JPS625403B2 - - Google Patents

Description

[Detailed description of the invention]

The present invention relates to a colored solid product having at least one conspicuous imprint and a process for making it. In order to make the present invention easier to understand, two expressions used herein are defined below:
“Imprinted product”: The word “imprinted” is related to the word “intaglio”, which means an image or mark placed into any solid material. In some dictionaries, the word "integrated" is defined as "incised" or "engraved". In this specification, the expression "engraved product" Compression punching, incision or engraving method on the surface of the product,
or a solid article having at least one image, indicia or indicia, or any combination thereof, formed by any other method producing a similar effect. “Optically anisotropic substance”: An anisotropic substance is one that exhibits different properties or effects in different directions. As used herein, the expression "optically anisotropic material" means any material that exhibits different refractive indices in different directions and has a minimum refractive index of 2.00 or less. Various methods are used in the pharmaceutical industry to imprint product names, active ingredient information, company identification marks, and/or similar information on the surface of unit dosage forms, such as tablets. For example, some known methods include providing coated unit dosage forms, such as printed information on coated tablets. Other methods include the use of imprinted unit dose forms, where the information, etc. is present in the form of an imprint on the surface of the dosage form. In the methods described above that include printed information, etc., the information, etc. can be applied in one or more colors. However, printing is a relatively difficult, slow and expensive process and involves the use of specialized machinery. In contrast, the process of the present invention involves the use of a variety of coating equipment widely used in industry, is a cheap and rapid process, and the resulting product is similar to that obtained by the printing-involving process described above. better than. With the above-mentioned known methods involving stamping, it has not heretofore been possible to produce stamped unit dosage forms in which the stamp is a different color from the rest of the dosage form. The present invention obviates this drawback. Colored (i.e. not white) and stamped tablets (which may or may not already have a coating) are placed in an optically anisotropic coating in a perforated coating drum with side openings. It has been found that upon coating with a film consisting of a substance and a film-forming agent, the color of the non-imprinted portion of the tablet changes very slightly from its original color, but the imprint becomes contrastingly colored and therefore more noticeable. did. The scientific explanation for the results obtained appears to be as follows, although it is not certain that this explanation is correct, and the scope of the invention is in no way limited to this explanation: The optically anisotropic material is oriented within the coating on the non-stamped portion of the tablet such that its refractive index is similar to that of the coating, i.e. the coating appears nearly transparent, while the optically anisotropic material is The anisotropic material is oriented within the coating such that its refractive index exceeds the refractive index of the coating, ie, the coating appears relatively opaque. The real effect is therefore that the inscription is clearly and conspicuously shown against the colored background, making the engraved information easier to read. It is known that optically anisotropic substances such as calcium carbonate, magnesium carbonate, sutucarose or lactose are included in coating compositions, but such coating compositions can also be colored to make the imprint more visible. The application of stamped products, such as colored and stamped tablets, is neither known nor obvious. The invention has wide applicability and is not limited solely to the pharmaceutical field. For example, in the field of veterinary medicine,
Applications, for example in the production of veterinary pills (i.e. veterinary tablets) or in the confectionery industry, e.g. in the production of sugar confectionery (i.e. sweets or candy) and in other areas requiring stamped products with noticeable markings. be able to. Colored products herein are to be understood as representing non-white products. According to the invention, a colored solid product having at least one noticeable imprint is obtained, the product comprising:
It consists of a colored and engraved article having at least one layer of a coating containing at least one optically anisotropic substance with a minimum refractive index of less than or equal to 2.00 and at least one film-forming agent. Products that are colored and stamped prior to the application of the coating that is a feature of the invention may be uncoated. For example, the product may be an uncoated pharmaceutical tablet or veterinary pill. Alternatively, the product, which is colored and stamped prior to the application of the coating that is a feature of the invention, may have at least one layer of coating, for example the product may be coated pharmaceutical tablets or veterinary pills or coated It may be sugar confectionery. The coating that may be present on the product prior to application of the coating that is a feature of the invention may be any film-forming agent(s) known in the art, such as cellulose ethers, such as methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropyl It may consist of cellulose, hydroxypropylmethylcellulose or sodium carboxymethylcellulose or mixtures thereof or cellulose acetate phthalate, hydroxypropylmethylcellulose phthalate, polyvinyl acetate, polyvinyl acetate phthalate, cellulose acetate, shellac or acrylic resins or mixtures thereof. The coating, which may optionally be present, may contain one or more auxiliaries customary in the coating art, such as plasticizers, surfactants and/or waxes. The optional coatings are applied in a conventional manner using conventional equipment (see below) and using organic solvent-based coating methods, such as those involving mixtures of methylene dichloride and methanol, or aqueous coating methods. The color characterizing the stamped product before applying the coating according to the invention may be present throughout the product;
Alternatively, it may be applied to the surface of the product. i.e. the colored substance, for example the colored pharmaceutical or veterinary agent or coloring agent in the case of products with pharmaceutical or veterinary markings, may be present throughout the product, or the coloring agent may be present as such or in the form of a colored film. May be applied to the surface of the product. For general purposes in the field;
Any conventional coloring agent, e.g. approved for pharmaceutical use, e.g. iron oxide (red, yellow or black), carmine, natural dyes, e.g. turmeric or beta-carotene, water-soluble dyes, e.g. tartrazine or water-soluble dye aluminum lake. or mixtures of any of these may be used, optionally mixed with at least one opaque, white pigment, such as titanium dioxide. The following general description of optically anisotropic materials, film-forming agents and colorants that can be used in accordance with the present invention is made in the singular for ease of reading and understanding; It is to be understood that mixtures of two or more optically anisotropic substances, film-forming agents and/or colorants also apply. According to the invention, the optically anisotropic substance is used in powder form. Suitable optically anisotropic substances include, for example, white optically anisotropic substances, such as the known transparent, white pigments (also known as "extender pigments" or "inert" white pigments), Examples include aluminum hydroxide, chia clay (kaolin), talc, calcium carbonate or barium carbonate. Other suitable optically anisotropic substances are magnesium carbonate (light or heavy form), sucrose, lactose or tartaric acid. Alternatively, in the case of pharmaceutical tablets or veterinary pills, the pharmaceutical or veterinary drug present therein may be used as an optically anisotropic substance. Thus, pharmaceutical or veterinary agents are used in a dual role, as active substance in tablets or pills and as optically anisotropic substances. Suitable film-forming agents for use in the coatings (layers) characterizing the invention are those described above. As mentioned above, optically anisotropic materials have a minimum refractive index of 2.00 or less. This selection of materials applies together in that optically anisotropic materials should be used with a minimum refractive index the same as or similar to that of the film-forming agent (i.e. in the same coating suspension). in)
Depends on film forming agent. It is advantageous to use optically anisotropic materials with a maximum refractive index as different as possible from the minimum refractive index, as this gives the best visual results. Details regarding representative materials used in accordance with the present invention are as follows: Film Forming Agent Refractive Index Methylcellulose 1.50 Ethylcellulose 1.47 Hydroxyethylcellulose 1.51 Hydroxypropylcellulose 1.56 Hydroxypropylmethylcellulose 1.49 Sodium Carboxymethylcellulose 1.52 Cellulose Acetate 1.48 Cellulose 1.52

Table: The amount of optically anisotropic material applied depends on the degree of color contrast required, the refractive index of the material and the particle size. For example, if the film-forming agent is hydroxypropyl methylcellulose and stamped tablets are used as starting material, and they themselves have a red or black iron oxide colored film, the optical The amount of anisotropic material varies within 0.1-1.0% (w/w of tablet weight)
(as %). In the case of corresponding tablets with a pastel-colored coating, the amounts mentioned are from 0.5 to
It is 5.0%. Almost three times as much heavy magnesium carbonate is required as compared to light magnesium carbonate to achieve the same effect. The mixture of optically anisotropic substances and film-forming agents can be prepared using film-forming aids commonly used in the coatings industry, such as plasticizers,
For example glycerin, propylene glycol, polyethylene glycol, diethyl phthalate, glyceryl monostearate or castor oil and surfactants such as polyoxyethylene sorbitan monooleate (“Tween” 80 (Tween is a trademark)) and waxes such as honey. It may contain one or more waxes or carnauba waxes. Alternatively or additionally, the mixture may optionally contain at least one colorant, for example one or more of the colorants listed in detail above.
Thereby, at least one optically anisotropic substance
of a color substantially similar to that described below with respect to the situation where there is at least one additional layer of a coating (layer) comprising at least one coloring agent on the coating (layer) of the seed and at least one film-forming agent. It is possible to obtain a combination. The article of the invention may have at least one additional layer on top of the layer consisting of at least one optically anisotropic substance and at least one film-forming agent. This latter coating (layer) (hereinafter referred to as the "outer layer") contains one or more conventional film-forming agents and optionally one or more conventional film-forming aids as described above, and is applied in a conventional manner. be done.
The outer coating (layer) may further include at least one colorant to provide at least one colored outer coating. If more than one such coating is present, each such coating may contain the same or different colorant(s). [ “Encyclopaedia Britannica”
Micropaedia, Vol. 1974, 22]. A large number of color combinations are thus possible, and the markings are usually visible as bluish areas of color in the outer coating. If the main color of the product and the color of the outer film (layer) are so-called extra colors (see the above-mentioned literature), the main product will appear black and the marking will be a pastel color (i.e., the color of the outer film (layer)). visible as a pale white area). According to one embodiment of the invention, therefore, (a) the first
(b) at least one optically anisotropic substance, at least one film-forming agent, and optionally the colored and stamped product of (a); at least one layer of at least one colorant of the same or different color, and on the outside of this layer (c) at least one film-forming agent and (a) of the colored and stamped product. A colored and engraved product is obtained which has at least one coating of at least one colorant of the same or different color. Another embodiment of the invention consists of a colored, stamped, solid pharmaceutical or veterinary unit dosage form, such as a tablet or pill, containing at least one pharmaceutical or veterinary agent and at least one optically different It is characterized in that it has at least one layer of a tropic substance, at least one film-forming agent and optionally at least one film-forming auxiliary agent known in the coatings industry. As stated above, the invention has wide applicability and therefore the precise nature of the pharmaceutical or veterinary agent is not important. Another embodiment of the invention comprises a colored and imprinted product of sugar confectionery contained in the common name: sweets or candy, comprising at least one optically anisotropic substance.
It is characterized in that it has at least one layer consisting of a seed, at least one film-forming agent, and optionally at least one film-forming aid known in the coatings industry. (a) the above-mentioned coating (layer) comprising at least one optically anisotropic substance and at least one film-forming agent; and (b) any coating applied to the outside of (a). It is understood that the (layer) is transparent or translucent (provided that the coating (layer) (a)
appears opaque within the engraving). That is, those skilled in the art will recognize that in order to obtain the desired results of the present invention, it is necessary for the observer to be able to see through the coating within the inscription to a reasonable degree. According to another feature of the invention, a method is provided for producing a colored solid product having at least one conspicuous imprint, which method may itself be coated or uncoated. A film coating suspension consisting of at least one optically anisotropic substance with a minimum refractive index of 2.00 or less and at least one film forming agent is applied to the product, and this process is applied to the product by frictional action between the coated products. It consists of being carried out in conventional coating equipment such that The colored and engraved products used as starting materials may be manufactured using known materials in any known manner. For example, solid pharmaceutical or veterinary unit dosage forms, such as tablets or pills, may be manufactured in conventional manner using conventional excipients and suitable active agents. the optically anisotropic substance and the film-forming agent applied together, and any film-forming aids and/or
Alternatively, the colorant is applied in the form of a coating suspension, which may be an organic solvent-based suspension, for example, where the solvent is a mixture of methylene dichloride and methanol, or an aqueous suspension. If all components are water-soluble, they should be applied in an organic solvent-based suspension. The coating method can be carried out using conventional coating equipment or machines, such as coating pans or coating drums, such as perforated coating drums with side openings;
Alternatively, it is carried out using a so-called Wurster coating device (fluidized bed coating device). The frictional action between the applied stamped products is that which normally occurs between coated products in any conventional film application equipment or machine, and is a necessary feature of the method of the present invention. Next, the present invention will be explained in detail with reference to Examples, but the present invention is not limited thereto. Placebo tablets are those that do not contain medicine, and pharmaceutical tablets are those that contain medicine. Example 1: Coated with a film colored with red iron oxide,
Batches of 50,000 200 mg stamped white tablets (a mixture of placebo and pharmaceutical tablets) were placed in a perforated coated drum with side openings [24 inch Accela-Cota mas-chine; Manesty
Manufactured by Machines Ltd. Lives in Speke, Liverpool 20, UK. ) and heated to 60°C. Hydroxypropyl methylcellulose containing 1 w/v % glycerin and suspended calcium carbonate (30 g) [“Pharmacoat” trademark 606, Shin-Etsu Chemical
Company Limited, Tokyo, Japan〕5w/v%-
Aqueous solution 4 was sprayed using a low pressure air spray unit.
It was applied continuously at 50ml/min. The speed of the drum is
Maintain the speed at 16 rpm, and the temperature of the dry air at the inlet is 60℃.
I kept it. Once all the suspension has been applied, stop the drum and remove the tablets. Tablets with a reddish-brown coating and a white, noticeable marking were thus obtained. Example 2 Tablets are used as starting materials which have been coated with a coating colored with a mixture of carmine and titanium dioxide, and the coating suspension to be applied consists of light magnesium carbonate (60 g) in addition to calcium carbonate and polyethylene instead of glycerin. glycol 1w/v
The method of Example 1 was repeated except that %. This gave pink coated tablets with white noticeable markings. Example 3 200 coated with red iron oxide
A batch of 50,000 mg stamped white tablets (a mixture of placebo and pharmaceutical tablets) with an opening on the side.
It was heated to 60°C in a perforated coated drum (24 inch - Accelerator Coater machine). Glycerin 0.4w/v
2 w/v of hydroxypropyl methylcellulose (“Fumacoat” 606) in methylene dichloride/methanol (70:30 v/v) with % and aluminum hydroxide (90 g) suspended.
% solution was applied continuously at 250 ml/min using a high pressure airless spray unit. Keep the drum speed at 20rpm and the temperature of the drying air at the inlet.
It was kept at 60℃. When all of the suspension had been applied, the drum was stopped and the tablets were removed. In this way, tablets with a reddish-brown coating and a noticeable white marking were obtained. Example 4 Batches of 50,000 200 mg stamped, carmine-colored tablets (mixture of coated placebo tablets and uncoated pharmaceutical tablets) were placed in a perforated coating drum with openings on the side (24 inch - Accelerator Coater machine) for 60 ℃
heated to. A 5 w/v % aqueous solution of hydroxypropyl methylcellulose (“Fumacoat” 606) containing 1 w/v % glycerin and dispersed light magnesium carbonate (30 g) was added at 50 ml/min using a low pressure air spray unit. Applied continuously. Keep the drum speed at 16rpm,
And the temperature of the dry air at the inlet was maintained at 60℃. When all of the suspension had been applied, the drum was stopped and the tablets were removed. This gave pink coated tablets with white noticeable markings. Example 5 Approximately 100 colored, coated and stamped tablets (mixture of placebo and pharmaceutical tablets) were added to a batch of 50,000 200 mg white placebo tablets. Some of the latter tablets had white noticeable markings and were colored gray; others had white noticeable markings and were colored carmine (red) (these tablets were obtained as follows: Ta). The resulting mixed batch of tablets was heated to 60°C in a perforated coated drum (24 inch - Accelerator coater machine) with openings on the sides. A 3.3 w/v % aqueous solution of hydroxypropyl methyl cellulose ("Fumacoat" 606) containing tartrazine water-soluble yellow dye (1 g) and 0.66 w/v % glycerin (plasticizer) - 1 was sprayed in 50 ml/ml using a low pressure air spray unit. It was applied continuously in minutes. The drum speed was kept at 14 rpm and the inlet drying air temperature was kept at 60°C. When all the solution had been applied, the drum was stopped and the tablets were removed. Thus, among others: (i) a green coated stamped tablet (from the original gray tablet) with a pale yellow prominent stamp; and (ii) an orange-brown coated stamped tablet with a pale yellow prominent stamp. (from the original carmine tablets) was obtained. The stamped tablets with gray and carmine coating used in the above method were prepared from 80 to 650 mg of white stamped tablets (mixture of placebo and pharmaceutical tablets), which were first treated with a mixture of black iron oxide and titanium dioxide. or coated with a colored film of a mixture of carmine and titanium dioxide, respectively. The resulting tablets with a colored film were coated as described in Example 4 with a suspension of hydroxypropyl methylcellulose and light magnesium carbonate. Gray tablets with the above-mentioned noticeable markings and carmine tablets were thus obtained. Example 6 To a batch of 50,000 200 mg white placebo tablets were added approximately 100 differently colored and coated stamped tablets (mixture of placebo and pharmaceutical tablets) with a white prominent stamp (a mixture of placebo and pharmaceutical tablets). Reddish-brown stamped tablets, obtained as follows). The resulting mixed batch of tablets was heated to 60°C in a perforated coated drum (24 inch - Accelerator coater machine) with openings on the sides. Brilliant Blue FCF Water Soluble Dye [Food, Drugs & Cosmetics
A 3.3 w/v % aqueous solution 1 of hydroxypropyl methyl cellulose (“Fumacoat” 606) containing 0.25 g) and 0.66 w/v % glycerin (plasticizer) was sprayed using a low pressure air spray unit. It was applied continuously at 50 ml/min. The drum speed was kept at 14 rpm and the inlet drying air temperature was kept at 60°C. When all the solution had been applied, the drum was stopped and the tablets were removed. In this way, stamped tablets with a black coating were obtained (from the original reddish-brown stamped tablets) with a particularly noticeable pale-blue marking. The reddish-brown tablets were prepared from approximately 200-400 mg white stamped tablets, which were first coated with a red iron oxide pigment. The resulting coated tablets were coated as in Example 4 with a suspension comprising hydroxypropylmethylcellulose and light magnesium carbonate.
In this way, the above-mentioned reddish-brown stamped tablets with noticeable white markings were obtained. Example 7 415 mg in a batch of 50,000 200 mg white placebo tablets
Approximately 100 stamped tablets with a reddish-brown coating were added (the latter tablets are a mixture of placebo and pharmaceutical tablets and have a coating colored with red iron oxide). Contains Brilliant Blue FCF water-soluble dye (0.25g) and 0.66w/v% glycerin,
A 3.3 w/v % aqueous solution 1 of hydroxypropyl methyl cellulose ("Furmacoat" 606) containing dispersed light magnesium carbonate (30 g) was placed in a porous coated drum (24 inches) with openings on the side.
The mixed batches of tablets were coated in an accelerator coater machine. The suspension was applied continuously at 50 ml/min using a low pressure air spray unit. drum speed
Maintain the temperature at 16 rpm and the temperature of the dry air at the inlet to 60℃.
I kept it. When all of the suspension had been applied, the drum was stopped and the tablets were removed. In this way, tablets with a black coating were obtained which had a particularly noticeable marking of a pale blue color (compared to the original stamped tablet with a reddish-brown coating).

Claims (1)

[Scope of Claims] 1. Having at least one layer of a film containing at least one optically anisotropic substance having a minimum refractive index of 2.00 or less and at least one film forming agent.
Colored solid product with at least one noticeable imprint, characterized in that it consists of a colored and stamped product. 2. The product according to claim 1, which is used in the pharmaceutical or veterinary field. 3. The product according to claim 2, which is a pharmaceutical tablet or pill. 4. The product according to claim 1, which is a sugar confectionery. 5. Before the application of the coating (or coating layer) with at least one optically anisotropic substance and at least one film-forming agent, the stamped product has at least one layer with at least one coloring agent. The product according to any one of claims 1 to 4. 6. The coloring is due to the presence of at least one coloring agent selected from red, yellow and black iron oxides, carmine, natural dyes, water-soluble dyes and aluminum lakes of water-soluble dyes and mixtures thereof. The product according to any one of clauses 5 to 5. 7. The product of claim 6, wherein the colorant(s) are mixed with at least one opaque white pigment. 8. The product of claim 7, wherein the opaque white pigment is titanium dioxide. 9. The product according to any one of claims 1 to 8, wherein the optically anisotropic substance is white. 10. The product of claim 9, wherein the optically anisotropic substance is a known transparent white pigment. 11. Claim 9, wherein the optically anisotropic substance is aluminum hydroxide, kaolin, talc, calcium carbonate, barium carbonate, magnesium carbonate, sutucarose, lactose, or tartaric acid.
The product described in Section 1 or Section 10. 12. A product according to claim 3, containing a pharmaceutical or veterinary agent which is also used as an optically anisotropic substance. 13. Claims 1 to 1, wherein the film-forming agent is cellulose ether, cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate, polyvinyl acetate, polyvinyl acetate phthalate, cellulose acetate, shellac, or acrylic resin, or a mixture thereof.
The product described in any one of Section 2. 14 Cellulose ether is methylcellulose,
14. The product of claim 13 which is ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose or sodium carboxymethylcellulose or mixtures thereof. 15. The product according to any one of claims 1 to 15, wherein the film contains at least one film-forming aid selected from plasticizers, surfactants, and waxes. 16. A patent in which the optically anisotropic substance has a minimum refractive index that is the same as or similar to the refractive index of the film-forming agent and a maximum refractive index that is as different as possible from the minimum refractive index. A product according to any one of claims 1 to 15. 17 Film (layer) consisting of at least one optically anisotropic substance and at least one film forming agent
17. A product according to any one of claims 1 to 16, wherein the product contains at least one coloring agent. 18 Film (layer) consisting of at least one optically anisotropic substance and at least one film forming agent
18. A product according to any one of claims 1 to 17, having at least one outer coating on the top surface of the product, the outer coating having at least one film-forming agent. 19. The product according to claim 18, wherein the outer film (layer) contains at least one film-forming aid selected from plasticizers, surfactants, and waxes. 20 Claim 18 or 1, wherein the outer film (layer) contains at least one colorant
Products listed in item 9. 21. Claim 18, wherein the film forming agent is cellulose ether or cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, polyvinyl acetate, polyvinyl acetate phthalate, cellulose acetate, shellac or acrylic resin, or a mixture thereof.
The product according to any one of Items 20 to 20. 22. Claims 18-21, wherein the colorant(s) are selected from red, yellow and black iron oxides, carmine, natural dyes, water-soluble dyes and aluminum lakes of water-soluble dyes and mixtures thereof. The product described in any one of the following. 23. Colored and engraved products having at least one layer of at least one optically anisotropic substance selected from the group consisting of known transparent white pigments, magnesium carbonate, sutucarose, lactose and tartaric acid. A product according to claim 1, comprising: 24. The product of claim 23, wherein the known transparent white pigment is aluminum hydroxide, kaolin, talc, calcium carbonate or barium carbonate. 25. The product of claim 23 or 24, which is a pharmaceutical tablet or pill. 26 Claim 23, which is sugar confectionery
The product described in Section 2 or Section 24. 27 At least one piece of colored and engraved product having at least one layer of at least one optically anisotropic substance with a minimum refractive index of less than or equal to 2.00 and at least one film-forming agent A method for producing a colored solid product having a conspicuous imprint, wherein the colored and imprinted product comprises at least one optically anisotropic substance having a minimum refractive index of 2.00 or less and at least one film-forming agent. Applying a film coating suspension consisting of
A process for producing colored solid products having at least one noticeable imprint, characterized in that this process is carried out in a conventional coating device in which a frictional effect occurs between the products to be coated. 28 The suspension is an organic solvent-based suspension;
The method according to claim 27. 29. The method of claim 27, wherein the suspension is an aqueous suspension. 30. A method according to any one of claims 27 to 29, carried out in a coating drum.