Intersolubility sheath and method of coating a shell of solid pharmaceutical compositions

 

(57) Abstract:

The invention relates to chemical-pharmaceutical industry, namely intersolubility shell of solid dosage forms having two layers, one of which contains a film-forming component, and a second plasticizer, dye and technological additives. Shell effectively retains therapeutic properties of the active substance. 2 C. and 7 C.p. f-crystals.

The invention relates to chemical-pharmaceutical industry, in particular drugs and medicines for therapeutic purposes, namely medical preparations characterized by special physical form, in particular to the shells of solid pharmaceutical forms.

Renowned pharmaceutical composition suitable for single oral administration in the form of tablets, containing an inner core in the amount of 10-45% by weight of the tablet, which contains a biologically active compound and a pharmaceutically acceptable carrier, corroded polymer layer comprising 30-85% by weight of the tablet (RF application 95104236. Publ. 10.11.1997,).

Known composition of rapamycin for oral administration, containing the core and external sugar pokrytie, and (C) one or more sugars (RF application 98104946. Publ. 27.01.2000 year).

Known oral pharmaceutical compound isolated in form of tablets containing excipients for tablets and individually covered with layers Intercollege coating unit of the core material (RF application 96107115. Publ. 27.07.1998 year).

Known composition for the application of pas compressed pharmaceutical tablet containing sugar, hormonal steroid in an amount of 0.1-20 wt.% and microcrystalline cellulose in an amount of 0.1-3 wt.% (U.S. Pat. RF 2152207. Publ. 10.07.2000,).

A method of obtaining a tablet form of the drug, in which the tablet form of the drug is applied film coating consisting of a mixture of methylcellulose-8, titanium dioxide and tropeolin About at a ratio of one tablet, wt.%: 63,80:33,60:2,60 (U.S. Pat. RF 2123330. Publ. 20.12.1998 year).

Renowned pharmaceutical composition having anti-ulcer activity, in the form of a solid dosage form in which the shell composition comprises a copolymer of methacrylic acid, polyethylene glycol and titanium dioxide (U.S. Pat. RF 2155035. Publ. 27.08.2000 year).

There is a method of coating on the dosage form of enteric-soluble coating to the er - polyvinylacetate, derivatives of cellulose and other , loosening means, thickening agents, alkaline agents, antifoams, plasticizers and pigments. The coating process is carried out by sputtering technique, and pharmacodynamics of the drugs depends on the compounds contained in the coating composition, its thickness and nature of the active ingredients and auxiliary agents (U.S. Pat. USA 6013282. Publ. 11.01.2000,).

There is a method of making a composition for coating drugs, in which granules applied three layers, the first layer contains triglyceride fatty acid, then a layer composed of a mixture of the above triglyceride fatty acids and a complex ester of phthalic acid and a derivative of cellulose, soluble in water at pH>4,5, and ester is a phthalate of oksipropilmetiltselljulozy and the middle layer represents the specified triglyceride fatty acid content of ester 10-95 wt.%, and the total amount of coverage is 50-90% by weight of the total finished product (U.S. Pat. SU 1836082. Publ. 23.08.93 year).

However, the known method of making a composition for coating drugs is rather time-consuming and expensive because of the use for palupi drawing the shell solid pharmaceutical form tablets.

The present invention is to develop intersolubility shell and method of coating a shell of solid pharmaceutical compositions, which will allow for a relatively simple technology to create a comfortable and pleasant for the patient drug and at the same time to maintain the desired concentration of the active substance from the action of gastric juice and also protect the gastric mucosa.

The problem is solved in that intersolubility shell containing film-forming component, plasticizers, colorants and processing AIDS, in which the mixture is sprayed on the solid pharmaceutical form that has two layers, one of which consists of a mixture comprising film-forming component, and the second consists of a mixture in which add a plasticizer, dye and technological additives for application which use the method of coating a shell of solid pharmaceutical compositions, comprising preparing and spraying of solutions, in which a preheated core of solid pharmaceutical forms spraying the first solution comprising a film-forming component, and then spraying a second solution, include the completion of the spraying, and then have it increase by 10-15oFor drying, after which the cores coated with intersolubility shell cool.

In the embodiment of the invention, the receiving quality coverage at optimized process reach if for the first layer intersolubility shell as a film-forming component used acetylcellulose (AFC), and the second layer is a mixture AFC, titanium dioxide and castor oil, with one solid pharmaceutical form component ratio, wt.%: acetylcellulose 82,00-82,33; castor oil 7,00-7,06; titanium dioxide 10,00-or 10.60, the proposed composition of gain, using the two solutions, while for solution 1 as a film-forming component use pre-swollen in acetone AFC, and for solution 2 use the first solution, to which is added a colorant and a plasticizer in accordance with the component ratio, wt.%: a solution of 1 - acetylcellulose a 5.25-5,4; alcohol 21,5-22; acetone 72,5-73, and a solution of 2 - acetylcellulose 4,8-5,0; alcohol 19,0-19,5; acetone 74,5-75,0; castor oil 0,11-0,12; titanium dioxide 0,25-0,30, with alcohol and acetone in the enta to use a copolymer of methacrylic acid, in this embodiment, processing AIDS should represent a mixture of the colorant is titanium dioxide, the plasticizer is castor oil and polyethylene oxide, in addition, it can be entered "separator" and anti-foam emulsion, to prepare a water dispersion varnish as a film-forming component used is a copolymer of methacrylic acid, and for the preparation of pigment dispersion using castor oil, polyethylene glycol, talc, titanium dioxide and silicone emulsion, then lacquer the aqueous dispersion is mixed with the pigment dispersion in the ratio of 1:1 and applied to a solid pharmaceutical composition.

To prevent sticking, gluing of solid pharmaceutical compositions when applied to them intersolubility shell suitable as a "separator" to use talc, and as anti-foam emulsion, silicone emulsion, when this composition on one of the solid pharmaceutical composition should be, wt.%: copolymer of methacrylic acid 45,00-45,15; titanium dioxide 5,00-5,88; castor oil 3,00-3,71; polyethylene oxide 14,00-14,22; talc 30-30,92; silicone emulsion 0,69-0,72.

It is advisable to save devochki was no more than 5-6% of the average weight of the solid pharmaceutical compositions.

Perhaps intersolubility shell to put on a solid pharmaceutical composition in the form of tablets and granules.

Patented intersolubility membrane and a method of coating a shell of solid pharmaceutical compositions explain the detailed description and specific embodiments of the invention.

Patentable invention is as follows.

Intersolubility shell cover finish solid pharmaceutical composition in the form of tablets and granules. The thickness of the offer intersolubility shell is microns and visually it is almost not visible on cross-section of solid pharmaceutical forms. The weight of the shell is 5-6% of the average weight of the solid pharmaceutical composition, which provides the quantitative composition of the kernel depending on the age aspect (adult - 0.25 g or baby 0.1 g). In addition, the specified percentage helps to protect the stomach from the action of the active substance and to save the action to the intestine.

For applying intersolubility shell to solid pharmaceutical compositions used cooked on a specific technology relatoria prepared in accordance with the claimed invention, and spray.

When using intersolubility shell based on organic ingredients pre-prepared mixture AFC in acetone, which is then used in solutions 1 and 2. For mixing the latter are in charge of different proportion AFC and acetone, mix and leave for 24 hours to swell.

After swelling in the mixture solution 1 add acetone, ethyl alcohol in the ratio, wt.%: acetone 73, alcohol 22, AFC 5,4.

To obtain the solution of 2 in the swollen AFC pour acetone, ethyl alcohol, also add a plasticizer, which is obtained by dissolving in acetone castor oil, and dye, which is injected into the solution in the form of a suspension obtained after grinding the titanium dioxide in a small amount of acetone. Mix all together. When this component take part in the match, wt. %: AFC 4,8, titanium dioxide of 0.3, acetone, 75, alcohol 4,8, castor oil 0,12. Alcohol and acetone in the preparation of the solutions evaporate and applied intersolubility shell is missing.

Solid pharmaceutical composition in the form of tablets, granules, the core of which is the drug pre-dedust and place in which the temperature of the inlet air 35-45oS. of Tablet cores were heated for 10 min warm air when rotating couture. The air pressure on the spray system is 1.6 ATM. Then through a nozzle serves him the prepared solution 1. Similarly served previously prepared solution of 2 and increase the speed of Kotera. Thus increasing the temperature of the inlet air. After filing a solution of 2 tablets coated with intersolubility shell is dried, maintaining the temperature of the tablets 40oC. After drying, the tablets intersolubility shell is cooled to a temperature of 18-20oWith and unload.

When applying intersolubility membrane-based water dispersion as a film-forming ingredient used is a copolymer of methacrylic acid. Required a 30% aqueous dispersion can be prepared from a powder Eudragit 100-55 or Collicut MAY 100P.

The aqueous dispersion obtained from powder Eudragit 100-55, wetting it without the formation of lumps of water, mixing them with the addition of a mixture of alkali solution.

The aqueous dispersion of the powder Collicut MAE 100 P receive, wetting it with water without forming lumps, and then stirring the mixture to obtain her uniform status is I varnish aqueous dispersion.

Pigment dispersion receive, mixing the plasticizer in the form of a mixture of castor oil 0.1 wt. % of polyethylene oxide of 0.5 wt.%, "separator" in the form of talc 1.1 wt.% and anti-foam emulsion, which is a silicone emulsion. The component ratio of the variance is wt.%: copolymer of methacrylic acid 1,6; titanium dioxide 0,2; castor oil 0.1; polyethylene oxide of 0.5; talc 1,1; silicone emulsion 0,004; the rest is water.

Water lacquer dispersion is stirred slowly with pigment dispersion in the ratio of 1:1 and put the resulting composition for solid pharmaceutical composition.

Application of the obtained composition intersolubility membrane-based water dispersion carried out using the automatic installation JI es(GS) HT/M 150 Coating Systems. Tablets or granules pre-dedust and placed in the boiler installation. Give effect to the spray system. This sets the temperature of the inlet air 55-65oWith the speed of rotation of the boiler 3 rpm, the air pressure in the sputtering system of 1.6 ATM and heat kernel tablets, granules to a temperature of 45-50oC. Heating of the complete submission of the film-forming solution with a rate of 300 ml/min After the filing of 20 liters of the thus increase the temperature of the inlet air 70oC. After the filing of a just solution of the solid pharmaceutical composition is dried for 40 minutes at a temperature of inlet air to the 60oC and the temperature in tablets, granules 40oC. Then, tablets, granules, cooled to a temperature of 20-25oWith and unload.

Examples of patentable inventions.

Example 1, in which the film-forming component used acetylcellulose (AFC).

For solution 1, using electronic scales PV-30 weighed LFC in the amount of 1.2 kg, poured into an enamel tank capacity 15 l, poured acetone in an amount of 4.0 liter, stirred it up with a shovel, left for a day (24 h) for swelling.

For solution 2, using electronic scales PV-30 prepared sample AFC in the amount of 4.0 kg, poured into an enamel tank capacity 15 l, poured acetone in an amount of 10.0 l, shuffled scapula, left for a day (24 hours) for swelling.

Then the reactor was filled to 20.0 l of acetone, added swollen AFC for solution 1, and when the stirrer was filled with 6.0 liters of ethyl alcohol. This will be the solution of 1 in the amount of 30.0 l For solution 2 in the reactor was filled to 68.0 liters of acetone, added swollen AFC for whom and by dissolution of 0.13 kg of castor oil in 2.0 l of acetone, added to a solution of 2 with constant stirring. Then he took a sample of titanium dioxide on electronic scales PV-30 in number 0,211 kg and portions were ground in a mortar with a small amount of acetone (0.5 to 0.1 l). The resulting solution of castor oil and a suspension of titanium dioxide combined with a solution UFC and mixed for 30 minutes It will be the solution of 2 in the amount of 100 liters

Tablet cores in the amount of 100 kg pre-dedust and placed in the boiler installation. Enter the distribution system. Set the temperature of the inlet air 35-45oWith the speed of rotation of the boiler 3 rpm, air pressure on the spray system of 1.6 ATM. Tablet cores were heated for 10 min to a temperature of 25-27oC. After warming up include the submission of a solution of 1 with a film-forming component AFC in the amount of 30 l with a rate of 300 ml/min for 100 minutes For solution 1 solution serves 2 in the amount of 80 l with a speed of 500 ml/min and increase the speed of rotation of the boiler up to 5 Rev/min the temperature of the inlet air to increase 45-49oC. After the solution supply 2 for 160 min tablets are dried for 40 minutes at a temperature of inlet air 45-49oWith temperature and tablets 38-40oC. Then, the coated tablets enterocci check using a solution of 0.06 mol/l hydrochloric acid.

Example 2, in which the film-forming component used is a copolymer of methacrylic acid.

Pre-prepared 30% aqueous lacquer dispersion of Eudragit L 30 D of the powder Eudragit 100-55.

Eudragit L 30 D received by redispersible powder Eudragit 100-55. Redispersion Eudragit 100-55 held in a glass with a volume of 2 liters was Added to a glass of 700 ml of water and portions made 300 g Eudragit L 100-55, just moistening the powder without forming lumps. Within 10 min were mixed, then drops were added 100 ml of a 1 N solution Paon, followed by stirring for 30 minutes Obtained from a powder dispersion was used as purchased water dispersion of Eudragit L 30 d

During execution of the method is possible using 30% aqueous lacquer dispersion of the powder Collicut MAY 100 P.

Redispersion Collicut MAE 100 P held in the Cup by volume of 2 l without the addition of alkali. In a glass poured water 700 ml portions were introduced 300 g of the powder Collicut MAE 100 P, moistening the powder without forming lumps. Stirred the mixture for 1 h

The coating used pigment dispersion, kesuki small portions was added castor oil 30 g and 40 g of polyethylene glycol-4000 (PEG 4000). Then add the talc 25 g, titanium dioxide 15 g, last added silicone anti-foam emulsion CE mark 10-16(TU 6-02-810-73). The mixture for 5-10 min homogenized using a mixer Ultra - Turrax, type TR 118710 (Germany).

The pigment dispersion is prepared the day before the operation, so that the air is completely absorbed vanished.

Function talc is the "separation" of substances. It reduces the stickiness of drying of the varnish film. The talcum powder should be, as far as possible, fine (with a particle size of about 15 microns). Titanium dioxide (particle size of 5-20 μm) was used to give a uniform color film coating. In order to increase the plasticity of the film composition was injected plasticizer (castor oil and polyethylene glycol 4000), that ensure timely stress relaxation in the process of film formation.

Immediately before use pigment dispersion was mixed with 30 wt.% lacquer aqueous dispersion in the ratio of 1:1 with slow stirring.

Application of the obtained composition intersolubility membrane-based water dispersion carried out using the automatic installation JI es(GS) HT/M 150 Coating Systems. For example, typicially system. Set the temperature of the inlet air 55-65oWith the speed of rotation of the boiler 3 rpm, air pressure on the spray system of 1.6 ATM and warm up the tablet cores to a temperature of 45-50oC. After warming up include the submission of a film-forming solution intersolubility shell with a speed of 300 ml/min After the filing of 20 l of a solution increases the speed of rotation of the boiler up to 5 rpm, and the feed rate of the coating solution to 500 ml/min While increasing the temperature of the inlet air 70oC. After the filing of a just solution of the tablets are dried for 40 minutes at a temperature of inlet air to the 60oC and the temperature in tablets 40oC. After drying, the tablets are cooled to a temperature of 20-25oWith and unload.

Offer intersolubility sheath and method of applying such a membrane will increase its output of finished pharmaceutical products in the form of tablets in a convenient and pleasant for consumers form.

Patented intersolubility sheath and method of application should prevent the bitter taste of the active substance is a solid pharmaceutical composition, prolonging its action during transport through the stomach and protect the mucous membrane.

Cu the century This intersolubility shell from the nucleus mass is 5-6%, which is almost invisible, but strong to acidic layer and cross section solid pharmaceutical forms little visually distinguishable from the kernel. Ready solid pharmaceutical composition, covered intersolubility sheath of the proposed method are white or white with a slight grayish hue.

Offer intersolubility membrane and its preparation can be used for the manufacture of finished pharmaceutical products from duly registered domestic substances active principle, and imported.

1. Intersolubility shell containing film-forming component, plasticizers, colorants and processing AIDS, for application to a solid pharmaceutical composition, characterized in that it has two layers, the first of which consists of a film-forming component, the second of the film-forming component, a plasticizer, colorant and additives.

2. Intersolubility shell under item 1, characterized in that as the film-forming component, it contains acetylcellulose (ACF), with the components; is astrove oil - 7,00-7,06; titanium dioxide - 10,00-or 10.60.

3. Intersolubility shell under item 1, characterized in that as the film-forming component it contains methacrylic acid copolymer, and as a technological additive is a mixture of the colorant is titanium dioxide, the plasticizer is castor oil and polyethylene oxide, "separator" and anti-foam emulsion.

4. Intersolubility shell under item 3, characterized in that as a "separator" use talc, and as anti-foam emulsion, silicone emulsion, while the composition of one solid pharmaceutical form is, wt.%: copolymer of methacrylic acid - 45,00-45,15; titanium dioxide - 5,00-5,88; castor oil - 3,00-3,71; polyethyleneoxide - 14,00-14,22; talc - 30-30,92; emulsion silicone - 0,69-0,72.

5. Intersolubility shell under item 4, characterized in that its weight is not more than 6% of the average weight of the solid pharmaceutical forms.

6. Method of coating solid pharmaceutical composition intersolubility shell, comprising preparing and spraying the solution on the solid core, wherein a preheated core of solid pharmaceutical forms when th temperature spraying the second solution, includes film-forming component, a plasticizer, a dye, and processing AIDS, with the consequent increase of the temperature at 15-20oFor drying, after which the cores coated with intersolubility shell cool.

7. The method according to p. 6, characterized in that as the film-forming component used acetylcellulose, as pigment - titanium dioxide, and as a plasticizer is castor oil in the following ratio of components in solutions, wt.%:

in the first solution:

Acetylcellulose - 5,25-5,4

Alcohol - 21,5-22

Acetone is 72.5-73

second solution:

Acetylcellulose - 4,8-5,0

Alcohol - 19,0-19,5

Acetone is 74.5-75,0

Castor oil - 0,11-0,12

Titanium dioxide - 0,25-0,30

while alcohol and acetone in the process of coating removed.

8. The method according to p. 6, characterized in that as the film-forming component used is a copolymer of methacrylic acid, thus preparing a 30% water dispersion varnish and pigment dispersion, which is used for making castor oil, polyethylene glycol, talc, titanium dioxide and silicone emulsion, and then they are mixed in the ratio of 1:1 and applied to solid parmeet solid pharmaceutical form, made in the form of tablets or granules.

 

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