JP2000302672A - Chewable coated tablet - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a coated tablet chewable as a chewable tablet, and hardly causing problems such as breakage by selecting the hardness of an inner core tablet of the coated tablet so as to be within a given range regulated by the diameter of the inner core tablet. SOLUTION: This chewable coated tablet comprises an inner core tablet (preferably the one containing easily oxidizable medicine or a discoloring medicine as an active ingredient), and a coating layer for coating the inner core tablet (preferably sugar coating), and obtained by regulating the hardness (N) of the inner core tablet so as to be 4-8 times as much as the value of the diameter (mm) of the tablet. The shape of the tablet can be formed into the disk shape same as a conventional chewable tablet. The diameter of the inner core tablet of the tablet is preferably 5-14 mm, and the thickness is preferably >=0.3, especially 0.5-0.75 when the diameter of the tablet is 1. As a result, a variety of medicines in a shape of the chewable tablet can be provided.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a chewable tablet, and more particularly to a tablet which can be sufficiently chewed while having a coating layer such as sugar coating.

[0002]

2. Description of the Related Art Chewable tablets, so-called chewable tablets, are one of the forms for oral administration of drugs or the like for dissolving or chewing in the oral cavity and taking them in a form as small as possible. For preferred pharmaceutically active ingredients,
Before taking, while being easy to handle as a tablet,
It is widely used as one of the administration forms that can satisfy the desirable dosage form as described above.

[0003] Conventional chewable tablets are chewable in the oral cavity, and are thus made easy to chew by adding components such as sweeteners and flavoring agents to the whole tablet. No coating was provided.

[0004] However, there are drugs which are liable to undergo changes such as oxidation and discoloration due to the presence of oxygen and moisture. When such drugs are contained in the conventional uncoated chewable tablets as described above, antioxidants and drying agents are required. An agent or the like must coexist in a chewable tablet container, or such a drug cannot be contained in a chewable tablet in some cases depending on the form of packaging.

[0005] Therefore, chewable tablets are coated with oxygen such as sugar coating,
It is conceivable to provide a coating layer that blocks moisture, but when a chewable tablet having a hardness selected as a conventional uncoated one is coated with sugar coating or the like, it becomes difficult to chew as a chewable tablet. It has been found.

[0006] On the other hand, if the hardness of the core tablet that is simply coated is made low in order to make it easy to chew, tableting itself becomes difficult, and it becomes difficult during tablet production including tableting and thereafter. It is conceivable that tablet damage during the packaging process, transportation process, and the like will increase.

Accordingly, there is provided a coated chewable tablet which can be sufficiently chewed as a chewable tablet even when coated with a sugar coating or the like and which does not cause the above-mentioned problems in the production and distribution processes. If necessary requirements can be set, various drugs as new dosage forms can be provided in the form of chewable tablets by simple packaging, and are considered to be extremely useful.

[0008] Tablets having a coating, such as conventional sugar-coated tablets, are swallowed and taken, and are not premised on being chewed. Therefore, they have a considerably high hardness and cannot be chewed.

[0009]

Accordingly, an object of the present invention is to provide a coated tablet composition which can be chewable as a chewable tablet and which does not cause a problem such as breakage in the course of production, packaging, distribution and the like. That is.

[0010]

Means for Solving the Problems The inventors of the present invention have conducted intensive studies to achieve the above object, and as a result, the hardness of the cored tablet of the coated tablet has been set within a certain range defined by the tablet diameter of the cored tablet. It has been found that a coated chewable tablet which can achieve the above object can be provided by selecting the following.

Accordingly, the present invention comprises a core tablet and a coating layer covering the core tablet, and the hardness of the core tablet (N, 1N = 0.10)
(2 kg) is 4 to 8 times the tablet diameter (mm).

In a preferred embodiment of the coated tablet of the present invention, the coating layer is sugar-coated and the coated tablet is sugar-coated.

[0013] In a preferred embodiment of the coated tablet of the present invention, the core tablet contains at least one drug selected from drugs that are easily oxidized and drugs that change color.

[0014]

Embodiments of the present invention will be described below in detail.

[0015] The chewable coated tablet of the present invention (hereinafter sometimes simply referred to as "tablet of the present invention") comprises an inner core tablet and a coating layer covering the inner core tablet.
(mm) 4 to 8 times.

Although the form of the tablet of the present invention is not particularly limited, it can be usually formed in the same disc shape as a conventional chewable tablet. However, the planar shape of the tablet of the present invention is not limited to a circle, but may be an ellipse, a polygon such as a square, or the like.

Since the tablet of the present invention is provided with a relatively thin coating layer on the core tablet, the form of the tablet of the present invention is roughly determined by the form of the core tablet. This core tablet is, for example, a so-called no-edge form in which the upper and lower surfaces are flat and the corners of the upper and lower surfaces and the side surfaces are not chamfered, a rounded flat surface chamfered to a surface having a curvature, a corner angle chamfered to a flat surface A so-called two-stage R having a shape such as a flat surface and upper and lower surfaces having curvature
Surface, sugar-coated surface and the like. Particularly preferred are a two-step R surface, a sugar-coated surface and the like. Even if the upper and lower surfaces of the core tablet do not have a curvature, by providing a coating layer such as sugar coating as described later, the tablet of the present invention can be formed into a two-step R surface having upper and lower surfaces having a curvature. Or a sugar-coated surface.

The core tablet of the tablet of the present invention can be produced by the same method as for a normal tablet. That is, the active ingredient is added to a known additive, mixed evenly, and then compression-molded as it is (direct powder compression method, direct compression method), or granulated into granules, which can be used as it is or as an additive. In addition, it can be mixed and compression-molded (wet and dry granulation, indirect compression) to produce. The production of such a core tablet can be carried out using a commercially available tableting machine such as a rotary tableting machine used for the production of ordinary pharmaceuticals.

The additives include excipients, binders, disintegrants, dispersants, solubilizers, coloring agents, flavors, sweeteners, sweeteners, etc., and are used in combination of at least one of them. be able to.

Since the tablet of the present invention is a chewable tablet, the excipient used for the core tablet is preferably a saccharide or a sugar alcohol. Examples of such sugars and sugar alcohols include, for example, glucose, fructose,
Examples include galactose, sorbitol, mannitol, sucrose, maltose, lactose, isomaltose, palatinose, maltulose, lactulose, maltitol, lactitol, palatinit, xylitol, erythritol, trehalose and the like.

The active ingredient is not particularly limited, but is preferably a component such as a drug which is easily oxidized or a component which is easily discolored for the purpose of the present invention. Examples of components that are easily oxidized include ascorbic acid (vitamin C), vitamin D, vitamin A, vitamin B12, mequitazine, bromhexine, ranitidine and the like. Examples of components that are easily discolored include ascorbic acid (vitamin C) and vitamin B2. The active ingredient is not limited to a pharmaceutically active ingredient, but may be another active ingredient such as a physiologically active substance. It is preferable to add a bitter or odorous active ingredient after coating it with a polymer or a saccharide in advance.

Although the size of the core tablet of the tablet of the present invention is not particularly limited, it is generally about 5 to 14 mm, preferably about 8 to 12 mm in diameter (the maximum diameter when the planar shape is not circular). Although the thickness is not particularly limited, it is preferably 0.3 or more when the tablet diameter is 1, and particularly preferably about 0.5 to 0.75.

The hardness (N) of the core tablet of the present invention is the tablet diameter.
(mm, the planar shape diameter of the above-mentioned core tablet) is manufactured to be 4 to 8 times. Here, the hardness of the core tablet means a value measured by a method used in a normal tablet hardness test. Pressure is applied to the core tablet (in a direction parallel to the upper surface and the lower surface), and the core tablet disintegrates. Pressure (N). Tableting is performed so that the hardness value becomes 4 to 8 times the tablet diameter expressed in mm. For example, in the case of a core tablet having a diameter of 10 mm, the core tablet is manufactured to have a hardness of 40 to 80N.

As described above, the hardness of the core tablet is defined by the tablet diameter. The larger the tablet diameter, the more likely it is that the same hardness will cause breakage or the like. Therefore, a higher hardness is required. This is based on the fact that even if the hardness is increased to some extent, the friability is not impaired. Such a desired hardness can be easily obtained by adjusting the compression pressure at the time of tableting, the components of the core tablet, and the like. If the hardness is lower than such a range, the tablet is likely to be damaged in the course of production, packaging, distribution, and the like, and if the hardness is higher than such a range, the hardness is too high, and the tablet becomes difficult to chew. .

The chewability of a chewable tablet can be affected by the shape and thickness of the tablet. However, in the shape and thickness of the core tablet as described above, the hardness of the core tablet is determined as described above. By setting the diameter in the range defined by the diameter, chewing easiness is ensured.

As described above, the coating layer is provided for the purpose of shielding the active ingredient from oxygen, moisture and the like, and includes, for example, sugar coating, film, glue and the like, and is formed using a usual tablet coating apparatus and method. be able to. Since the tablet of the present invention is a chewable tablet that can be chewed in the oral cavity, the coating layer is preferably sugar-coated.

The components of these coating layers include gelatin, pullulan, gum arabic, shellac, hydroxypropylmethylcellulose, sucrose, calcium carbonate, talc, coloring agents, polishing agents and the like. Can be selected on the basis of the barrier performance of oxygen, moisture and the like required for the above.

Although the thickness of the coating layer is not particularly limited, the weight of the coating layer is usually 0.1 when the weight of the core tablet is 1.
The amount or the thickness is set to 1.5.

[0029]

The present invention will be described below in more detail with reference to examples and comparative examples, but the present invention is not limited to these examples.

Example 1 Lactose for direct injection 130 mg, corn starch 55 mg, low molecular weight hydroxypropylcellulose 17.5 mg, low substituted hydroxypropylcellulose (LH21) 11 m
g, light silicic anhydride 2.4 mg, crystalline cellulose 18 m
g, and 1.1 mg of magnesium stearate were homogeneously mixed, and the mixture was mixed with a rotary tableting machine (Collect 1 manufactured by Kikusui Seisakusho).
Using 2HU), an inner core tablet was tableted with a punch having an 8 mm sugar-coated surface at a tableting pressure of 0.5 ton to obtain 235 mg of a core tablet (tablet diameter: 8 mm, tablet thickness: 5.20 mm). The hardness of the core tablet was 32.3N.

3 kg of the tablet is coated with a breathable coating device (Doria Coater: DRC-500, manufactured by Powrex).
20mg per tablet with a film consisting of 50% hydroxypropylmethylcellulose and 50% sucrose
Was spray-coated so that Thereafter, sugar coating was carried out by a conventional method using a syrup mainly composed of pullulan and sucrose, to obtain 405 mg of a sugar-coated tablet.

Example 2 Using the same ingredients as in Example 1, a core tablet was produced in the same manner, but the tableting pressure was 0.75 tons. The hardness of the obtained core tablet was 60.8 N, the tablet diameter was 8 mm, and the tablet thickness was 5.01 mm. This core tablet was coated in the same manner as in Example 1 to obtain a sugar-coated tablet.

Comparative Example An inner core tablet was produced in the same manner as in Example 1 by using the same components, but the tableting pressure was set at 1.0 ton. The hardness of the obtained core tablet is 87.2 N, the tablet diameter is 8 mm, and the tablet thickness is 4.
It was 91 mm. This core tablet was coated in the same manner as in Example 1 to obtain a sugar-coated tablet.

When the sugar-coated tablets of the Examples and Comparative Examples were chewed in the mouth, all of the sugar-coated tablets of the Examples could be chewed, but the sugar-coated tablets of the Comparative Example were difficult to chew.

[0035]

The coated tablet of the present invention is a tablet that can be chewable as a chewable tablet and does not cause problems such as breakage in the course of production, packaging, distribution and the like.
A variety of drugs can be provided in the form of chewable tablets, which is extremely useful.

 ──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Yasushi Nakagawa 3- 24-1, Takada, Toshima-ku, Tokyo Taisho Pharmaceutical Co., Ltd. (72) Inventor Takashi Yamazaki 3- 24-1, Takada, Toshima-ku, Tokyo F term (reference) in Taisho Yaku Co., Ltd. 4C076 AA37 BB01 DD27 DD41 DD67 EE31 EE33 EE38 FF26 FF27 GG14 GG16

Claims (3)

[Claims] 1. A chewable coated tablet comprising a core tablet and a coating layer covering the core tablet, wherein the hardness (N) of the core tablet is 4 to 8 times the tablet diameter (mm). 2. The chewable coated tablet according to claim 1, wherein the coating layer is a sugar-coated tablet and is a sugar-coated tablet. 3. The chewable coated tablet according to claim 1, wherein the core tablet contains at least one drug selected from drugs that are easily oxidized and drugs that change color.