Pharmaceutical composition eliciting antiviral activity as solid dosed formulation and method for its preparing

FIELD: medicine, pharmacy, pharmaceutical industry.

SUBSTANCE: invention relates to tablets covered by envelope for masking taste of active substance. The core pharmaceutical composition comprises ciprofloxacin as an active component and the following accessory substances - microcrystalline cellulose, crosspovidon, magnesium stearate, lactose, talc, and maize starch. The core envelope comprises hydroxypropylmethylcellulose, titanium dioxide, collidone, propylene glycol, polyethylene oxide and talc. Also, invention describes a method for preparing the sold dosed formulation. Invention provides satisfactory technological properties of tableted mass, preparing plastic, luster core envelope not delaying the release of ciprofloxacin.

EFFECT: improved and valuable properties of composition, improved method for preparing formulation.

3 cl, 5 ex

 

The present invention relates to the field of medicine, particularly to drugs, characterized by special physical forms, such as tablets, coated for taste masking of the active substance.

Known antiviral composition containing as the active substance is ciprofloxacin, as excipients microcrystalline cellulose, crospovidone, magnesium stearate, Aerosil, corn starch (C. Russia №96111063, And from 61 To 04.06.96., publ. 27.09.98).

The disadvantage of this composition is the high content of the active substance is ciprofloxacin, which can lead to side effects in patients. In addition, the amount of excipients in the form of microcrystalline cellulose is not enough for a good raspadaemosti and solubility funds in its consumption, and the absence of talc and lactose impair the technological properties tool in the process of its production - flowability and compressibility.

This song is selected by the applicant as a prototype.

Known tablet form of the drug with the application shell, consisting of a mixture of methylcellulose-8, titanium dioxide and tropeolin (p. Russia No. 2123330, a 61 K 9/20 from 02.04.97, publ. 20.12.98).

The drawback claimed shell for coating tablets is that p is imeninnaya as a film-forming substance methylcellulose-8 has poor solubility in water, which makes the release of active ingredient from the tablets. In addition, the film on the basis of methylcellulose-8 unstable when stored on surface tablets cracks, i.e. the film does not have sufficient ductility.

The tool chosen by the applicant as a prototype.

A method of obtaining tablets of ciprofloxacin, providing for the preparation of the masses for tableting by mixing powdered ingredients, moistening the mixture, wet granulation, drying, dry granulation, powder, tableting (p. Russia No. 231265, a 61 K 47/00, 9/20 from 04.0696, publ. 10.06.99).

The disadvantage of this method is that the active substance is ciprofloxacin injected into pre-mixed and moistened corn starch and microcrystalline cellulose are mixed, and then moisturize again that it is not possible to get strong enough, but at the same time plastic granules. Worse technological properties of the granulate in flowability and compressibility.

The dusting at the specified method is carried out with a mixture of crospovidone, Aerosil, magnesium stearate, corn starch and microcrystalline cellulose. This suggests that due to poor pressuemosti and flowability of the granules when dusting is necessary to add adhesive and easily shaped into tablets of substances which, can then easily break the tablet, as specified pressure on the tablet press is great.

The technical objectives of the proposed invention are the creation of a pharmaceutical composition having sufficient therapeutic activity, with a high rate of release of drug substances and obtaining plastic, shiny shell that won't slow down the release of the active substance.

The task is achieved by the fact that in the pharmaceutical composition having antiviral activity in the form of a solid dosage form that includes a core containing the active substance is ciprofloxacin and as excipients microcrystalline cellulose, crospovidone, magnesium stearate and corn starch, according to the invention, the core further comprises talc and lactose in the following ratio of ingredients, wt.%:

ciprofloxacin 61,84-69,7

microcrystalline cellulose 7,8-25

crospovidon 0,1-3,4

the stearate of 0.1-0.4

lactose 2,0-10

talc 0,1-3,0

corn starch else,

the nucleus coated, taste masking of ciprofloxacin and contains oksipropilmetiltselljuloza, titanium dioxide, kollidon, propylene glycol, polyethylene oxide and talc, with the following ratio of ingredients of the shell in % of total the weight of the composition:

oksipropilmetiltselljuloza 0,5-1,0

titanium dioxide 0,1-0,8

kollidon 0,1-0,6

propylene glycol 0.2 to 1.0

the polyethylene oxide of 0.1-0.3

talc 0,1-3,0.

The inventive pharmaceutical composition is used for infections of the respiratory tract, skin, soft tissues, bones and joints, gastrointestinal tract, including infections caused by Salmonella, Shigella, Campylobacter and other pathogens, gonococcal infections, meningitis, postoperative infectious complications, sepsis and other inflammatory processes.

The claimed value of the active substance is ciprofloxacin allows you to obtain the product with a sufficient therapeutic activity, which does not cause patients side effects when taking it.

The claimed ratio of excipients provides:

- microcrystalline cellulose - good solubility;

- crospovidon - raznijsmot;

- stearate - lubricating effect, the pill does not stick to the press;

- lactose and talc - improvement of technological properties of tablets - flowability and compressibility;

- starch - receiving paste for humidification of the engine components.

For taste masking of the active substance core cover masking the taste of the shell.

The stated ratio of the ingredients included in the composition of the shell, ozbolat to provide:

- oksipropilmetiltselljuloza, kollidon - obtaining soluble in water shells;

- propylene glycol, a polyethylene oxide - getting plastic shell;

- talc - prevents the adhesiveness of their tablets in the coating;

- titanium dioxide to get a shell in white.

In a method of producing a pharmaceutical composition having antiviral activity in the form of a solid dosage form according to claim 1, comprising a core containing the active substance is ciprofloxacin, coated, taste masking of ciprofloxacin, including the preparation of the masses for tableting by mixing powdered ingredients, moistening the mixture, wet granulation, drying, dry granulation, powder, tabletting and coating membrane according to the invention the active substance is ciprofloxacin mixed with lactose and microcrystalline cellulose, wetting the mixture carry out pre-cooked starch 10%paste, cooled to 30-35°wet granulation carry out, passing the mass through sieve granulator with a cell diameter of 6-7 mm, dry granulation is carried out, passing the mass through sieve granulator with a cell diameter of 3-4 mm, and dusting spend a mixture of talc, magnesium stearate and crospovidone when the room is based temperature.

Mixing in a dry form of the active substance is ciprofloxacin lactose and microcrystalline cellulose allows to obtain a homogeneous mixture, which is easily moistened and formed into granules.

Moistening the mixture with 10% starch paste provides good wetting of the mixture.

Passing the moistened mixture through a granulator with a cell diameter of 6-7 mm allows to obtain large granules and prevent them from overdrying during the drying process.

The implementation of the dry granulation through a granulator with a cell diameter of 3-4 mm allows to destroy the formed pellets to size, providing further good flowability and compressibility tablet mass.

The dusting mixture components with the claimed ratio allows you to get loose, easily compressible granulate.

As a result of patent trials have revealed similar solutions, suggesting the relevance of the proposed inventions criteria of “novelty” and “inventive step”. You can find application in medicine, i.e. considered to be “industrially applicable”.

The essence of the invention is illustrated by the following examples.

Example 1.

To obtain a pharmaceutical composition having antiviral activity, take the ingredients in the following ratio, wt.%: 6,84 ciprofloxacin - 61,84, microcrystalline cellulose - 7,8, lactose - 2,0, mixed and the resulting mixture is moistened pre-cooked starch 10% paste and carry out wet granulation, dry, carry out dry granulation, the granulate optivault mixture wt.%: talc - 0.1, stearate and 0.1, crospovidon - 0,1.

The obtained pharmaceutical composition does not have sufficient therapeutic activity, in addition, the amount of microcrystalline cellulose and lactose is not enough to obtain granules for tableting sufficiently loosened and good compression.

Mixture for dusting with such quantitative content of talc, magnesium stearate and crospovidone not provide good technological properties of tablet mass - flowability and pressuemosti. An effect of "sticky" tablets at a press tool, and, in addition, received the tablets do not have sufficient raspadaemost and solubility.

Example 2.

In example 1 the ratio of ingredients is, wt.%: ciprofloxacin - 65,77, microcrystalline cellulose 16,4, lactose - 6,0. The granulate optivault mixture wt.%: talc - 1.55V, magnesium stearate - of 0.25, crospovidon is 1.75.

Get a pharmaceutical composition having sufficient therapeutic activity, tableting mass with good technology with which the properties - flowability, compressibility, with no adhesion to the press when pelletizing, the resulting tablets have sufficient raspadaemost and solubility.

Example 3.

In example 1 the ratio of ingredients is, wt.%: ciprofloxacin - 669,7, microcrystalline cellulose - 25, lactose - 6.0. The granulate optivault mixture, wt.%: talc - 3.0, stearate - 0,4, crospovidon - 3,4.

Get a pharmaceutical composition having high therapeutic activity leading to the emergence of side effects experienced by patients taking the medicine. Tableting the mixture has good technological properties is too loose, poorly compacted, the resulting tablets have sufficient excess raspadaemost and solubility.

Shell for coating pharmaceutical composition was prepared as follows.

Example 1.

The ratio of ingredients to get the shell is, wt.%: film-forming substance: oksipropilmetiltselljuloza - 0,5, kollidon - 0.1, plasticizers include propylene glycol and 0.2, polyethyleneoxide - 0.1, dye: titanium dioxide is 0.1, and talc - 0,1 prevent the sticking of the tablets in the coating process.

For swelling oksipropilmetiltselljulozy and kollidon them with boiling and cold water respectively and leave to swell. Then combine estuary oksipropilmetiltselljulozy and kollidon, propylene glycol is mixed with water and added to the previous mixture of solutions. Talc and titanium dioxide pound in a mortar, add water, mix thoroughly and add to the previously obtained solution. The suspension is filtered. Coating of tablets is carried out in the boiler for applying a film coating - automatic installation company IMA (Italy).

The resulting shell does not have sufficient solubility in water, which makes the release of the active substance from the tablets, unstable when stored, not plastic, the color of the coating not intensive enough.

Example 2.

In example 1 the ratio of ingredients to get the shell is, wt.%: film-forming substance: oksipropilmetiltselljuloza - 0.75, kollidon - 0,35, plasticizers include propylene glycol - 0.6, polyethylene oxide - 0.2 dye: titanium dioxide - 0,45, and talc - 1.55V, prevent the sticking of the tablets in the coating process

The resulting membrane has good solubility in water, stable in storage tablets, color tablets intense white color.

Example 3.

In example 1 the ratio of ingredients to get the shell is, wt.%: film-forming substance: oksipropilmetiltselljuloza - 1.0 kollidon - 0.6, plasticizers include propylene glycol - 1.0, polyethylene oxide and 0.3, dye: titanium dioxide is 0.8,and talc - 3,0, prevent the sticking of the tablets in the coating process.

The resulting shell low solubility in water volatile storage, an excessive amount of plasticizer is going to increase the drying time in the coating process, which increases the duration of the process.

Thus, the pharmaceutical composition having antiviral activity, obtained by the claimed method with the claimed ratio of ingredients of the core and shell, has sufficient therapeutic activity, has an attractive appearance.

Obtaining the pharmaceutical composition is as follows.

Example 1.

In the mixer load pre-chopped, wt.%: ciprofloxacin - 61,84, microcrystalline cellulose - 7,8, lactose - 2,0, mixed for 10 min and the resulting mixture is moistened pre-cooked starch 10% paste, cooled to 30°With moistened mass is stirred for 25 min, carry out the wet granulation through a granulator with a cell diameter of 6 mm, dried, perform a dry granulation through a granulator with a cell diameter of 3 mm Granulate optivault mixture, wt.%: talc - 0.1, stearate and 0.1, crospovidon - 0.1 and tabletirujut. The obtained tablet cover gastric-soluble shell.

The ratio of ingredients shell for p the closure of tablets is wt.% oksipropilmetiltselljuloza - 0,5, titanium dioxide - 0.1, kollidon - 0.1, propylene glycol and 0.2, polyethyleneoxide - 0.1, talc and 0.1.

The obtained pharmaceutical composition does not have sufficient therapeutic activity, tableting the mixture has technological properties, providing sufficient flowability and compressibility. At this temperature, the paste has a high viscosity, which affects the wettability of the mixture pararescuemen ingredients and increases the mixing time. Granules after wet granulation through a pellet mill with a 6-mm cells are not quite sturdy and large and get too dry during the drying, and after the dry granulation through a pellet mill with a 3 mm cells there is an excessive amount of fines. In addition, the shell coating does not possess plasticity and surface tablets after coating is not enough glansevin.

In the mixer load pre-chopped, wt.%: ciprofloxacin - 65,77, microcrystalline cellulose 16,4, lactose - 6,0, mixed for 10 min and the resulting mixture is moistened pre-cooked starch 10% paste, chilled to 32.5°With moistened mass is stirred for 15 minutes, carry out the wet granulation through a granulator with a cell diameter of about 6.5 mm, dried, perform a dry granulation h is the cut pellet with a diameter of cells in the 3.5 mm. The granulate optivault mixture, wt.%: talc - 1.55V, magnesium stearate - 0.2, crospovidon is 1.75 and tabletirujut. The obtained tablet cover gastric-soluble shell. The ratio of ingredients membrane for coating of tablets is, wt.%: oksipropilmetiltselljuloza - 0.75, titanium dioxide - 0,45, kollidon - 0.35 propylene glycol - 0.6, polyethylene oxide is 0.2, talc - 1.55V.

The obtained pharmaceutical composition has a sufficient therapeutic activity, tableting mass has good technological properties, providing sufficient flowability, compressibility. At this temperature, the paste has a reduced viscosity, which increases the wettability of the ingredients of the mixture and reduces the mixing time. Granules after wet granulation through a granulator with a 6.5-mm cells obtained sufficient size not to be too wet, but once dry granulation through a granulator with a 3.5-mm cells is quite strong and loose. The shell coating has plasticity, surface tablets after coating glansevin, aesthetic.

Example 3.

In the mixer load pre-chopped, wt.%: ciprofloxacin - 69,7, microcrystalline cellulose 16,4, lactose - 6,0 mixed for 10 min and the resulting mixture is moistened pre-cooked starch 10% paste, Oh Addendum to 35° With moistened mass is stirred for 15 minutes, carry out the wet granulation through a granulator with a cell diameter of 7 mm, dried, perform a dry granulation through a granulator with a cell diameter of 4 mm Granules optivault mixture wt.%: talc - 3.0, stearate - 0,4, crospovidon - 3,4 and tabletirujut. The obtained tablet cover gastric-soluble shell. The ratio of ingredients membrane for coating of tablets is, wt.%: oksipropilmetiltselljuloza - 1.0, titanium dioxide - 0.8, kollidon - 0.6 propylene glycol - 1.0, polyethylene oxide - 0.3, and talc - 3,0.

The obtained pharmaceutical composition has a high therapeutic activity, which can lead to side effects experienced by patients taking the medicine, the tableting properties of mass worsen, do not provide sufficient flowability, compressibility. At this temperature, the paste has a low granulomatosa ability that allows you to get a strong enough granules. Granules after wet granulation through a pellet mill with a 7-mm cells obtained large size that does not provide them with adequate hydration, and after the dry granulation through a pellet mill with 4-mm cells is sufficiently dried. Shell to cover too plastic, which increases the drying time of the coating process. An excessive amount of plantours the participating components leads to an increase in time of dissolution of tablets and poor bioavailability.

Thus, the pharmaceutical composition having antiviral activity, obtained by the claimed method with the claimed ratio of ingredients kernel has sufficient therapeutic activity, have good solubility and raspadaemost when taken ill, has an attractive appearance due to the plastic coating, glossy, white shell.

1. Pharmaceutical composition having antiviral activity, in the form of a solid dosage form that includes a core containing the active substance is ciprofloxacin and as excipients microcrystalline cellulose, crospovidone, magnesium stearate and corn starch, wherein the core further comprises talc and lactose in the following ratio of ingredients, wt.%:

Ciprofloxacin 61,84-69,7

Microcrystalline cellulose 7,8-25

Crospovidon 0,1-3,4

The stearate of 0.1-0.4

Lactose 2,0-10

Talc 0,1-3,0

Corn starch Else

in this case, the core coated, taste masking of ciprofloxacin and contains oksipropilmetiltselljuloza, titanium dioxide, kollidon, propylene glycol, polyethylene oxide and talc, with the following ratio of ingredients shell, % by weight of the total composition:

ACS is prophylatically 0,5-1,0

Titanium dioxide 0,1-0,8

Kollidon 0,1-0,6

Propylene glycol 0.2 to 1.0

The polyethylene oxide of 0.1-0.3

Talc 0,1-3,0

2. A method of obtaining a pharmaceutical composition having antiviral activity, in the form of a solid dosage form according to claim 1, comprising a core containing the active substance is ciprofloxacin, coated, taste masking of ciprofloxacin, including the preparation of the masses for tableting by mixing powdered ingredients, moistening the mixture, wet granulation, drying, dry granulation, powder, tabletting and coating sheath, in which the active substance is ciprofloxacin mixed with lactose and microcrystalline cellulose, wetting the mixture carry out pre-cooked starch 10%paste, cooled to 30-35°wet granulation carry out, passing the mass through sieve granulator with a cell diameter of 6-7 mm, dry granulation is carried out, passing the mass through sieve granulator with a cell diameter of 3-4 mm, and dusting spend a mixture of talc, magnesium stearate and crospovidone at room temperature.



 

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