Pharmaceutical composition for prevention ot treatment of arthrosoarthritis, containing rebamipide as active ingredient

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to pharmaceutics, in particular a pharmaceutical composition in the form of a peroral drug form is described. The composition includes rebamipide as an active ingredient and a pharmaceutically acceptable carrier. Rebamipide is contained in an amount from 0.5 to 50 mg/kg, preferably from 0.6 to 6 mg/kg.

EFFECT: application of the rebamipide-based pharmaceutical composition for the prevention and treatment of arthrosoarthritis.

5 cl, 3 dwg, 1 tbl, 1 ex

 

AREA of TECHNOLOGY

The present invention relates to a pharmaceutical composition for the prevention or treatment of artresources containing rebamipide as the active ingredient.

PRIOR art

Artresources, one type of arthritis, also called degenerative arthritis. They say that artresources is arthritis caused by degenerative changes in the cartilage and adjacent bone in synovial joints. That is, artresources is characterized by gradual loss of articular cartilage combined with thickening of the subchondral bone, bony outgrowths at the edges of joints and nonspecific synovial inflammation. Artresources is caused by destruction of cartilage associated with aging and/or physical stress (e.g., obesity, trauma, etc.). Therefore artresources causes acute pain and/or stiffness in the joints, weight bearing, such as knee and hip joint and dismissive attitude towards this for a long time leads to deformation of the joints.

Usually artresources develops in the following stages: the stage of change of the cartilage where there is swelling due to the increase of water content in the cartilage (stage 1); stage fibrillation, where the cartilage is destroyed, which leads to erosion of the cartilage surface, obna�of the bone and narrowing of the joint cavity (stage 2); stage General reduction of cartilage, which, although chondrocytes and initiate compensatory cartilage formation, cartilage destruction is faster than the formation of cartilage (stage 3); stage deformation of the bone on which the change in the bones leads to joint strain and dysfunction (stage 4); and phase changes of articular soft tissue, which is soft tissue becomes condensed (stage 5).

Rheumatoid arthritis, which belongs to another type of arthritis than artresources, is a chronic autoimmune disease characterized by inflammation and proliferation of synovial cells, and cause osteoporosis and bone erosion everywhere in the joints, unlike artresources. Usually rheumatoid arthritis develops in the following stages: inflammation of the synovial membrane extends to the articular capsule, ligaments, tendons, etc. (stage 1); the gradual destruction of the articular cartilage leads to a narrowing of the joint cavity and weakening of the joint capsule and ligaments (stage 2); inflammation penetrates into the bone, which leads to partial bone erosion (stage 3); and in the joint functional disorder occurs (stage 4). Therefore rheumatoid arthritis and artresources quite different in their etiology and development and therefore methods of treatment are also quite different.

Treatment of artresources used� in the prior art, includes the use of therapeutic agents, such as acetaminophen, tramadol, nonsteroidal anti-inflammatory drugs (NSAIDs), diacerein, glucosamine, etc. Among them, about nonsteroidal anti-inflammatory drugs has been reported to cause side effects in the gastro-intestinal tract, such as gastric ulcer, duodenal ulcer etc. Therefore, when these drugs are used for patients suffering from artresources and which may be a problem with side effects from the gastrointestinal tract, appointed jointly cytoprotector (e.g. rebamipide, etc.), a blocker of H2receptors (e.g., cimetidine, ranitidine, etc.) and/or a proton pump inhibitor (e.g. omeprazole).

In the treatment of various patients suffering from artresources, in the clinics of the authors of the present invention unexpectedly found that rebamipide as such, jointly appointed to avoid side effects from the gastrointestinal tract, has activity for the prevention or treatment of artresources. This is very surprising since it was not reported that rebamipide may be related to the improvement and/or therapeutic effects when artresources.

Therefore, the present invention provides a pharmaceutical composition for preven�ICA or treatment of arthrosurface, containing rebamipide as the active ingredient.

TECHNICAL SOLUTION

In accordance with an aspect of the present invention is provided a pharmaceutical composition for the prevention or treatment of artresources containing rebamipide as the active ingredient and pharmaceutically acceptable carrier.

The pharmaceutical composition may be intended for oral administration and can be, for example, a solid dosage form for oral administration in the form of tablets or capsules. The pharmaceutical composition may be produced in the form of a unit dosage form suitable for oral administration of rebamipide in a dosage of from 0.5 to 50 mg/kg, preferably from 0.6 to 6 mg/kg.

POSITIVE EFFECTS

Thanks to the present invention was first discovered that rebamipide has activity for the prevention or treatment of artresources. Therefore, the pharmaceutical composition of the present invention may be used for the prevention or treatment of arthrosurface, alone or in combination with another therapeutic agent (other therapeutic drugs) for the treatment of artresources.

BRIEF description of the DRAWINGS

FIG. 1 shows the results obtained by observation under a microscope for the femur and tibia bones taken from rats on the seventh day after induction artresources.

FIG. 2 shows the results obtained by histological analysis of the destruction of the cartilage with coloring TRCF (tartrate-resistant acid phosphatase - note. etc.), safranin-O and G-e (hematoxylin and eosin - note. translation.).

FIG. 3 is a graph illustrating the degree of histological activity, calculated on the basis of histological analysis.

The BEST EXAMPLE of carrying out the INVENTION

In accordance with the use of the term "rebamipide" includes all forms of rebamipide, such as anhydrous form, a hydrate form (e.g., polyhydrate form, crystalline form, etc.; and its pharmaceutically acceptable salt. Pharmaceutically acceptable salt includes an inorganic ion salt, obtained from, for example, calcium, potassium, sodium and magnesium; an inorganic acid salt, obtained from, for example, hydrochloric acid, nitric acid, phosphoric acid, Hydrobromic acid, itestosterone acid and sulfuric acid; organic acid salt, obtained, for example, from acetic acid, formic acid, succinic acid, tartaric acid, citric acid, trichloroacetic acid, trifluoroacetic acid, gluconic acid, benzoic acid, lactic acid, fumaric acid and maleic acid; the salt of the acids obtained, for example, and� of methansulfonate, econsultancy, benzolsulfonat, p-base and naphthalene sulfonic acid; the salt of the amino acids obtained, for example, glycine, arginine, and lysine; and amine salt obtained from, for example, trimethylamine, triethylamine, ammonia, pyridine and picoline.

The present invention provides a pharmaceutical composition for the prevention or treatment of artresources containing rebamipide as the active ingredient and pharmaceutically acceptable carrier.

As described in the example below, when artresources was induced in rats by injection of iodoacetate sodium 1-substituted (monosodium iodoacetate, MIA), known as an inducer of arthrosurface, then the rats was orally introduced rebamipide, and destruction of cartilage was largely ingibirovalo (see FIG. 1). As a result of histological analysis, when rebamipide was administered orally, loss of cartilage and its components was similar to that of the normal rats; were noted favorable changes in cartilage loss and degradation of its components (see FIG. 2 and FIG. 3). These results show that rebamipide used as a cytoprotector, has excellent activity for the treatment of artresources.

The pharmaceutical composition of the present invention includes a pharmaceutically acceptable carrier and mo�em to be manufactured in accordance with conventional methods in the form of dosage forms for oral administration, such as powders, granules, tablets, capsules, suspensions, emulsions, syrups or aerosols; formulations for topical use; suppositories or sterile injection solution. Preferably, the pharmaceutical composition of the present invention can be a form for oral administration, for example, a solid dosage form in the form of tablets or capsules. For example, the pharmaceutical composition of the present invention may be in the form of commercially available tablets containing rebamipide (for example, "Mucosta™ Tablet", Otsuka Pharmaceutical Co., Ltd.). Pharmaceutically acceptable carrier includes lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, aritra, maltitol, starch, gum Arabic, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methylcellulose, microcrystalline cellulose, hydroxypropyl cellulose, nitrosamino hydroxypropyl cellulose, hydroxypropyl methylcellulose 2910, polyethylene glycol 6000, polyvinylpyrrolidone, methylhydroxybenzoate, propylhydroxybenzoate, titanium dioxide, talc, magnesium stearate and mineral oil, but is not limited to them. The pharmaceutical composition may additionally include a diluent or filler, such as filler, extender, binder, humectant, raising agent, or a surfactant. Solid composition for oral administration VK�uchet, for example, tablet, pill, powder, granule or capsule. Such solid compositions can include at least one filler selected from, for example, starch, calcium carbonate, sucrose, lactose and gelatin. In addition, such solid compositions may additionally include a moving substance, such as magnesium stearate or talc. In particular, the pharmaceutical composition of the present invention may be in the form of tablets containing rebamipide as the active ingredient and nitrosamino hydroxypropyl cellulose, microcrystalline cellulose, titanium dioxide, hydroxypropyl methylcellulose 2910, polyethylene glycol 6000, hydroxypropyl cellulose and magnesium stearate as a carrier. Liquid composition for oral administration include a suspension, solution, emulsion or syrup.Furthermore, the liquid composition may include a diluent, such as water, liquid paraffin; a humidifier; a sweetener; a fragrance or preservative.The composition for parenteral administration include sterilized aqueous solution, an anhydrous solution, suspension, emulsion, freeze-dried composition or a suppository. Anhydrous solvents or suspendida substances include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, or injectable esters, for example ethyloleate.Bases for suppositories could�t be witepsol, macrogol, Tween 61, cacao butter, Laurin or glitserinovoye gelatin.

In the pharmaceutical composition of the present invention, the dose of rebamipide may vary depending on status or body weight of the patient, severity of disease, dosage forms, routes of administration and the period of administration of the drug and can be appropriately determined by the conventional specialist. For example, rebamipide can be prescribed in a dosage of from 0.1 to 100 mg/kg, preferably from 0.5 to 50 mg/kg, more preferably from 0.6 to 6 mg/kg per day. Therefore, the pharmaceutical composition may be produced in the form of a unit dosage form suitable for oral administration of rebamipide in a dosage of from 0.5 to 50 mg/kg, preferably from 0.6 to 6 mg/kg. Reception can be one or several times a day. The pharmaceutical composition of the present invention can also be taken separately or in combination with another therapeutic agent (therapeutic drugs) for the treatment of arthrosurface, such as non-steroidal anti-inflammatory drugs (NSAIDs), etc. In case of combined receiving therapeutic agent (therapeutic agent) can be taken sequentially or simultaneously.

Hereinafter the present invention will be described in more detail with the following working example. However, the following working example of pregnatn�Chen for illustration only, and thus, the present invention is to him or them shall not be limited.

Example: Evaluation of therapeutic efficacy of rebamipide in respect of artresources oral ingestion

(1) test Method

Used male Wistar rats at the age of about 5 weeks. Iodoacetate

sodium 1-substituted (MIA) was dissolved in physiological solution, and then

introduced rats in a dosage of 4 mg / 50 MCL in his right knee to induce

artresources.

Rats were divided into 3 groups of 5 rats in each group. The first group (without arthritis) was a group that was not treated, that is, the normal control group. The second group (MIA) was the group that was induced by artresources by introducing MIA. Rats of the third group (MIA+rebamipide) introduced MIA to induce artresources, and then was orally given rebamipide every day for 7 days.

On the seventh day after MIA induction of the femur and tibia were seized from rats of each group and then examined using a dissecting microscope. After coloring of G-e inspected the parts of the knee using lenses small increase. In the results of the kernel was blue and the cytoplasm pink.After completion of dyeing cloth were inspected when you split into two areas, i.e. upper part of the knee (shown� as "BC", what is the abbreviation for femur) and the lower portion of the knee (shown as "BBK", which is a reduction from tibia). Knee joints were stained with the safranin-O, which can reveal the loss of cartilage proteoglycans. Coloring tartrate-resistant acid phosphatase (TRCF) for osteoclasts was carried out at 37°C for 30 minutes, using a set of acid phosphatase of leukocytes (Sigma 387-A, USA). TRCF-positive cells were stained in red-violet color. Multinucleated cells (with more than 3 nuclei) were considered TRCF-positive cells (osteoclasts), which were counted under an optical microscope.

(2) the Results of tests

As a result of inspection using a dissecting magnifier femur and tibia, removed from the rats of each group on day 7 after induction MIA, in a group where not introduced rebamipide, observed the destruction of cartilage sections (see red arrows middle images in FIG. 1). However, in the group where rebamipide administered orally, only a slight destruction of cartilage sections (see FIG. 1).

And as a result of histological analysis by staining TCRF, safranin-O and G-e group, which did not enter rebamipide, there was severe destruction of cartilage, while the cartilage remained intact without fracture group, which was orally given re�lipid (see FIG. 2). That is the result of histological analysis by staining G-e, it was noted that the group, which was orally given rebamipide (MIA+rebamipide) were favorable changes compared to the MIA group. Also the analysis by staining with safranin-O for the group, where rebamipide administered orally (MIA+rebamipide), it was observed that the surface area of the cartilage of the femur was smooth and was visible in the orange-red color that was similar to the group without arthritis. Conversely, for the group MIA it was noted that the entire cartilage was weekly in spots due to the loss of proteoglycans and its surface became rough. In addition, as a result of counting the number of osteoclasts in the tibial subchondral bone with coloring TRKF the number of osteoclasts was significantly decreased in the group, where he introduced rebamipide, compared to the MIA group.

And were also rated the degree of histological activity by counting based on the standards in table 1 below, and the results were shown in FIG. 3. As shown in FIG. 3, in the MIA group there was a decrease in staining with safranin-O, and the uneven surface of the cartilage. However, in the group treated rebamipide, it was observed that the cartilage surface remains smooth, with only a small loss of safranin-O in the cartilaginous area.

Table 1
SymptomThe degree of histological activity
Norm1
Small superficial reduce staining by safranin-O2
The decrease in staining safranin-O and a small roughness of the surface3
Significant surface roughness and/or cleft4
Full thickness loss not calcined cartilage5
The loss of calcined cartilage6

The above results suggest that rebamipide inhibits deformation of the cartilage, thus demonstrating the great prophylactic and therapeutic activity against artresources.

1. Pharmaceutical composition for prevention or treatment of artresources containing rebamipide as the active ingredient and pharmaceutically acceptable carrier.

2. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is suitable for oral administration.

3. Pharmaceutical with�becoming according to claim 2, in which the pharmaceutical composition is a solid dosage form for oral administration in the form of tablets or capsules.

4. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is made in the form of a unit dosage form suitable for oral administration of rebamipide in a dosage of from 0.5 to 50 mg/kg.

5. The pharmaceutical composition according to claim 4, wherein the pharmaceutical composition is made in the form of a unit dosage form suitable for oral administration of rebamipide in a dosage of from 0.6 to 6 mg/kg.



 

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