Preparation containing biologically active substances

FIELD: medicine.

SUBSTANCE: invention refers to pharmaceutical industry and represents a preparation containing a biologically active substance, characterised by the fact that it contains a powder based on dried microdrops of the active substance stabilised by a dry high-disperse inert hydrophobic disconnector representing silicone dioxide with the components of the preparation being in the certain mass ratio per 1 g of the preparation.

EFFECT: invention provides higher dispersity of the preparation and preservation of the active substances in the preparation.

13 ex, 2 tbl

 

The invention relates to medicine, biotechnology and pharmaceutical industries, namely finely dispersed preparations containing biologically active ingredients in the solid phase.

A method of obtaining dry bacterial drugs, according to which a fine dry powder of silicon dioxide is added to a broth culture of microorganisms in the ratio 1:2 and stirred until a homogeneous density mass which is dried in a thermostat at 27-32°C or in air and then dispersed for two hours until finely dispersed state (RU patent 2104299 C1, C12N 1/04, 10.02.1998).

The preparation obtained in this way may not have high variance, because it contains large amounts of Aerosil, shredding which not only increases its dispersion, but, on the contrary, significantly degrades her, and the longer the duration of grinding, the worse the dispersion of Aerosil and, consequently, of the drug.

Known complex bacterial preparation, including the media, representing the sorbent, and cells eubiotics with components of the nutrient medium, immobilized on a specified media, biometra 108-1010CFU/ml, and in use as a sorbent material with antacid properties, developed mesoporous, macropha the East of structure and volume of macropores is not less than 0.01 cm 3/g with the following proportions of the components of the drug, wt.%: cells eubiotics with components of the nutrient medium with a titer of 108-1010CFU/ml to 1.0-50,0, media-sorbent - the rest is up to 100% (RU patent 2118535 C1, AC 35/74, C12N 11/14, 10.09.1998).

Known dry probiotic preparation and method thereof, involving the receipt of liquid biomass by mixing native culture of lactic acid bacteria with a protein-carbohydrate complex, contact the dehydration of the obtained liquid biomass moisture capacity ion exchange resin KB-4P-2 with a particle size of from 1 to 800 microns, pre-treated with a mixture of anhydrous lactose and hydrophobic Aerosil (RU patent 2268926 C2, C12N 1/20, AS 9/12, F26B 5/16, 10.03.2005).

Known drugs do not provide improve the dispersion and persistence of active substances due to the stabilization of highly dispersed solid phase with bioactive active substances dry finely dispersed inert hydrophobic disconnector with nano particles.

The basis of the invention is to improve the dispersion of the preparation containing bioactive active substances in the solid phase in an effective amount and increase the persistence of active ingredients during storage.

The problem is solved by the fact that the preparation containing a biologically active force ve is esta, is a dispersed system with a solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio, wt.%: solid disperse phase 0,15-0,50, fine dry disconnector from 0.50 to 0.85. The drug may contain as dry superfine inert hydrophobic disconnector with nanosized particles of silicon dioxide.

As a result of our research for the first time it is shown that the dehydration drip powders constituting the dispersed system with a liquid dispersed phase in drip condition, containing biologically active ingredients stable dry finely dispersed inert hydrophobic disconnector with nano particles, stabilizing the hydrophobic layer of the disconnector around each droplet of the dispersed phase is not destroyed, and in the process of moisture removal with decreasing particle size of the dispersed phase is formed around each of the dried particles. As a result, each particle of the solid dispersed phase containing biologically active ingredients, is surrounded by a stabilizing layer of dry fine-grained hydrophobic disconnector with nano particles.

A stabilizing layer of dry superfine razor is Italia around each particle prevents cohesive interaction of the particles of the dispersed phase and the appropriate education of their agglomerates, and by reducing the rate of diffusion of water vapor from the surrounding space humidification of the solid dispersed phase that ensures high dispersion and satisfactory activity of the claimed preparation on the stages of its preparation and storage.

The claimed preparation containing bioactive active substances, which are new and are not described in literature.

The technical result of the claimed invention is to improve the dispersion of the preparation containing bioactive active substances in the solid phase in an effective amount, and increase the persistence of active ingredients during storage due to the stabilization of highly dispersed solid phase with bioactive active substances dry finely dispersed inert hydrophobic disconnector with nano particles.

The invention is illustrated in the following examples, suggesting that a greater dispersion of the preparation containing bioactive active substances in the solid phase in an effective amount, and increase the persistence of active ingredients during storage due to the stabilization of highly dispersed solid phase with bioactive active substances dry finely dispersed inert hydrophobic disconnector with what razmeri particles.

Example 1. Dehydration drip powder Francisella tularensis strain No. 33 NIIEG content of viable microorganisms 408×109CFU/g of the resulting preparation tularemia vaccine with the content of viable microorganisms 530×109CFU/g of solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio of components in 1 g of the drug: solid dispersed phase of 0.25, fine dry disconnector 0,75.

Check the dispersion of the obtained product, which was carried out on a laser analyzer of grain Malvern Instruments" S according to the method developer, showed that the content of the target fraction of particles (10 μm) was 31% and in comparison with the product obtained by known manufacturing techniques, has increased 1.5 times.

The results of storage of the product are presented in example 14.

Example 2. Dehydration drip powder Yersinia pestis strain EV, NIIEG content of viable microorganisms 250×109CFU/g obtained the drug plague vaccine with the content of viable microorganisms 405×109CFU/g of solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio of components in 1 g of the preparation is the same: solid dispersed phase 0,29, fine dry disconnector 0,71.

Check the dispersion of the obtained product, which was carried out as described in example 1 showed that the content of the target fraction of particles (10 μm) was 42% and in comparison with the product obtained by known manufacturing techniques, increased 1.8 times.

The results of storage of the product are presented in example 14.

Example 3. Dehydration drip powder Serratia marcescens pieces VKM-851 with a content of viable microorganisms 130×109CFU/g obtained the drug culture test to check air filters with a content of viable microorganisms 219×109CFU/g of solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio of components in 1 g of the drug: solid dispersed phase 0,2, fine dry disconnector 0,8.

Check the dispersion of the obtained product, which was carried out as described in example 1 showed that the content of the target fraction of particles (10 μm) was 36% and in comparison with the product obtained by known manufacturing techniques, increased 1.2 times.

The results of storage of the product are presented in example 14.

Example 4. Dehydration drip powder Bifidobacterium bifidum pieces 1C maintained with the eating of viable microorganisms of 1.9×10 9CFU/g obtained probiotic preparation with a content of viable microorganisms of 2.8×109CFU/g of solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio of components in 1 g of the drug: solid dispersed phase of 0.25, fine dry disconnector 0,75.

Check the dispersion of the obtained product, which was carried out as described in example 1, showed that the median particle diameter was 24 μm and compared with the product obtained by known manufacturing techniques, decreased 2.3 times.

The results of storage of the product are presented in example 14.

Example 5. Dehydration drip powder Entherococcus faecium with the content of viable microorganisms of 1.4×109CFU/g obtained probiotic preparation with a content of viable microorganisms of 2.7×109CFU/g of solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio of components in 1 g of the drug: solid dispersed phase 0.4, fine dry disconnector 0,6.

Check the dispersion of the obtained product, which was carried out as described in example 1, showed that the median particle diameter was 31 μm and with whom avanyu drug obtained by known manufacturing techniques, decreased 1.4 times.

The results of storage of the product are presented in example 14.

Example 6. Dehydration drip powder of immunoglobulins IgG, IgA, IgM with protivoallergennoy activity 1:640 in the credits TPHA received immunobiological preparation with protivoallergennoy activity 1:640 in the credits TPHA solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio of components in 1 g of the drug: solid dispersed phase 0,335, fine dry disconnector 0,665.

Check the dispersion of the obtained product, which was carried out as described in example 1, showed that the median particle diameter was 12 μm and compared with the product obtained by known manufacturing techniques, decreased 1.4 times.

The results of storage of the product are presented in example 14.

Example 7. Dehydration drip powder with benzocaine concentration of the active ingredient 200 mg/g received local anesthetic drug with a content of active substance is 500 mg/g of solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio of components in 1 g of the drug is: a solid dispersed phase 0,3, fine dry disconnector 0,7.

Check the dispersion of the obtained product, which was carried out as described in example 1, showed that the median particle diameter was 16 μm and compared with the product obtained by known manufacturing techniques, has decreased by a factor of 1.2.

Inactivation of the active substance during storage of the drug during the year does not occur.

Example 8. Dehydration drip powder Bifidobacterium bifidum pieces 1C mixed with immunoglobulins IgG, IgA, IgM with protivoallergennoy activity 1:640 in the credits TPHA and content of viable microorganisms of 1.5×109CFU/g of the obtained complex biologic drug with protivoallergennoy activity 1:640 in the credits TPHA and content of viable microorganisms of 2.6×109CFU/g of solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio of components in 1 g of the drug: solid dispersed phase of 0.25, fine dry disconnector 0,75.

Check the dispersion of the obtained product, which was carried out as described in example 1, showed that the median particle diameter of the finished product was 25 μm (preparation by known technology does not exist).

Example 9. Dehydration micro is abulnaga powder sodium chloride solution with a concentration of active substance 87 mg/g of the obtained aerosol drug containing the active ingredient 200 mg/g of solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio of components in 1 g of the drug: solid dispersed phase of 0.5, fine dry disconnector 0,5.

Check the dispersion of the obtained product, which was carried out as described in example 1, showed that the median particle diameter was 8 μm and compared with the product obtained by known manufacturing techniques, decreased 1,25 times.

Inactivation of the active substance during storage of the drug during the year does not occur.

Example 10. Dehydration drip powder of immunoglobulins IgG, IgA, IgM mixed with the antibiotic ooxacin with protivoallergennoy activity 1:640 in the credits TPHA and antibiotic concentration 23 mg/g obtained combined immune-antimicrobial drug with protivoallergennoy activity 1:640 in the credits TPHA and the concentration of antibiotic 50 mg/g of solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio of components in 1 g of the drug: solid dispersed phase of 0.25, fine dry disconnector 0,75.

Check the dispersion of the obtained product, which was carried out as described in example 1 showed that the medians of the initial diameter of the particles of the finished product was 30 μm (preparation by known technology does not exist).

Example 11. Dehydration drip powder vaccine strain La Sota virus Newcastle disease with a content of viable viruses 10,3 lg EID50/g of the resulting preparation of viral vaccines with the maintenance of viable viruses 10,2 lg EID50/g solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio of components in 1 g of the drug: solid dispersed phase of 0.25, fine dry disconnector 0,75.

Check the dispersion of the obtained product, which was carried out as described in example 1 showed that the content of the target fraction of particles (10 μm) was 77% and in comparison with the product obtained by known manufacturing techniques, increased 1.1 times.

The results of storage of the product are presented in example 14.

Example 12. Dehydration drip powder paracetamol concentration of the active substance 156 mg/g obtained analgesic drug containing the active substance is 500 mg/g of solid dispersed phase, stable dry finely dispersed inert hydrophobic disconnector with nano-particles, in the following ratio of components in 1 g of the drug: solid dispersed phase of 0.15, fine dry disconnector 0,85.

Check the dispersion of receiving the aqueous drug, which was carried out as described in example 1, showed that the median particle diameter was 4.3 μm and compared with the product obtained by known manufacturing techniques, decreased by 3.9 times, and the content of fractions up to 5 μm was 56%, i.e. increased 7.3 times.

Inactivation of the active substance during storage of the drug during the year does not occur.

Example 13. Compared aerobiological characteristics of aerosols of dry preparations, prepared by known techniques, and preparations with a solid dispersed phase (claimed) for example, cultures of Serratia marcescens pieces VKM-851, Francisella tularensis strain No. 33 NIIEG, Yersinia pestis strain EV, NIIEG. Drip powders were obtained in the electromagnetic dispersed in a continuous mode using suspension cultures of microorganisms, submerged culture with lactase protective environment. Drugs with a solid dispersed phase received sorption by dehydration of the corresponding drip powders. Before spraying all medicines prepared by known techniques, mixed in the ratio 1:2 with filler is finely dispersed hydrophobic carbon fiber CSM. The materials were transferred to the aerosol at a temperature in the aerosol chamber 20-22°C and a relative humidity of 50-70% by pulse method. Sampling of aerosols was carried out by h is cut at regular intervals for 30 min wool aerosol.

The rate of the loss of biological concentration of the aerosol was characterized by a logarithmic factor inactivation (CTL), calculated by the formula

CTL=(lgCB1-lgCB2)/t,

where CB1the concentration of living cells in the aerosol at the beginning of the experience, CFU/l;

WithB2the concentration of living cells in the aerosol at the end of the experience, CFU/l;

t - duration of the experiment, minutes

Utilization of the bio-component (Sb, %), characterizing the degree of transfer of a biological product in the aerosol was calculated by the formula

KIb=100 CB1V/QK,

where CB1the concentration of living cells in the aerosol at the beginning of the experience, CFU/l;

V - volume aerosol chamber, l;

Q - mass aerosolising drug, g (ml);

Bq - concentration of cells in the preparation CFU/g (CFU/ml).

The results are presented in the table.

Sawn materialThe values of parameters
The number of cells before spraying, CFU/gThe number of cells in the aerosol, CFU/lThe degree of translation in the aerosol, %Logarithmic coefficient inactivation,
min-1
Dry the prep is at Serratia marcescens56×10919,0×1054,10,096±0,041
F.tularensis220×10989,9×105a 4.90,112±0,064
Y.pestis171×10954,1×105the 3.80,130±0,058
With a solid dispersed phase (claimed)Serratia marcescens74×10938,2×1056,2of 0.081±of 0.066
F.tularensis175×10912,2×1068,40,077±0,059
Y.pestis130×109of 83.4×1057,70,092±0,071

As follows from the analysis of the data table, the degree of transfer of microorganisms in aerosol in the atomization of all products is almost the same. In the natural with those drugs with a solid dispersed phase (claimed) are characterized by a significantly greater survival of bacterial cells in the aerosol compared to drugs, prepared by known techniques, long wool aerosol in the air, which is achieved by the protective effect stabilizing layer of highly dispersed hydrophobic disconnector with nano particles.

Example 14. The persistence of biologically active substances in preparations prepared according to known manufacturing techniques, and claimed the drugs were evaluated during storage during the year at 2-8°C and relative humidity 55%.

The results are presented in the table.

Drug-basedBiological activityResidual moisture, %
to storageafter storageto storageafter storage
Francisella tularensisknown670×109435×1094,64,6
declare530×109520×109that 0 4,1
Yersinia pestisknown389×109218×1094,04,3
declare405×109401×1094,14,0
Serratia marcescensknown330×109231×109a 4.9the 4.7
declare219×109203×1095,1a 4.9
Bifidobacterium bifidumknown1,8×109of 1.9×1094,34,4
declareof 1.6×109of 1.6×1094,54,5
Entherococcus faecium knowna 2.5×109of 2.0×1094,44,4
declareof 2.7×1092,8×1094,14,0
immunoglobulins IgG, IgA, IgMknown1:12801:6404,34,4
declare1:6401:6404,54,5
virus Newcastle diseaseknown10,4 lg10,0 lg4,24,6
declare10,2 lg10,2 lg4,04,1

Data analysis the table shows that the inventive preparations after storage under these conditions have a higher biological activity compared with products prepared according to known what echnology, reflecting increasing the persistence of biologically active substances in the inventive preparations. Moreover, as it follows from the analysis of the data table, the claimed preparations after storage have the same value of residual moisture before storage. Therefore, wetting of materials during storage is due to the protective effect stabilizing layer of highly dispersed hydrophobic disconnector with nano particles.

Preparation containing bioactive active substance, characterized in that it includes a powder-based dried droplets of the active substance, stable dry finely dispersed inert hydrophobic disconnector, which are silicon dioxide, in the following ratio of components per 1 g of the drug, wt.%:

biologically active substance0,15-0,50
silicon dioxidefrom 0.50 to 0.85



 

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FIELD: medicine, pharmaceutics.

SUBSTANCE: aqueous pharmaceutical composition containing: a) 0.005-10 wt % of one or more water-soluble pharmaceutically active components or their pharmaceutically acceptable salts; b) 0.01 to 10 wt % of hydroxypropylmethylcellulose with viscosity 2500 to 5500 sP (mPa*s); and c) a buffer for maintaining a pH level of a pharmaceutical composition within 5 to 7, can be prepared by a method which involves: i) dissolution of said components in water to form an aqueous solution, and ii) filtering of the aqueous solution prepared at the stage i), through a filter of pore size ≥ 1 micron and ≤10 micron.

EFFECT: compositions prepared by said method are able to exhibit improved mucoadhesive ability and stability.

13 cl, 2 tbl, 8 ex

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