Yeast-containing pharmaceutical preparation

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutical industry and represents a pharmaceutical preparation for controlled release of a contained active ingredient, differing by the fact that said pharmaceutical preparation contains medically acceptable yeast able for alcoholic fermentation.

EFFECT: invention provides release of the active ingredient from the pharmaceutical preparation regardless of the environmental conditions.

13 cl, 4 ex, 3 dwg

 

The present invention relates to pharmaceutical drug controlled release contained in current medicinal ingredient containing yeast capable of fermentation and the formation of carbon dioxide, which leads to the release of the current medicinal ingredient of a pharmaceutical product.

When drug therapy of many diseases, such as infectious diseases, disorders of the cardiovascular system, allergies, medical conditions or disturbance of the hormonal balance, it is desirable for an extended period of time to maintain a constant level of current drug ingredient in the blood or tissue. With this purpose, the use of the dosage form with controlled release of active ingredient, in particular of active medicinal ingredients that do not have a long half-life from plasma. Such dosage forms include systems with prolonged release of the active ingredient, system slow-acting and system with a pulsed release of active ingredient. The main problem in this case is to reduce the variability of its concentration in plasma from the same individual and among different individuals. In particular, the objective is the prevention of peak levels with the holding in the plasma and thereby increased risk of side effects. In addition, when using these dosage forms can avoid incorrect reception of medicines and improve patient compliance with the regimen and the regimen, in particular due to the simplicity of the treatment and reduce the frequency of administration of the medicine.

Dosage forms with controlled release of active ingredient are also used in drug therapy of painful conditions, which are subject to colostomy rhythms and symptoms which are usually more often or to a greater extent manifest in certain hours of the day.

In the prior art there are many methods of influence on the current release of the medicinal ingredient of the pharmaceutical preparation. For example, physico-chemical properties of the current medicinal ingredient can be adjusted in such a way as to change the rate of dissolution. To this end, among other things, bind active pharmaceutical ingredient with ion exchange resins or choose the size of the particles. Pharmacotechnology measures concerning the choice of fillers and development of dosage forms. Thus, the regulation of the release of the current medicinal ingredient may be achieved by coating properties or patriciabrasel substances or structure of the dosage form. With regard to the kinetics vysvobozhdeny the active ingredient, in General we can distinguish systems with controlled diffusion-controlled erosion and osmotically controlled release.

However, in the known pharmaceutical preparations with controlled release of the current medicinal ingredient release current medicinal ingredient is not independent of the surrounding conditions, so the release of active ingredient may be subject to unpredictable fluctuations. In this regard, the present invention is the task of creating a pharmaceutical preparation, the release current medicinal ingredient which is as far as possible, regardless of ambient conditions.

The solution to this problem is provided by a pharmaceutical product containing microorganisms which are capable of alcoholic fermentation and are acceptable from a medical point of view, such as yeast. After taking pharmaceutical drug release current medicinal ingredient contained in the above-mentioned pharmaceutical preparation is governed by the progress of the formation of carbon dioxide, which occurs after the start of alcoholic fermentation.

Known pharmaceutical preparations containing yeast cells. For example, are produced in capsules under the trade name is of Perenterol® and Yomagi®, which contain medicinal yeast Saccharomyces boulardii. In these pharmaceutical drugs designed for the treatment of diseases associated with indigestion, the yeast should be considered as having a therapeutic effect component of a pharmaceutical product, because their function is to restore intestinal flora and thereby combating diarrhea.

In addition, the prior art of pharmaceutical preparations, in which the formed carbon dioxide upon reception. For example, in published applications WO 03/0112 A1 and US 2006/003003 A1 described can linger in the stomach system, which is used resulting in the formation of carbon dioxide their ability to stay on the surface of the chyme or contained in the stomach fluid. This method can be achieved for a long time holding a pharmaceutical preparation in the stomach.

According to WO 2006/024638 A2 carbon dioxide produced after administration of the pharmaceutical preparation can also be used for mixing current medicinal ingredient with food in the stomach, which should cause the inhibiting effect.

The formation of carbon dioxide within the pharmaceutical preparations can also be used to accelerate the disintegration of the dosage form after admission, as described, e.g. the, in JP 2003231629 A.

In the known pharmaceutical preparations, which uses carbon dioxide generated upon reception, the formation of carbon dioxide occurs as a result of exposure to salt, usually sodium carbonate, acid. This chemical reaction is difficult to adjust, if at all possible.

The present invention is the idea according to which for the current release of the medicinal ingredient, is basically not dependent on the surrounding conditions, would require adjustable carbon dioxide and according to which we could regulate the formation of carbon dioxide that occur during alcoholic fermentation in pharmaceutical drug.

Surprisingly, conducted by the applicant's studies have shown that the kinetics of release of the current medicinal ingredient of the pharmaceutical preparation can indeed be controlled by the carbon dioxide formed during fermentation of yeast.

Figure 1 shows the time-dependent volumetric expansion content 20-ml syringes Omnifix® as a result of formation of carbon dioxide during fermentation, yeast,

figure 2 shows the time-dependent release of paracetamol from the model of a medicinal product under the action of the carbon dioxide formed during Brogan and yeast,

figure 3 schematically presents a monolithic system with floor to release current medicinal ingredient containing sugar syrup, yeast, and active pharmaceutical ingredient.

Thus, an object of the present invention are pharmaceutical preparations, which in addition contained in current medicinal ingredient contain pharmaceutically acceptable yeast cells capable of fermentation. In the context of the present invention the yeast cells contained in the pharmaceutical preparations are invariably many yeast cells, even if the term "yeast" is used in the singular.

Yeast or Blastomyces (yeast) are protoscolices. Typical yeast a type of asexual reproduction in the broadest sense of the word is budding. However, some yeasts reproduce by fission or have transitional forms of reproduction between fission and budding. So, the kidney may be connected to each other form clusters kidney or pseudomycelium (liegeplatz) or may be completely separated from each other, with many yeast species form deceptively or septate hyphae (mycelium threads).

The yeast, which is particularly applicable in pharmaceuticas is their preparations according to the invention, are yeast used in baking, brewing and wine-making industries. As examples of the yeast include Saccharomyces cerevisiae Saccharomyces cerevisiae, Saccharomyces carlsbergensis, Saccharomyces uvarum, Saccharomyces boulardii, Saccharomyces exiguus and Saccharomyces ludwigii. However, you can also use not related to the Saccharomyces cerevisiae yeast, such as Candida famala, Candida stellata, Dekkera bruxellensis, Hanensula uvarum, Kluyveromyces lactis, Kluyveromyces thermotolerans, Metschnikowia pulcherrima, or Torulaspora delbrueckii.

In the pharmaceutical preparation according to the invention preferably use pure yeast strains. In one of the preferred embodiments the pharmaceutical preparation contains Baker's yeast (Saccharomyces cerevisiae). Nevertheless, in order to regulate the course of the fermentation inside pharmaceutical drug, it is also possible to use combinations of two or more strains of yeast.

In principle, the yeast may be contained in the pharmaceutical preparation in the form of fresh yeast. However, for the manufacture of pharmaceuticals is particularly preferable to use dry yeast instant yeast.

During alcoholic fermentation, yeast converts glucose under anaerobic conditions in the ethanol and carbon dioxide:

With6H12About6→2C2H5HE+2SD2

Thus, glucose is an essential product of alcohol, broj the deposits. In particular embodiments, the implementation of a pharmaceutical preparation according to the invention can be used is the fact that located in the digestive tract the chyme contains carbohydrates, in particular glucose, which can be used during fermentation of yeast contained in the pharmaceutical preparation. In these embodiments, the implementation is not required to proposed invention the pharmaceutical preparation also contained sugar, necessary for fermentation, provided that the data contained in the chyme sugar is able to penetrate into the pharmaceutical drug.

However, in preferred embodiments, the implementation of the pharmaceutical preparation according to the invention also contains carbohydrate(s)required for fermentation. Pharmaceutical drug particularly preferably contains glucose.

Instead of or in addition to glucose can also use other sugars or mixtures thereof, which can be used during fermentation the yeast contained in the pharmaceutical preparation. For example, in the pharmaceutical preparation can be used fructose, galactose, sucrose, maltose, maltotriose, raffinose, or any mixture of these sugars. In addition, you can use sugar or starch derivatives, for example dextrins.

Pharmaceuticals are coated. The following substances are applicable for the manufacture of aircraft is s:

ethers of cellulose, such as hypromellose or ethylcellulose,

esters of cellulose, such as acetylcellulose, acetobutyrate cellulose or azeotroping pulp,

the polyacrylates and polymethacrylates, such as products, industrial manufactured under the trademark Eudragit® RS, Eudragit® RL or Eudragit® NE,

polyvinyl derivatives, such as, for example, polyvinyl acetate,

copolymers polimetilvinilovogo ether and maleic acid or a complex of ethyl esters, complex isopropyl esters and their n-butyl esters, for example the product of industrially produced under the trademark Gantrez® AN.

For the manufacture of coatings may also be used mixtures of the abovementioned polymers, such as ethylcellulose and hydroxypropylcellulose in a weight ratio of 60:40.

In addition, the coating can also be added to the applicable fillers, with which you can adjust the properties of the coatings. Applicable fillers are, for example, plasticizers, wetting agents or pigments. Examples of plasticizers that can be used are esters, such as triethylcitrate, tributyltin, acetyltributyl, dibutylated, diethylbenzene, dimethylphthalate, diethylphthalate, dioctylphthalate, castor oil, sesame oil, glycerol triacetate, diacetylpyridine, higher alcohols, such as glycerol or 1,2-propylene glycol or polyether, such as polyethylene glycols.

Apply wetting agents are, for example, glycol 400 stearate, servicemanuals and servicemanual peg.

Applicable pigments are, for example, titanium dioxide and iron oxide.

By adding these fillers can adjust the properties of the coatings, because of their mechanical properties such as flexibility, fragility and strength, as well as the thickness of the coating layer affect the current release of the medicinal ingredient.

So, in one of the embodiments the pharmaceutical preparation according to the invention can have a structure similar to the structure of the system with osmotically controlled release, so that the carbon dioxide produced in the fermentation, pushed the solution or suspension of active ingredient to the outside through the exhaust hole in the pharmaceutical preparation. This way you can ensure a continuous release of the current medicinal ingredient, which occurs over a long period of time.

The preferred coating in this embodiment is a coating acetylcellulose, because it is distinguished by a particularly high strength.

In other in which the options for the implementation of the pharmaceutical preparation may be a system, which releases the active drug ingredient portions or in pulsed mode. In this case, the release can occur relatively quickly or after a certain time delay. To ensure the current release of the medicinal ingredient, the system can be made monolithic or may consist of many individual blocks (multiple blocks). If all of the multiple blocks have the same release property, can be implemented in the release of portions of the existing medicinal ingredient contained in many blocks. If many blocks have different properties release may pulsating current release of the medicinal ingredient.

Depending on the properties of coating ferment the yeast can start immediately after administration of the dosage form or with a certain time delay, so it is also possible pharmaceutical preparations according to the present invention with a slow release current medicinal ingredient.

The preferred coatings for systems with batch, pulsed and/or delayed release of the current medicinal ingredient are coatings of ethyl cellulose or based on ethyl cellulose, properties which reg is to regulate by means of plasticizers and/or by changing the thickness of the layer. For example, adding a plasticizer such as triethylcitrate, flexibility and strength of the coating increases to a greater extent than when adding dibutylsebacate.

In particular, when using dry yeast, for reconstitution of the yeast requires water. Water can be introduced into the medical form from the outside when receiving a dosage form or in the form of water already present in the gastrointestinal tract. In one of the special options for the implementation of water required for reconstitution, is already contained in the dosage form. In order to avoid premature activation of yeast and fermentation inside the dosage form water initially should be placed separately from the yeast in a separate chamber. To activate the yeast wall of the chamber in which there is water, it is necessary to destroy, for example, by breaking. As a result of this water will come in contact with yeast, to restore the moisture content of the yeast and initiate fermentation.

Example 1

To explore whether there is enough even small amounts of released products for the formation of carbon dioxide, is able to provide the current release of the medicinal ingredient, blended from 25 to 100 mg yeast to 100 mg of glucose monohydrate and 500 l purified water and filled with a mixture of 20 ml disposable syringes (mnifix®), injection holes have been closed. In the filled syringes stuck pistons and kept the syringes at a temperature of 37°C. as the rate of formation of carbon dioxide was detected movement of the piston, pointing to a volumetric expansion of the contents of the syringe.

The results of this experiment are illustrated in figure 1, where the amount of yeast (Y) is specified in mg, the amount of glucose monohydrate (G) are indicated in mg, and the amount of purified water (And) shown in l. The mentioned values are average of six individual measurements. In addition to the time-dependent volume expansion obvious that the kinetics of formation of carbon dioxide was influenced by the ratio of the used yeast and glucose. It can be used in the manufacture of pharmaceutical products for the purpose of regulating the speed of release of the current medicinal ingredient contained in the pharmaceutical preparation.

Example 2

There was conducted an additional experiment in order to find out whether it is possible for a sufficiently long time to release the active pharmaceutical ingredient using carbon dioxide generated during fermentation. For this disposable syringe filled with a mixture of paracetamol, polyethylene glycol and vysokodispersnom the frame of silicon dioxide. The mixture was closed by a small plate that is inserted in the syringe; then the plate was placed a mixture of yeast, glucose and water, and closed the injection hole of the syringe. Signatures to 2 specify the appropriate amount of yeast (Y) in mg and monohydrate glucose (G) in mg Number used to activate the water was 125 l.

Testing the solubility created in this way a model of the dosage form its kept at 37°C in 900 ml of water in the installation, rotating with a speed of 100 rpm, and at different points in time determined the amount of paracetamol released into the surrounding water.

The results of this experiment are illustrated in figure 2. Shown values are average of n=3.

It was found that by using carbon dioxide, resulting from the fermentation of the model of the pharmaceutical drug for a long period of time may be released active medicinal ingredient. In addition, the kinetics of release of the current medicinal ingredient depends on the amount of yeast. Therefore, the rate of release of active ingredient can be adjusted due to the content of yeast and/or glucose in the pharmaceutical drug.

Example 3

System with "osmotically" controlled release preparations is the group

By analogy with the system of osmotically controlled release of the formed carbon dioxide is able to create pressure within the dosage form, displacing the solution/suspension of the current medicinal ingredient to the outside through the hole to release. This release had the following composition.

Separately was grained components corresponding internal phases of both layers. Then added the corresponding outer phase and compressed from both granulates biconvex two-layer tablets. On made in such a way that the pill has caused water-permeable, gas-tight coating for the manufacture of which 20 g of acetylcellulose dissolved in 970 ml of acetone and mixed with 4.5 g of polyethylene glycol 400, which was dissolved in 30 ml of water. After that, the coated two-layer tablet in the area containing the active ingredient layer was cut a hole for the release of active ingredient.

Example 4

Produced system release portions of the active ingredient having the following structure.

Sugar syrup
The glucose monohydrate71,4%
Purified water28,6%
Dosage form
Sugar syrup40%
Finely ground dry yeast40%
Active medicinal substance paracetamol20%

First got the sugar syrup. After cooling the syrup added yeast and active pharmaceutical ingredient and formed a small sphere, which then caused permeable, possible gas-tight coating, for which manufacturing 20 g ethylcellulose together with 4 g of dibutylsebacate dissolved in 200 ml of ethanol. This system is the current release of the medicinal ingredient containing yeast (▲) and active pharmaceutical ingredient (a), illustrated in figure 3.

1. Pharmaceutical drug for controlled release of the contained current medicinal ingredient, characterized in that the said pharmaceutical preparation contains acceptable from a medical point of view, the yeast capable of alcoholic fermentation.

2. The pharmaceutical preparation according to claim 1, characterized in that the said yeast is selected from the group, enabling the th Saccharomyces cerevisiae, Saccharomy-ces carlsbergensis, Saccharomyces uvarum, Saccharomyces boulardii, Saccharomyces exiguus and Saccharomyces ludwigii, Candida famala, Candida stellata, Dekkera bruxellensis, Hanensula uvarum, Kluyveromyces lactis, Kluyveromyces thermotolerans, Metschnikowia pulcherrima, Torulaspora delbrueckii, and mixtures thereof.

3. The pharmaceutical preparation according to claim 1, characterized in that the said yeast are fresh yeast or dry yeast.

4. The pharmaceutical preparation according to claim 1, characterized in that the said pharmaceutical preparation further comprises one or more carbohydrates, which are preferably chosen from the group comprising glucose, fructose, galactose, sucrose, maltose, maltotriose, raffinose, starch, derivatives of starch and dextrins.

5. The pharmaceutical preparation according to claim 1, characterized in that the said pharmaceutical preparation further comprises water in a separate chamber.

6. The pharmaceutical preparation according to claim 1, characterized in that the said pharmaceutical preparation has a coating, which preferably contains a substance selected from the group comprising ethers, cellulose, esters of cellulose, polyacrylate, polymethacrylate, polyvinyl derivative or copolymer polimetilvinilovogo ether and maleic acid.

7. The pharmaceutical preparation according to claim 6, characterized in that the substance mentioned coating contains one or more fillers, preferably selected isgroup, including plasticizers, wetting agents and pigments.

8. The pharmaceutical preparation according to claim 7, characterized in that the plasticizer is chosen from the group including triethylcitrate, tributyltin, acetyltributyl, dibutylated, diethylbenzene, dimethylphthalate, diethylphthalate, dioctylphthalate, castor oil, sesame oil, diacetate of glycerol, glycerin, 1,2-propylene glycol and polyethylene glycols.

9. The pharmaceutical preparation according to claim 7, characterized in that the wetting agent selected from the group including stearate polyethylene glycol 400, servicemanuals and servicemanual peg.

10. The pharmaceutical preparation according to claim 7, wherein the pigment is selected from the group including titanium dioxide and iron oxide.

11. A method of manufacturing a pharmaceutical preparation for continuous release of the current pharmaceutical ingredient according to claim 1, characterized in that contains the active ingredient layer and containing yeast layer pressed dual layer tablet, put on a two-layer tablet is permeable gas-tight cover and cut a hole in the floor in the area containing the active ingredient layer.

12. A method of manufacturing a pharmaceutical preparation for the release of portions of the existing pharmaceutical ingredient according to claim 1, otlichuy is the, what active drug ingredient and the yeast is introduced into the sugar syrup and put in the mixture permeable, possible gas-tight coating after the formation of small spheres.

13. The application is acceptable from a medical point of view yeast capable of alcoholic fermentation, for the manufacture of a pharmaceutical preparation for the controlled release of the current medicinal ingredient contained in the above-mentioned pharmaceutical preparation according to claim 1.



 

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3 cl, 2 ex, 2 tbl, 2 dwg

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmacology. A liposome suspension composition for prevention and treatment of respiratory infections, particularly tuberculosis, contains liposomes, propylene glycol pine wood extract, propylene glycol sage extract, marigold, bee balm and eucalyptus essences, Carbopol, glycerin, blanose, epo-phen, kathon, sodium hydroxide and water. In other version, the liposome suspension composition for prevention and treatment of respiratory infections, particularly tuberculosis, contains liposomes as a basis, propylene glycol pine wood extract, propylene glycol dandelion, burdock and cornflower extracts, lavender, bergamot and schizandra essences, Carbopol, glycerin, blanose, epo-phen, kathon, sodium hydroxide and water. A method for prevention and treatment of respiratory infections, particularly tuberculosis by inhalations; it involves aerosol processing of a room by the presented liposome suspension composition by making 10 applications of a dosing cock with the area of 20 sq. m.

EFFECT: using the offered invention enables widening the spectrum of ecologically safe high-effective immune-enhancing agents with antimicrobial, anti-viral and fungicidal effect for massive prevention and treatment of respiratory infections, including tuberculosis.

3 cl, 2 ex, 2 tbl, 2 dwg

FIELD: medicine.

SUBSTANCE: invention refers to cosmetology, and represents a hygienic lipstick in the form of a cosmetic stick, containing carnauba wax, candelilla wax, jojoba esters, a number of vegetable oils, and at least one additional moisturising agent with carnauba wax, candelilla wax and other waxes being other than jojoba esters and making approximately less than 20 wt % of total weight of the hygienic lipstick, while at least 90 wt % of total weight of the hygienic lipstick is prepared of vegetable sources with non-vegetable ingredients containing no materials prepared of mammal sources or oil; said number of vegetable oils contains at least three oils specified in a specific group with the hygienic lipstick representing a solid stick pulled out from a container and pulled there back.

EFFECT: invention provides improved lip sensation ensured by humidifying and softening.

16 cl, 1 ex, 1 tbl

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to cosmetics, more specifically concerns a hair care composition containing polymer having affinity to hair and representing a partial ester of poly(hydroxyethylacrylate) or poly(hydroxyethylmethacrylate) with 3,4-dihydroxybenzoic acid. The invention also concerns a method of hair care with using said composition.

EFFECT: compositions according to the invention provides deposition and delivery of the agents having a beneficial effect on hair more effectively and persistently.

4 cl, 3 tbl, 4 ex

FIELD: medicine.

SUBSTANCE: group of inventions refers to dental compositions for treating or preventing dry mouth syndrome. One of the versions of the composition for treating and/or preventing dry mouth syndrome and at least one accompanying pathology represents a composition containing at least one surfactant, at least one antimicrobial agent and at least one adhesive where at least one antimicrobial agent is sterically immobilised in a complex with one or more glycosaminoglycans. Said composition can represent a tooth paste, a tooth elixir or an oral spray. The other version of the composition contains at least one surfactant, at least one antimicrobial agent, and at least one adhesive; wherein at least one antimicrobial agent represents cetylpyridinium chloride in a complex with one or more glycosaminoglycans.

EFFECT: compositions provide the effective delivery of antimicrobial agents to oral mucosa, exhibits low irritability and high moisture-binding capacity.

18 cl, 2 ex

FIELD: medicine, oncology, amino acids.

SUBSTANCE: invention relates, in particular, to the development of an antitumor preparation based on natural substances. Invention relates to an amino acid preparation comprising at least one modified essential amino acid obtained by treatment of amino acid by ultraviolet radiation (UV) at wavelength 250-350 nm for 12-80 h at temperature 15-30oC or with ozone at temperature 15-25oC. The modified amino acid has no toxicity for health cells. Also, invention relates to a method for preparing such preparation. Invention provides the development of an antitumor preparation based on modified amino acids and expanded assortment of antitumor preparations being without cytotoxicity for normal cells.

EFFECT: valuable medicinal antitumor properties of preparation.

8 cl, 4 tbl, 2 dwg, 4 ex

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