Viscous medical product for injections, containing ethanol and fat-soluble, impenetrable connection for x-ray radiation

FIELD: medicine.

SUBSTANCE: invention is used for treatment venous malformations, administered by means of injections. The declared preparation contains ethanol with the degree of cleanliness from 70 to 99 % which is necessary for the effect causing sclerosis, a difficult ethyl ester of the iodated fat acid, and in addition contains ethyl cellulose or dextrin, providing viscosity of the solution from 10 to 700 cPz, for the preparation of gel with the emboli effect.

EFFECT: declared drug provides reliable application at all stages of course of the treatment and ability to formation of a selective steady sclerosis, also the invention provides biological compatibility, high ability to densifying, formation of biodegrading derivatives, an exception of local or system toxic effects.

6 cl, 1 tbl, 2 ex

 

The present invention relates to a viscous pharmaceutical preparation for injection containing ethanol and fat-soluble, impervious to x-rays connection. It applies in particular, but not exclusively, in the treatment of venous malformations, such as venous angiomas.

Typically, venous malformation characterized by swelling bluish color, which is soft, compressible, swollen at the bottom or when pressed.

They can be more or less pronounced volume and placed in hard to reach or the affected areas in which surgical resection is sometimes difficult or even impossible.

For the treatment of such zones was proposed pure ethanol for percutaneous introduction the purpose of education sclerosis malformations. Its effectiveness is not in doubt, but its use is associated with a significant risk for the following reasons:

defiant sclerosis substance is a liquid, and its spread beyond the pathological zone is controlled only partially carefully check the correct position of the injection needle in the area of malformations in the preliminary series angiography;

he is not radiopaque, and areas with the calling sclerosis substance not controlled or during injection or after it;

- described, although rare, is, but severe cases cardiac and General toxicity caused directly by the injection of ethanol in zone venous malformations.

For the safe and effective use of pure ethanol proposed a mixture of ethanol and connections to obtain a viscous product, such as ethylcellulose, dextrin or one of their derivatives. This mixture forms a gel with the following two main advantages:

- he is able to be injected with a needle into the area of venous malformations, and its spread into unwanted areas are severely limited compared to the pure ethanol

- due to their physical properties, the gel remains near the injection zone and creates a very high-sclerotic effect. The amount needed to obtain the same result, dramatically reduced compared to pure ethanol at reducing the risk of General toxicity.

However, this gel has two significant drawbacks:

he is not radiopaque,

- there is a direct occulation calling sclerosis mixture (ethanol/ethyl cellulose) in contact with water-soluble contrast agents commonly used in vascular radiology, impedes the movement of the gel in the needle during injection and precluding its use in the catheter.

The subject of the invention is to eliminate these drawbacks is s.

Therefore, the proposed medicinal preparation for injection containing ethanol and at least one fat-soluble compound of at least partial proof for x-rays.

According to the invention the specified drug differs in that it additionally contains soluble in ethanol compound whose viscosity in the solution is from 10 to 700 centipoise, preferably from 90 to 350 centipoise, at 25°C., to obtain a gel with the effect of embolism and that the degree of purity of the ethanol is from 70 to 99% by volume, preferably from 90 to 99% by volume, to obtain the caller sclerosis effect.

It should be stated that centipoise (CP) means a unit of dynamic viscosity equal to 10-3Pascal second (PA·s).

Needless to say that the specified connection with a viscosity in solution of ethanol from 10 to 700 centipoise, preferably from 90 to 350 centipoise, at 25°C, may contain at least one fat-soluble compound, which is at least partially impermeable to x-rays. These compounds are inert with respect to each other.

In the preparation according to the invention can be administered active substances.

More specifically, this preparation may consist of emulsion, which is in the state between the viscous phase, containing, at least, ethanol, and ironist oimoi phase, containing at least the specified fat-soluble compound, which is at least partially impermeable to x-rays.

The preparation according to the invention may contain from 10 to 50 volume% of the specified fat-soluble compounds, which are at least partially impermeable to x-rays.

While it is preferable to have in mind that the more emulsion contains fine particles, the more uniform will be the mixture and the more effective will be monitoring the passage of the mixture during injection.

Mentioned emulsion can be prepared by introduction of this fat-soluble compound, which is at least partially impermeable to x-ray radiation, or at the end of the preparation of the drug, or immediately before its introduction.

Fat-soluble compound, which is at least partially impermeable to x-ray radiation, may represent a non-metallic connection.

These non-metallic connection can serve ester, halogenated fatty acids, such as ethyl esters of iodized fatty acids.

Preferably, in the case of finding venous malformations near the skin, which are often treated mainly for aesthetic reasons, nonmetallic was sedimentational prevention of skin color in black color, such that it acquires when using metal compounds.

The specified connection, which has a solution viscosity of from 10 to 700 centipoise, preferably from 90 to 350 centipoise, can be selected in order to achieve the following properties:

biological compatibility in connection with the use of the drug for injection,

- a relatively high ability to thickening for increasing the viscosity of the mixture even at low content

- education biodegrading derived in situ, eliminating the need for surgical intervention in the treatment area,

- solubility in cold condition in ethanol to prepare a homogeneous preparation,

- minimize, even complete elimination of local and/or systemic toxic effects to reduce tolerability of the drug, and, if necessary, the possibility of preparation in powder form, not liquid to eliminate the need to dilute ethanol.

The specified connection with a viscosity of from 10 to 700 centipoise, preferably from 90 to 350 centipoise, at 25°C can be ethylcellulose.

Ethylcellulose can be contained in an amount of from 0.5 to 30 wt.%, preferably from 5 to 18 wt.%, the total weight of the preparation.

Therefore, the preparation according to the invention meets all the basic criteria, which are reliable use in all one hundred is the second course of treatment and the ability to form selective sustainable sclerosis.

Below as a non-limiting example describes a variant implementation of the invention with reference to the attached drawings, which represent:

figure 1 - measurement of viscosity in centipoise depending on the concentration in wt.% ethyl cellulose by weight;

figure 2 - measurement of viscosity in centipoise depending on the temperature in degrees Celsius.

Preparation

There are several drugs with different content of ethyl cellulose (Aqualon 100 NF®, Hercules), received its dissolution in number respectively 0,15; 0.45 and 0.75 g in 15 ml of ethanol with purity of from 70 to 99 volume%, preferably 95% by volume (d=0,8), which is 1,22; 3,61 and 5,88% wt. the total weight of the preparation. Was selected drug with a maximum concentration of ethyl cellulose. When dosing forty tanks at a ratio of 205 ml of 95% alcohol (by volume) and of 10.25 g of ethyl cellulose loss was 2.5%. In General, the content of ethyl cellulose ranged from 5 to 18 wt.%, preferably 5,88 wt.%, the total weight of the preparation.

In accordance with the Technological recommendations (1998) the drug is prepared in three stages: preparation of the gel, sterile packaging and sterilization of the product at the final conditioning. Initially indifferent substance (ethylcellulose) was mixed with ethanol in a sterile flask with a glass stopper with Nagravision magnetic shaking under reflux until complete dissolution. The whole complex continued to shake with the use of a dephlegmator for fifteen minutes, then shook to cool to re-condensation of the alcohol in the flask. Re-conditioning was conducted in a laminar box under a horizontal laminar flow when filling sterile sealable containers with a capacity of 5 ml (biological unit 42065). Finally, as recommended in the European Pharmacopoeia, the containers were sterilized in the autoclave with saturated steam at 121°C for twenty minutes.

The last stage of preparation of the drug was fat-soluble additive that causes the opacity of a substance, such as a complex ethyl ester of iodinated fatty acids (Laboratory coat of Arms, France), in varying amounts to obtain the necessary opacity, for example, from 10 to 50% by volume of the total volume.

Because this substance (fat-soluble phase) is not mixed with a mixture of ethanol/ethylcellulose (viscous phase), through the merger of the two phases formed suspension, the particle size of which depends on produced by mixing. It should be noted that the finer the particles, the more uniform injectable mixture and the more effective control over the injection.

This additive may be, for example, in the syringe before injection.

However, because this substance I which is inert and used in small quantities, it does not significantly affect the results of the control described below and carried out in respect of the drug to its Supplement.

Ongoing control measures

Compliance testing of the drug was carried out through a sterile test, as well as by chemical and physical control measures.

According to the recommendations of the European Pharmacopoeia possible presence of pathogens was determined by seeding 4 ml 250 ml broth of soy tryticase for aerobic microbes, thioglycolate for aerobic microbes and Sabouraud's yeast. The results of the sterility test confirmed the absence of pathogens in the product.

The alcohol content was determined after dilution and injection internal standard, propanol-1, by gas chromatography using flame ionization. The separation was carried out in the column of Porapak Q (80-100 mesh (cell), height: 3 m) using nitrogen as the gas vector (1,2 bar) on the device Delsi DN200. During the titration of alcohol received indicator 802 G.-1.

Specific titration additives for viscosity were not conducted, however, the concentration was determined by the method of dry residue, reception, namely, that the ethanol is evaporated in a thermostatted cuvette at a temperature of 110°C to obtain a constant weight of the sample. Method of dry residue allows you the option of submitting a correlation calculation of the concentration of ethyl cellulose concentration, measured experimentally and formed 5,88% by volume of the total sample weight.

The viscosity of the preparation was measured using a capillary viscosimeter the Boma (Prolabo). There have been several series of measurements at different temperatures and different concentrations of thickener of the drug. The viscosity measurements showed that at constant temperature the viscosity of the drug increases exponentially with the content of ethyl cellulose (figure 1). Simultaneously, the viscosity decreases exponentially with increasing temperature (figure 2).

Finally, a study was conducted to determine the physicochemical stability through the analysis of the phase changes of the parameters characterizing the drug, i.e. its viscosity and content of ethanol and adding the viscosity of the substance. The measurement was repeated through the day (J1), eight days (J8) and thirty days (J30).

The results are shown in table 1. The change factors of less than 3%, confirmed the stability of the mixture for up to 30 days, which allows to define the minimum shelf-life of the drug.

Table 1
The correlation of physico-chemical parameters of the drug from the storage duration
Duration ethanol, G.-1VsamplesmlPsamplesgdsamples, GML-1The dry residue, gThe ratio of dry residue/Psamples, %Viscosity, centipoise
J178421,6500,8250,1016,10320
J882121,7200,8500,1035,97339,5
J1578321,6100.800 to0,0976,00-
J3082021,6700,8300,099of 5.92332
Average802-1,6630,8260,1005,998330,5
Typical deviation21,370-0,0460,0210,0020,0769,836
The rate of change2,665-2,7512,4892,458the 1.2652,976

1. Drug for the treatment of venous malformations, administered by injection, containing ethanol and at least one complex ethyl ester of iodinated fatty acid, characterized in that it further comprises ethylcellulose or dextrin, providing the viscosity of the solution is from 10 to 700 centipoise, preferably from 90 to 350 centipoise, at 25°C., to obtain a gel with the effect of embolism, and that ethanol has a purity of from 70 to 99%, preferably from 90 to 99%, necessary to obtain the caller sclerosis effect.

2. The drug pop, characterized in that ethylcellulose, dextrin, ethanol and at least one complex ethyl ester of iodinated fatty acids are inert with respect to each other.

3. The preparation according to claim 1, characterized in that it comprises emulsion-based viscous phase containing ethanol, and at least one complex ethyl ester of iodinated fatty acids.

4. The preparation according to claim 1, characterized in that it contains about 10-50 vol.% complex ethyl ester of iodinated fatty acids.

5. The preparation according to claim 1, characterized in that ethylcellulose or dextrin have the following properties:
biological compatibility,
sufficiently high thickening ability to increase the viscosity of the mixture even at low contents,
the formation of derivatives with biological degradation in situ,
solubility in ethanol in a cold state,
minimize local and/or systemic toxic effects.

6. The preparation according to claim 1, characterized in that ethylcellulose or dextrin have a powder form.



 

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12 cl, 6 ex, 1 tbl, 1 dwg

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to chemical-pharmaceutical and cosmetic industry, and concerns development of a new safe and nontoxic composition of perfluorocarbon emulsion with colloidal silver, to ensure new, intensified properties for effective medicobiological and cosmetic application. Substance of the invention consists in development of a composition of perfluorodcalin (PFD) or perfluorotributylamine (PFTBA), or perfluoroctylbromide (PFOB), or perfluoromethylcyclohexyl-piperidine (PFMCP), proxanol, sodium chloride and colloidal silver; or mixed PFD/PFMCP, or PFD/PFTBA, or PFOB/PFTBA, or PFOB/PFMCP, proxanol, sodium chloride and colloidal silver; or mixed PFOB/PFD/PFMCP or PFOB/PFD/PFTBA, proxanol, sodium chloride and colloidal silver; or mixed PFOB/PFD/PFMCP/PFTBA, proxanol, sodium chloride and colloidal silver. The concentration of colloidal silver in the perfluorocarbon composition makes 0.00006-0.6 wt %.

EFFECT: composition exhibits high efficacy and stability.

17 cl, 12 ex

FIELD: chemistry.

SUBSTANCE: invention relates to novel chemical compounds and can be used in medicine, particularly radiology as an X-ray contrast agent during X-ray examination of various organs. The invention discloses a composite tantalate of rare-earth elements with the formula M1-xM'xTaO4, where 0.01≤x≤0.45; M and M' are elements selected from a group consisting of: yttrium, gadolinium, terbium, dysprosium, holmium, erbium, thulium, ytterbium, lutetium, as a contrast agent for X-ray diagnosis. The disclosed contrast agent, which provides a high level of X-ray absorption, enables to smoothly and continuously vary the level of absorption with the same quantitative content of the agent owing to change in values of x, i.e., owing to change in the ratio of atoms the first and second elements in the crystal lattice of tantalate.

EFFECT: contrast agent broadens the possibility of reliable diagnosis of cavernous organs.

10 ex

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