Antimicrobial therapeutic preparation in form of fast-dissolving effervescent tablet

FIELD: medicine.

SUBSTANCE: present invention refers to medicine. The preparation contains the active substance furacilin (nitrofural, 2-[(5-nitro-2-furanyl)methylen]hydrazine carboxamide), the excipient - sodium chloride, a gas-forming mixture, an acidity regulator for reducing pH from 6.5 to 7.5 and a lubricant if needed. The gas-forming mixture consists of an organic acid and sodium hydrocarbonate. According to the method for preparing effervescent tablets of furacilin, furacilin and sodium chloride are milled in a combination; all the ingredients are placed into a mixer, and the prepared mixture is tabletted by direct compression. The antimicrobial therapeutic preparation of furacilin in the form of effervescent tablets is used for septic wounds, bed sores, small skin damages, including scratch marks, abrasions, cuts; infectious-inflammatory oral and throat diseases, including acute tonsillitis, stomatitis, gingivitis and tonsillitis. The effervescent tablets of furacilin are storage-stable for two years and water-soluble at room temperature for 5 minutes.

EFFECT: preparing the antimicrobial therapeutic preparation in the form of the effervescent tablets used for preparing the solution for local and external application.

4 cl, 6 tbl, 3 ex

 

The present invention relates to medicine, namely to the composition of effervescent tablets used for preparation of solution for local and external use containing a pharmaceutical substance - derived nitrofuran - furatsilin (nitrofural, 2-[(5-nitro-2-furanyl)methylene]hydrazinecarboxamide) as active substances and excipients, method of production thereof, method of use as an antimicrobial drug with purulent wounds, ulcers, minor skin injuries, including abrasions, scratches, cracks, cuts, infectious-inflammatory diseases of the mouth and throat including sore throat, stomatitis, gingivitis, tonsillitis. Antimicrobial drug in the form of effervescent tablets used for preparation of solution for local and external use, contains active and excipients in the following ratio, wt.%: furatsilin (nitrofural) of 1.5 to 2.5; filler 0-80; gas-forming mixture 20-70, acidity regulator 0-30, lubricant is 0-7. Tablets produced by direct pressing method.

Known such dosage forms as spray for external use, ointment for external use, the topical solution (water), the solution for external use (alcohol, pills for cooking solution is for local or external use. All these dosage forms are used in medicine only externally or topically for the treatment of purulent wounds, bedsores, burns, minor skin trauma (including abrasions, scratches, cracks, cuts) and for the treatment of blepharitis, conjunctivitis, boils, ear, osteomyelitis, empyema of the paranasal sinuses, pleura (for washing cavities), and acute otitis media, quinsy, stomatitis, gingivitis, and other (see http://grls.rosminzdrav.ru/grls.aspx?s=).

The closest analogue of the claimed antimicrobial drug is a drug in pill form for solution for local and external use containing 20 mg of nitrofural (furatsilina) and as excipients sodium chloride [2]. These tablets produced by direct extrusion of the mixture furatsilina and sodium chloride.

A feature of the pharmaceutical substance furatsilin (nitrofural) is that it is very little soluble in water [2], so the lack of tablets for solution for local and external use containing furatsilin (nitrofural), is the inconvenience and long time solution for the application. For the preparation of a 0.02% aqueous solution furatsilina (nitrofural) one tablet, containing 20 mg furatsilina (nitrofural), must be dissolved when p is constant stirring in 100 ml of boiling water, for more rapid dissolution of the tablet it is necessary to grind. Then the resulting solution before use must be cooled to a temperature of approximately 36-37°C.

The complexity and duration of the preparation of these tablets solution for direct application determines the relevance of the development of the proposed medicinal preparation in the form of quick-dissolving effervescent tablets. One way to solve the problem of improving the dissolution of tablets pharmaceutical preparation containing as active substance furatsilin (nitrofural), is the development of a tablet formulation in the form of quick-dissolving effervescent tablets, how they receive and how they are used.

Thus, the technical result, which is aimed invention is to provide a composition and method of producing an antimicrobial drug in the form of quick-dissolving effervescent tablets used for preparation of solution for local and external use, containing as active substance furatsilin (nitrofural)dissolved in water at room temperature for 5 min, stable in storage for two years, obtained by direct pressing, subject to compliance with the requirements of the generic is the military form effervescent tablets" [1].

This technical result is achieved by the fact that the developed antimicrobial drug in the form of effervescent tablets used for preparation of solution for local and external use, containing as active substance furatsilin (nitrofural) and excipients: filler, gas-forming mixture, acidity regulator, lubricant; obtained by the method of direct compression; characterized in that it contains components in the following ratio, wt.%: the nitrofural (furatsilin) of 1.5 to 2.5; filler 0-80; gas-forming mixture 20-70; acidity regulator 0-30; lubricant 0-7.

At the same time declared antimicrobial product contains:

1) active ingredient: furatsilin (nitrofural);

2) the filler is sodium chloride or known analogue;

3) gas-forming mixture is a mixture of acid component: organic acids (tartaric, citric or succinic acid, or analog, or a mixture) with the alkaline component: hydrogen carbonates (sodium hydrogen or known analogue, or a mixture thereof);

4) acidity regulator: sodium carbonate, digitaltruth sodium, hydrocitric sodium or sodium citrate, or known analogue, or a mixture thereof;

5) lubricant: sodium benzoate, stearyl fumarate sodium, macrogol, soluble stearates of vegetable origin, glyceryl beginat or is no known analogue, or their mixture.

The essence of the invention is that the claimed composition in comparison with the known:

- changed dosage form: instead of tablets for solution for local and external application developed effervescent tablets used for preparation of solution for local and external use, and therefore introduced additional quality requirements in accordance with existing requirements effervescent tablets [1];

- announced a new composition and a new ratio of active substances and excipients;

- changed the method of obtaining the solution from the tablets. Instead of dissolving one tablet under stirring in 100 ml of boiling water and subsequent octogene solution to a temperature that allows it to apply, it is proposed to dissolve the tablets in water at room temperature and then to heat the solution up to the required temperature or dissolve tablets in water to the required temperature. There is no need to conduct additional manipulation in the form of constant stirring. The time of dissolution of the tablets does not exceed 5 minutes

The technical result of an antimicrobial drug in the form of effervescent tablets for the further preparation of a solution for local and external use different:

- ease of use;/p>

the stability during production and storage;

- efficiency (optimal composition, obtaining by dissolving tablet solution, the osmotic pressure close to isotonic and neutral environment resulting solution pH of 6.5 to 7.5).

Thus, new in the claimed composition of the antimicrobial drug is:

1) as a component for dissolving furatsilina (nitrofural) for 5 min, used razobratsya mixture.

2) the Use of substances, which being dissolved tablets, to obtain solutions with a pH of 6.5 to 7.5.

3) the Use of hydrophilic lubricants allows you to get the solution without visible inclusions.

It allows you to:

- to simplify the preparation of 0.02% solution of the tablets, at the same time, solution, ready-to-use, reduced to 5 min, the resulting solution has a neutral reaction medium pH of 6.5 to 7.5 and an osmotic pressure close to isotonic;

- get the pill, stable in storage for 2 years.

The proposed ratio of active substance and excipients and standards of conduct of the process are optimal and allow you to get a tablet, disintegrating within 5 min, corresponding to the requirements of the State Pharmacopoeia XI edition. Government the state Pharmacopoeia XII edition. European Pharmacopoeia 7th edition[1, 2, 3, 4, 5] using industrial equipment.

Antimicrobial drug obtained as follows. Previously conducted joint grinding furatsilina (nitrofural) and sodium chloride solution.

In the mixer load ingredients in the following ratio, wt.%: the nitrofural 1.5 to 2.5; filler - 0-80; gas-forming mixture 20-70; acidity regulator 0-30, lubricant 0-7.

This ratio is necessary to ensure the quality of the tablets, the amount of active ingredient in each tablet is within ±7.5% of the declared content.

The lower limit of the content of gas-forming mixture is selected based raspadaemosti tablet within 5 minutes, the Upper limit is set by the strength of test samples pills.

During the development of the composition of the claimed medicinal preparation has investigated the possibility of using different organic acids (citric, tartaric, succinic acid or analogue, or a mixture thereof) in the composition of the gas mixture. The experiments established that the organic acid, and their mixture may be used as the acid component of the gas mixture. However, depending on the selected acid is changing the mass ratio of acid and alkaline component of the gas mixture, the rate of "filler:gas-forming mixture, as well as the amount of acidity regulator.

In addition, as claimed by the present invention, the composition allows to implement the method of producing tablets by direct pressing.

For best compaction and more uniform color of the obtained tablets Pets grinding organic acid gas-forming mixture, in the presence of sodium chloride, and separately, as well as the grinding of sodium chloride. However, this is not mandatory, as it depends on the shape and size of the crystals of a given substance. It is not permitted joint grinding pharmaceutical substances furatsilin (nitrofural) with the alkaline component of the gas mixture and a pH regulator.

The content of the lubricant (sodium benzoate, stearyl fumarate sodium, macrogol, soluble stearates of vegetable origin, glyceryl begent, or known analogue, or a mixture thereof) 0-7 wt.% is optimal and is set experimentally. Pets complete lack of lubricant, as technological parameters of the mixture for tabletting allow you to get the tablets meet the requirements.

The introduction of the tablet acidity regulators (sodium carbonate, digitaltruth sodium, hydrocitric sodium or sodium citrate, or known analogue, or a mixture thereof) it is Timo for to the resulting solution had a neutral pH environment of 6.5 to 7.5. Its quantity varies from 0 to 30 wt.% depending on the content furatsilina (nitrofural) tablet (depends on volume of water, which dissolves the tablet, because the result will be a 0.02% solution), used as acidity regulator, organic acid included in the composition of the gas mixture, and the ratio of acid and alkaline component gas mixture.

The resulting mixture tabletirujut industrial Tabletpress. The diameter of the punches and the mass of the tablet depends on the content furatsilina (nitrofural) per tablet.

As can be seen from the above, the proposed intervals of the ratios of the current and auxiliary substances are optimal and can achieve effective antimicrobial drug in the form of effervescent tablets used to obtain the solution for local and external use. In accordance with this structure it is possible to obtain a tablet with a wide range of content of the active substance furatsilin (nitrofural) in one tablet (this changes the amount of water needed to dissolve one tablet) and the average weight of the tablets. In this case the obtained tablets meet the quality requirements[1, 2, 3, 4, 5] and stable during storage.

Example

Received samples of the tablets announced antimicrobial by direct pressing. In the mixer was downloaded estimated sample furatsilina (nitrofural), pre-milled with sodium chloride, powdered tartaric acid, powdered sodium chloride, sodium bicarbonate and sodium carbonate, stirred.

Experienced tablet mass extruded with the punches with a diameter of 14 mm tablet press RTM-12 with a rotor speed of 20 rpm Weight pills from 1045 mg to 1155 mg, height 3,8-4,2 mm

The composition of the funds presented in table 1. All experiments are within the limits declared by the claims.

220,0
Table 1
Experience No.42444546
Ingredient nameMass mg%Mass mg%Mass mg%Mass mg%
Furatsilin 20,01,8220,01,8220,01,8220,01,82
Sodium chloride760,069,09470,042,73450,040,91400,036,36
Tartaric acid100,0a 9.09200,018,18200,018,18200,018,18
Sodium bicarbonate140,0of 12.73260,023,64260,023,64260,023,64
Sodium carbonate80,07,27150,013,63170,015,4520,0
Weight pills1100,0100,01100,0100,01100,0100,01100,0100,0

The obtained tablets were subjected to tests for compliance with the quality requirements[1, 2, 3, 4, 5]. The results are presented in Table 2.

Table 2
Experience No.42444546
The average weight of the tablets mg1106109511091105
The deviation in the weight of individual tablets, %+2,0-1,4+2,0-2,7+2,0-1,3of +2.7-1.8
The time of dissolution, min4 min 55 sec3 min 30 sec3 min 25 sec3 min 10 sec
the pH of the solution6,75to 6.576,77,1
Content furatsilina mg19,120,519,821,1
Sodium chloride, mg756,6473,5456,0392,8

Table 2 shows that the tablets of operations 42, 44, 45, 46 correspond to the existing requirements for quality.

Example 2

Tablets of the claimed medicinal preparation has been in full compliance, as described in Example 1. Extruded by the punch 15 mm diameter tablet press with a rotor speed of 20 rpm Weight pills from 1140 mg to 1260 mg, height 3,8-4,2 mm

The composition of the funds presented in Table 3. All experiments are within the limits declared by the claims.

Table 3
Experience No.434748
The name of the ingredient is Mass mg%Mass mg%Mass mg%
Furatsilin20,01,6720,01,6720,01,67
Sodium chloride670,055,83500,041,67490,040,83
Tartaric acid150,012,5200,016,67200,016,67
Sodium bicarbonate210,0of 17.5260,021,67260,021,67
Sodium carbonate150,012,5220,018,32230,0 19,16
Weight pills1200,0100,01200,0100,01200,0100,0

The obtained tablets were subjected to tests for compliance with the quality requirements[1, 2, 3, 4, 5]. The results are presented in Table 4.

Table 4
Experience No.434748
The average weight of the tablets mg121011941211
The deviation in the weight of individual tablets, %+3,2-1,7+2,1-3,7+2,5-0,9
The time of dissolution, min3 min 50 sec3 min 10 sec3 min 10 sec
the pH of the solution6,756,917,1
Content furatsilina mg18,9 20,220,4
Sodium chloride, mg675492496

Table 4 shows that the tablets of operations 43, 47, 48 meet the quality requirements.

Example 3

In the laboratory received the samples of tablets announced antimicrobial by direct pressing. In the mixer was downloaded estimated sample furatsilina (nitrofural), pre-milled with sodium chloride and macrogol 4000, tartaric acid, sodium bicarbonate and sodium carbonate, stirred.

Extruded by the punch 15 mm diameter tablet press with a rotor speed of 20 rpm Weight pills from 1140 mg to 1260 mg, height 4.0 to 4.6 mm

The composition of the funds presented in Table 5. All experiments are within the limits declared by the claims.

8,33
Table 5
Ingredient nameMass mg%
Furatsilin20,01,67
Sodium chloride100,0
Tartaric acid300,025,0
Sodium bicarbonate390,032,5
Sodium carbonate330,027,5
Macrogol 400060,05,0
Weight pills1200,0100

The obtained tablets were subjected to tests for compliance with the quality requirements[1, 2, 3, 4, 5]. The results are presented in table 6.

Table 6
The average weight of the tablets mg1190,9
The deviation in the weight of individual tablets, %-061/+1.65
The time of dissolution, min1 min 58 sec
the pH of the solution6,86
Content furatsilina mg19,49

From Table 6 it is seen that the tablets meet sestvosemsestvosem to quality.

Literature

1. European Pharmacopoeia, edition 7,0, part 1, page 737.

2. European Pharmacopoeia, edition 7,0, part 2, page 2582.

3. State Pharmacopoeia, edition XI, part 2, pp. 154-157.

4. State Pharmacopoeia, edition XI, part 1, pp. 159-165.

5. State Pharmacopoeia, edition XII, part 1, page 89.

6. State Pharmacopoeia, edition XII, part 1, page 160.

1. Antimicrobial drug in the form of effervescent tablets used for preparation of solution for local and external use containing the active ingredient furatsilin (nitrofural) and the filler is sodium chloride, characterized in that it further comprises gas-forming mixture, acidity regulator to create a pH of 6.5 to 7.5 and, if necessary, a lubricant, in the following ratio, wt.%:

The nitrofural1.5 to 2.5
Sodium chloride8,33-69,09
Gas-forming mixture20-70
Acidity regulator7,27-27,5
Lubricantto 7

2. Antimicrobial drug under item 1, characterized in that gazoo the shedding mixture consists of organic acid and sodium bicarbonate.

3. Antimicrobial drug under item 1 or 2, characterized in that it further contains a lubricant in an amount up to 7 wt.%.

4. The method of obtaining an antimicrobial drug in the form of effervescent tablets used for preparation of solution for local and external use, which conduct joint grinding furatsilina (nitrofural) and filler is sodium chloride, is loaded into the mixer the ingredients in the following ratio, wt.%:

The nitrofural1.5 to 2.5
Sodium chloride8,33-69,09
Gas-forming mixture20-70
Acidity regulator
to create a pH of 6.5 to 7.57,27-27,5
Lubricant, if necessaryto 7

the resulting mixture tabletirujut by direct pressing.



 

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