Pharmaceutical composition for the treatment of fungal diseases

 

The invention relates to the field of medicine. The pharmaceutical composition is a tablet and contains as active substance griseofulvin 0,12888 g as the target additives sugar milk 0,02472 g potato starch 0,02030-0,02140 g calcium stearate 0,00180 g, polyvinylpyrrolidone molecular 0,00320-0,00430, the Invention provides stability during storage and meets the requirements of the Pharmacopoeia in appearance, raspadaemosti, dissolution and other requirements. table 2.

The invention relates to medicine, in particular for the treatment of fungal diseases.

One of the large groups of microorganisms that cause human diseases are fungi. Human pathogens are several dozen species of fungi. The most common dermatophytes, affecting the superficial layers of the skin, nails and hair.

Most antifungal drugs in therapeutic doses does not cause the death of the fungus, but only inhibit its development and the ability to divide, so to achieve a stable therapeutic effect, they should be used long-term. This is especially important when the treatment of dermatomycoses, because it is necessary that all layers of the skin that is zirovnice fungus.

Means the treatment of fungal infections should be capable of maintaining a high current concentration of the drug in the area of fungal, so it is extremely important to selecting the optimal route of administration and the respective dosage forms [1].

Preparations based grizeofulvina are antifungal antibiotics acting on the majority of dermatomycoses. It is prescribed in the treatment of patients suffering from favosa, trichophytosis and microsporia scalp and smooth skin, athlete's smooth skin caused by Trichophyton, and lesions of the nail (onychomycosis), caused by pathogenic fungi (Trichophyton, red epidermofiton) [2].

Take griseofulvin interior and local. Griseofulvin in suspension is designed mainly for children. For local applications use the liniment grizeofulvina of 2.5% [3].

The disadvantage of this composition is that its application is possible only when the initial forms of the disease and limited skin lesions. When extensive or severe skin lesions, as well as with fungal nails and scalp, it is necessary in order griseofulvin accumulated in the stratum corneum of the epidermis, the matrix s regulations 00480550-181-01 into tablets grizeofulvina 0.125 g, described pharmaceutical composition griseofulvina close to the claimed. It is made in the form of tablets containing the following components, g: Griseofulvin - 0,12888 Sugar milk 0,02556 Calcium stearate 0,00081 potato Starch - 0,02376 stearic Acid - 0,00099 Way to obtain this composition is the following. According to part 7 (see tab.1) give drug griseofulvin, fillers: milk sugar, calcium stearate, potato starch, stearic acid. Mix the sifted powders grizeofulvina, sugar, milk, potato starch are mixed and moistened. Humidifier, which includes milk sugar, starch and water, load evenly in 2-3 doses. Moist tabletow the mass is dried to a residual moisture content (1-2)% and granularit. Crushed granular optivault mixture of calcium stearate and stearic acid, then tabletirujut.

The tablets produced by this technology have a low dissolution rate, insufficient strength of the tablets.

The objective of the invention is the creation by selecting a certain quantitative composition of the components of the composition for the treatment of fungal diseases on the basis of grizeofulvina, which eliminates these weeks is eat, the proposed product contains as active ingredient griseofulvin, as fillers - milk sugar, potato starch, calcium stearate, and optionally contains low molecular weight polyvinylpyrrolidone (PVP) in the following ratio of ingredients, g: Griseofulvin - 0,12888 Calcium stearate 0,00180 Sugar milk 0,02472
PVP - 0,00320-0,00430
Potato starch - 0,02030-0,02140
The claimed ratio of ingredients is best found experimentally and provides the required quality of the composition, in accordance with the requirements of the global Fund XI (see tab.2).

To increase the degree of dissolution and microbial purity tablets suggested use as a solvent humidifier ethyl alcohol.

Compare the effect of binding agents (starch and sugar) on the effectiveness of the process of granulation and drying, as well as on the quality of the dosage form identified the need to include low-molecular polyvinylpyrrolidone (PVP) in the composition. For a more uniform distribution of the PVP used in the alcohol solution.

In the prototype the dusting spend calcium stearate and stearic acid, but acid stearic not always Bevis low melting point. Its effectiveness as a sliding fine-dispersed substance stearic acid and calcium stearate are the same, therefore, propose to replace stearic acid, calcium stearate.

The number you enter in the composition outrivaled agent (starch) is 2% of tabletas mass. The rest of the starch used as a filler together with sugar. The change of this ratio prevents the normal process of tabletting and degrades the appearance of the tablets.

The way to obtain a new composition includes a mixture of powder grizeofulvina, sugar, dairy, starch, wet with a solution of PVP in alcohol, drying, granulation, powder starch and calcium stearate, and tableting. The DPJ give a composition of the form of tablets obtained after dusting composition is pressed on a tablet machine.

The invention is illustrated by the following examples (see tab.1).

Example 1. Substance sifted grizeofulvina (718 g) is mixed with the filler, which consists of milk sugar (142 g) and potato starch (90 g). PVP in the amount of 20 g was dissolved in 78% aqueous alcohol. The mixture of the substance with filler moisturize 6,7% solution of PVP in alcohol in the amount of 300 g. the void. Crushed granular optivault starch (20 g) and calcium stearate (10 g), then tabletirujut. Get 900 g of tablets with an average weight 0.125 g, which satisfy the requirements of the pharmaceutical agent.

Examples 2-5 carried out analogously to example 1.

The resulting composition complies with the requirements of the global Fund XI in appearance, raspadaemosti, dissolution and other requirements, stable during storage and has a shelf life of 3 years and 6 months (table.2)
Sources of information
1. Medications that You choose / Directory. JSC "TF "WORLD", St. Petersburg, 2000, S. 607.

2. Mashkovsky M. D. Medicines, H. 2, S. 427, M., 1993.

3. Navashin S. M. , Fomin, I. P. Handbook of antibiotics, S. 269, M., 1974.

4. Industrial regulations 00480550-181-01 into tablets grizeofulvina 0,125, JSC "Biosynthesis" 17.01.2001.


Claims

Pharmaceutical composition for the treatment of fungal diseases, containing the active ingredient and pharmaceutically acceptable additives target, characterized in that the active substance it contains griseofulvin and as the target additives, milk sugar, potato starch, calcium stearate, low molecular weight polyvinylpyrrolidone (PVP) when s

PVP 0,00320 - 0,00430

Potato starch 0,02030 - 0,02140

 

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