Pharmacological composition for intranasal introduction for cerebral delivery of pharmacologically active component, and method for preparing it

FIELD: medicine, pharmaceutics.

SUBSTANCE: declared group of inventions refers to a pharmacological composition for intranasal introduction for cerebral delivery, and a method for preparing said composition. The declared composition comprises a container base formed by porous particles of calcium carbonate and titanium dioxide of particle size 100-5000 nm and a pharmacologically active component - loperamide. The container surface is modified by surfactants specified in polysorbates, or by polymers specified in a group containing glycosaminoglycanes and polypeptides, or their combination. A method for preparing the pharmacological composition consists in preparing the container base by porous particle synthesis, sorption of loperamide in its pore spaces and modification of the container surface by polymers and surfactants by container incubation in their solutions.

EFFECT: invention provides preparing the pharmacological composition which is applicable for cerebral loperamide delivery after the intranasal introduction.

5 cl, 5 dwg, 1 ex

 

The claimed group of inventions relates to the field of pharmacology and medicine and is intended for use in the treatment of diseases that require immediate delivery of the active substance in the brain, bypassing the blood-brain barrier (BBB), for example in the treatment of Parkinson's disease.

Targeted delivery of compounds to the brain is the most important issue of principle from the point of view of fundamental science, and from the point of view of application in medicine. The unsolved problem severely limits the development of modern approaches to diagnosis and treatment of cerebral pathologies. Currently great interest of researchers is attracted intranasal route of administration of a number of drugs (primarily peptide). It is believed that entered intranasal substances are able to penetrate directly into the Central nervous system (CNS) through the olfactory system, bypassing the BBB. The advantages of this route of administration is clear: the introduction of non-invasive, and bioavailable substance is rapidly absorbed and starts to work after a few minutes, which is important for emergency.

However, not all substances can be effectively introduced in this way, therefore expanding Arsenal of substances injected intranasally, of course, important and necessary. A good nasal of biodot what prostu possess lipophilic compounds with low molecular weight. Peptides and proteins with molecular weight greater than 1000 Da can overcome the nasal membrane only in small quantities. This pronounced protective mechanism - cleansing ciliated epithelium - limits the residence time in the nasal cavity of both liquids and powders, the half-life of elimination is 15-30 min [1]. To reduce the speed of cleansing and improving the bioavailability of drugs use special enhancers of absorption". Their action is mainly on the change of permeability of the epithelial cell membrane by modification of the phospholipid bilayer, removal of proteins from the membrane, or even remove the outer layer of the mucosa. The use of such auxiliary connection allows you to increase the bioavailability of many drugs, including peptides like insulin.

It is now known intravenous compositions based nanoparticles containing an active substance, which is achieved by overcoming the BBB.

Known pharmacological composition intended for administration into the brain of the active component with the penetration through the blood-containing substance container, the pharmacologically active ingredient and surfactant (U.S. patent No. 6117454, Drag targeting to the nervous system by nanoparticles", IPC A61K 9/51, publ. 12.09.2000).

The disadvantages of the known compositions are:

- it is Timoti use some expensive components, namely cyanoacrylates, acrylamido, polylactates, alkylenearomatic, polyanhydrides and others;

polymer particles are mechanically fragile, which may inhibit their storage and transport;

- the release of the active ingredient occurs due to degradation of the polymer particles, thereby limiting the time of the release of the active ingredient by the time of the destruction of the particle;

one of the decay products polyalkylacrylate particles is formaldehyde with toxicity and have a strong negative effect on the Central nervous system.

The objective of the proposed technical solution is to provide a composition, which uses a budget basis-container, and the introduction of the composition is administered.

The technical result is a composition that uses inexpensive ingredients, not harmful impact on the human body.

The goal of the project and the results achieved by the fact that in pharmaceutical compositions intended for introduction into the brain active component, bypassing the BBB, containing the base container and pharmacologically active component, as the basis of container used porous particles of an inorganic substance, and the surface of the container is modified by surfactants,polymers, or their combination. Containers made from inorganic substances have a size in the range from hundreds of nanometers to tens of microns (100 to 5000 nm). As the base container may use inorganic substances selected from the group of salts or oxides of metals, such as calcium carbonate or titanium oxide, in the form of porous particles of micron or submicron size. As modifying the surface of the substance can be applied surfactants selected from the group of polysorbates, or polymers selected from the group comprising glycosaminoglycans, polypeptides, or combinations thereof.

A method of obtaining a pharmaceutical composition intended for administration into the brain of the active component with penetration through the BBB, including the production of nanoparticles with sorption of pharmacologically active substances and modification of their surface (U.S. patent No. 6117454, Drag targeting to the nervous system by nanoparticles", IPC A61K 9/51, publ. 12.09.2000). As the nanoparticles in the known method using synthetic polymer nanoparticles, for example polyalkylacrylate, albumen, polylactide and other particles.

The disadvantages of this method are:

- sterilization polyalkylacrylate particles is a difficult process. Autoclaving these particles leads to a significant increase of their size. Prep the rat polyalkylacrylate particles, the resulting freeze-drying, it is very difficult to resuspendable, making it very difficult to obtain a suspension for injection;

- scaling method of obtaining polyalkylacrylate particles may be associated with difficulties, because the processes centrifugeuse and dialysis, held at clearing polyalkylacrylate particles during synthesis, causing their aggregation;

- getting polylactide particles associated with the use of organic solvents (acetone), which significantly limits their use, in particular for biomedical purposes;

- obtaining polymer particles associated with the use of labour-intensive methods of polymer chemistry (emulsion polymerization, polymerization on the surface and others);

- during the synthesis of albumen particles used glutaric aldehyde, which is a toxic substance that causes lesions of the mucous membranes of the eyes, nose, throat;

- by intra release of the active component of polyalkylacrylate particles is difficult, because they are stable at acidic pH values (pH of the nasal cavity is 4.5-6.0).

The objective of the proposed technical solution is the creation of a method that allows to overcome the mentioned drawbacks of the known method.

The technical result is the development on the panorama and inexpensive method of producing a pharmaceutical composition, intended for intranasal brain pharmacologically active component.

The goal of the project and the results achieved by the fact that in a method of producing a pharmaceutical composition intended for delivery to the brain pharmacologically active component, comprising obtaining basics container, the sorption in the volume of its pores pharmacologically active substances and modification of its surface, the base of the container are synthesized from inorganic substances in the form of porous particles of micron or submicron size. Then, the surface of these particles optionally modify polymers selected from the group of glycosaminoglycans or polypeptides, or surfactants selected from the group of polysorbates, or combinations thereof. The base container may be obtained by mixing aqueous solutions containing ions of Ca2+and CO32-, removing unbound ions obtained by washing the precipitate and drying the formed microparticles. Perhaps getting the basics of the container by the interaction of the powder of titanium carbide with nitric acid. As a pharmacologically active substance compositions can be used loperamide. Modification of the surface of the base container may be made as follows: particulate matter used as osnovatelnee, placed in a solution of hyaluronic acid in aqueous NaCl solution, kept under stirring this solution, remove the excess hyaluronic acid by washing with an aqueous solution of NaCl, and then dried.

The substance of the proposed group of inventions is illustrated by diagrams and photographs presented on the figures:

figure 1 - scheme of the method of obtaining a pharmacological composition;

figure 2 - image of the particles of calcium carbonate, obtained using scanning electron microscopy;

figure 3 - image of particles of titanium dioxide obtained by transmission electron microscopy;

Fig 4 - the results of in vivo test particles of titanium dioxide, polybutylcyanoacrylate and calcium carbonate loaded with loperamide:

* reliable differences from control group at p<0,05,

+ reliable differences from control group at p<0,1,

p - statistical significance of the criteria Kruskal-Wallis.

figure 5 - results of in vivo test is not modified particles of calcium carbonate, loaded with loperamide, and such particles coated with hyaluronic acid.

The scheme of operations for obtaining the proposed pharmacological composition is illustrated in figure 1.

The first operation is the synthesis of the particles, which will perform the function of a container, which is a carrier of active substances. In which the quality of such particles were formed porous particles of calcium carbonate and titanium dioxide.

Calcium carbonate

The formation of particles of calcium carbonate - the subject of numerous scientific studies thanks to the wide use of this material in various fields of industry, technology, medicine. For the synthesis of porous CaCO3microparticles was used the method of [2], which is in direct mixing of solutions containing ions of Ca2+and CO32-. When it first formed amorphous precipitate of nanoparticles CaCO3and then in the extent of their units have growth centers of the microparticles. The quality of the resulting particles essentially depends on experimental conditions such as the type of salts used, their concentration, pH, temperature, mixing speed solutions and the intensity of stirring of the reaction mixture. The particles had a fairly narrow distribution of sizes (from 4 to 5 μm) and a pipe-like mesoporous structure. The structure of the particles visible on the pictures presented in figure 2. Powder CaCO3kept in a dry atmosphere, as in the presence of moisture porous microporosity formed by Wouter, gradually moving in rhombohedral crystals of calcite.

Titanium dioxide

Mesostructured particles of titanium dioxide was obtained vzaimodeistvie powder of titanium carbide with 5 M nitric acid [3]. According to the transmission electric power is evident microscopy particles formed elongated nanocrystallites (Fig 3). Using dynamic light scattering was determined that the average particle size of 1.5 microns.

The obtained particles of calcium carbonate and titanium dioxide were adsorbing loperamide by placing the hinge of the aforementioned particles in alcohol solution loperamide, followed by stirring the suspension on a shaker. The number of loperamide included in the containers was determined spectrophotometrically by the difference of the peak intensity of the absorption of the supernatant at 259 nm before and after adsorption.

For surface modification of containers hyaluronic acid particles enabled loperamide was placed in a solution of hyaluronic acid in aqueous NaCl solution and kept under stirring by means of a shaker. Upon completion of the modification process, the particles were dried and stored in this form.

For comparative tests were made polybutylcyanoacrylate particles with loperamide. Such particles were synthesized via emulsion polymerization of butylcyanoacrylate in the presence of loperamide.

A specific example of implementation of the method for obtaining the composition

Pre-formed inorganic nano - or microparticles were incubated in an alcohol solution of loperamide for 1-3 h with stirring on a shaker (IKA-VIBRAX-VXR, IKA, Germany). After incubation, the particles were besieged by centrifugation (ROTINA 38/38, Hettich, Germany) and separated supernatant. Determining the concentration of loperamide in the supernatant was carried out on a spectrophotometer (PerkenElmer Lambda 650, USA).

The obtained nano - or microcontainer were placed in an aqueous solution of polymer, surfactant, or combinations thereof, and incubated for 15-30 min under stirring on a shaker (IKA-VIBRAX-VXR, IKA, Germany). After incubation containers besieged by centrifugation (ROTINA 38/38R, Hettich, Germany).

These modified containers were dried for 2 h at 50-60°C. the Storage of the composition was carried out in a sealed tube at room temperature.

To test the efficiency of the developed composition was carried out "in-vivo" test evaluation of the delivery of the active component in the brain. This purpose was applied formalin test using loperamide [4-6]. As experimental animals rats were used. It is known that loperamide is not able to penetrate the BBB. Previously targeted delivery of loperamide in CIS mouse was successfully implemented using intravenous polybutylcyanoacrylate nanoparticles. In a comparative study of particles polybutylcyanoacrylate containing loperamide was administered intranasally and data on the efficiency of injection of loperamide with porous particles of calcium carbonate and titanium dioxide were mapped on nami particle polybutylcyanoacrylate.

Conclusions about the delivery of loperamide in the CNS of rodents was done on the basis of changes in their pain sensitivity. The suspension is loaded with loperamide particles were intranasally administered to Wistar rats weighing 200-250 g after subcutaneous injection of formaldehyde in the rat paw animal was placed in a transparent aquarium for observation. After a certain period of time recorded the behavior and evaluate pain perception in rats on the points system. All time points were averaged for the group, the data were processed using STATISTICA-7. As a control solution was used loperamide in 5% glucose solution without particles, and a suspension of particles without loperamide.

Scores in the control groups of animals was not significantly different from each other, so they were combined for further calculations took the average of the control.

All of the used particles loaded with loperamide, reduced pain sensitivity in rats (figure 4). This means that the containers based on the porous inorganic particles, as well as polybutylcyanoacrylate particles ensure delivery of loperamide in the Central nervous system of the rat. The dynamics of reduction of pain sensitivity is different for different types of particles. Particles of titanium dioxide, as polybutylcyanoacrylate particles, the most effective at small time steps, although faster n the start to act in a plastic container. Qualitycorporate particles showed good performance on large time steps (42-60 min).

Modification of the particles mucoadhesive connection led to increase the efficiency of the containers at the beginning of the test and at long times (figure 5). When using particles of calcium carbonate coated with hyaluronic acid, pain sensitivity in rats at the 6 th minute and 48-second 66th minute is reduced almost twice. Considering the fact that at large times the particle CaCO3with loperamide more effective than polybutylcyanoacrylate particles, we can conclude that the containers on the basis of calcium carbonate coated with hyaluronic acid, of the investigated systems are most effective for delivery of loperamide in the Central nervous system of the rat.

Thus, pharmacological composition and the way of obtaining help to ensure the delivery of functional connections in the brain when they intranasal administration. The ease of obtaining a composition in combination with the advantages of intranasal route of administration of drugs provide prospects of the proposed system for medical applications.

Sources of information

1. Soane R.J., Frier, M., Perkins A.C., Jones, N.S., Davis SS, Illum L. // Int. J. Pharm. 1999. V.178. P.55-65.

2. Volodkin D.V. Petrov, A.I., M. Prevot, G.B. Sukhorukov // Langmuir. 2004. V.20. P.3398-3406.

3. Shieh, D.-L., Li Jr-Sh., Shieh, M.-Jr, Lin J.-L. // Microporous and Mesoporou Materials. 2007. V.98. P.339-343.

4. Matthies B.K., Franklin K.B. // Pain. 1992. V.51. R-206.

5. Matthies B.K., Franklin K.B. // Behav. Brain Res. 1995. V.67. P.59-66.

6. Rosland J.H., Tjolsen, A., Maehle Century, Hole K. // Pain. 1990. V.42. R-242.

1. Pharmaceutical composition intended for intranasal order delivery to the brain pharmacologically active component containing the base container, the pharmacologically active component and modifying the surface of a substance, characterized in that the container used porous particles of calcium carbonate or titanium dioxide with a particle size of 100-5000 nm, as the pharmacologically active ingredient is loperamide, and the surface of the container is modified by surfactant selected from the group of polysorbates, or a polymer selected from the group of glycosaminoglycans or polypeptides, or a combination of these surfactants and polymers.

2. A method of obtaining a pharmacological composition according to claim 1, intended for intranasal order delivery to the brain pharmacologically active component, comprising obtaining basics container through a synthesis of porous particles of calcium carbonate or titanium dioxide with a particle size of 100-5000 nm, sorption in the volume of its pores pharmacologically active substance representing loperamide, and modification of the container surface by surfactant selected from grupamocarta, or polymer selected from the group of glycosaminoglycans or polypeptides, or a combination of the above surfactants and polymers by incubation containers in their solutions.

3. A method of obtaining a pharmacological composition according to claim 2, characterized in that the container is obtained by mixing aqueous solutions containing ions of Ca2+and CO32-, removing unbound ions obtained by washing the precipitate and drying the formed microparticles.

4. A method of obtaining a pharmacological composition according to claim 2, characterized in that the container is produced by interaction of the powder of titanium carbide with nitric acid.

5. A method of obtaining a pharmacological composition according to claim 2, characterized in that the modification of the surface of the substrate container microparticles of these compounds is placed in a solution of hyaluronic acid in aqueous NaCl solution, kept under stirring this solution, remove the excess hyaluronic acid by washing with an aqueous solution of NaCl, and then dried.



 

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Barrier fabric // 2473428

FIELD: process engineering.

SUBSTANCE: invention relates to hygiene and sanitary, particularly, to barrier fabric. Fabric with layer of nanofibre for mechanical trapping of organic matter consists of sandwich structure containing bearing nonwoven material to support, at least, one layer of nanofibre. Note that said layer of nanofibre has protective layer wherein separated sandwich structures are interconnected. Layer of nanofiber creates barrier to prevent an ingress of allergens and consists of organic polymer material. Said coating layer may be made of nonwoven material of spanbond type, meltblown type, cotton fabric and/or mix of cotton with polyester. In compliance with one version, at least one layer of nanofibre is arranged on case material to create barrier against microorganisms. Note also that said layer consists of organic hydrophobic material of polyurethane or PVDF, or their copolymers. Note that separate layers of sandwich structure are interconnected. In compliance with another version, barrier fabric consists of sandwich structure including base spanbond-type nonwoven material to carry, at least, one layer of nanofibre secured thereto consisting of hydrophobic polymer of polyurethane or fluoropolymer PVDF, or copolymer thereof. Note here that separate sandwich structures are interconnected.

EFFECT: higher efficiency of entrapping organic substances and fluids.

9 cl, 2 dwg, 4 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: declared group of inventions refers to an intra-articular fluid (synovial fluid) simulator formulation, and to a method for preparing an additive to said formulation. The intra-articular fluid simulator formulation contains 15% aqueous medium molecular polyvinyl pyrrolidone, (0.5-1.5)-10-3 wt % of an additive with the antimicrobial properties and 0.05-2.5% of hyaluronic acid sodium salt in deionised water at the weight relation: of polyvinyl pyrrolidone: hyaluronic acid sodium salt as 1:(0.2-0.3). The additive is prepared of silver modified silicone nanoparticles at nanoparticle size 10-40 nm and silver amount in the additive 0.8-1.1 wt %. The method for preparing the additive to intra-articular fluid simulator formulation consists in preparing silicone nanoparticles by pyrolytic laser processing of monosilane (SiH4), modifying their surfaces by nanoparticle processing in 2-5% silver nitrate in deionised water and centrifuging the solution, multiply washing the deposition and centrifuging at each washing stage.

EFFECT: group of inventions provides preparing the biologically compatible intra-articular fluid simulator formulation showing the effective rheology, antimicrobial activity, and promoting repair action on cartilaginous tissues.

6 cl, 1 tbl, 1 dwg, 4 ex

FIELD: chemistry.

SUBSTANCE: invention relates to novel derivatives of 2-heteroaryl-substituted benzothiophene and benzofuran, precursors thereof and therapeutic use of said compounds, having structural formula (1a) where R1, R2, X9 and Q assume values given in the description, and pharmaceutically acceptable salts thereof, which are suitable for imaging amyloid deposits in living patients. The invention also relates to pharmaceutical compositions based on compounds of formula 1a, use and methods of producing said compounds. More specifically, the present invention relates to a method of imaging brain amyloid deposits in vivo for intravital diagnosis of Alzheimer's disease, and measuring clinical efficiency of therapeutic agents against Alzheimer's disease.

EFFECT: high efficiency of using said compounds.

15 cl, 1 tbl, 14 ex

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