Method for preparing microcapsules of rivanol in water-soluble polymers

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to microencapsulation of drugs through the example of rivanol which can be used as an antimicrobial, antifungal topical preparation. A method for preparing microcaplues of rivanol in a water-soluble polymer representing polyvinyl alcohol or polyvinyl pyrrolidone is implemented by physical-chemical precipitation with a solvent wherein a precipitant is acetone. The process is carried out at 25°C with no special equipment required.

EFFECT: method for preparing the microcapsules of rivanol provides simplifying the process of microencapsulation.

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The invention relates to the field of microencapsulation of drugs on the example of rivanol, which can be used as an antimicrobial, antifungal drugs topical use.

Previously known methods for producing microcapsules of drugs. Thus, in U.S. Pat. 2092155 IPC AC 047/02, AK 009/16 published 10.10.1997 Russian Federation proposed a method for microencapsulation of drugs, based on the use of irradiation with ultraviolet rays.

The disadvantages of this method are the duration of the process and the use of ultraviolet radiation, which can influence the formation of microcapsules.

In Pat. 2173140 IPC AC 009/50, AK 009/127 Russian Federation published 10.09.2001 method for obtaining kremnijorganicheskih microcapsules using a rotary cavitation plants with high shear effort and powerful acoustic phenomena of sound and ultrasound range for dispersion.;

The disadvantage of this method is the use of special equipment - rotary-quotational installation, which has ultrasonic action that affects the formation of microcapsules and can cause adverse reactions due to the fact that ultrasound destructive de is there on polymers of protein nature, therefore, the proposed method is applicable when working with polymers of synthetic origin.

In Pat IPC AC 009/56, A61J 003/07, B01J 013/02, A23L 001/00 published 27.06.2009 Russian Federation proposed a method of producing microcapsules using spray cooling in the spray tower Niro under the following conditions: air temperature at the inlet 10°C, the temperature at the outlet 28°C, the speed of rotation of the spray drum 10000 rpm/min Microcapsules according to the invention have improved stability and provide adjustable and/or prolonged release of the active ingredient.

Disadvantages of the proposed method are the duration of the process and the use of special equipment, a set of conditions (temperature of inlet air 10°C, the temperature at the outlet 28°C, the speed of rotation of the spray drum 10000 rpm).

In Pat IPC B05D 7/00 20060101 B05D 007/00, VS 3/02 20060101 VS 003/02; VS 11/00 20060101 VS 011/00; B05D 1/18 20060101 B05D 001/18; B05D 3/02 20060101 B05D 003/02; B05D 3/06 20060101 B05D 003/06 from 10.03.2011 US described a method of producing microcapsules by the method of suspension polymerization, belonging to the group of chemical methods with the use of the new device and ultraviolet radiation.

The disadvantage of this method is the complexity and duration of the process, the use of special equipped with the I, obtaining microcapsules by the method of suspension polymerization using ultraviolet radiation.

The closest method is the method proposed in U.S. Pat. 2134967 IPC A01N 53/00, A01N 25/28 published 27.08.1999 Russian Federation (1999). Water is dispersed solution of a mixture of natural lipids and a PYRETHROID insecticide in the weight ratio of 2-4: 1 in an organic solvent, which leads to simplification of the method of microencapsulation.

The disadvantage of the method proposed in U.S. Pat. 2134967 is a dispersion in water, which makes the proposed method applicable to the production of microcapsules of water-soluble drugs in water-soluble polymers.

The technical problem is to simplify the process of production of microcapsules of vodorastvorimogo drug in water-soluble polymers of synthetic origin (polyvinyl alcohol, polyvinylpyrrolidone), increase the stability of the medicinal product rivanol with his conclusion in a water-soluble polymer shell synthetic origin (microencapsulation).

The solution of the technical problem is achieved by a method of producing microcapsules of rivanol in water soluble polymers, wherein upon receipt of the microcapsules physico-chemical method for the deposition nerastvorim as precipitator is used acetone at 25°C the process of receiving is carried out without special equipment (using rotary-cavitation installation the spray tower Niro).

A distinctive feature of the proposed method is the use of the method of precipitation with acetone as herstories a method of producing microcapsules of water-soluble drug in a water-soluble polymer shell synthetic origin without special equipment. The result of the proposed method are obtaining microcapsules of rivanol in polyvinylpyrrolidone and polyvinyl alcohol at 25°C for 30 minutes, which have greater stability than the original rivanol. The output of the microcapsules is 90%.

Required for the reaction source rivanol was industrial production (PRC).

Illustrations to the patent:

Fig 1. The IR spectrum of the surface of the microcapsules of rivanol in PVP, the ratio of 1:3

Figure 2. The IR spectrum of the surface of the microcapsules of rivanol in PVS, the ratio of 1:3

Figure 3. The IR spectrum of the surface of the microcapsules of rivanol in PVS, the ratio of 1:1

Figure 4. The IR spectrum of the surface of the microcapsules of rivanol in PVP, the ratio of 1:1

Figure 5. The IR spectrum of rivanol

6. The IR spectrum of polyvinylpyrrolidone(PVP)

7. Crystals of rivanol, zoom 505 times.

Fig. Microcapsules of rivanol in polyvinylpyrrolidone:

a) ratio of 1:3, zoom 260 times;

b) the ratio of 1:1, increasing 2830 times.

Fig.9. Microcapsules of rivanol in polyvinylpyrrolidon is:

a) ratio of 1:3, zoom 260 times;

b) the ratio of 1:1, increasing 2830 times.

Figure 10. Microcapsules of rivanol in polyvinyl alcohol:

a) ratio of 1:1, increasing to 260 times;

b) the ratio of 1:3, zoom 2830 times.

11. Confocal laser scanning microscopy solution of microcapsules of rivanol in polyvinylpyrrolidone, the ratio of 1:1

a) 2% aqueous solution of microcapsules of rivanol, increasing 1400 times;

b) 1% aqueous solution of microcapsules of rivanol, zoom 505 times;

C) 0.5% aqueous solution of microcapsules of rivanol, the increase in 1770 times;

g) 0.25% aqueous solution of microcapsules of rivanol, increasing 1400 times.

Fig. Confocal laser scanning microscopy solution of microcapsules of rivanol in eleveneleven alcohol, the ratio of 1:1

a) 2% aqueous solution of microcapsules of rivanol, an increase of 260 times;

b) 1% aqueous solution of microcapsules of rivanol, zoom 505 times;

C) 0.5% aqueous solution of microcapsules of rivanol, increasing 620 times;

g) 0.25% aqueous solution of microcapsules of rivanol, increase 900 times.

Fig. Confocal scanning laser microscopy 2% aqueous solution rivanol:

a) increase 2830 times;

b) increase 1400 times.

EXAMPLE 1. Obtaining microcapsules of rivanol in polyvinylpyrrolidone (PVP) using a 5% solution of acetic acid in acetone as a precipitator, ratio :3.

In a beaker with a volume of 150 ml was placed 18 g 5% aqueous solution of PVP, put on a magnetic stirrer and include mixing. 0.3 g of rivanol dissolved in 2 ml of ethanol under heating. The resulting solution is cooled and transferred dropwise into a solution of PVP. After the formation of the rivanol separate the solid phase from the aqueous phase is poured first precipitator (5% solution of acetic acid in acetone containing 0.2% OS-20 (a mixture polyoxyethyleneglycol ethers of higher fatty alcohols) as a surfactant) in an amount of 50 ml, and then the second 0.2% solution OS-20 in 15 ml of acetone. The resulting suspension of microcapsules is filtered by the filter SCHOTT and washed with acetone. Dried in a desiccator over calcium chloride. Get 1,08 g (90%) of the microcapsules in the form of a yellow powder. The amount of the substance in the capsule 33%.

The IR spectrum of the surface, see figure 1.

The obtained capsules were investigated using IR spectroscopy. In the spectra of the surface of the microcapsules in the areas 1655-1013,3 cm-1there are absorption bands characteristic of rivanol, such as 1655.44 cm-1WITH.

EXAMPLE 2. Obtaining microcapsules of rivanol in polyvinyl alcohol(PVA) using a 5% solution of acetic acid in acetone as a precipitator, a ratio of 1:3.

In a beaker with a volume of 150 ml was placed 18 g 5% aqueous solution of PVA, put on a magnetic stirrer and include mixing. 0.3 g of rivanol dissolve Aut in 2 ml of ethanol under heating. The resulting solution is cooled and transferred dropwise into a solution of PVA. After the formation of the rivanol separate the solid phase from the aqueous phase is poured first precipitator (5% solution of acetic acid in acetone containing 0.2% OS-20 as surfactant) in an amount of 50 ml, and then the second 0.2% solution OS-20 in 15 ml of acetone. The resulting suspension of microcapsules is filtered by the filter SCHOTT and washed with acetone. Dried in a desiccator over calcium chloride. Obtain 1.07 g (89%) of the microcapsules in the form of a yellow powder. The amount of the substance in the capsule 27%.

PC-range surface, see figure 2.

The obtained capsules were investigated using IR spectroscopy. In the spectra of the surface of the microcapsules in the areas 1655-1013,3 cm-1there are absorption bands characteristic of rivanol, such as 1655.44 cm-1-C=O.

EXAMPLE 3. Obtaining microcapsules of rivanol in polyvinyl alcohol (PVA) using acetone as herstories, 1:1 ratio.

In a beaker with a volume of 150 ml was placed 0.6 g of rivanol, 100 ml of acetone, 1 ml of 0.2% OS-20, put on a magnetic stirrer, include mixing. After the formation of the rivanol independent solid phase poured dropwise 12 g of 5% aqueous solution of PVA. The resulting suspension of microcapsules is filtered by the filter SCHOTT and washed with acetone. Dried in a desiccator over calcium chloride. Obtain 1.12 g (93%) microcaps the l in the form of a yellow powder. The amount of the substance in the capsule 65,5%.

The IR spectrum of the surface, see figure 3.

The obtained capsules were investigated using IR spectroscopy. In the spectra of the surface of the microcapsules in the areas 1655-1013,3 cm-1there are absorption bands characteristic of rivanol, such as 1655.44 cm-1-C=O.

EXAMPLE 4. Obtaining microcapsules of rivanol in polyvinylpyrrolidone (PVP) using acetone as herstories, 1:1 ratio.

In a beaker with a volume of 150 ml was placed 0.6 g of rivanol, 100 ml of acetone, 1 ml of 0.2% OS-20, put on a magnetic stirrer, include mixing. After the formation of the rivanol independent solid phase poured dropwise 12 g of 5% aqueous solution of PVP. The resulting suspension of microcapsules is filtered by the filter SCHOTT and washed with acetone. Dried in a desiccator over calcium chloride. Get 1,08 g (90%) of the microcapsules in the form of a yellow powder. The amount of the substance in the capsule of 60.5%.

The IR spectrum of the surface, see figure 4.

The obtained capsules were investigated using IR spectroscopy. In the spectra of the surface of the microcapsules in the areas 1655-1013,3 cm-1there are absorption bands characteristic of rivanol, such as 1655.44 cm-1-C=O.

EXAMPLE 5. The technique of the analysis of microencapsulated products by thin-layer chromatography with densitometry

A necessary condition for the analysis of the data by the method is the choice of the universal solvent, solvent and the polymer shell microcapsules, and capsuleneo substance.

Two plates is installed vertically in the camera for hromatografische to eluent passed through the plate, and the plate is washed, and then dried. For analysis weighed 0.03-0.02 g of pure sample, which was used in kapsulirovanie (standard), and 0.02 g of the analyzed capsules and dissolve them in 3-5 ml of DMF or DMSO, if necessary, heat. Then in tubes with standard injected 2 ml of 1.5% of the internal standard solution in DMF and dissolved capsules 1 ml. Forth from each test solution taken in separate test tubes 70 μl of a solution and dilute their 200 μl DMF.

At a distance of about 2 cm from the edge of the plate (Silufol) pencil spend the starting line. On 2 plates on the starting line by capillary put samples of the obtained solutions. The spot diameter should be 2-3 mm Plate is dried over tile. This operation if necessary, repeat 2-3 times. The two plates is installed vertically in the chamber for chromatography was carried out so that the spots of the samples were above the surface of the eluent (solvent system acetone:acetic acid in a volume ratio of 15:0,1 for analysis of microcapsules containing the APK and acridan or 10:0,5-for microcapsules containing 4-carboxamide and acridone lifemed). The plate should not touch each other. The plate should not touch the walls of the chamber. The process stops once the eluent will be held from the start line not less than 7, then the plate is removed, mark the position of the eluent front, carefully dried over electric tile. Then the plate is treated with videodensitometry "Sorbfil" and "Sorbfil 1.8".

The obtained microcapsules were photographed on atomic force scanning electron microscope combined with confocal OmegaScope AIST-NT.

From a powder of microcapsules obtained according to the methods described in examples 3,4 were prepared aqueous solutions of concentrations 2%, 1%, 0,5%, 0,25% and an aqueous solution of the comparison source rivanol concentration of 2%. Next, a drop of each of the prepared solutions were placed on a glass slide prior to complete drying and the dried surface was carried out confocal scanning microscopy atomic force scanning electron microscope combined with confocal OmegaScope AIST-NT.

Thus, the obtained microcapsules physico-chemical method for the deposition nerastvorim using acetone as a precipitator, which increases output. The process is simple to perform and lasts for 30 minutes, requires no special equipment.

The data presented above shows that h is of spherical shape are microcapsules, containing a smaller amount of the active substance obtained in the ratio of 1:3. Appearance products has significant differences from the original crystals of rivanol. However, the size of the particles does not depend on the ratio when receiving, as the smallest size recorded during the quantity of active substance, 65% polyvinylpyrrolidone, and the largest, with 65.5% of rivanol in polyvinyl alcohol. Both samples were obtained in a 1:1 ratio. The content of drugs can vary in the range from 15 to 99% by weight of microcapsules. In our case, the samples with the lowest and the average for the pharmaceutical industry the number of the active substance. It should also be noted that the instability of solutions of rivanol in light of a well - known fact. They change color from yellow to dark brown and sometimes black within 3-7 days of storage. The stability of the obtained solutions microcapsule was investigated for a long time at room temperature, resulting in the term discoloration of the solutions is not installed. This suggests that using the proposed method it is possible to obtain microcapsules unstable drugs with the aim of obtaining a stable system for solving the problems of stability unstable drugs of different pharmacological groups.

The way the floor is the treatment of microcapsules of rivanol in the water-soluble polymer, represents polyvinyl alcohol or polyvinylpyrrolidone, characterized in that upon receipt of the microcapsules physico-chemical method for the deposition nerastvorim as precipitator is used acetone at 25°C and the process is carried out without special equipment.



 

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