Method for manufacturing a compressed product

Abstract

A method for making a compressed product consisting of a multi-layer tablet formed in a single compression operation is disclosed.

Description

Technical Field

[0001] The present invention relates to a method for manufacturing a multi-layer tablet by a single compression operation, which includes a number of layers having the same surface area or different surface areas.

Background Art

[0002] U.S. Patent No. 4,139,589 discloses a method for manufacturing a multi-layer tablet, which forms a number of individual layers by repeating separate compression steps with the materials / components constituting each single layer, and then performs a final compression by applying a force greater than the force applied in the previous compression to generate continuous aggregation of various layers and desirable hardness and smoothness of the tablet surface. The above method requires that various layers have the same surface area.

[0003] It was not possible to use the above technology to manufacture a tablet characterized by layers having different surface areas or different shapes, such as the product shown in FIG. 1. In fact, if the individual layers to be compressed do not have the same surface area, the following undesirable results will occur. a) The components of various layers are mixed, which has an adverse effect on both the appearance of the product and the formulation. For example, when various layers contain different active ingredients that should not come into contact or mix with each other. b) Punch breakage

[0004] EP 2929870 discloses a multi-layer tablet containing chips, and the tablet is obtained by compressing granular materials both above and below the chips. GB 743222 discloses tablet compression for manufacturing coated tablets in which the tablets are not removed from the mold during manufacturing. With the disclosed apparatus, it is not possible to prepare a multi-layer tablet having an embossed part.

Prior Art Documents

Patent Documents

[0005] [Patent Document 1] U.S. Patent No. 4,139,589 [Patent Document 2] EP 2929870 Publication [Patent Document 3] GB 743222 Publication [Summary of the Invention] [Problems to be Solved by the Invention]

[0006] Detailed Description of the Invention A method for preparing a multilayer tablet characterized by layers having different surface areas has been found here. [Means for Solving the Problems]

[0007] Unlike known methods, the method according to the present invention involving a single final compression includes the following steps: a) Filling the upper surface of a punch (hereinafter also referred to as a "mold") that slides within the compression chamber of a tableting machine with a first granular material; b) Raising the mold until the layer of material is conveyed to the upper end of the compression chamber; c) Removing excess granular material using a suitable device; d) Lowering the mold within the compression chamber and filling it with a second granular material; e) Optionally, repeating steps b), c), and d) the number of times corresponding to the desired number of layers of the completed tablet; f) Compressing and discharging the formed tablet. [Brief Description of the Drawings]

[0008]

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BEST MODE FOR CARRYING OUT THE INVENTION

[0009] The mold can have any shape suitable for forming confectionery products, particularly multi-layer candies. According to a preferred embodiment of the present invention, the mold has grooves / recesses that enable the creation of an embossed layer to form figures and / or decorations in one of the layers of the tablet. Examples of said embodiments are shown in FIGS. 2A and 2B, representing a side view and a front view of the tablet respectively, and reference numerals 2 and 3 represent layers having different regions made in a specific mold having grooves / recesses.

[0010] When operating according to the prior art, in order to enable the compression of layers 2 and 3 and prevent the mold and the upper punch from contacting each other and being damaged as a result, the grooves / recesses would have to be filled with more material than is necessary to fill the recesses. However, after the compression of said material, a surface portion of the compressed material that is not retained in the recesses is formed, and as illustrated in FIG. 3, the color of the layers shown as 2 and 3 will bleed into the immediately adjacent layer 5, resulting in an unsightly appearance.

[0011] Conversely, if one wants to avoid the problem of different layer components mixing when operating according to the prior art, it is necessary to use a minimum amount of material to prevent such bleeding during compression. However, if only a minimum amount of material is used as described above, there is a risk that the mold or the upper punch will be damaged and the machine will stop.

[0012] The method of the present invention is characterized by removing excess granular material after mold filling, thereby solving the above problems. The excess granular material can be removed using tools such as blades, spatulas, brushes or similar devices, which are attached to a tablet press and operated by mechanical, pneumatic or electromechanical means, according to the prior art.

[0013] The granular materials used in steps a) and d) may have the same composition or different compositions. Examples of the most commonly used materials include polyols such as sucrose, lactose, xylitol, maltitol, sorbitol, isomalt, starch, coloring agents, and conventional compression excipients (anti-caking agents, lubricants).

[0014] Next, with reference to FIGS. 4 to 7 showing a mold characterized by recesses that will form layers 2 and 3 illustrated in FIGS. 2a and 2b, the process will be described in detail. The mold (7 in FIG. 4) is disposed within a compression chamber (6) and maintained at a predetermined desired height (8).

[0015] The material for filling the recesses is introduced into the compression chamber in a predetermined amount. This necessarily means that the introduced material does not exactly match the volume of the recesses and is in excess.

[0016] Thereafter, the mold (7) rises to the height of level (9). At this time, a scraper element or device (10) operates to remove the excess material (11).

[0017] Thereafter, the mold (7) descends from level (9) to a predetermined height within the compression chamber. The space (12) thus formed is filled with the material necessary to form the next layer. The above operations can be repeated the number of times required for the necessary layers to form the finished product.

[0018] Once the desired number of layers is reached, lower the upper punch (13). The punch, which can be characterized by any desired shape, compresses the material, thereby forming the final product.

[0019] Furthermore, in the manufacture of multilayer tablets, it is known that the weight ratio of each layer to the finished product must be 25% or more (International Journal of Pharmaceutical Science & Research - Volume 9 - March 1, 2018 - Multilayer Tablets: A Novel Approach for Oral Drug Delivery - Page 878).

[0020] When manufacturing multilayer tablets where each layer has the same area, it has been demonstrated by many technical tests that a product according to the conventional method can be obtained as long as the weight ratio of a single layer to the total weight of the final product does not fall below 10%.

[0021] Conversely, the present invention enables the manufacture of multilayer tablets having layers with different surface areas, and in some cases even layers having a minimal area or a much smaller area than other layers, and the weight ratio of a single layer to the total weight of the product can even be less than 2%.

[0022] The method of the present invention enables the manufacture of layers with different shapes and volumes, so it is particularly suitable for enabling the use of active ingredients (such as colorants, flavors, plant extracts, whitening components, omega-3 fatty acids, antihalitosis agents, vitamins, minerals, etc.) in tablet formation, and they can also be the sole components of a given layer without being mixed with another material having only the purpose of enabling them to reach the minimum compressible volume.

[0023] In addition to the above advantages related to the manufacture of multilayer products having layers with different surface areas, the present invention can also solve various drawbacks in the manufacture of tablets having multiple layers with the same surface area by maintaining the possibility of manufacturing them in a single compression operation.

[0024] The method of the present invention prevents irregularities in the formation of layers that would appear non-linear and thus unappealing if of different colors.

[0025] If the compression chamber is filled with material, this problem occurs when an excessive amount of granular material is not removed because a horizontal, linear, and homogeneous distribution is not guaranteed. That is, as shown in FIG. 8, the granular material can be dispersed to form layers (14) and (15).

[0026] The method of the present invention also solves the problem of layer peeling that may occur when excessive compression is applied in an attempt to solve the unevenness problem.

Example

[0027] The present invention will be described in more detail with the following examples. Example 1 Tablet machines commonly used in pharmaceutical and food companies for manufacturing tablets use molds characterized by grooves and indentations. These molds and indentations / grooves may be small if necessary or may be designed to produce layers of a specific shape, particularly layers forming the eyes and nose of a cow's head (FIG. 2).

[0028] The mold (7) drops into the compression chamber (6) of the tablet press machine to a desired depth (8) of 0 mm and fills the indentation with a 70 mg mixture of powdered sorbitol, aspartame, flavoring, magnesium stearate, and blue coloring agent. At this stage, only the future mouth and eyes of the cow are filled.

[0029] The mold (7) remains at the 0 mm level (9), and the scraper device (10) operates to remove the excess powder (11) on the upper plane of the mold.

[0030] Thereafter, when the mold is filled, it descends to a desired depth (12) of 6 mm in the compression chamber (6) of the tablet press, and the compression chamber is filled with 630 mg of a mixture of powdered sorbitol, aspartame, flavoring, and magnesium stearate.

[0031] The upper punch (13) descends within the compression chamber (6), applying a pressure of 15 Pa to form a 700 mg tablet, with the eyes and mouth of the cow colored and the remaining part white.

[0032] The upper punch (13) rises back to its original position, the mold (7) rises to the floor surface (9), and the tablet is discharged.

Claims

1. A method for preparing a multilayer tablet, comprising the following steps: a) filling a top surface of a mold that slides within a compression chamber of a tablet press with a first granular material; b) raising the mold until the layer of material is conveyed to the upper end of the compression chamber; c) removing excess granular material using a suitable device; d) lowering the mold within the compression chamber and filling it with a second granular material; e) repeating steps b), c) and d) a number of times corresponding to the desired number of layers of the finished tablet without compressing the layers; f) inserting an upper punch from the upper part of the compression chamber and compressing the filled multi-layers to form a multilayer tablet; and g) discharging the formed tablet The method is characterized in that the mold has one or more recesses designed such that the layer formed by filling the recess of the mold has a different surface area from the layer formed by filling the second granular material.

2. The method according to claim 1, wherein the removal in step c) of the first granular material removes the first granular material other than the recesses.

3. The method according to claim 1 or 2, wherein the weight ratio of at least one layer is less than 25% of the weight of the finished product.

4. The method according to any one of claims 1 to 3, wherein the layer formed by filling the recess of the mold has a weight percentage of less than 2% of the weight of the tablet.

5. The method according to any one of claims 1 to 4, wherein the first granular material contains an active ingredient different from the second granular material.

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