulose, corn gelatin starch, calcium carbonate, magnesium stearate, sodium starch glycolate. These substances are combined in different proportions and amounts. A suitable combination serves to prepare the tablet by granulation. Coatings sold under the commercial name Opadry were used as film forming agents.

A disadvantage of said process for the preparation of an oral formulation containing fexofenadine hydrochloride is complicated technology requiring treatment of the active ingredient and excipients prior to processing, wet granulation, wet granulation treatment, wet granulation drying, dry granulation treatment. Wet granulation, on the one hand, most reliably results in a compliant tablet, but on the other hand it is one of the unsafe methods when the wet mixture is heated during drying, which leads to thermal degradation in the more sensitive substances.

Patent application WO 03/041683 describes an orally soluble form of fexofenadine. This mold was also produced by a wet granulation process.

Surprisingly, however, it has now been found that the dosage form of fexofenadine can be prepared by dry means, i.e. without wet granulation.

SUMMARY OF THE INVENTION

The present invention provides a medicament comprising fexofenadine hydrochloride, i. j. the active substance used in the treatment of allergic manifestations. The medicinal product contains fexofenadine hydrochloride as active substance, is obtainable by dry mixing and either by direct tabletting or briquetting or compacting, in the form of a tablet or coated tablet or capsule filling containing the active substance - fexofenadine hydrochloride in an amount of 100 mg to 1000 mg %, representing 15 to 50 wt.

based on the total weight of the formulation, and further comprises at least one excipient selected from the group of polyols and / or carbohydrates. The excipient of the polyol group is preferably one or more mannitols having a particle size of 100 to 520 µm, preferably 180 to 360 gm.

Preferably, the medicament composition further comprises 0.1 to 10 wt. %, preferably 0.5 to 2 wt.% of at least one flow modifier, preferably silica colloidalis anhydrica.

Preferably, the medicament composition may further comprise 1 to 25 wt. %, preferably 1.5 to 10 wt. %, at least one disintegrant, preferably sodium carboxymethyl starch (carboxymethylamylum natricum).

The medicament composition may further comprise 0.1 to 10% by weight, preferably 0.5 to 4% by weight, of at least one glidant, preferably calcium stearate, and preferably further comprises 10 to 45% by weight of dry binders, preferably cellulose derivatives.

The principle of the production method consists in that the mixture of the active ingredient and at least one excipient from the group of polyols and / or saccharides is prepared by dry mixing, and further processed either by direct tabletting or briquetting or compacting, in the range of 100 to 2000 µm, preferably 800 µm, followed by finishing of the thus prepared tablet.

The tablet prepared in this way can be used for the compression of cores and / or tablets, and / or microtablets, and / or for the preparation of pellets, and / or micropellets, and / or powders and / or granules, and / or as a capsule filling.

The preparation of the pulp is technologically simple, the preparation is limited to energy and time-saving technological steps.

Said methods of preparation do not include stressful processes such as introducing a wetting agent into a mixture of the active ingredient and excipients for the preparation of a tablet. Said methods of preparation and selection of excipients according to the invention also ensure very good stability of the formulation and the desired physical properties of the dosage form.

In addition to the active ingredient, the tablets described in the invention contain fexofenadine hydrochloride of the formula:

other excipients such as: polyols - such as fillers and flow modifiers, glidants to facilitate tabletting, tablet disintegration aids.

Film-forming substances are the commonly used film-forming substances available under the commercial name Sepifilm, respectively. Sepisperse.

Polyols are pharmaceutical excipients which are ideal for dry solid formulation formulations. Due to their physico-chemical parameters, the formulation provides very good stability and satisfactory physico-chemical parameters of the tablets. According to the present invention, these properties have been repeatedly achieved by the use of physically modified polyols, respectively. mannitol.

Modified mannitol (Pearlitol) is a white, crystalline powder (or granulate). Due to its properties it ensures very good flow properties of the pulp and very good tabletability. Other properties are low hygroscopicity and chemical stability. These properties contribute to the excellent stability of the fexofenadine hydrochloride formulation prepared according to the present invention.

The essence of the technological process is that the active substance fexofenadine hydrochloride is mixed with a corresponding amount of:

saccharides and / or polyols having a particle size of 10 to 1000 µm;

or mannitol having a particle size of 100 to 520 µm, preferably 180 to 360 µm;

or in a mixture of 20 to 75 wt. % mannitol with a particle size of 100 to 520 µm, preferably 180 to 360 µm, and 10 to 40 wt. % dry binder, preferably cellulose derivatives;

or in a mixture of 50 to 80 wt. % mannitol with a particle size of 100 to 520 µm, preferably 180 to 360 µm, and 0.1 to 10 wt.%, preferably 0.5 to 2 wt. % of a flow control agent of the tablet, preferably colloidal anhydrous silica (Aerosil 200);

or in a mixture of 50 to 80 wt. % mannitol with a particle size of 100 to 520 µm, preferably 180 to 360 µm, preferably Pearlitol 400 DC, and 0.4 to 25 wt. %, preferably 1.5 to 10 wt.% disintegrant, preferably sodium carboxymethyl starch (carboxymethylamylum natricum);

or in a mixture of 50 to 80 wt. % mannitol with a particle size of 100 to 520 µm, preferably 180 to 360 µm, and 0.1 to 10 wt. %, preferably 0.5 to 4 wt. a glidant, preferably calcium stearate (Calcii stearas);

or in a mixture of 50 to 80 wt. % mannitol with a particle size of 100 to 520 µm, preferably 180 to 360 µm, and 0.1 to 10 wt. %, preferably 0.5 to 2 wt. % of a flow control agent of the tablet, preferably colloidal anhydrous silica (Aerosil 200), and 0.1 to 10% by weight, preferably 0.5 to 4% by weight, of a glidant, preferably calcium stearate (Calcii stearas);

or in a mixture of 50 to 80 wt. % mannitol with a particle size of 100 to 520 µm, preferably 180 to 360 µm, and 0.1 to 10 wt. %, preferably 0.5 to 2 wt. % of a flow control agent of the tablet, preferably colloidal anhydrous silica (Aerosil 200), and 0.4 to 25 wt. %, preferably 1.5 to 7 wt. a disintegrant, preferably carboxymethyl starch sodium (carboxymethyl starch sodium);

or in a mixture of 50 to 80 wt. % mannitol with a particle size of 100 to 520 µm, preferably 180 to 360 µm, and 0.1 to 10 wt. %, preferably 0.5 to 2 wt. % of a flow control agent of the tablet, preferably colloidal anhydrous silica (Aerosil 200), and 0.4 to 25 wt. %, preferably 1.5 to 7 wt. % disintegrant, preferably sodium carboxymethyl starch (carboxymethylamylum natricum), and 0.1 to 10 wt. %, preferably 0.5 to 4 wt. a glidant, preferably calcium stearate (Calcii stearas);

From these mixtures, it is possible to prepare a tablet, resp. tablets dry way in several ways. And that:

1. Direct tabletting (preparation of a mixture of tablets —► —► solid dosage form)

2. Compacting (preparation of a tablet mixture —► compacting —► particle size adjustment —► finishing —► solid dosage form)

3. briquetting (preparation of mixture of tablets —► briquetting —► adjustment of particle size —► finishing -> solid dosage form)

The tablets thus prepared guarantee reproducibility of the manufacturing process.

The advantage of these processes is the energy and time-consuming nature, in particular of the first of the above mentioned processes for preparing the tablet and solid dosage forms containing fexofenadine hydrochloride.

Said processes for preparing the tablet and solid dosage forms containing fexofenadine hydrochloride by direct tableting and the selection of excipients according to the invention make it possible to prepare the tablet and solid dosage forms with excellent physical and chemical parameters.

DETAILED DESCRIPTION OF THE INVENTION

The subject matter of the invention is illustrated in the examples without being limited thereto.

Example 1:

(a) a pharmaceutical preparation containing in the composition of tablets:

composition Weight in g Weight% Fexofenadine hydrochloride 0.12000 g 30,00% Pearlitol 400 DC 0,26000 g 65.00% Silica colloidalis (Aerosil 200) 0.00200 g 0,50% Carboxymethyl starch sodium 0.01200 g 3,00% Calcium stearate 0.00600 g 1.50% Together: 0,40000 g 100.00%

(b) method of preparation:

The homogenizer was charged with the drug and 50% of the Pearlitol 400 DC batch and Aerosil 200. The mixture was stirred for 20 minutes (Mixing I). The mixed premix is discharged into a container and then sieved through a sieve of 1.25 mm mesh. The sieve premix no. 1 and 50% of Pearlitol 400 DC batch. The mixture was stirred for 15 minutes (Stir II). Calcium stearate and sodium starch glycolate are added to the blended mixture in the homogenizing pear. Stir 15 minutes (Finish). Tablets are compressed from the finished tablet on a tablet press.

Example 2:

(a) a pharmaceutical preparation containing in the composition of tablets:

composition Weight in g Weight% Fexofenadine hydrochloride 0,06000 g 30,00% Pearlitol 400 DC 0,04000 g 20,00% Hydroxypropylmethylcellulose (LH 11) 0,08200 g 41.00% Silica colloidalis (Aerosil 200) 0.00200 g 1.00% Carboxymethyl starch sodium 0.01300 g 6.50% Calcium stearate 0.00300 g 1.50% Together: 0,20000 g 100.00%

(b) method of preparation:

The homogenizer was charged with the drug and 50% of the Pearlitol 400 DC batch and Aerosil 200. The mixture was stirred for 20 minutes (Mixing I). The mixed premix is discharged into a container and then sieved through a 1.25 mm mesh screen. The sieve premix no. 1 and 50% of Pearlitol 400 DC feed and hydroxypropyl methylcellulose (LH 11). The mixture was stirred for 15 minutes (Stir II). Calcium stearate and sodium starch glycolate are added to the blended mixture in the homogenizing pear. Stir 15 minutes (Finish). Tablets are compressed from the finished tablet on a tablet press.

Example 3:

(a) a pharmaceutical preparation containing in the composition of tablets:

composition Weight in g Weight% Fexofenadine hydrochloride 0,06000 g 24,00% Pearlitol 400 DC 0.10500 g 42,06% sucrose 0,06000 g 24,00% Silica colloidalis (Aerosil 200) 0.00300 g 1.20% Carboxymethyl starch sodium 0.01800 g 7.20% Calcium stearate 0.00400 g 1,60% Together: 0,25000 g 100.00%

(b) method of preparation:

The homogenizer was charged with the drug and 50% of the Pearlitol 400 DC batch and Aerosil 200. The mixture was stirred for 20 minutes (Mixing I). The mixed premix is discharged into a container and then sieved through a 1.25 mm mesh screen. The sieve premix no. 1 and 50% of Pearlitol 400 DC batch and sucrose. The mixture was stirred for 15 minutes (Stir II). Calcium stearate and sodium starch glycolate are added to the blended mixture in the homogenizing pear. Stir 15 minutes (Finish). Tablets are compressed from the finished tablet on a tablet press.

Example 4:

(a) a pharmaceutical preparation containing in the composition of tablets:

composition Weight in g Weight% Fexofenadini hydro- 0,06000 g 24,00% chloride Pearlitol 400 DC 0.14500 g 58.00% Hydroxypropyl 0,02000 g 8,00% tylcellulose (LH 11) Silica colloidalis (Aerosil 200) 0.00300 g 1.20% Sodium salt of carboxy- 0.01800 g 7.20% carboxymethylcellulose, carboxymethyl starch Calcium stearate 0.00400 g 1,60% Together: 0,25000 g 100.00%

(b) the method of its preparation:

The homogenizer was charged with the drug and 50% of the Pearlitol 400 DC batch and Aerosil 200. The mixture was stirred for 20 minutes (Mixing I). The mixed premix is drained into a container and then sieved through a 1.25 mm mesh screen. The sieve premix no. 1 and half of the calcium stearate feed and the carboxymethyl starch sodium salt. The mixture was stirred for 10 minutes. From the mixture thus prepared, briquettes with a strength of 50-70 N are pressed, which are then ground through a sieve with a mesh size of 0.8 mm. 50% of a batch of Pearlitol 400 DC and hydroxypropyl methylcellulose (LH 11) are added to the thus prepared tablet. The mixture was stirred for 15 minutes (Stir II). The second half of the calcium stearate feed and the carboxymethyl starch sodium salt are added to the blended mixture in the homogenizing pear. Stir 15 minutes (Finish). Tablets are compressed from the finished tablet on a tablet press.

Example 5:

(a) a pharmaceutical preparation containing in the composition of tablets:

composition

Fexofenadine hydrochloride

Pearlitol 400 DC

Silica colloidalis anhydrica (Aerosil 200) Carboxymethyl starch sodium

Calcium stearate

Together:

Weight in g

0,06000 g

0.22650 g

0.00150 g

0.00750 g

0.00450 g

0,30000 g

Weight%

20,00%

75.50%

0,50%

2.50%

1.50%

100.00%

(b) the method of its preparation:

The homogenizer was charged with the drug and 50% of the Pearlitol 400 DC batch and Aerosil 200. The mixture was stirred for 20 minutes (Mixing I). The mixed premix is drained into a container and then sieved through a 1.25 mm mesh screen. The sieve premix no. 1 and half of the calcium stearate feed and the carboxymethyl starch sodium salt. The mixture was stirred for 10 minutes. From the mixture thus prepared, briquettes with a strength of 50-70 N are pressed, which are then ground through a sieve with a mesh size of 0.8 mm. 50% of Pearlitol 400 DC batch was added to the thus prepared tablet. The mixture was stirred for 15 minutes (Stir II). The second half of the calcium stearate feed and the carboxymethyl starch sodium salt are added to the blended mixture in the homogenizing pear. Stir 15 minutes (Finish). Tablets are compressed from the finished tablet on a tablet press.

Example 6:

(a) a pharmaceutical preparation containing in the composition of tablets:

composition Weight in g Weight% Fexofenadine hydrochloride 0,06000 g 20,00% Pearlitol 400 DC 0.22650 g 75.50% Silica colloidalis (Aerosil 200) 0.00150 g 0,50% Carboxymethyl starch sodium 0.00750 g 2,50% Calcium stearate 0.00450 g 1.50% Together: 0,30000 g 100.00%

(b) the method of its preparation:

The homogenizer was charged with the drug and 50% of the Pearlitol 400 DC batch and Aerosil 200. The mixture was stirred for 20 minutes (Mixing I). The mixed premix is discharged into a container and then sieved through a 1.25 mm mesh screen. The sieve premix no. 1 and a half of the stearate batch and the carboxymethyl starch sodium salt. The mixture was stirred for 10 minutes. The mixture thus prepared is compacted. The prepared compact is ground through a sieve with a mesh size of 0.8 mm. 50% of Pearlitol 400 DC batch was added to the thus prepared tablet. The mixture was stirred for 15 minutes (Stir II). The second half of the calcium stearate and sodium starch sodium salt are added to the blended mixture in the homogenizing pear. Stir 15 minutes (Finish). Tablets are compressed from the finished tablet on a tablet press.

Example 7:

(a) a pharmaceutical preparation containing in the composition of tablets:

composition Weight in g Weight% Fexofenadine hydrochloride 0,03000 g 20,00% Pearlitol 200 SD 0.10875 g 72.50% Silica colloidalis an- 0.00075 g 0,50% hydrica (Aerosil 200) Carboxyme sodium 0.00375 g 2,50% tylškrobu Calcium stearate 0.00675 g 4.50% Together: 0.15000 g 100.00%

(b) method of preparation:

The active ingredient and 50% of the Pearlitol 200 SD and Aerosil 200 batches are loaded into the homogenizer. The mixture is stirred for 20 minutes (Mixing I). The mixed premix is discharged into a container and then sieved through a 1.25 mm mesh screen. The sieve premix no. 1 and half of the calcium stearate feed and the carboxymethyl starch sodium salt. The mixture was stirred for 10 minutes. The mixture thus prepared is compacted. The prepared compact is ground through a sieve with a mesh size of 0.8 mm. 50% of Pearlitol 200 SD batch was added to the thus prepared tablet. The mixture was stirred for 15 minutes (Stir II). The second half of the calcium stearate feed and the carboxymethyl starch sodium salt are added to the blended mixture in the homogenizing pear. Stir 15 minutes (Finish). The finished tablet is filled into gelatin capsules.

Example 8:

(a) a pharmaceutical preparation containing in the composition of tablets:

composition

Fexofenadine hydrochloride

Pearlitol 200 SD

Silica colloidalis anhydrica (Aerosil 200) Carboxymethyl starch sodium

Calcium stearate Total:

Weight in g Weight% 0,03000 g 20,00% 0.10875 g 72.50% 0.00075 g 0,50% 0.00375 g 2,50% 0.00675 g 0.15000 g 4.50% 100.00%

(b) method of preparation:

The active ingredient and 50% of the Pearlitol 200 SD and Aerosil 200 batches are loaded into the homogenizer. The mixture is stirred for 20 minutes (Mixing I). The mixed premix is discharged into a container and then sieved through a 1.25 mm mesh screen. The sieve premix no. I and half of the calcium stearate feed and sodium starch glycolate. The mixture was stirred for 10 minutes. From the mixture thus prepared, briquettes with a strength of 50-70 N are pressed, which are then ground through a sieve with a mesh size of 0.8 mm. 50% of Pearlitol 200 SD batch was added to the thus prepared tablet. The mixture was stirred for 15 minutes (Stir II). The second half of the calcium stearate feed and the carboxymethyl starch sodium salt are added to the blended mixture in the homogenizing pear. Stir (Finish). The finished tablet is filled into gelatin capsules.

Example 9:

(a) a pharmaceutical preparation containing in the composition of tablets:

composition Weight in g Weight% Fexofenadini hydro- 0.12000 g 20,00% chloride Pearlitol 200 SD 0.45300 g 75.50% Silica colloidalis an- 0.00300 g 0.50% hydrica (Aerosil 200) Carboxyme sodium 0.01500 g 2,50% tylškrobu Calcium stearate 0.00900 g 1.50% Together: 0,60000 g 100.00%

(b) the method of its preparation:

The active ingredient and 50% of the Pearlitol 200 SD and Aerosil 200 batches are loaded into the homogenizer. The mixture is stirred for 20 minutes (Mixing I). The mixed premix is discharged into a container and then sieved through a 1.25 mm mesh screen. The sieve premix no. 1 and half of the calcium stearate feed and the carboxymethyl starch sodium salt. The mixture was stirred for 10 minutes. From the mixture thus prepared, briquettes with a strength of 50-70 N are pressed, which are then ground through a sieve with a mesh size of 0.8 mm. 50% of Pearlitol 200 SD batch was added to the thus prepared tablet. The mixture was stirred for 15 minutes (Stir II). The second half of the calcium stearate feed and the carboxymethyl starch sodium salt are added to the blended mixture in the homogenizing pear. Stir 15 minutes (Finish). Tablets are compressed from the finished tablet on a tablet press.

Example 10:

(a) a pharmaceutical preparation containing in the composition of tablets:

composition Weight in g Weight% Fexofenadine hydrochloride 0.12000 g 20,00% Pearlitol 200 SD Silica colloidalis (Aerosil 200) 0.45300 g 0.00300 g 75.50% 0,50% Carboxymethyl starch sodium 0.01500 g 2,50% Calcium stearate 0.00900 g 1.50% Together: 0,60000 g 100.00%

(b) the method of its preparation:

The active ingredient and 50% of the Pearlitol 200 SD and Aerosil 200 batches are loaded into the homogenizer. The mixture is stirred for 20 minutes (Mixing I). The mixed premix is discharged into a container and then sieved through a 1.25 mm mesh screen. The sieve premix no. 1 and half of the calcium stearate feed and the carboxymethyl starch sodium salt. The mixture was stirred for 10 minutes. The mixture thus prepared is compacted. The prepared compact is ground through a sieve with a mesh size of 0.8 mm. 50% of Pearlitol 200 SD batch was added to the thus prepared tablet. The mixture was stirred for 15 minutes (Stir II).

The second half of the calcium stearate feed and the carboxymethyl starch sodium salt are added to the blended mixture in the homogenizing pear. Stir 15 minutes (Finish). Tablets are compressed from the finished tablet on a tablet press.

Example 11:

(a) a pharmaceutical preparation containing in the composition of tablets:

composition Weight in g Weight% Fexofenadine hydrochloride 0.18000 g 19.57 Pearlitol 400 DC Silica colloidalis (Aerosil 200) 0.67950 g 0.00450 g 73.85 2.45 Carboxymethyl starch sodium 0.02250 g 0.49 Calcium stearate 0.01350 g 1.47 Total core: 0,90000 g - Sepifilm 752 white Sepifilm 3084 orange 0.01600 g 0.00400 g 0.43 1.74 Purified water 0.10500 g - Total coated tablet: 0,92000 g 100.00% (b) the method of its preparation:

The homogenizer was charged with the drug and 50% of the Pearlitol 400 DC batch and Aerosil 200. The mixture was stirred for 20 minutes (Mixing I). The mixed premix is discharged into a container and then sieved through a 1.25 mm mesh screen. The sieve premix no. 1 and 50% of Pearlitol 400 DC batch. The mixture was stirred for 15 minutes (Stir II). Calcium stearate and sodium starch carboxylate are added to the blended mixture in the homogenizing pear. Stir 15 minutes (Finish). Tablets are compressed from the finished tablet on a tablet press. The tablets are film-coated in a coating machine.

Dissolution results of the active substance

The in vitro dissolution of fexofenadine hydrochloride is monitored for:

Used equipment: Ph.Eur dissolution equipment.

, paddles, 100rpm

Medium: buffer pH 7.2,900 ml

Temperature: 37 ° C ± 0.5 ° C Time: 45 minutes

Determination of drug dissolution: HPLC

The dissolution of the active compound is illustrated in the embodiment no. 11 and the dissolution results are shown in the table.

Table:

Dissolution of the active substance:

Time Amount of active substance released (%) 5 minutes 10 minutes 20 minutes 30 minutes 45 minutes 94.01 95.32 95.90 96.25 97.62

Industrial usability

The invention is useful in the pharmaceutical manufacture of tablets, tablets, coated tablets, microtablets, for the preparation of pellets, micropellets, powders, granules and as fillers for capsules.

Said dosage forms containing fexofenadine hydrochloride can be used therapeutically in the treatment of allergic manifestations.

Claims (7)

PATENT CLAIMS Pharmaceutical preparation containing fexofenadine hydrochloride as active substance, characterized in that it contains the active substance in an amount of 100 mg to 1000 mg, which represents 15 to 50% by weight, of at least one excipient from the group of polyols and / or carbohydrates, at least one substance modifying the flow properties of the tablet in an amount of 0.1 to 10% by weight, at least one disintegrant in an amount of 1 to 25% by weight, at least one glidant in an amount of 0.1 to 10% by weight, and dry binders in an amount of 10 to 45% % wt. based on the total weight of the preparation. Medicinal product containing fexofenadine hydrochloride according to claim 1, characterized in that the polyol excipient is one or more mannitols having a particle size of 100 to 520 μηι. Medicinal product containing fexofenadine hydrochloride according to claim 1, characterized in that it contains colloidal anhydrous silica in an amount of 0.5 to 2% by weight as the flow modifier of the tablet. Medicinal product containing fexofenadine hydrochloride according to claim 1, characterized in that it contains as disintegrant sodium carboxymethyl starch in an amount of 1.5 to 10% by weight. Medicinal product containing fexofenadine hydrochloride according to claim 1, characterized in that it contains as a glidant calcium stearate in an amount of 0.5 to 4% by weight. Medicinal product containing fexofenadine hydrochloride according to claim 1, characterized in that it contains hydroxypropylmethylcellulose as a dry binder. A process for the preparation of a medicament comprising fexofenadine hydrochloride according to claims 1 to 6, characterized in that it is prepared by dry mixing, either by direct tabletting or by briquetting or compacting, in the form of a tablet or coated tablet or filler. capsules, wherein the mixture of the active ingredient and at least one excipient of the group of polyols and / or saccharides is prepared by dry mixing, further adjusting the particle size of the mixture - tablet in the range of 100 to 2000 µm, followed by finishing the thus prepared tablet, it is compressed into cores or tablets, or microtablets, or pellets, micropellets, or powder or granules, or capsules are prepared. The results of the dissolution of the active substance show that more than 95% of the active substance is released within 10 minutes.