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Orally-disintegrating tablet and manufacturing method thereof

A technology of orally disintegrating agents and orally disintegrating tablets, which is applied in the field of orally disintegrating agents and its manufacturing, can solve problems such as poor disintegration, residual fiber, and poor taste and taste, and achieve smooth swallowing, Good disintegration, good texture and taste

Active Publication Date: 2008-10-15
NIPRO CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when a large amount of cellulose is contained, the fiber remains when ingested, and the texture and taste deteriorate.
In addition, when granules of sugar alcohols are used, they can be compressed into tablets, but the disintegration properties in the oral cavity are deteriorated, and the disintegration time of the tablets needs to be more than 1 minute.

Method used

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  • Orally-disintegrating tablet and manufacturing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] 500 g of D-mannitol was added to a fluidized bed granulator (manufactured by Pazureck Co., Ltd., multiplexed), and a 10% aqueous solution of D-mannitol (manufactured by Nikken Chemical Co., Ltd.) was sprayed as a spray liquid to perform fluidization. Bed granulation. After spraying 500 g, it dried and obtained the granulated mannitol (150-220 micrometers of average particle diameters).

[0048] In addition, 500 g of erythritol (manufactured by Mitsubishi Chemical Industry Co., Ltd.) was added in the same manner, and a 10% aqueous solution of erythritol was sprayed as a spray liquid to perform fluidized bed granulation, and after spraying 500 g, it was dried. Granulated erythritol (average particle size: 80-130 μm) was obtained.

[0049] As a commercially available granulated sugar alcohol, direct-pressed mannitol (Pertec 100M, manufactured by Merck, granulated mannitol, average particle diameter 90 to 120 μm) was used as the granulated product.

[0050] As additives, ...

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Abstract

An orally-disintegrating tablet comprises a principal agent, a sugar alcohol powder and a sugar alcohol granule, wherein the orally-disintegrating tablet has a hardness of 30 N or greater. According to the present invention, a smooth swallowing orally-disintegrating tablet, for which both the mechanical strength and the disintegration properties in the buccal cavity are favorable with using a normal tableting machine and without using special devices and the feeling on the tongue and taste are favorable, is provided.

Description

technical field [0001] The present invention relates to an oral disintegrating agent and a manufacturing method thereof, and more specifically, relates to an oral disintegrating agent which is easily disintegrated in the oral cavity despite high hardness and a manufacturing method thereof. Background technique [0002] Orally disintegrating tablet is a dosage form that is easy to take for the elderly, children, and patients with dysphagia, and can be taken without water, so it has attracted attention as a dosage form that improves the quality of life (QOL) of patients. [0003] Generally, orally disintegrating tablets disintegrate quickly after ingestion, but due to their weak mechanical strength, there is a problem that it is difficult to seal with an automatic dispenser. [0004] In addition, in its production method, the following methods are known: that is, a method of injecting a dispersion of a drug and an additive into a PTP bag or the like and freeze-drying it; a met...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/10A61K47/38
CPCA61K9/0056A61K9/2013A61K9/2018A61K9/2027A61K9/2054A61K9/2095
Inventor 樱木志保横江淳一片山直久甲斐俊哉
Owner NIPRO CORP