Oral film drug and method for preparing it

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine and chemical-pharmaceutical industry, particularly creating an oral film drug which when taken adheres to an oral mucosa, and even if adheres is easily detached therefrom. The oral film drug has at least one agent-containing layer, and at least one surface of the oral drug has a convex portion. Said convex portion is presented in the form of at least one forms specified in cones, columns, hemispheres, truncated cones. The agent-containing layer consists of a therapeutic agent and a base.

EFFECT: preparing the oral film agent.

10 cl, 4 ex, 1 tbl, 9 dwg

 

The technical field of the invention

The present invention relates to accept oral film of the medication and how to obtain it.

The prior art inventions

Usually orally taken drugs are in the form of solid medicines, such as tablets, capsules or the like. Since people are having trouble with the direct ingestion of such hard drugs, often they are forced to take such medications with plenty of water. Even if they do, some still very difficult to swallow, which can lead to poor adherence. When hard drugs cause similar difficulties swallowing, it is also likely that people randomly in the trachea stuck solid drugs or hard drugs will stick to the esophagus, leading to the formation of tumors in the esophagus.

Since especially the elderly and children most often experience difficulties with swallowing solid medications, it is desirable to use a gelatinous, semi-solid medications in order to avoid difficulties swallowing, associated with hard drugs, as well as to promote the convenience and security in the admission process. However, such gel-like, semi-solid medications contain more water, respectively, they are adversely reduce the stability of the elemental composition of medical devices (in particular, easy-hydrolyzed).

For this reason, it was proposed to produce medicines in the form of films (or sheets)to increase the stability of the elemental composition of medical devices (see, for example, the following patent document 1). When medicines are processed in the film, the water content of the medication may be reduced. This leads to increased stability of medical devices (particularly prone to hydrolysis in drug and also simplifies the handling of medicines and reduces packaging costs.

Patent document 1: international publication WO 2002/087622 (see points 1 and 2 claims and figure 1).

Disclosure of invention

Problems to be solved by this invention

When you take this film to the drug, he may, at the time of admission sometimes stick to the mucosa of the oral cavity, especially the mucosa of the upper jaw. Stuck medication is not easy to separate.

In light of the aforementioned problems, this invention aims at the creation of accepted oral film of medications while receiving less likely to adhere to the mucosa of the oral cavity and could easily be separated from her, even in the case of sticking to it, as well as the development of the retrieval method.

Solutions to these problems

According to the first aspect of the present invention taken oral film drug includes, at least the layer containing medical tool, in which at least on one surface orally taken drug formed a bump. The formation of the convex section allows the upper surface of the convex section to come into direct contact with the mucous membrane of the mouth, making smaller the area of contact of the mucous membranes of the oral cavity to accept oral medication. Accordingly, accept oral medication, even adhering to the mucosa of the oral cavity during the reception, it's easy to separate.

Preferably the composition is orally taken drug enters the gel-forming layer as the outer layer of the given orally taken drug, and on the surface of the gel-forming layer formed convex section. If you accept oral medication gelation slowly, he is more likely to stick to the mucosa of the oral cavity. To avoid this, create a bump, to increase the overall surface area accept oral medication, to facilitate the process of gelation and make less likely sticking orally taken drug to the mucosa of the mouth.

Preferably convex section has at least one geometric type, selected from: cones, columns, and p is luster and truncated cones. Preferably the height of the convex section must be in the range from 10 to 5000 μm. Preferably convex section is created in the form of a set of convex sections, at least one surface orally taken drug.

Depending on orally taken drug of the present invention containing medicines layer preferably includes medicine and substance basis. Preferably the thickness of the layer containing medical tool, is in the range from 0.1 to 1000 μm. Preferably the gel-forming layer includes a means forming a swelling in water gel, and film-forming agent. Preferably the thickness of the gel-forming layer including the thickness of the convex section, is in the range from 20 to 6000 microns.

According to the second aspect of the present invention is a method of obtaining take oral medication involves the following stages: application covering liquid to gel-forming layer on a film base having formed therein a concave section, and drying; applying a covering liquid containing medicines layer on the gel-forming layer and drying, forming, thus, a multilayer substrate having a layered containing medicines layer/gel-forming layer/film-the basis described in the order; alum is of two such multilayer substrates and compounds, as well as gluing two such multilayer substrates together containing medicines layers to each other; and removing films-fundamentals and cutting residue on predefined templates to get taken oral medication.

According to a third aspect of the present invention is a method of obtaining take oral medication involves the following stages: application covering the fluid to the first gel-forming layer on the first film base having formed therein a concave section, and drying for the formation of the first gel-forming layer; imprinting covering fluid containing medicines layer in the first gel-forming layer and drying for the formation containing medicines layer that is smaller than the first gel-forming layer; applying a covering liquid for the second gel-forming layer on the second film base having formed therein a concave section, and drying for the formation of the second gel-forming layer; and bonding the outer edges of the first and second gel-forming layers together to get taken oral medication.

The effect of the invention

Take oral medication according to the first aspect of the present invention is, even in the form of a film, less able to stick to the mucous obolos the E. of the mouth, and even sticking his to it, can easily be separated from her, which leads to better adherence to treatment.

The second and third aspects of the present invention it is possible to create take oral medications, which are less able to stick to the mucous membrane of the mouth, and even sticking his to it, can easily be separated from her, which leads to better adherence to treatment.

Brief description of drawings

Figure 1 schematically shows a cross-section taken oral medication according to this invention;

on figa and 2B schematically shows the structure of convex sections on the first version of the implementation, which are formed on the surface taken oral medication according to the invention;

on figa and 3B schematically shows the structure of convex sections on the second version of the implementation, which are formed on the surface taken oral medication according to the invention;

on figa and 4B schematically shows the structure of the convex sections of the third variant of implementation, which are formed on the surface taken oral medication according to the invention;

figure 5 schematically shows the structure of the convex sections according to the fourth variant of implementation, which are formed on the surface taken oral copper is amenta according to the invention; and

figure 6 schematically shows a cross-section of the second taken oral medication according to this invention.

Description of positional notation

1 - take oral medication

2 - take oral medication

11 - containing medicines layer

12 is a gel-forming layer

13 - gel-forming layer

21 - the first gel-forming layer

22 - second gel-forming layer

23 - containing medicines layer

24 - the surface of the gel-forming layer

The best option of carrying out the invention

Take oral medication according to this invention is described below with reference to figure 1.

Take oral medication according to this invention, labeled 1, takes the form of a film comprising, at least, only containing medicines layer 11. Take oral medication 1 according to this invention may include only containing medicines layer 11, or may include multiple containing medicines layers. In the latter case containing various medicines layers 11 can contain different medicines. When taken oral medication 1 according to this invention includes several containing medicines layers 11, last mouthbut stacked directly on each other, or the sandwiched adhesive layer. Alternatively, these layers can be connected to each other in the direction perpendicular to the stacking direction of the stack, forming a solid containing medicines layer; in this case, these layers can be connected together via the bonding layer.

At least either the upper or lower front part of the solid containing medicines layer 11, which may be composed of several containing medicines layer 11, preferably covered with a gel-forming layer. Especially, it is preferable to create a form of swelling in water, the gel layers 12 and 13 on the upper and lower front sides respectively integral containing medicines layer 11 as the outer layers taken oral medication 1. When released into the oral cavity of the patient forming a swelling in water of the gel layers created as the outer layers taken oral medication, swell under the action of such fluids as saliva and others, and turn into a gel, thereby transforming accept oral drug in dosage form, having the appropriate size, shape, flexibility and adhesion for swallowing. Thus, the patient can easily take the medication taken orally. Even if the patient is an elderly person or child is ncom, he can safely take the medication taken orally due to the fact that during reception of the reduced risk of being stuck in the trachea of the patient this take oral medication. If the patient is unable to secrete saliva enough to turn layers, forming a swelling in water of the gel in the finished gel, the same effect can be obtained by letting the patient take oral medication with a small amount of water or giving this medication to swell in water before taking. The amount of water required in these cases, required significantly less than for the admission of such hard drugs as tablets, capsules and the like. In addition, after the layers, forming a swelling in water of the gel that was created as the outer layers taken oral medication, swells under the action of such fluids as saliva and others, and turn into a gel in the oral cavity of the patient, the gel serves to mask tastes (for example, bitterness, astringency and smells of medical devices included in this containing medicines layer.

Convex parts formed at least either on the surface of the gel-forming layer 12 or on the surface of the gel-forming layer 13. If you take oral medication gelation slowly, he is more of veroia is completely adheres to the mucous membrane of the mouth. To avoid this, create a convex sections to increase the surface area taken oral medication, facilitating the process of gelation and reduce the likelihood of sticking taken oral medication to the mucous membrane of the mouth. In addition, since the formation of the convex sections reduces the area of direct contact of the surface taken oral medication with the mucous membrane of the mouth, taken oral medication can be easily separated from the mucous membrane of the mouth, even if he sticks to it during the reception. In this case, it is preferable that the convex sections were created on both surfaces of the gel-forming layers 12 and 13, which serve as outer layers taken oral medication 1. This is because to take oral medication, there is less opportunity to adhere to the mucosa of the upper jaw of the mouth, whatever side up he was adopted, and because it can easily be separated from her, even if he sticks to it.

Convex areas can be of any shape provided that it reduces the contact area of the convex sections with the mucous membrane of the mouth; this can be the form that makes possible a flat contact or point contact. For example, it is possible to form the convex part is Cove include cones, poles, hemispheres, truncated cones and the like. Cones include cones, the bases of which are circular or ellipsoidal; pyramid; substantial cones and substance of the pyramid. Columns include substantial columns, such as columns, the front surface of which is curved. Hemisphere include those that contain a curved surface, partially truncated hemisphere and the like. Truncated cones include truncated pyramids, truncated cones, the bases of which are circular or ellipsoidal; substantially truncated cones; and include not only those that are formed by the truncated cone by a plane parallel to its base, but also those that are formed by the truncated cone by a plane not parallel to its base.

When you create only one convex area, all surfaces taken oral medication 1 except that this is a bump, with a high probability in contact with the mucous membrane of the mouth. In this case, the surfaces taken oral medication 1 are not formed ducts for saliva or the like. Does it take oral medication 1 less gelirem due to the lack of water access. In the accept oral medication 1 cannot easily be separated from the mucosa of the upper jaw of the mouth in case the e it sticking. For this reason, it is preferable for the formation of several convex areas on all surfaces taken oral medication 1. Several convex areas can be created, for example, having them linearly or "polka dot". When creating multiple convex areas of space between the convex parts do not come into direct contact with the mucous membrane of the mouth, and they can serve as channels of saliva. These streams of saliva guarantee the necessary moisture inflow for the gelatin and facilitate gelation. As a result, even if taken oral medication sticks to the mucous membrane of the mouth, it is easier to separate from her. Especially preferred is the formation of a large number of convex sections on the driven microscopic patterns when each convex section, for example, is of the order of a few micrometers. In Fig. 2A through 5 shows the preferred examples of the formed convex sections. As shown in Fig. 2A through 5, the formation of such convex sections allows the upper surface of each convex section to come into contact with the mucous membrane of the mouth. In this case, the total contact area taken oral medication with the mucous membrane of the mouth is smaller than the flat of the drug in the form of foxes is ka, and may be provided with ducts for saliva and the like. Therefore, even if taken oral medication sticks to the mucous membrane of the mouth, it's easy to separate. In addition, since the surface area taken oral medication increases can be reduced gelation time, making it less likely that the adhesion of this drug to the mucosa of the oral cavity.

On figa and 2B explains the shape of the convex sections on the first version of the implementation. On figa presents a partially enlarged image of the gel-forming layer 12, which form the set of convex sections on the first version of the implementation, and figv presents its cross-section. Convex areas on the first version of the implementation are truncated pyramids, the bases of which are square in shape and the upper surface of the truncated pyramids come in contact with the mucous membrane of the mouth. The size of each of the convex sections on the first version of the implementation presented on figa and 2B, that is, for example, that one side of its square base is 450 μm in length, one side of the upper square surface is 184 μm in length, and the height between the base and the top surface is 30 mm.

These convex parts in the first embodiment is sushestvennee can be formed in a regular manner over the entire surface of the gel-forming layer 12 or randomly. A typical example of the formation of the convex sections, is shown in figa and 2B, is a lattice, where the convex parts are arranged with a 100-μm intervals.

On figa and 3B are explained in the form of convex sections on the second version of the implementation. On figa presents a partially enlarged image of the gel-forming layer 12, which form two or more convex sections on the second version of the implementation, and figv presents its cross-section. According to the second variant implementation of the convex sections are truncated pyramids, the bases of which are square in shape and the upper surface of the truncated pyramids come in contact with the mucous membrane of the mouth. The size of each of the convex sections on the second version of the implementation presented on figa and 3B, that is, for example, that one side of its square base is 600 μm in length, one side of the upper square surface is 100 μm in length, and the height between the base and the top surface is 66 μm.

These convex sections on the second version of the implementation can also be formed in a regular manner over the entire surface of the gel-forming layer or randomly. A typical example of the formation of the convex sections, is shown in figa and 3B, is a lattice, where the convex is e sites are located at intervals of 75 microns.

On figa and 4B explain the shape of the convex sections of the third variant of implementation. On figa presents a partially enlarged image of the gel-forming layer 12, which form two or more convex sections of the third variant of implementation, and figv presents its cross-section. Convex sections by the third variant of implementation are truncated cones, and the upper surface of the truncated cones come in contact with the mucous membrane of the mouth. The size of each of the convex sections of the third variant of implementation, presented at Figo and 4B, that is, for example, that the diameter of its base is 1750 mm, the diameter of its upper surface is 1000 μm, and the height is 183 μm. These convex sections can also be formed in a regular manner over the entire surface of the gel-forming layer or randomly. A typical example of the formation of the convex sections, is shown in figa and 4B, is a checkerboard.

In addition, as shown on the convex parts 5 according to the fourth variant of implementation, on the surface of the gel-forming layer 12 may be formed convex areas of two or more species (three species figure 5). Convex areas on figure 5 include those according to the third variant of implementation, presented at Figo and 4B, the convex Uch is strict in the form of truncated pyramids, which bases are rectangles and convex areas in the form of truncated pyramids, the bases of which are diamonds. The size of each of the convex sections in the form of truncated pyramids with rectangular bases such, for example, that the area of its base is 1500 μm × 1150 μm, the area of its upper surface is 750 μm × 150 μm, and the height is 183 μm. The size of each of the convex sections in the form of truncated pyramids, the bases of which are diamonds, that is, for example, that the area of its base is 1680 μm × 1680 μm, the area of its upper surface is 1150 μm × 1150 μm, and the height is 23 μm. These convex parts of these two types (in the form of truncated pyramids) may vary in height, as described above, or may be of the same height. When forming two or more types of convex sections, as shown in figure 5, they may be formed in a regular or random.

Preferably the height of the convex sections are in the range from 10 to 5000 μm and more preferably in the range from 20 to 1000 μm. The reasons are that the formation of the convex sections of a height of more than 5000 μm is associated with certain difficulties, and that the formation of the convex sections of a height of less than 10 μm makes it more likely that the adhesion of the entire surface area, which formed the data volume is small areas the mucosa of the oral cavity. Also this is the preferred formation of the convex sections to 100 mm2was from 1 to 10000 convex sections. In addition, when the upper surface of the convex sections are flat, total area of all surfaces of the convex sections taken oral film drug is preferably from 0.01 to 30%, more preferably from 0.1 to 20% of the surface area on which data generated convex areas. When the above total area is in the data range, you can get comfortable orally taken medicine which provides better adherence to treatment.

Thickness containing medicines layer 11 can be adjusted at will in accordance with the number of medical devices and within the thickness at which the drug can be administered orally. Preferably, this thickness is in the range from 0.1 to 1000 μm and more preferably in the range from 10 to 200 μm. When the thickness containing medicines layer 11 is less than 0.1 μm, the content of the health funds may vary across the layer 11. On the other hand, when the thickness containing medicines layer 11 exceeds 1000 μm, the patient may be difficult to take such a thick medicine.

T is Lina each of the gel-forming layers 12 and 13, including convex parts formed on them, preferably is in the range from 20 to 6000 microns and more preferably in the range from 30 to 2000 μm. When the thickness is less than 20 μm, accept oral medication 1 is less likely to turn into a dosage form, having the appropriate size, shape, flexibility and viscosity for swallowing. When, on the other hand, this thickness exceeds 6000 μm, the patient may be difficult to take such a thick medicine.

Although containing medicines layer 11 may include only medical means, preferably containing medicines layer 11 included substances foundations, which serve to maintain the desired state data of medical devices. Containing medical tool, the layer 11 may include a number of medical devices, starting with the input in small quantities (for example, at a dose of 1 mg or less) to enter in large quantities (for example, at a dose of 300 mg or more). Besides containing medicines layer 11 may include plasticizers to give it the necessary flexibility.

Gel-forming layers 12 and 13 include at least swellable in water substance, namely, means forming a swelling in water gels that swell under the action of moisture, forming a gel. However, when zatrudnitel is but to produce film medicines, using the gel-forming layers 12 and 13 only such form of swelling in water gels funds, it is preferable to add to the gel-forming layers 12 and 13 of the film-forming means. In addition, these gel-forming layers can include plasticizers to give them the necessary flexibility.

Containing medicines layer 11 and the gel-forming layers 12 and 13 may also include: masking tools, dyes, preservatives, and the like. When you need to produce take oral medications, which include only containing medicines layers, it is preferable to use as substances basics in containing medical devices layers 11 substances, acting also as a means of forming a swellable in water gels; the selection of such additives can be carried out in accordance with the objectives.

The remainder of this document discusses in detail the substances that can be included in the above containing medicines layer 11 and the gel-forming layers 12 and 13.

Medicine

Medical devices are not limited to specific substances, provided that these medical devices are those which must be administered to the patient and can be administered orally. Examples of medical devices that can be entered peroral is about, include: medicines that affect the Central nervous system; medicines that affect the respiratory system; medicines affecting the blood system; hematological and hematogenous tools, medical tools, acting on the digestive system, and medical facilities, operating with metabolic diseases. Medicines that affect the Central nervous system include: sleep medications, such as amobarbital, estazolam, triazolam, nitrazepam, pentobarbital and others; psychotropic drugs, such as amitriptyline hydrochloride, imipramine hydrochloride, oksazolov, chlordiazepoxide, chlorpromazine, diazepam, sulpiride, haloperidol, and others; medicines for Parkinson's disease, such as trihexyphenidyl, levodopa, and the like; analgesic and anti-inflammatory drugs such as aspirin, isopropylaniline, indomethacin, diclofenac sodium, mefenamovaya acid, streptokinase, streptodornase, serrapeptase, pronase, dically glycyrrhizin, the disodium glycyrrhizinate and the like; as well as metabolic activators of the Central nervous system, such as ATP, Vinpocetine, and the like. Medicines that affect the respiratory system include: expectorants, such as carbocisteine, hydrochlori the Bromhexine and the like; and anti-asthma drugs, such as hydrochloride azelastina, oxatomide, theophylline, sulfate terbutalina, tranilast, hydrochloride procaterol, ketotifen fumarate and the like. Medicines that affect the circulatory system include: cardiotonic agents such as aminophylline, digitoxin, digoxin and the like; antiarrhythmic agents such as aymalin, disopyramide, procainamide hydrochloride, hydrochloride meksiletina and the like; antianginal agents such as amyl nitrate, hydrochloride alprenolol, isosorbide dinitrate treatment, nicorandil, oksifedrin, dipyridamole, hydrochloride, dilazep, diltiazem hydrochloride, nitroglycerin, nifedipine, verapamil hydrochloride, and the like; peripheral vasodilator, such as kallidinogenase and the like; antihypertensive agents, such as atenolol, captopril, clonidine hydrochloride the tartrate metoprolol, spironolactone, triamterene, trichlormethiazide, nicardipine, hydralazine hydrochloride, hydrochlorothiazide, prazosin hydrochloride, furosemide, propranolol hydrochloride, enalapril maleate, hydrochlorothiazide methyldopa, hydrochloride labetalola, reserpine and the like; and antiarteriosclerotic tools, such as clofibrate, dextran sulfate, nicomol, niceritrol and the like. Hematological and g is pathogenie tools include: hemostatic agents, such as sodium sulfonate carbazochrome, tranexamic acid and the like; anti-platelet agents such as hydrochloride, ticlopidine, warfarin potassium and the like; and Antianemic agents such as ferrous sulfate and the like. Medicines that affect the digestive system include: antiozone tools such as azulene, aldioxa, cimetidine, ranitidine hydrochloride, famotidine, teprenone, rebamipide and the like; anti-emetics such as domperidone, metoclopramide and the like; laxatives such as sennoside and the like; digestive enzymes and anti-liver diseases, such as glycyrrhizin, products containing liver extract, and the like. Medicines that affect metabolic diseases include: antidiabetic agents such as glibenclamide, hlorpropamid, tolbutamide and the like; and anti-gout, such as allopurinol, colchicine and the like. Next, examples of medicines that can be taken orally, include: medical tools from the field of ophthalmology, such as acetazolamide and the like; medical tools from the field of otolaryngology, including remedies for motion sickness, such as hydrochloride difenidol, Maisy is at betahistine and the like; chemotherapeutic agents and antibiotics such as isoniazid, ethambutol hydrochloride, ofloxacin, erythromycin stearate, cefaclor, norfloxacin, fosfomicin calcium hydrochloride, minocycline, rifampicin, rokitamycin and the like; anti-cancer drugs, such as cyclophosphamide, tegafur and the like; immunosuppressants, such as azathioprine and the like; hormones and means for treating the endocrine system, such as hormones, contributing to the pregnancy hormones salivary glands, tiamazol, prednisolone, betamethasone, liotironin, levothyroxine, and the like; and physiologically active substances. Physiologically active substances include: antihistamines such as fumarate of clemastine, maleate, d-chlorpheniramine, diphenhydramine hydrochloride, hydrochloride prometazina and the like; and vitamins, such as alfacalcidol, kobamamid, tocopherol nicotinate, mecobalamin and the like. One or more of the above substances may be used in accordance with the medical purpose.

The share of medicines in containing medical devices layer is not limited to specific quantities and can be optionally adjusted depending on the type of medical devices. The weight percent share of medical tools in containing medical devices layer usually, the composition of AET 80% weight. or less, preferably 40 wt%. or less and more preferably 30 wt%. or less. When the weight percentage share of medical devices exceeds 80 wt%, the effectiveness of oral film of the medication is reduced. The lower limit of the proportion of medical tools in containing medical devices layer can be set optionally depending on the type of medical devices, which will be located in this containing medicines layer, and typically is about 0,001% of the weight. or so.

Substances basics

Substances bases present in containing medical devices layer together with medical means, not limited to specific substances and can be selected depending on the desired purposes. Examples of substances of the bases present in containing medical devices layer include cellulose and its derivatives such as crystalline cellulose, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hypromellose, hydroxypropylmethylcellulose, methylcellulose, ethylcellulose, cellulose acetate, acetated cellulose phthalate of hydroxypropylmethylcellulose, acetylsuccinate hydroxypropylmethylcellulose, karboksimetiltselljuloza and the like; or their pharmaceutically acceptable salts such as salts of sodium

Examples of substances of the bases present in containing medical devices layer include: starch and its derivatives such as alpha-starch, oxidized starch, natrocarbonatite, hydroxypropylmethyl, dextrin, dextran and the like; sugars such as sucrose, maltose, lactose, glucose, fructose, pullulan, xanthan gum, cyclodextrin and the like; sugar alcohols such as xylitol, mannitol, sorbitol and the like; derivatives of acrylic acid such as a copolymer of diethylaminoethylmethacrylate and methacrylic acid, copolymer of methacrylic acid and ethyl acrylate, a copolymer of methacrylate and methyl methacrylate, copolymer of methacrylate, methacrylic acid and trimethylammoniumchloride, a copolymer of dimethylaminoethylmethacrylate and chlorotrimethylsilane, a copolymer of methacrylate and khlorehtilaminami and the like. Examples of substances of the bases present in containing medical devices layer include: shellac; diethylaminoacetate polyvinylacetal; vinyl acetate; polyvinyl alcohol; polyvinylpyrrolidone; natural rubbers such as gum Arabic, tragacanth gum and the like; polyglucosan, such as chitin, chitosan and the like; proteins, such as gelatin, casein, soybean protein and the like; titanium oxide; secondary acidic calcium phosphate; calcium carbonate; talc; with earth; aluminometasilicate magnesium; magnesium silicate; silicon dioxide; and a copolymer of vinyl acetate and vinemirovicha. You can use one or more of the above substances.

These substances bases are preferred edible polymers. Data are edible polymers can be synthetic polymers or natural polymers and are not limited to specific types.

Preferred edible polymers are those which are soluble in the stomach or intestines. Examples of such edible polymers include cellulose and/or its derivatives, especially hydroxypropylcellulose, phthalate of hydroxypropylmethylcellulose and the like. Hydroxypropylcellulose and phthalate of hydroxypropylmethylcellulose particularly useful due to its exceptional ability to form a film.

The proportion of edible polymers containing medicines layer represents a number, which makes possible the formation of such a layer, and this number can be adjusted at will depending on the type of edible polymers and the like. The weight percent share of the edible polymer containing medicines layer is usually 20% of the weight. or more, preferably 60 wt%. or more and more preferably 70 wt%. or more. The weight percent share of the edible polymer clay is s less than 20% weight. leads to incomplete formation containing medicines layer. The upper limit on the proportion of edible polymers containing medicines layer can be obtained by subtracting the minimum share of medicines in containing medical devices layer of 100 wt%. and can be set optionally in accordance with the type of medical devices and the like.

Plasticizers

Examples of plasticizers include propylene glycol; polyethylene glycol; glycerin and sorbitol; triacetate of glycerol; diethylphthalate and triethylcitrate, lauric acid, sucrose and the like; and you can use one or more of these plasticizers.

When the composition containing medicines layer includes a high proportion of plasticizer to prevent splitting and cracking containing medicines layer 11, this contains medicines layer 11 can sometimes drain the edge taken oral medication. To prevent such runoff is preferably used as a substance fundamentals of polyvinylpyrrolidone with a value of K equal to 70 or more. The value of K shows the intrinsic viscosity of the polymer solution, and it is also called a constant viscosity Fikentscher. Polyvinylpyrrolidone with a value of K equal to 70, or more useful, because it serves the quality of the ve excipient, stabilizer and binder. The use of such a polyvinylpyrrolidone with a value of K equal to 70, or more, protects containing medicines layer from splitting and cracking, even if the amount of plasticizer present in the containing medicines layer, a little, and also reduces the amount of water in the containing medicines layer, thereby allowing to increase the stability of medicines in containing medical devices layer.

As a matter of bases containing medicines layer can be used polyvinylpyrrolidone with a value of K equal to 70 or higher self. You can also use one of the above substances basics in addition to this polyvinylpyrrolidone. In this case, one of the substances of the basics can be a polyvinylpyrrolidone with a value of K less than 70. It is preferable to use in combination hydroxypropylcellulose and phthalate of hydroxypropylmethylcellulose, both of these substances have excellent film-forming properties.

The overall proportion of substances basics in containing medical devices layer 11 is the number that makes possible the formation of such layer 11, and this number can be adjusted as desired, depending on the type of materials fundamentals and the like. The weight percent on the Lee substances basics in containing medical devices layer 11 is usually 30 wt%. or more, preferably 60 wt%. or more and more preferably 70 wt%. or more. The weight percent of the total shares substances fundamentals of less than 30 wt%. leads to incomplete formation containing medicines layer 11. The upper limit of the total substances basics in containing medical devices layer 11 can be obtained by subtracting the minimum share of medicines in containing medical devices layer 11 made of 100% weight. (or received, if the containing medicines layer 11 also contains plasticizers, subtracting the minimum share of medical products and plasticizers present in containing medical devices layer 11, made of 100% weight.) and can be adjusted at will in accordance with the type of medical devices, type plasticizers, and the like. For example, when the minimum percentage of health funds in containing medical devices layer 11 is 0.01% wt., the upper limit of the total substances basics in containing medical devices layer 11 is 99.99 wt%. When the minimum percentage of health funds and the minimum share of plasticizers in containing medical devices layer 11 0.01% weight. and 2 wt%. accordingly, the upper limit of the total substances basics in containing medical devices layer 11 is 97,99% weight.

In this case, the proportion of plasticizer in steriade the medicines layer 11 can be adjusted at will depending on the amount of polyvinylpyrrolidone with a K, equal 70 or more, present in containing medical devices layer 11, and so on. The amount of plasticizers in containing medical devices layer 11 typically ranges from 2 to 25 wt%, preferably from 4 to 21 wt%, more preferably from 6 to 17 wt%. When the proportion of the plasticizer exceeds 25 wt%, containing medical tool, the layer 11 can flow with the edge taken oral medication 1. When, on the other hand, the proportion of plasticizer is below 2 wt%, the plasticizer cannot successfully function as such.

When in containing medical devices layer 11 contains a plasticizer, it is preferable that the proportion of polyvinylpyrrolidone with a value of K equal to 70, or more, containing medical devices layer 11 was 30 wt%. or higher and that the proportion of plasticizer in containing medical devices layer 11 ranged from 2 to 25 wt%. This effectively prevents containing medicines layer 11 from splitting, cracking and draining from the edge taken oral medication 1.

When in containing medical devices layer 11 contains a plasticizer, the proportion of funds in containing medical devices layer 11 can be adjusted at will depending on the type of medical devices. The share of medical tools in containing medical substances the as layer 11 is 70 wt%. or less, preferably 40 wt%. or less and more preferably 30 wt%. or less. When the share of medical devices exceeds 70%, the film strength is reduced. The lower limit of the proportion of medical devices can be set optionally depending on the types of medical devices that will be present in containing medical devices layer 11, and is usually 0.01% by weight. or so.

Means forming a swelling in water gel

Means forming a swelling in water gel, not limited to specific substances, provided that they are able to swell under the action of water and form a gel. Examples of means forming a swelling in water of the gel include: carboxyvinyl polymers, starch and its derivatives, agar, alginic acid, arabinogalactan, galactomannan, cellulose and its derivatives, such as carboxymethylcellulose and the like, carrageenan, dextran, tragakant, gelatin, pectin, hyaluronic acid, Gellan gum, collagen, casein, xanthan gum, glucomannan, and the like. Such gel-forming means may be or may not be cross-stitched. Preferred gel-forming means are cross-stitched carboxyvinyl polymers, and particularly preferred is a cross-crosslinked polyacrylic acid. Primaniyarta stitched carboxyvinyl polymers or more preferably, the cross-crosslinked polyacrylic acid gives a suitable strength gel gel-forming layers 12 and 13 during the swelling, without affecting the ability of the film-forming means to form a film. As polyvinylpyrrolidone with a value of K equal to 70, or more, interacts with cross-crosslinked polyacrylic acid, giving a suitable strength of the gel, the use of such polyvinylpyrrolidone as a matter of fundamentals is also preferable.

Cross-linking is carried out using a cross-linking means, which is selected in accordance with the type of molecules that have to sew. From the above means, forming a swelling in water gel, carboxyvinyl polymers, alginic acid, pectin, carboxycellulose, glucomannan, and the like can be cross-stitched, for example, by using compounds of polyvalent metals. Examples of such compounds of polyvalent metals include calcium chloride, magnesium chloride, aluminum chloride, aluminum sulfate, potassium sulfate and aluminum, alum ferric chloride, ammonium alum, ferric sulfate (II), aluminum hydroxide, aluminum silicate, aluminum phosphate, iron citrate, magnesium oxide, calcium oxide, zinc oxide, zinc sulfate and the like. When a substance fundamentals of applied polyvinylpyrrolidon the value of K, equal 70 or more, the use of compounds of trivalent metals such compounds of polyvalent metals increases the degree of cross-linking polyacrylic acid and promotes the formation of a gel with high strength during the interaction between cross-crosslinked polyacrylic acid and polyvinylpyrrolidone with a value of K equal to 70 or above.

Film-forming means

Film-forming means is not limited to specific types provided that they have film-forming ability. Examples of film-forming means include: polyvinyl alcohol; polyvinylpyrrolidone; polyvinyl acetate; polyvinyl acetate phthalate; hydroxyethylcellulose, such as hydroxypropylcellulose, hypromellose, hydroxymethylcellulose and hydroxyethylcellulose; alkylaryl, such as methylcellulose and ethylcellulose; carboximetilzellulozu, such as carboxymethylcellulose; (meth)acrylic acid and its esters; xanthan gum; carrageenan; alginic acid and the like.

Film-forming means is preferably soluble in water. If so, water can easily penetrate into the layers, forming a swelling in water gel, contributing to the swelling of the gel-forming layers and the formation of gel in the mouth.

Examples of water-soluble plancor is based funds include: polyvinyl alcohol; hydroxyethylcellulose, such as hydroxypropylcellulose, hypromellose, methylcellulose and the like; polyvinylpyrrolidone; xanthan gum; carrageenan; alginic acid and the like. Of them, preferred are polyvinyl alcohol or similar, which also act as a masking agent.

The proportion of film-forming means in the gel-forming layers 12 and 13 can be adjusted on request depending on the types of film-forming means, and it is preferably from 30 to 85 wt%.

Masking tools

Examples of the masking means include acidifying agents such as citric acid, tartaric acid, fumaric acid and the like; sweeteners such as saccharin, aspartame, stevioside, glycyrrhizin acid, sucrose, fructose, mannitol and the like; a refreshing facilities such as menthol, peppermint oil, peppermint, spearmint and the like; natural or synthetic flavorings and the like. For use may be selected one or more of these substances.

Dyes

Examples of dyes include food alizarin dyes and the like.

Preservatives

Examples of preservatives include: methoxybenzoate, propylacetate and the like.

As indicated above, predpochtitelney compounds of polyvalent metals as a cross-linking means, since high strength gel that occurs when the gel-forming layers swell under the action of water, does take oral medication legalteam. However, when the gel-forming layers are formed using the forming of swelling in water gel tools, cross-stitched using ions of polyvalent metals, the viscosity of the covering liquid for formation of a gel-forming layers can be increased, complicating the application of the covering liquid. Thus, in the absence of gel-forming layers, but if the containing medicines layer include compounds of polyvalent metals, which generate ions of polyvalent metals, and in the presence of gel-forming layers, which include gel-forming tools, cross-stitching ions of polyvalent metals, you can get taken oral medication whose gel-forming layers have sufficient strength. As compounds of polyvalent metals in this case, you can use the above compounds of polyvalent metals.

When compounds of polyvalent metals included in containing medical devices layer, the above-mentioned substances bases can be used as substances basics of such a layer. It is preferable to use substances basics that are ionic functioning of the social group, capable of reacting with ions of polyvalent metals generated by the compounds of polyvalent metals. This is because if the substance bases containing medicines layer include ionic functional group capable of reacting with ions of polyvalent metals, these ions of polyvalent metals generated by the compounds of polyvalent metals, are used for cross-stitching substances basics of this containing medicines layer when the layers, forming a swelling in water gel, swell under the action of such fluids as saliva and the like, in the mouth of the patient. This can lead to insufficient cross-linking means forming a swelling in water of the gel contained in the gel-forming layers.

Examples of ionic functional groups capable of reacting with ions of polyvalent metals include: carboxyl group, sulfate group, phosphate group, a phenolic hydroxyl group and the like. Among the above substances foundations of those who have no ionic functional group capable of reacting with ions of polyvalent metals are, for example: polyvinyl alcohol, polyvinylpyrrolidone, cellulose and its complex alkalemia ethers, starch and its derivatives, polyvinyl acetate, polyethylene glycol, sugar, with the polymer complex alilovic esters and (meth)acrylate; the copolymer of vinyl acetate and vinylpyrrolidone, and the like.

When compounds of polyvalent metals included in containing medical devices layer, the total number of substances fundamentals, present in containing medical devices layer 11 represents a number, which makes possible the formation of this layer 11, and this number can be adjusted at will depending on the types of substances foundations and the like. Mass percentage share of substances basics in containing medical devices layer 11 is usually 30% of the mass. or more, preferably 60 wt%. or more, more preferably 65 wt%. or more. Mass percentage share of substances fundamentals of less than 30% of the mass. will lead to incomplete formation containing medicines layer 11. The upper limit on the share of substances basics in containing medical devices layer can be set optionally depending on the number of medical devices.

When compounds of polyvalent metals included in containing medical devices layer, the share of medicines in containing medical devices layer 11 is not limited to specific quantities and can be adjusted at will depending on the types of medical devices. Mass percentage share of medical devices in containing medical devices layer 11 ordinary which is 70% of the mass. or less, preferably 40 wt%. or less, and more preferably 35% by mass. or less. When the mass percentage share of medical devices exceeds 70 wt. -%, the strength of the film taken oral medication 1 is reduced. The lower limit of the share of medicines in containing medical devices layer can be set optionally depending on the type of medical devices that will be included in containing medical devices layer 11, and is usually 0.01% by mass. or so.

Given the above, means forming a swelling in water of the gel present in containing medical devices layer can be cross-stitched using ions of polyvalent metals in the process of swelling gel-forming layers under the action of water. This eliminates the need to include sufficient cross-stitched tools, forming a swelling in water of the gel, the gel-forming layers. Accordingly, when forming the gel-forming layers viscosity them covering the fluid is not increased, consequently, does not cause difficulties in the coating, and you can get a sufficient gel strength.

Means forming a swelling in water gel that may be present in the form of swelling in water, the gel layers 12 and 13 and a cross-stitched using ions of polyvalent metal is s, do not have specific restrictions. Examples of such gel-forming means are: polyacrylic acid, polymethacrylic acid, carboxyvinyl polymers, alginic acid, pectin, carboxymethyl cellulose, glucomannan, and others. One or more of these substances may be selected for use.

Forming a swelling in water of the gel layers 12 and 13 can also include forming a swelling in water of the gel means, which cannot be cross-stitched using ions of polyvalent metals. Examples of such gel-forming means, which cannot be cross-stitched using ions of polyvalent metals include: starch and its derivatives, agar, carrageenan, Gellan gum, gelatin, collagen, hydroxypropylcellulose, xanthan gum and the like. One or more of these substances may be selected for use.

The number of forming a swellable in water gel tools that are present in the form of swelling in water, the gel layers 12 and 13 and can be cross-stitched using ions of polyvalent metals, can be adjusted on request depending on the types of forming a swellable in water gel tools and the like. The share of funds, forming a swelling in water of the gel, the gel-forming layers 12 is usually from 5 to 90 wt. -%, preferably from 10 to 80 wt. -%, and valueproposition - from 15 to 70% of the mass.

A number of compounds of polyvalent metals present in containing medical devices layer 11, can be adjusted on request depending on the amount of funds that make up swelling in water gel that is present in the gel-forming layers 12 and 13 and can be cross-stitched using ions of polyvalent metals. The mass fraction of such compounds of polyvalent metals containing medicines layer 11 typically range from 0.01 to 10 parts by mass relative to 1 part by mass, forming a swelling in water gel tools that can be cross-stitched using ions of polyvalent metals; preferably from 0.03 to 8 parts by mass, and more preferably from 0.05 to 5 parts by weight. If compounds of polyvalent metals are less than 0.01 part by weight, the amount of ions of polyvalent metals generated by the compounds of polyvalent metals, is insufficient, when the gel-forming layers swell under the action of such fluids as saliva and the like, in the mouth of the patient. This leads to insufficient cross-linking of forming a swellable in water gel means present in the gel-forming layers. If, on the other hand, compounds of polyvalent metals exceeds 10 parts by mass may result in the following: reduction telemedicine funds in containing medical devices layer 11, the patient's perception of taste compounds of polyvalent metals (bitterness, and the like), plastic deformation containing medicines layer 11 due to the absorption of moisture by the compounds of polyvalent metals, stability containing medicines layer 11 and the like.

You can create intermediate layers between the gel-forming layers containing medicines layer, and compounds of polyvalent metals can be included in these intermediate layers. In this case, the intermediate layers may have the same substances basics that contains medicines layer, in order to retain compounds of polyvalent metals. By creating a form of swelling in water, the gel layers 12 and 13 as the outer layers taken oral medication 1, when each of them is layered directly on the intermediate layers, compounds of polyvalent metals present in the intermediate layer, can be ionized to generate ions of polyvalent metals, as the gel-forming layers 12 and 13 swell under the action of such fluids as saliva and the like, for gel formation in the oral cavity of the patient. Means forming a swelling in water of the gel, the gel-forming layers 12 and 13 are cross-stitched with the help of these ions of polyvalent metals. Accordingly, the can is to be formed gel sufficient strength without the use of pre sufficiently cross-stitched funds forming a swelling in water of the gel, the gel-forming layers 12 and 13.

In addition, the surface forming a swelling in water of the gel layers 12 and 13 may be coated with compounds of polyvalent metals. Compounds of polyvalent metals are the same as included in containing medical devices layer 11 taken oral medication 1. It should be noted that the containing medicines layer 11 taken oral medication 1 may include compounds of polyvalent metals, but this is not required.

When the gel-forming layers 12 and 13 taken oral medication 1 swell under the action of such fluids as saliva and the like, forming a gel in the oral cavity of the patient, layers, compounds of polyvalent metals in the form of swelling in water, the gel layers 12 and 13 are ionized, generating ions of polyvalent metals. Means forming a swelling in water of the gel present in the form of swelling in water, the gel layers 12 and 13, a cross-stitched with the help of these ions of polyvalent metals. Respectively, may be formed with a sufficient gel strength without the use of pre sufficiently cross-stitched means forming a swelling in water of the gel, in the form of swelling in water, the gel layers 12 and 13.

The thickness of each layer of the compounds of polyvalent metals on layers 1 and 13, forming a swelling in water, the gel can be adjusted to the thickness at which accept oral medication may be administered orally. This thickness is preferably from 1 to 500 microns and more preferably from 5 to 100 μm. When the thickness of each layer of the compounds of polyvalent metals is less than 1 μm, it is difficult to achieve uniform thickness, and the number of compounds of polyvalent metals in each layer is not high enough to obtain a sufficient strength of the gel. When, on the other hand, the thickness of each layer of the compounds of polyvalent metals exceeds 500 μm, it is impossible to achieve sufficiently formed gel with small amounts of such fluids as saliva and the like, in the admission process, which complicates the reception.

When the gel-forming layers swell under the action of such fluids as saliva and the like, forming a gel in the oral cavity of the patient, medical devices present in containing medical devices layer, can sometimes melt and drain to take oral medication due to the fact that moisture has penetrated to containing medical devices layer. In such cases, the taste, the smell, and similar medical devices, it is impossible to sufficiently disguise, even if there are some of Viseu azannyh masking means. To protect medical devices in containing medical devices layer from moisture and prevent cold medicines to take oral medication, thus, preferably, the sparingly water soluble polymers are present in containing medical devices layer as its substances basics. Use sparingly water soluble polymers leads to more effective masking of taste, smell, and similar medical devices.

In this case, preferably, between the gel-forming layers containing medicines layer were created intermediate layers comprising polyvinylpyrrolidone, in order to increase the strength of the gel when the gel-forming layers swell under the action of moisture. The reason is that the means forming a swelling in water of the gel present in the gel-forming layers interact with pyrrolidone contained in the intermediate layer, making possible the formation of a gel with a higher strength.

Poorly water-soluble polymers that may be present in containing medical devices layer 11, do not have specific restrictions. Examples of the sparingly water soluble polymers include polyvinyl alcohol, ethylcellulose, hypromellose acetate succinate, phthalate of hydroxypropylmethylcellulose, atsetilts is llulose, acetated cellulose, carboxymethyl cellulose, oxypropylated starch, copolymers of (meth)acrylate and dimethylaminoethyl(meth)acrylate, copolymer of (meth)acrylate and ethyl acrylate, copolymer of (meth)acrylate and methyl(meth)acrylate, copolymer of ethyl(meth)acrylate and trimethylammoniumchloride(meth)acrylate, copolymer of dimethylaminoethyl(meth)acrylate and methyl chloride(meth)acrylate, copolymer of (meth)acrylate and ethylchloride, diethylaminoacetate polyvinylacetal, polyvinyl acetate, shellac and the like. One or more of these substances may be selected for use. It is preferable to use polyvinyl alcohol alone or to use other poorly water-soluble polymers in combination with polyvinyl alcohol. As polyvinyl alcohol, as described above, effectively masks the taste, smell, and similar medical devices, its use in containing medical devices layer 11 effectively prevents data medical tools in containing medical devices layer 11 from runoff to accept oral medication 1, and also makes possible the effective masking of taste, smell, and similar medical devices in containing medical devices layer 11.

The number of poorly water soluble polymers present in containing medical devices layer 11, typically the composition is yet 10% or more by weight containing medicines layer 11, preferably 15 wt%. or more, and more preferably 20 wt%. or more. When the number of poorly water soluble polymers containing medicines layer 11 is within these limits, the runoff of medicines to take oral medication 1 can be effectively prevented. The upper limit on the number of poorly water soluble polymers containing medicines layer 11 represents the number obtained by subtracting the minimum share of medical devices made from 100% mass. For example, when the minimum percentage of health funds in containing medical devices layer 11 is 0.01% wt., the upper limit of the content of the sparingly water soluble polymers is 99.99% of the mass.

Containing medical tool, the layer 11 may include as its substances basics only poorly water-soluble polymers, but may also include water-soluble polymers along with a poorly water-soluble polymers. Examples of the water-soluble polymers include polyvinylpyrrolidone, a copolymer of vinyl acetate and vinylpyrrolidone, polyethylene glycol, hydroxypropylcellulose, hypromellose, pullulan, xanthan gum, gum Arabic, starch, gelatin, dextrin, dextran and the like. The amount of water-soluble polymers containing medicines is white 11 is usually 50% or less by weight containing medicines layer 11, preferably 30% of the mass. or less, and more preferably 20 wt%. or less. The lower limit of the content of the water-soluble polymer is null.

If the containing medicines layer 11 consists of poorly water-soluble polymers, the preferred intermediate layers are those that include polyvinylpyrrolidone, as described above. Intermediate layers can include only polyvinylpyrrolidone or may also include substances foundations that support the polyvinylpyrrolidone in the intermediate layers in the correct state. The amount of polyvinylpyrrolidone in the intermediate layer is usually 10% or more by weight of the intermediate layer, preferably 20% or more by weight, more preferably 40% or more by weight. The value of K polyvinylpyrrolidone contained in the intermediate layers is preferably 90 or more, although the value of K over 30 is sufficient for the formation of a gel of sufficient strength.

The thickness of the intermediate layer is from 1 to 80 μm and preferably from 10 to 50 μm. If the thickness is in this range, then take oral medication 1 can be administered orally.

Each of the above taken oral medication according to this invention may include adhesive layers, which differ from those described above Prohm is filling layers and located between these layers. Adhesive contained in the adhesive layers have no particular restrictions, provided that they are pharmaceutically acceptable. Adhesives exhibiting their adhesive properties when used with solvents contained in the adhesive substances are, for example: carboxyvinyl polymers; polyacrylic acid and its pharmaceutically acceptable non-toxic salts, such as sodium polyacrylate, and the like; copolymers of acrylic acid and their pharmaceutically acceptable salts; hydrophilic cellulose derivatives such as sodium carboxymethyl cellulose and the like; pullulan; povidone; gum karaya; pectin; xanthan gum; tragakant; alginic acid; gum Arabic; acidic polysaccharides, their derivatives or their pharmaceutically acceptable salts, and the like. One or more of these substances may be selected for use. In addition, adhesives, showing their adhesive properties when heated (thermoadhesive)include, for example: vinyl acetate; homopolymers, such as polyvinylpyrrolidone and the like; copolymers of vinyl acetate and vinylpyrrolidone, and the like. One or more of these substances can also be selected for use.

The thickness of the adhesive layer can be adjusted at will in the range of thicknesses, to the Torah accept oral medication can be administered orally. The thickness is preferably from 1 to 50 μm and more preferably from 10 to 30 μm. The thickness of the adhesive layer is less than 1 μm may lead to deterioration of the bonding. On the other hand, the thickness exceeding 50 μm can prevent the swelling of the gel-forming layers, which occurs under the action of saliva and the like in the process of receiving input of oral medication, and at the same time can cause discomfort when receiving, when the adhesive contained in the bonding layer, insoluble in water.

Next is discussed the method of obtaining take oral medication 1.

First, cook covers the liquid to gel-forming layers 12 and 13 and containing medicines layer 11. Next, cover the liquid to gel-forming layer applied to the film base and then dried. Film-based create with concave sections so as to form the desired convex parts on the surface of the gel-forming layer 12 taken oral medication 1. Thus, by applying a covering liquid on the film-based, you can get gel-forming layer having the desired convex portions on its surface. For example, the use of base film having on the surface of the embossed pattern from the reverse concave-convex affinity between concave and convex parts, the AK on figa and 2B, facilitates the formation of the convex sections micron range. After forming another gel-forming layer covering the fluid containing medicines layer 11 is applied on the surface of each gel-forming layer (the surface opposite the surface on which is formed a convex sections of the gel-forming layer) and then dried for formation containing medicines layer 11. The resulting two-layered substrate, each of which has a layered: containing medicines layer/gel-forming layer/the film is based in the described order, glued and pressed together with containing medicines layer 11 face each other. After this film-the foundations excavated and removed, and the residue is cut in a particular pattern, thereby forming accept oral medication 1. Formed so take oral medication 1 has convex portions on both of its surfaces. It should be noted that of base film can be left, keep to the dose of the medication.

The above method is used, when the convex parts formed on both surfaces taken oral medication 1. When the convex sections should be formed only on one side taken oral copper is amenta 1, you can use a flat film-based as of base film side, which do not form a convex sections.

Of base film with the concave parts can be made using embossing or the like for forming a concave plastic films-the basics, which include: polyester, such as polyethylene terephthalate, polyethylenterephthalat and the like; polyolefin, such as polypropylene, polymethylpentene, and the like, or thermoplastic resin such as polycarbonate and the like. Optionally, at least, any of the surfaces of base film can peel.

In the above method of obtaining the convex parts formed to take oral medication 1 using films basics with concave areas. Alternatively, for formation of the convex sections of the desired pattern can be applied pressing in the mold or partial coverage.

When the surface forming a swelling in water of the gel layers 12 and 13 should be coated with compounds of polyvalent metals, the solution containing compounds of polyvalent metals, capable of generating ions of polyvalent metals (solvent is, for example, purified water, ethanol or the like), or put razbryzgivayut on of base film having a concave is e sections and convex sections, in order to form a desirable convex areas, and then dried. Following this, the covering liquid for forming a swelling in water, the gel layer is applied or razbryzgivayut on layers of compounds of polyvalent metals, and then the film is dried, forming a forming a swelling in water of the gel layers 12 and 13. Alternatively, the surface forming a swelling in water of the gel layers 12 and 13 may be coated with compounds of polyvalent metals, causing or espressiva solution containing compounds of polyvalent metals, which are capable of generating ions of polyvalent metals, the surface forming a swelling in water of the gel layers 12 and 13, and then drying. The above solutions may contain water-soluble polymers, examples of which include film-forming tools listed above substances bases containing medicines layer 11 above, and the like.

With reference to Fig.6 below describes how to take oral medication according to the second variant embodiment of the invention. Take oral medication 2 6 includes the first gel-forming layer 21, the second gel-forming layer 22 and containing medicines layer 23, which is smaller than the first and second gel-forming layers 21 and 22. Take oral medication 2 is formed on the principle of "send the cha", laying containing medicines layer between the gel-forming layers and connecting the gel-forming layers on the peripheral ends so that the containing medicines layer 23 was covered with the first and second gel-forming layers 21 and 22. In this case also, the surface 24 of each gel-forming layer create with convex parts so as to reduce the area of contact taken oral medication 2 with the mucous membranes of the oral cavity of the patient. Preferably convex sections formed on such samples, as shown in figa-5.

Take oral medication 2 preferably formed from the same substances as mentioned previously taken oral medication 1, and it may include intermediate layers and adhesive layers.

According to the method of obtaining the second taken oral medication 2 according to this invention is first prepared covering the fluid to the first and second gel-forming layers 21 and 22 and containing medicines layer 23. Then covering the fluid to the first gel-forming layer 21 is applied to the first film-based, having a concave areas, so that the surface 24 of the first gel-forming layer 21 to form the desired convex areas, and then dried, forming a first gel-forming layer having convex portions on its n the surface. Following this, covering the fluid containing medicines layer 23 type in the first gel-forming layer 21 by using a known method such as screen printing or similar, to ensure that medical devices layer 23 was less than the first gel-forming layer 21, and then dried, forming a containing medicines layer 23. Meanwhile covering the liquid for the second gel-forming layer 22 is applied to the second film-based, having a concave areas, so that the surface 24 of the second gel-forming layer 22 to form the desired convex areas, and then dried, forming a second gel-forming layer having convex portions on its surface. Next, the peripheral ends of the first and second gel-forming layers 21 and 22 are combined together, thereby forming accept oral medication 2. Ways of connecting peripheral ends include, for example: (i) the manner in which the peripheral end of the first gel-forming layer 21 moisten with water, resulting in gelation of this peripheral end, a second gel-forming layer 22 presoviet in generowanie peripheral end, and then dried for connection; (ii) the manner in which the peripheral ends of the first and second gel-forming layers 21 and 22 are connected directly to each on the natives of the hot-melt connection; and (iii) the way in which form the adhesive(s) layer(s) either on the first gel-forming layer 21 or the second gel-forming layer 22, or both, and the gel-forming layers 21 and 22 connected by means of an adhesive(a) layer(s).

The above method is used, when the convex parts formed on both surfaces taken oral medication 2. When the convex sections should be formed only on one surface of the take oral medication, you can apply a flat film-based as the first of base film or the second film base.

Take oral medication according to the third variant embodiment of the invention is one in which the convex sections formed by folding accept oral film of drug 1 in the accordion. In this case, the drug has a much smaller area of contact, since only the folds of an accordion drug come into contact with the mucous membrane of the mouth. Thus, even in the case of adhesion to the mucosa of the oral medication can be separated easily.

Example 1

The invention is discussed below with more illustration on various examples. It should be noted that the invention is not limited to these examples.

(1) preparation of the LM covering the bones for the gel-forming layer

0.3 g of calcium chloride (trade name "calcium chloride H, Tomita Pharmaceutical Co., Ltd) was added as a cross-linking means to 300 g of purified water and the water was stirred until complete dissolution of calcium chloride. Then 11.3 g of polyacrylic acid (trade name "Carbopol 974P", a Noveon, Inc.), serving as forming a swelling in water of the gel means, was slowly added to the resulting solution while stirring the solution and dissolved with stirring. Then of 33.8 g of polyvinyl alcohol (trade name "Gohsenol EG-05T", Nippon Synthetic Chemical Industry Co., Ltd.), serving as a film-forming means, was slowly added to the solution while stirring the solution and completely dissolved by stirring the solution for one and a half hours while heating the solution to 70° Celsius in a water bath. After this solution was cooled to room temperature, to the solution was added 4 g of concentrated glycerin (trade name - "concentrated glycerin according to the Pharmacopoeia of Japan," Asahi Denka Co., Ltd.) as a plasticizer and the solution was stirred for 5 minutes, thereby completing the preparation of the covering liquid to gel-forming layer.

(2) Preparation covering the fluid containing medicines layer

2.5 g of famotidine (drug prescribed for ulcer), which serves as copper is Ty means, and 0.6 g of titanium oxide (trade name "Tipaque CR-50", Ishihara Sangyo Kaisha, Ltd)serving as matter basis, was added to of 53.7 g of purified water and thoroughly dispersively it using a homogenizer. Then 13.8 g of polyvinylpyrrolidone (trade name - "Plasdone K-90", ISP Japan Ltd.), also serving as matter basis, was added to the solution while stirring the solution and completely dissolved by stirring the solution for about half an hour. Then the solution was cooled to room temperature, to the solution was added 4 g of concentrated glycerin (trade name - "concentrated glycerin according to the Pharmacopoeia of Japan," Asahi Denka Co., Ltd.) as a plasticizer and the solution was stirred for 5 minutes, thereby completing the preparation of the covering fluid containing medicines layer.

(3) the Formation of a gel-forming layer

After careful elimination of foam covering the liquid to gel-forming layer it evenly applied using the applicator on the film base of polyethylene terephthalate (PET), printed in the specified way (film had such concave areas that could form the convex parts provided on figa and 2B). Then cover the liquid to gel-forming layer was dried at 80° C for 5 minutes, thereby forming forming nabua is the seer in the water gel layer. The thickness of the obtained gel-forming layer including a convex areas was 38 mm.

(4) Formation containing medicines layer

After careful elimination of foam covering the fluid containing medicines layer it evenly applied on the gel-forming layer using an applicator, whose gap was adjusted so that the amount of coating after drying would be 50 g/m2(thickness 50 μm). Then covering the fluid containing medicines layer was dried at 80° C for 5 minutes, thereby forming containing medicines layer. Thus, there were obtained two plates having the layered film based, gel-forming layer and containing medicines layer in this order.

Two plates obtained as described above, composed of a layered film-based, gel-forming layer and containing medicines layer in this order, and then thermally connected along its containing medicines layers together by pressing at 100 kgf/cm2for 1 second at 100° Celsius. Once printed PET of base film was separated from the gel-forming layers, used stamp with a diameter of 15 mm for moulding taken oral medication that has layered gelora the ith layer/containing medicines layer/gel-forming layer and having convex portions on the outer surfaces of gel-forming layers, the convex parts are formed by transfer of the embossed patterns on the films-the basics.

Example 2

Take oral medication was produced in the same manner as in example 1, except that used film base, which had such embossed drawings that were allowed to form convex parts shown in figa and 3B, on the entire surface of the gel-forming layers. The thickness of each of the gel-forming layers, including their convex plots was 80 μm.

Example 3

Take oral medication was produced in the same manner as in example 1, except that used film base, which had such embossing, which was allowed to form the convex sections, is shown in figure 5, over the entire surface of the gel-forming layers. The thickness of each of the gel-forming layers, including their convex areas, was 205 mm.

Comparative example 1

Take oral medication was produced in the same manner as in example 1, except that used flat PET film-basics without embossed images.

The ability to take oral medication to adhere to the mucosa of the oral cavity

Take oral medications manufactured in examples 1-3 and comparative example 1 was injected five sub is Cham people without water for to medicines could easily touch the top of the jaws of the subjects, and the ability to take oral medication to adhere to the upper jaw was evaluated based on the following scale of five points. The results are presented in table 1.

1: One surface taken oral medication completely stuck to the upper jaw and cannot be easily separated.

2: One surface taken oral medication partially stuck to the upper jaw and the stuck part cannot be easily separated.

3: Although one surface taken oral medication partially sticks to the upper jaw, the subject can easily separate the sticky part using their language and are able to take the medication.

4: Although one surface taken oral medication partially sticks to the upper jaw, the stuck part quickly separated, and the subject is able to take the medication.

5: the Subject can take take oral medication quickly, without sticking it to the upper jaw.

Table 1
Embossed patternSubject 1Subject 2Subject 3 Subject 4Subject 5Average
Example 1Fig. 2433433,4
Example 2Fig. 3455454,6
Example 3Fig. 5545554,8
Comparative example 1Flat112221,6

Table 1 shows that take oral medications examples 1-3 with convex areas received high scores due to poor ability to adhere to the mucous membrane of the mouth and easy to swallow, even without water. N is against, it was found that accept oral medication of comparative example 1, it is difficult to accept because of its tendency to stick to the mucous membrane of the mouth.

1. Taken oral film drug containing gel-forming layer as the outer layer taken oral medication where the gel-forming layer includes a convex sections formed on its surface, the number to 100 mm2was from 1 to 10000 convex sections and at least the layer with the medical facility where the height of the convex sections is in the range from 20 to 1000 μm, and the thickness of the gel-forming layer including a convex sections, is in the range from 30 to 2000 μm.

2. Take oral medication according to claim 1, where the upper surface of the convex sections are flat, and the total area of all surfaces of the convex sections is from 0.1 to 20% of the surface area of the gel-forming layer on which is formed a convex sections.

3. Take oral medication according to claim 1, where each of the convex sections has at least one form selected from the cones, columns, hemispheres and truncated cones.

4. Take oral medication according to any one of claims 1 to 3, where the convex parts in the form of a set of convex sections on at least one surface of this accept is the first oral medication.

5. Take oral medication according to any one of claims 1 to 3, where the layer with the medical tool includes a medical tool and the substance of the framework.

6. Take oral medication according to any one of claims 1 to 3, where the thickness of the layer with the medical tool is in the range from 0.1 to 1000 microns.

7. Take oral medication according to any one of claim 2 or 3, where the gel-forming layer includes forming a swelling in water gel agent and film-forming agent.

8. Take oral medication according to claim 2, where the gel-forming layer is formed on both sides take oral medication.

9. Take oral medication according to claim 1, where the gel-forming layer and the layer containing medical tool, have between them bonding layer.

10. Take oral medication according to claim 1, where the gel-forming layer includes swelling in water forming a gel means that cross-stitched using ions of polyvalent metals.



 

Same patents:

FIELD: chemistry.

SUBSTANCE: invention relates to a collagenic film and a method of making said film. The film contains at least one collagenic layer. The surface of the collagenic layer is formed by a plurality of domains with predominant orientation of collagenic fibres in each domain and continuous variation of orientation of fibres from one domain to another. There are pores on the domain boundary.

EFFECT: possibility of stable formation of structures similar to natural collagen.

22 cl, 21 dwg, 13 tbl

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is a therapeutic system for introduction of a pharmaceutically active substance, nonvolatile at least at room temperature, with a daily dose max. 30 mg, comprising a skin non-contact and active substance impenetrable external layer, an adjacent skin distant polymeric layer of polyisobutylene of the coating weight at least 80 g/m2, an adjoining skin contact adhesive polymeric layer of acrylate copolymers of the coating weight max. 50 g/m2, and also an active substance impenetrable protective layer (easily) removed from the skin contact layer.

EFFECT: transdermal therapeutic system has a high level of using the active ingredient and a higher dose accuracy.

18 cl, 2 ex

FIELD: medicine.

SUBSTANCE: present invention refers to medicine, more specifically to a gel composition for a medical material or a hygienic material which contains a liquid rubber ingredient having a functional group able to create cross linkages, in a molecule, and 90 weight parts or more and 1250 weight parts or less of an organic liquid ingredient in relation to 100 weight parts of the rubber ingredient with the gel composition being cross-linked.

EFFECT: composition for the medical material or the hygienic material contains a great amount of the organic liquid ingredient, has sufficient elasticity and can hold its shape.

7 cl, 4 tbl

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine. What is described is an adhesive composition containing donepezil and a stabiliser. The stabiliser containing one or more compounds specified in a group consisting of ascorbic acid, metal salt or ester of such, isoascorbic acid or metal salt of such, ethylene-diamine-tetraacetic acid or metal salt of such, cysteine, acetylcysteine, 2-mercaptobenzimidazole, 3(2)-tert-butyl-4-hydroxyanisol, 2,6-di-tert-butyl-4-methylphenol, tetrakis[3-(3',5'-di-tert-butyl-4'-hydroxyphenyl)]propionate pentaerythrite, 3-mercapto-1,2-propanediol, tocopherol acetate, rutin, quercetin, hydroquinone, metal salt of hydroxymethansulphinic acid, metabisulphite metal salts, sulphite metal salt and thiosulphate metal salts; it is added to a layer of a pressure sensitive adhesive applied on at least one side of the substrate.

EFFECT: prepared high reliable and stable adhesive composition which inhibits formation of donepezil-related compounds in the layer of the pressure sensitive adhesive.

14 cl, 4 tbl

FIELD: medicine.

SUBSTANCE: invention refers to medicine. There are described Transdermal Therapeutic Systems having a silicone adhesive layer, and a method for producing and using them.

EFFECT: transdermal therapeutic systems provide achieving a certain plasma concentration.

23 cl, 3 tbl, 4 dwg, 1 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is disclosed is a dosage form containing a base and a self-adhesive layer which contains a medicinal agent and covers at least one of the base sides; wherein the base consists of a polyester film of the thickness of 0.5 to 6.0 mcm, and a polyester non-woven material directly coupled with the film. The base is coated with the self-adhesive layer either directly or through an intermediate layer from the non-woven material.

EFFECT: adhesive preparation have sufficient elasticity for the purpose of tracking of the skin shape, as well as shows low ability to irritate the skin and high stability.

7 cl, 5 tbl, 7 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is a film containing as a film-forming agent an alginic acid salt with monovalent cation or mixed alginic acid salts containing at least one alginic acid salt with monovalent cation with 10% aqueous solution of the film-forming agent at temperature 20°C characterised by the viscosity of 100-1000 mPa-sec in accordance with the values measured at shear velocity 20 rpm with using a Brookfield viscometre equipped with a spindle No.2, as well as a method for making such film.

EFFECT: film is applicable for active ingredient delivery in a mammal's body and fast soluble while contacting with a wet surface.

18 cl, 2 tbl, 10 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, namely an adhesive preparation for percutaneous introduction of 2-(4-ethyl-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydrocyclooctate[b]pyridine (compound A). The preparation contains an adhesive layer formed on one base surface wherein the adhesive layer contains (1) the compound A or its physiologically acceptable salt formed by salt addition, and (2) an acryl adhesive, or (1) the compound A or its physiologically acceptable salt formed by salt addition, (2) the acryl adhesive and (3) a permeability enhancing agent.

EFFECT: preparation inhibits metabolite generation and continuously maintains the blood drug concentration.

19 cl, 7 tbl, 1 dwg, 63 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine. What is described is an adhesive composition which decreases a number of donepezil related compounds formed in the donepezil-containing adhesive composition containing one, two or more types of combinations of the compounds selected from the following groups of the combinations of the compounds from (a) to (j) which are mixed in a layer of a donepezil-containing pressure sensitive glue: (a) isoascorbic acid or its metal salts and 2-mercaptobenzimidazole; (b) isoascorbic acid or its metal salts and 2,6-di-tert-butyl-4-methylphenol; (c) isoascorbic acid or its metal salts and metal salts of hydroxymethane sulphinic acid; (a) isoascorbic acid or its metal salts and rutin; (e) 2-mercaptobenzimidazole and 2,6-di-tert-butyl-4-methylphenol; (f) 2-mercaptobenzimidazole and metal salts of of hydroxymethane sulphinic acid; (g) 2-mercaptobenzimidazole and rutin; (h) 2,6-di-tert-butyl-4-methylphenol and metal salts of hydroxymethane sulphinic acid; (i) 2,6-di-tert-butyl-4-methylphenol and rutin; and (j) metal salts of hydroxymethane sulphinic acid and rutin.

EFFECT: adhesive composition is highly reliable and stable.

12 cl, 2 tbl

Adhesive product // 2441649

FIELD: medicine.

SUBSTANCE: invention describes adhesive product consisting of stretchable base and adhesive layer that is put in thin layer on at least one side of the base, where the stretchable base contains connective layer of fabric subject to goffering process, the adhesive layer contains 10% by weight or more of methyl salicylate from total mass of the layer, moisture permeability of all adhesive product is 1-350 g/m2*24 hours measured at the temperature 40°C and relative humidity 90%, and methyl salicylate has AUC0-24 in plasma in the range from 3.0 to 60.0 ng*h/ml in the values of average ± standard deviation, salicylic acid as the metabolite of methyl salicylate has AUC0-24 in plasma in the range from 5,000 to 13,000 ng*h/ml in the values of average ± standard deviation, when the adhesive product is put on the human skin for 8 hours so that the contacting amount of adhesive layer is 50-300 g/m2 and the area of contact is 280 cm2.

EFFECT: product is capable of stable absorption through the skin.

7 cl, 3 tbl, 3 dwg, 6 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to chemical-pharmaceutical industry, in particular - to composition of a medication possessing antiviral action and manufactured in the form of solid gelatine capsules as well as to such medication production method. The antiviral medication contains granules the active substance represented by sodium salt of 2-methylthio-6-nitro-1,2,4-triazolo[5,1-c]-1,2,4-triazin-7-on, a dehydrate and physiologically acceptable accessory substances: starch as filler and disintegrant and talc as the anti-friction substance. The granules size is within the range of 0.5-0.63 mm. The gelatine capsules weight is from 0.290 to 0.300 g. The method for production of the antiviral medication in the form of granules contained in gelatine capsules is implemented by way of wet granulation.

EFFECT: according to the invention, the medication is noted for a pronounced virus-inhibiting action, satisfactory organoleptic properties and pharmacological safety and extends the arsenal of antiviral medications.

12 cl, 3 dwg, 7 tbl, 3 ex

Forming of capsules // 2450798

FIELD: process engineering.

SUBSTANCE: invention relates to chemistry and pharmaceutics, particularly, to method and device for producing capsule with solid shell wherein capsule components are formed from material to be gelled after heating, for example, HPMC. Drying conditions after dipping are accurately controlled for controlling drying rate.

EFFECT: heater for multiple dies.

21 cl, 3 dwg

Oral dosage form // 2450797

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine and chemical-pharmaceutical industry, namely an oral dosage form. The dosage form comprising a liquid containing section in which there are water-soluble edible films jointed on the periphery to form an enclosed volume between the films with a water-insoluble layer coating an internal surface of the films; while between the layers there is a water liquid; and a drug containing section adjoining the liquid containing section in which the coating edible films are jointed on the periphery to form an enclosed volume which contains a drug between the films.

EFFECT: development of the effective dosage form.

4 cl,13 dwg

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutics, and concerns a dosage form presented in the form of a capsule having a shell wall, a linker or another capsule subunit consisting of a pharmaceutically acceptable composition containing (i) ammonium methacrylate copolymer type A (Eudragit RL), (ii) at least one excipient modifying dissolution and presenting a hydroxypropyl cellulose polymer blend of various molecular weights and (iii) a lubricating agent.

EFFECT: invention provides polymer compositions applicable for melt extrusion and injection moulding, enabling time variations of shell dissolution and components release from the capsule.

32 cl, 12 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine and pharmaceutical industry, namely preparation of a pharmaceutical and similar product. The product contains a number of ingredients having active substances delivered in an integrated delivery device, or a carrier.

EFFECT: product provides selective release speed control of each active substance delivered in the same product.

24 cl, 99 dwg

FIELD: chemistry.

SUBSTANCE: composition contains 15-25 wt % hydroxymethyl cellulose per total weight of the aqueous composition. Hydroxypropyl methylcellulose contains 27.0-30.0% (wt/wt) methoxy groups and 4.0-7.5% hydroxypropoxy groups and has viscosity of 3.5-6.0 Sp in form of 2 wt % solution at 20°C. The method of producing hard capsules from hydroxypropyl methylcellulose by via dip coating involves preparation of an aqueous composition, preheating the dipping rods, immersing the preheated dipping rods into the aqueous composition, removing the rods from the composition and drying the film on the dipping rods. The dipping rods are preheated to 55-95 °C. Temperature of the aqueous composition during immersion of the dipping rods is kept 10°C-1.0°C below its gelling temperature. The obtained shell of the hard capsule contains hydroxymethyl cellulose in amount of 70-99% of the weight of the shell.

EFFECT: obtained capsules have high transparency, excellent solubility and good mechanical characteristics.

16 cl, 2 tbl, 9 ex

FIELD: process engineering.

SUBSTANCE: invention maybe used for efficient fire extinguishing, fast cooling of overheated structures and production of lower-flammability compounds. Microcapsules have a micro-sphere-like core containing water or water solution in gel state, main shell around said core to provide for core stable shape and composition and rule out water evaporation therefrom the core, and, additionally, comprises outer shell with lyophilic properties. Versions of proposed methods comprises producing aforesaid core via interaction of appropriate initial water solutions to be placed in microsphere and containing appropriate components of the shell with components of solutions to be precipitated and used for producing and cross-linking of gel, and producing additional lyophilic shell via interaction of components of initial solutions with appropriate components in organic medium.

EFFECT: high efficiency in fire extinguishing or fast cooling of overheated structures.

21 cl, 1 tbl, 10 ex

Transportation line // 2415068

FIELD: transport.

SUBSTANCE: transportation line is intended for transportation of capsules between capsule filling station and capsule sealing station. Transportation line includes loading area (10), unloading area (20) and multiple transportation modules (30) on conveyor (40). Cavities (31) of each transportation module have the possibility of placing the groups of filled capsules consisting of two parts, when they are located in loading position in loading area, and output of groups, when they are located in unloading position in unloading area. Conveyor has the possibility of supporting transportation modules for their transportation from loading position to unloading position, and vice versa, at their being retained in one and the same position.

EFFECT: providing integrity and non-blockage of capsules to each other during their transportation.

14 cl, 4 dwg

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to chemical-pharmaceutical industry and medicine. Method includes: formation of hollow capsules, their hardening and following packing, which differs in the act that as material for manufacturing of capsules applied are substances, able to dissolve in gastric juice with speed, depending on its acidity degree, and manufacturing of capsules is carried out in chamber with increased gas atmosphere pressure. Packing of capsules can also be carried out in chamber with increased pressure, it is necessary to do packing of capsule able to preserve said pressure and provide air-tightness during fixed term of capsule storage.

EFFECT: increased efficiency of method of manufacturing capsules for determination of gastric juice acidity.

3 cl, 1 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to field of medicine and pharmaceutics, namely to medication for treatment or prevention of cardiovascular system and/or nervous system diseases. Medication contains ethylmethylhydroxypyridine succinate, pyridoxine hydrochloride, pharmaceutically acceptable salt of magnesium and auxiliary substances in quantities given in invention formula. Method of cardiovascular and/or nervous system diseases treatment includes peroral introduction of medication by invention in efficient quantity. Also described is method of obtaining claimed medication.

EFFECT: obtaining highly technological medication characterised by low cost and high therapeutic effect.

13 cl, 6 tbl, 3 ex

FIELD: medicine.

SUBSTANCE: preparation comprises Amlodipine taken in quantity corresponding to free base content from 6 mg to 10 mg and Benazepril/benazeprilate corresponding to Benazepril hydrochloride content not exceeding 40mg.

EFFECT: enhanced effectiveness of arterial blood pressure control.

28 cl

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