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Orally disintegrating tablet

A tablet and weight technology, which is applied in the field of orally disintegrating tablets, can solve the problems of poor production efficiency, unsatisfactory disintegration time of orally disintegrating tablets, and reduced disintegration of tablets, and achieves a simple preparation method and a good feeling of taking , the effect of rapid disintegration

Inactive Publication Date: 2008-10-01
SHIONOGI & CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] In the preparations of Patent Documents 3, 4, and 5, in order to improve disintegration and tablet hardness, an additional preparation step is necessary, so the production efficiency is poor
[0019] In addition, the disintegration time of the formulation in Patent Document 6 far exceeds 3 minutes, which does not satisfy the disintegration time of an orally disintegrating tablet.
[0020] In the formulation of Non-Patent Document 1, as described above, it is described that anhydrous calcium hydrogen phosphate, crystalline cellulose, carmellose, and a lubricant magnesium stearate are mixed into tablets, but the amount of magnesium stearate mixed is 1 % by weight, tablet disintegration may be reduced under heat and humidity

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0099] (Example 1, Comparative Examples 1 to 5)

[0100] In Example 1, Comparative Examples 1 to 5, as shown in Table 2, the powder for tablets with different types of disintegrants was compressed, and the hardness, disintegration time, and oral disintegration time of the tablets were evaluated. Dryness in the mouth. It should be noted that Ceolus PH102 (manufactured by Asahi Kasei Co., Ltd.) is used for crystalline cellulose, calcium dibasic anhydrous GS (manufactured by Kyowa Chemical Co., Ltd.) is used for anhydrous calcium hydrogen phosphate, and acesulfame potassium (Nutrinova Japan) is used as a sweetener. system). Perform tablet compression with a tableting pressure of 5-7kN.

[0101] (Experimental results)

[0102] The experimental results are shown in Table 2. From this result, it can be seen that when carmellose is used, the hardness of the tablet is high, the disintegration time and the disintegration time in the oral cavity are short, and there is no dry feeling in the...

Embodiment 1～3

[0113] In Examples 1 to 3, as shown in Table 2, the powder component of a tablet whose average particle size of crystalline cellulose was changed was compressed, and the hardness, disintegration time, and oral disintegration time of the tablet were measured. It should be noted that NS-300 (manufactured by Gotoku Pharmaceutical Co., Ltd.) is used for carboxymethyl cellulose, GS (manufactured by Kyowa Chemical Co., Ltd.) is used for anhydrous calcium hydrogen phosphate, and acesulfame potassium is used for sweetener. (Manufactured by Nutrinova Japan). The preparation method of the tablet is the same as in Example 1.

[0114] (Experimental results)

[0115] The experimental results are shown in Table 3. From this result, it can be seen that using crystalline cellulose of any particle size, the hardness, disintegration time, and oral disintegration time all meet the target values. Especially when Ceolus PH-102 with an average particle size of 100μm is used, the hardness of the tablet ...

Embodiment 2

[0119] · Example 2: Ceolus PH-101 (manufactured by Asahi Kasei Co., Ltd.)

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Abstract

Disclosed is an orally disintegratable tablet having a reliable tablet hardness, a good disintegrating property and a pleasant feeling in the mouth. The tablet can be produced by mixing an active ingredient, crystalline cellulose, an inorganic excipient, carmellose and a lubricant in an amount of 0.8% by weight or less per tablet with one another and then tableting the mixture or tableting these components by external lubricant addition method.

Description

Technical field [0001] The elderly or children have poor swallowing ability, so it is difficult to take tablets. It is desired to develop a preparation that can be easily taken by the elderly or children, disintegrates quickly in the oral cavity even for adults with swallowing ability, and can be taken without feeling bitterness. There are several known preparations. Background technique [0002] When preparing an orally disintegrating tablet, in order to ensure disintegration, sugars and / or disintegrating agents are usually used. Examples of documents disclosing orally disintegrating tablets containing sugars or disintegrating agents include the following documents. [0003] Patent Document 1 describes an orally disintegrating tablet containing a pharmaceutical ingredient, erythritol, crystalline cellulose, and a disintegrant. [0004] Patent Document 2 describes an orally disintegrating tablet containing a pharmaceutical ingredient, D-mannitol, celluloses, and a disintegrant. T...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/12A61K9/20A61K47/02A61K47/38A61K31/166A61K31/4152A61K31/4196A61K31/546
CPCA61K9/2095A61J3/02A61J3/10A61K9/0056A61K9/1652A61K9/1694A61K9/2077A61P43/00A61K9/14A61K9/16A61K9/20
Inventor 今元千绘子丰田智淳友田宜孝
Owner SHIONOGI & CO LTD
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