Absorbable ceramic compositions

FIELD: medicine.

SUBSTANCE: present group of inventions concerns medicine, more specifically coated implants and devices. There is offered ceramic composition-precursor for making high-strength bio-elements used as an absorbable or partially absorbable biomaterial where the composition contains at least one silicate with Ca as a base cation with the absorption rate less or equal to the bone growth rate, and this at least one silicate acts as a base binding phase in a biomaterial, and this at least one silicate Ca is present in amount 50 wt % or more, and all other components if any are presented by additives, such as an inert phase, and/or additives which make a biomaterial to be radiopaque. There is offered hardened ceramic material which is based on the ceramic composition-precursor and is in the hydrated form. There is offered a medical implant, application of the medical implant, and also a device or a substrate coated with the uncured ceramic composition-precursor and/or hardened ceramic material.

EFFECT: invention provides a biomaterial having initial and constant durability which is dissolved in due time and reacts with an organism to generate a new tissue.

29 cl, 1 ex, 3 tbl

 

The present invention relates to ceramic compositions predecessors and chemically bound ceramic (HSC) materials, especially on the basis of Sa, and to the composite biomaterial suitable for use in orthopaedic practice. HSC system includes a binder phase (chemical cement) and additional phases with defined chemical properties, which give the biomaterial initial strength, followed by interaction with the tissues of the body, including the internal environment of the body, forming a resorbable or partially resorbable biomaterial. The invention also relates to otverzhdennom ceramic material, implants and devices with surface coating.

Those materials that are used as placeholders cavities in the bones and which interact with tissues of the human body, should have the following advantage: these biomaterials must be as biocompatible and bioactive, to the extent possible. Fundamentally this can be achieved in at least two ways: by developing stable biosovmestimye materials and resorbable materials that allow bone substitute biomaterial. The first way is the production of more stable materials, for example materials based on polymethylmethacrylate (PMMA) or m is materials based on calcium aluminate - especially suitable for clinical cases of osteoporosis. For active or young patients the most attractive way is the use of absorbable materials, such as soluble glass and materials based on phosphates, where the interaction with living tissue are most pronounced. It is well known that calcium aluminates and calcium silicates may have a compressive strength that is significantly higher than the compressive strength of modern absorbable materials (about 100 MPa).

Traditional absorbable phase containing oxides of CA and P (or S). Phosphates and sulphates of CA and glass containing CaO, P2O5, SiO2and Na2O - this is typical representatives of this category of Bioelements with low mechanical strength.

In patents EP 1123081 B1 and EP 0555807 as an additional phase for use in therapeutic purposes, as well as additional divalent compounds for products, bone replacement, mentioned silicate CA (less than 10%). With regard to the biocompatibility of CA-silicate materials was a lot of work for endodontic treatment of the material Proroot (Proroot) or MTA (MTA) and wollastonite materials. Cm. work Jseiden (J.Saidon) with co-authors "Reactions of cells and tissues on the particles of mineral trioxide and Portland cement" ("Cells and tissue reactions to mineral trioxide aggregate and Portlnd cement") in "Oral surgery medicine pathology", April 2003, 483-489. The wollastonite is approved biomaterial in the form of pieces of sintered ceramics. Review by bone cements can be found working Smeni and Mbigi "Bone cements and fillers: a review" (S.M.nn, Mbidde "Bone cement and fillers: A Review"in "Journal of Materials Science: Materials in Medicine, 14 (2003) 923-938.

If we consider inherent in prior art materials used, in particular, for filling cavities in the bones, it becomes clear that there is a need for biocompatible material having rassasivaetsia and relatively high strength, and therefore, the ability to withstand the load immediately after application and later.

To meet the specified requirement, the present invention proposed a ceramic composition of the precursor and cured products having the aforementioned features.

The purpose of the present invention is to provide a ceramic composition precursor on the basis of chemically bound ceramic as a main phase (phases), which, after curing, provides a relatively high strength (compressive strength of 100-150 MPa) ceramic product. This strength is achieved soon after the application of slurry, paste or semi-solid mixture of ceramic composition of the precursor on the damaged area. High initial strength provide which ensures the ability of the damaged area to carry high loads at the stage of resorption, which bone tissue takes the ability to withstand the load.

During curing of the proposed binder phase (phase) consumes or absorbs a large amount of water, and cured ceramic product has a low residual porosity, which gives the contribution to high strength.

In accordance with the first aspect of the present invention proposed a ceramic composition, the precursor comprising particles of at least one silicate of CA and possibly particles of other compounds CA, selected from phosphates, carbonates, sulphates and combinations thereof, where calcium is the major cation. The specified connection (connection) forms the bulk binder phase (phase) of the cured material. Ceramic composition, the precursor defined in paragraph 1 of the claims.

In another embodiment of the invention the above ceramic composition precursor also includes a second binder phase (for example, high strength calcium aluminates), which contribute to high compressive strength, as in the initial moment of time, and later.

The components of the ceramic composition of the precursor are materials in the form of particles, unless otherwise noted. The percentage given for the composition of the precursor, and the cured ceramic mA is Arial, are given in weight percents, unless otherwise specified.

In accordance with the second aspect of the invention presents cured ceramic material, which is obtained by mixing the composition of the precursor and curing of the liquid, i.e. water. Cured ceramic material defined in paragraph 11 of the claims.

In accordance with a third aspect of the invention proposed medical implant that includes the uncured ceramic composition of the precursor and/or cured ceramic material according to the invention. Medical implant defined in paragraph 27 of the claims. The specified medical implant can be used as a material carrier for drug delivery. This method of application is defined in paragraph 28 of the claims.

In accordance with the fourth aspect of the invention, the proposed device with a surface coating selected from the group consisting of artificial orthopedic devices, spinal implants, joint endoprosthesis, fastening element, bone pins, bone screws, bone hardening of the plate, and the device or substrate is coated with the uncured ceramic composition of the predecessor and/or utverzhdennym ceramic material in accordance with the invention. Arrange the creation or surface with the coating identified in paragraph 29 of the claims.

The main advantage of the proposed composition predecessor of the cured material and product when introduced into the body or installation in the body is that they have a high rasskazyvaemoe, so achieving a high rate of growth of the bone. The rate of resorption is less than or equal to the rate of growth of the bone. This is important for maintaining the ability to withstand the load during the entire period of treatment.

The level of compressive strength obtained using the proposed cured material is in the range of 100-150 MPa (for comparison, the compressive strength of other rassasyvanii biomaterials is the interval of 20-60 MPa).

The strength level proposed in the present invention biomaterials at least equal to the strength level of stable biomaterials for use as aggregates of voids in bones, such as materials based on PMMA (polymethylmethacrylate), which do not have the same degree of rasskazyvaemoe.

Proposed in the invention, the ceramic material has the following advantages compared to systems/materials of the previous prior art, such as bistecca, glass ionomer cements and systems based on pure phosphate CA or filling materials based on the monomers, it retains its bioactivity, it has a higher initial strength and stability of the ilen retains its dimensions, that is, it expands limited (in contrast to the known absorbable materials which shrink), and this extension improves the contact with the tissues.

We offer ceramic materials have been specially developed for biomaterials used in the quality of aggregates of voids in bones for use in orthopaedic practice, but they can also be used as a resorbable filling material in dentistry, including endodontics.

In the present invention proposed bioactive ceramics based on resorbable ceramics. And in addition, the present invention also describes aspects of the development of strength with time and the achieved level of strength. Accordingly, the present invention aims to materials, preferably biomaterials having initial and ongoing strength, which will eventually dissolve and interact with the body to receive the new tissue.

In the basic form of the proposed ceramic composition, the precursor includes a main binder phase (phase) of chemically bound ceramic, preferably silicates Sa, where Sa is the major cation. The binder phase (phase) preferably includes one or more of the following phases:

C 3 s=3(CaO)(SiO2), C2S=2(CaO)(SiO2) and CS=(CaO)(SiO2). The main binder phase (phase) ke is amicucci composition precursor comprises more than 50 wt.% at least one silicate of CA. In an additional preferred embodiment of the invention the main binder phase includes 3CaO×SiO2. In the preferred embodiment of the invention the main binder phase (phase) of the cured ceramic material includes hydrates 3CaO×SiO2. The specified main binder phase (phase) may also include phosphates, carbonates, sulphates of calcium and combinations thereof. All other components, if any, represented by such additives as an inert phase, and/or additives which make the material radiopaque.

It is preferable to use soluble chemically bound based ceramics Sao×SiO2as it has rassasivaetsia and high initial consumption or absorption of water, which reduces the porosity, resulting in a high strength is achieved at an early stage after application of the ceramic composition of the precursor mixed with a hardening liquid.

As the second binder phase (phases) of the ceramic composition, the precursor may further include a connection Sa based on phosphates and/or sulfates in an amount less than 20 wt.% from the number of main binder phase (phases), and preferably in the amount of 5-10 wt.%. The specified second binder phase may include soluble glass, for example glass containing phosphorus, the materials on the basis of patita, preferably soluble San phosphates.

Ceramic composition, the precursor may include additives, which impart a high degree of rentgencontrastnoe, for example sulfates such as sulfate VA, as well as other very slowly soluble inorganic or inert mineral phases. It is preferable to use oxides having a high degree of rentgencontrastnoe, such as zirconium oxide. These inert phase preferably include mineral-based calcium silicate or calciseptine glass. These glasses can preferably contain fluorine or phosphorus for the formation of fluoride and phosphate ions, which participate in the formation of fluorapatite. These additives can be incorporated into the composition in the form of glass particles, fibers, whiskers and/or platelets at concentrations less than 20 wt.% of the total weight of the composition, more preferably 5-15 wt.% and most preferably 8-12 wt.%.

Ceramic composition, the precursor may optionally include particles of hydrated chemically bound ceramic of the same or similar composition as the main binder phase (phases), in the amount of less than 40 wt.%, preferably 10-30 wt.%. This improves the homogeneity of the microstructure and improves the coupling between reactive chemically bonded ceramics and material-filler on the initial study is cured.

To further improve the properties of the initial strength, it is possible to introduce additives, which improve the initial closing of the pores in the ceramic material by absorption of pure water, for example, from hemihydrate (CaSO4X 1/2H2O) to gypsum (CaSO4×2H2O). So that at the initial moment otvetit all ceramic product, add a combination of phosphoric acid and phosphate Zn, forming zinc oxide. These phases do not affect srednerazmernye or long-term properties, and only improve the initial closing of the pores and initial strength.

Initial strength up to several hours after initialization, the curing reaction can be improved by adding material on the basis of acrylic polymer (PA). When as biomaterials use of glass-ionomer cements (with additives PA), one of the main problems is the low pH value and low chemical stability of the secondary phases. However, in the proposed ceramic compositions precursor pure polyacrylic acid is used only in low concentrations, less than 8 wt.%, preferably less than 5 wt.% and more preferably 2-3 wt.%, and thus the acid acts as an agent reducing the pH in the early stages, beginning with pH values higher than 11-12 for initially highly basic silicate and aluminate compounds, and to the pH values less than 10 for 60 minutes, preferably for 30 minutes in a mixture of ceramic composition of the precursor and water.

In order to improve long-term mechanical strength, the ceramic composition of the precursor include high strength stable additive on the basis of chemically bound ceramic, preferably CA aluminates, forming hydrates in the cured material, in quantities less than 40 wt.%, preferably 5-30 wt.%.

The viscosity of the ceramic material before curing can be controlled in a wide range during the initial mixing of the powder material and the hydration liquid from the wet pellets to a suspension suitable for injection. However, it is preferable to reduce the ratio of water-to-cement (W/C) to the extent that it is possible to obtain a viscosity suitable for specific applications. The ratio of the W/C should be less than 0.55, and more preferably is in the range 0,35-0,45. For orthopedic applications may use slightly higher values of the ratio W/C than for dental filling materials, and it is desirable to provide easy insertion of the biomaterial.

The materials show a low rate of dissolution in water and internal environments of an organism when introduced into the body, i.e. more than 95% of the injected mass OST the fast intact after a period of seizure lasting 5 minutes, and more preferably after a period of seizure lasting 10 minutes. This is an advantage, because it is important that the material was time for setting and it is not too intensively mixed with the surrounding fluid. The setting time is in the range from 5 to 12 minutes. The time required for a specific degree of partial or complete collapse, can be varied in the range from several months to several years.

Cured ceramic material has a compressive strength that exceeds 100 MPa. He has a compressive strength within 24 hours of at least 40 MPa, more preferably 50 MPa within 1 hour and more than 90 MPa within 24 hours. Compressive strength of 120 MPa after more than 7 days.

After more than 7 days after curing, the cured ceramic material has a value of KICexceeding 0.5 Nam1/2preferably greater than 0.7 Nam1/2and more preferably greater than 1.0 Nam1/2.

Dimensional changes of the material during curing is less than 0,3 linear %, and/or a pressure of expansion of less than 5 MPa, preferably less than 3 MPa.

Cured ceramic product in accordance with the present invention by introducing into the organism possesses the rate of resorption, which is less than or ravenscrest growth of the bone. More than 60 wt.% the material is dissolved in 3 years, preferably more than 50 wt.% dissolved in 2 years, and more preferably more than 40 wt.% within 12 months.

The term "bioelement" as it is used here, refers to all types of ceramics or articles with a coating intended for insertion into the body, such as medical implants, including carrier material for drug delivery, and, in particular, orthopedic implants. We offer ceramic composition, the precursor mixed with a hardening fluid can also be introduced in the form of a suspension, paste or plastic mass, which after curing forms a specified bioelement.

Example

To study the speed of resorption of the proposed composition of bone cement containing calcium silicate as a main binder phase (phases), used an experimental model on the animal.

Description of raw materials

Used here as a raw material is tricalcium silicate (C 3 s), dicalcium silicate (C2S), odnalezieniu silicate (CS) (Nycomynerals), odnalezieniu aluminate (CA), hemihydrate calcium sulphate (Merck), tricalcium phosphate (Merck), dicalcium phosphate (Merck), Apatite (Merck) and cement "Norian" (from Syntes Stratec). C 3 s, C2S SA in the form of powders were synthesized on the spot.

Description of materials

In the table the CE 1.1 presents the number of compositions of powders, which are derived from the raw materials listed above.

td align="left">
Table 1.1
Composition of tested formulations in volume %
number ofTricalcium silicateDicalcium silicateOdnalezieniu silicateOdnalezieniu aluminateCalcium sulfateTricalcium phosphateThe dicalcium phosphateApatite
1100
2100
3701515
4701515
57030
67030
77030
870 30
9602020
10602020
117525
1280 (gidratirovana 20%)20

Description tests

Powder formulations were mixed with water and the hardening accelerator (30 wt.% CaCl2) to obtain the ratio of the calcium silicate/water 0,4 when on the measures of the mixing machine (Rotomix 3MSEPE) in plastic containers. Mixing the powder and water, gave the pasta, suitable for introduction. Paste examined for changes in pH and the development of strength (measured as compressive strength) over time. Those samples that were tested for compressive strength, kept in a liquid that simulates the internal environment of the body (it changed every third day), and perform consecutive measurements after 1 hour, 24 hours, 7 days, 30 days, 3 months and 12 months. Those samples that were tested for pH, kept in a liquid that simulates the internal environment of the organism, within 5 minutes, 30 minutes, 24 hours, 7 days and 30 days. Some formulations (formulations 1-2, 5-6 and 10-11) was added 2 wt.% polyacrylic acid. Was determined by the change of pH with time.

Each paste was also introduced in the experimental model on the animal. On the distal part of the femur of adult goats was established bilateral defects. Expose the medial condyle of the femur and created the transverse defect with a diameter of 10 mm from the medial cortical layer to the lateral cortical wall (from the medial cortex to the lateral cortical wall). This damaged area was placed graft. Each of the formulations was tested at six locations. After 52 weeks did the autopsy. The medial condyle were subjected to histological analysis to determine decalcomania. The samples were subjected to dehydration, were placed in methyl methacrylate and the case is and coronal slices with a thickness of 20 micrometers. To measure the ratio of the area of bone/defect, the graft/bone defect and/transplant was performed histomorphometry.

Results

The results of tensile tests along with the results of studies on the absorption are presented in tables 1.2 and 1.3. In the strength test was also tested industrial calcium phosphate cement "Norian", which is used as ceramics comparison. The pH was quickly moved from the initial interval 11-12 for all proposed structures to values less than 10 in 30 minutes and less than 9 in 1 hour. For samples containing additive polyacrylic acid, changing the pH to neutral values occurred even faster. The pH value in a stable condition was higher than the neutral value.

Table 1.2
The increase with time of the compressive strength for the investigated compositions (MPa)
number of1 hour2 hours7 days30 days3 months12 months
160100150150150
24085110130130130
3501001101109090
450901001108080
5459090120120120
65095100125125125
755100120125130 130
84070901009070
955100110130130130
1060100120130130130
1170105130130130130
1260100130130130130
Norian to compare204040404040

Table 1.3
The percentage of bone and transplanted material in the damaged area after 12 months
number of% bones% of transplanted material
13050
22066
34040
44035
52055
63035
73535
85035
93040
104050
1135 63
123060

The results show that all compounds dissolve with time and that the maximum strength at the slowest speed of resorption can be achieved using calcium silicate as a material for bone transplantation.

1. Ceramic composition, the precursor to obtain a high strength of Bioelements used as absorbable or partially absorbable biomaterial, where the composition includes at least one silicate with CA as the main cation with the speed of resorption is less than or equal to the rate of growth of the bone, and this at least one silicate acts as the main binding phase in the biomaterial, and that at least one silicate of CA is present in the amount of 50 wt.% or more, and all other components, if they are presented additives such as inert phase, and/or additives which make the material radiopaque.

2. Ceramic composition precursor according to claim 1, where the main binder phase (phase) further includes phosphates, carbonates, sulphates of calcium, or combinations thereof.

3. Ceramic composition precursor according to claim 1, where the main binder phase (phase) includes 3CaO·SiO2.

4. To rumichaca composition precursor according to claim 1, additionally comprising at least one second binder phase based on phosphates and/or sulfates in an amount less than 20 wt.% from the number of main binder phase/phases.

5. Ceramic composition precursor according to claim 4, where the second binder phase comprises a water soluble glass, for example fosforsoderzhashchie glass materials on the basis of Apatite, preferably soluble San phosphate.

6. Ceramic composition precursor according to claim 1, additionally comprising glass particles, fibers, whiskers and/or plates slowly dissolving inorganic or inert mineral phases, preferably a mineral-based CA silicate or calcium silicate glass, and highly radio-opaque oxides, preferably zirconium oxide.

7. Ceramic composition precursor according to claim 6, where these inorganic slowly dissolving phase or inert mineral phases present in amount less than 20 wt.%.

8. Ceramic composition precursor according to claim 1, further comprising hydrated particle phases is identical or similar to those phases which are used as the main binder in the amount of less than 40 wt.%.

9. Ceramic composition precursor according to claim 1, further comprising ceramic powder type aluminate Sa in the amount of less than 40 wt.%.

10. keramicheskaja composition precursor according to any one of the preceding paragraphs, additionally includes small amounts, less than 8 wt.%, material based on acrylic polymer.

11. Cured ceramic material, characterized in that the ceramic material is based on the composition of the precursor according to claims 1-10 and is in hydrated form.

12. Cured ceramic material according to claim 11, where the main binder phase (phase) further includes phosphates, carbonates, sulphates of calcium, or combinations thereof.

13. Cured ceramic material according to claim 11, where the main binder phase (phase) includes hydrates 3CaO·SiO2.

14. Cured ceramic material according to claim 11, comprising at least one second phase based on phosphates and/or sulfates in an amount less than 20 wt.% from the number of main binder phase/phases.

15. Cured ceramic material according to 14, where the second binder phase comprises a water soluble glass, for example fosforsoderzhashchie glass materials on the basis of Apatite, preferably soluble San phosphate.

16. Cured ceramic material according to claim 11, further comprising slowly dissolving or inert mineral phase, preferably a mineral-based CA silicate or calcium silicate glass.

17. Cured ceramic material according to clause 16, where inorganic slowly dissolving or inert mineral phases present in quantity is the Eney 20 wt.%.

18. Cured ceramic material according to claim 11, further comprising stable chemically bound ceramic type hydroalumination calcium in the amount of less than 40 wt.%

19. Cured ceramic material according to claim 11, where the material also includes small quantities of material based on acrylic polymer, less than 8 wt.%

20. Cured ceramic material according to claim 11, where the pH of the material, mixed with a hardening fluid changes during curing from values higher than 11-12 to less than 10 after 60 minutes

21. Cured ceramic material according to claim 11, where the material has a compressive strength within 24 hours of at least 40 MPa.

22. Cured ceramic material according to claim 11, where the material has a compressive strength in excess of 120 MPa after more than 7 days.

23. Cured ceramic material according to claim 11, where the material through more than 7 days after curing is set ToICexceeding 0.5 Nam1/2.

24. Cured ceramic material according to claim 11, where the material has a sizing less than 0.3 linear % and/or pressure expansion during solidification and curing of less than 5 MPa.

25. Cured ceramic material according to claim 11, where the ceramic material in the introduction or the introduction into the organism has a low rate of dissolution in water and the internal environment of the body during the entire period shatavari is, i.e. more than 95% of the introduced mass remains intact after a period of seizure lasting 5 minutes

26. Cured ceramic material according to any one of § § 11-25, where more than 60 wt.% material when introduced into the body is dissolved within 3 years.

27. Medical implant, comprising the uncured ceramic composition precursor according to claim 1 and/or cured ceramic material according to item 11.

28. Medical implantant on item 27 as a material carrier for drug delivery.

29. The device or the substrate with a surface coating selected from the group consisting of artificial orthopedic devices, spinal implants, joint endoprosthesis, fastening element, bone pins, bone screws and strengthening the bone plate, and the device or substrate is coated with the uncured ceramic composition precursor according to claim 1 and/or utverzhdennym ceramic material according to claim 11.



 

Same patents:

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine. Claimed is composition with hyaluronic acid (HA), which includes gel particles of bound water-insoluble hydrated HA. HA includes bindings, represented with the following structural formula: HK'-U-R2-U-TK'. Where each group HA' represents the same or other molecule of bound HA'; each U independently represents optionally substituted 0-acylisourea or N-acylurea; and R2 represents optionally substituted alkyl, alkenyl, alkinyl, alkoxy, cycloalkyl, cycloalkenyl, cycloalkinyl, aryl, heteroaryl, heterocyclic radical, cycloaliphatic alkyl, aralkyl, heteroaralkyl or heterocyclolalkyl. Also claimed is method of developing tissues in individual, including introduction of needle into individual in place where development of tissues is necessary, needle is connected to syringe filled with composition with HA, and applying force to syringe in order to supply composition with HA to individual. Method of obtaining composition with HA includes formation of water-insoluble dehydrated particles of bound HA, separating insoluble in water particles by their average diameter, selection of subset of particles by average diameter and hydration of subset of dehydrated particles by means of physiologically compatible water solution. Other method of obtaining composition with bound HA includes binding precursor of bound HA by means of bis-carbodiimide in presence of pH buffer and dehydration of bound HA. Also included is method of developing tissues in individual that needs tissue development. Method of stabilisation of bound HA includes hydration of water-insoluble dehydrated bound HA by means of physiologically compatible water solution which includes local anesthetic, so that value of elasticity module G' for stabilised composition constitutes not less than approximately 110% from value G' for non-stabilised composition.

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27 cl, 22 ex, 2 tbl, 7 dwg

FIELD: chemistry.

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3 cl, 3 ex

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EFFECT: implants of simplified injection.

14 cl, 4 ex

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1 tbl, 3 ex

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12 cl, 6 ex, 1 tbl

FIELD: medical equipment.

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EFFECT: high hardness of covering; low elasticity module; high durability of coupling with a substrate; low factor of friction and rate of deterioration; high firmness to elastic deformation of destruction and plastic deformation; low roughness of the surface; negative charge of the surface in physiological mediums; bioactive surface; biocompatibility and absence of toxicity.

16 ex, 1 tbl

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EFFECT: high quality with minimum material and labour cost.

1 ex

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EFFECT: improved preparing method.

3 tbl, 3 ex

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FIELD: medicine.

SUBSTANCE: claimed invention relates to field of medications, in particular to solid compositions used to improve water-solubility of pharmaceutically active ingredient, including (1) pharmaceutically active ingredient represents diethyl ether of 2-(2-{3-dimethylcarbamoyl-4-[(4'-trifluoromethylbiphenyl-2-carbonyl)amino]phenyl}acetoxymethyl)-2-phenylmalonic acid or its salt, (2) water-soluble polymer substance (polyvinylpyrrolodone or hydroxypropylcellulose) (3) inorganic porous (water-free silicic acid), and pharmaceutically active ingredient forms solid dispersion in form of particles together with water-soluble polymer substance, and water-soluble polymer substance in form of particles is supported in state in which it is able to be adsorbed and/or to stick to surface of inorganic porous substance. Invention also relates to method of obtaining said compositions.

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22 cl, 2 dwg, 2 tbl, 6 ex

FIELD: medicine.

SUBSTANCE: invention refers to a carrier for drugs, biologically active substances, biological objects used in medicine for diagnostics and treatment in pharmaceutical industry. The carrier represents a material sensitive to external magnetic or electric fields and consisting of magnetic or ferroelectric material filmed with biocompatible thermosensitive, biodegradable polymer and/or dispersed in thermosensitive medium properties of which change with varying temperature relative to that of human body within 15.9 to 42°C. The magnetic or ferroelectric materials are made of substance with great magnetocaloric or electrocaloric component effect 1 to 13 K, have temperature of magnetic or ferroelectric phase transition within temperature range 33 to 37°C, and are chosen from the group including rare-earth, transition and precious metals, their alloys and compounds.

EFFECT: invention also concerns methods of controlled drug delivery by means of such carrier with enabling release thereof (regulated desorption) in the preset point.

32 cl, 9 ex

FIELD: medicine.

SUBSTANCE: pain management agent contains comenic and benzylcomenic acids. The invention can be used for manufacturing of high-effective synthetic nonnarcotic analgesic agent to be applied in medicine and veterinary science for managing pain of various aetiologies. The analgesic agent represents an aqueous solution of comenic acid, benzylcomenic acid, and an adjuvant - sodium hydrocarbonate in the following ratio, wt %: comenic acid - 1-2, benzylcomenic acid to 0.025, sodium hydrocarbonate - 0.55-1.1, water for injection - to 100. Besides, there is disclosed therapy of pain syndrome of various aetiology, consisting that said agent is introduced to the patient intravenously in a dose to 350 mg (in equivalent of comenic acid) a day during 5-30 days.

EFFECT: analgesic agent does not cause dependence and addiction, and intoxication.

4 cl, 8 ex, 6 tbl

FIELD: medicine.

SUBSTANCE: invention concerns chemical-pharmaceutical industry, namely development of a therapeutic agent for external application to be used for prevention of thromboses and disturbed circulation. The therapeutic agent represents nanostructured gel containing n-3 polyunsaturated fatty acids, α-tocopherol-acetate, phospholipid concentrate, alkali, water and liquid paraffin.

EFFECT: advantages of such composition are thermodynamic stability, possibility to introduce biologically active substances of both hydrophilic and amphiphilic, and hydrophobic nature, ability to promote percutaneous substance delivery and ease of production.

9 ex, 2 tbl

FIELD: medicine.

SUBSTANCE: invention relates to medicine, particularly to sexopathology, and method and drug for treating erectile dysfunction in men. Proposed is a drug with the following components, in mg: Kelp - 20.9182, active tadalafil - 5.44, mint - 2.0, aspartame - 0.8, glycerine - 2.0, FD&C Red 40 - 0.2, starch - 3.2, L-Menthol - 2.12, moisture - 2.432, polysorbate-80 - 0.6. The method is realised by introducing the said drug in the sublingual area in form of flavoured tablets.

EFFECT: overcoming asthenoneurotic component of erectile dysfunction, individual dosage of the drug and prolonged use without side effects.

2 tbl, 2 cl

FIELD: medicine.

SUBSTANCE: invention concerns medicine area, namely to pharmacy and concerns a composition of ingredients of a dissolvent for reception of a medicinal injection solution. The offered agent contains water for injections, low-molecular polyethylene, T-2 emulgent, microcrystallic gelatin, olive oil at a certain parity of components. The offered agent provides reliable fixation of a medical product in tissues at an injection way of introduction, raises its pharmaceutical availability at the expense of incoming auxiliary substances, possesses prolonged action, is convenient and hygienic in use.

EFFECT: provision of reliable fixation of a medical product which possesses prolonged action, is convenient and hygienic in use, in tissues at an injection way of introduction, rising of its pharmaceutical availability at the expense of entering incoming substances.

4 ex

FIELD: medicine.

SUBSTANCE: there is disclosed pharmaceutical product as prepared solution. The pharmaceutical product comprises a reservoir filled with dissolved zoledronic acid or its pharmaceutically acceptable salt. At least the internal surface of said reservoir contains plastic material that is polyolefin. The product is exposed to thermal sterilisation, preferentially to moist thermal sterilisation. Besides the product can contain a buffer component, preferentially the buffer organic base. Additionally, the product can contain an isotonic component, preferentially mannitol. The invention provides product sterilisation at high temperature 121°C during 150 minutes without visible deformations and damages of sealed integral reservoir, as well as decomposition of pharmaceutical substance.

EFFECT: thermal stability allows for multiple sterilisation cycle that leads to sterility assurance level at least 10-12.

38 cl, 19 ex

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