Process for producing coated preparation having relieved unpleasantness

A manufacturing method and preparation technology, which is applied in the field of coating preparation manufacturing, can solve problems such as incomplete covering, and achieve the effect of improving unpleasant taste

Active Publication Date: 2009-08-19
SHIONOGI & CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is pointed out that the masking of the coated preparation is not complete, so the original drug is exposed on the surface of the granule, and a bitter taste can be felt

Method used

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  • Process for producing coated preparation having relieved unpleasantness
  • Process for producing coated preparation having relieved unpleasantness
  • Process for producing coated preparation having relieved unpleasantness

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] (1) Plain granules (granulation process)

[0080] The granule ingredients of the two components shown in the following table were mixed for 15 minutes with a V-type mixer (50 L). After molding the mixed powder into flakes with a roller compressor (ロ-ラ-ユンパクタ-・タ-ボ Industries Co., Ltd.), use a roller granulator (Japan Granulator Co., Ltd.) to adjust the granulation, and use a vibrating sieving machine to Sieve to obtain 30-100 mesh plain granules.

[0081] (2) Hot melt coating process

[0082] Pack the plain granules into a fluidized bed drying device (Flower-FLO-5 type; Daheyuan Manufacturing Co., Ltd.), after heating to a product temperature of 80 to 85° C., put the hardened castor oil into the in the fluid layer. After being made to flow for 10 to 30 minutes at a product temperature of 80 to 85° C., it was passed through a 30-mesh screen to obtain hot-melt coated granules.

Embodiment 2

[0084] Carry out in the same manner as in Example 1. The compositions of Examples 1 and 2 are shown in Table 2.

[0085] [Table 2]

[0086]

reference example 1

[0088] [table 3]

[0089]

[0090] (1) Plain granules (granulation process)

[0091] The components listed in Table 3 were mixed for 15 minutes with a V-type mixer (50 L). After molding the mixed powder into flakes with a roller compressor, adjust the granules with a roller granulator stand, and sieve with a vibrating sieving machine to obtain plain granules of 30 to 100 meshes.

[0092] (2) Thermal melting (heating) process

[0093] Put the plain granules into a fluidized bed drying device, and make them flow for 30-40 minutes at a product temperature of 80-85° C., then pass through a 30-mesh net to obtain hot-melt granules.

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PUM

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Abstract

According to the present invention, a coated preparation with improved unpleasant taste can be produced by heating the plain granules containing the drug compound and the waxy substance, adding the powdery waxy substance at a temperature at which the surface of the waxy substance is wetted, and then The surface of the plain granule is coated with heat-melt coating. Furthermore, sweet fine granules obtained by wet granulation by using a binding solution in which sweetener and binder are dissolved or dispersed are mixed with the coated preparation to further improve the administration property.

Description

technical field [0001] The present invention relates to a method for producing coated preparations, in particular, to a method for manufacturing coated preparations containing unpleasant-tasting pharmaceutical compounds. Background technique [0002] When the drug has an unpleasant taste such as bitterness, it is particularly difficult for patients to take it by oral preparation (particularly powder or granule). Therefore, in order to mask the unpleasant taste in the mouth when ingested, processing such as coating is generally performed. A film coating method is known in which a film of sugar or the like is formed on the surface to mask the bitter taste, but the sugar coating process is very complicated. In addition, in these cases, the drug is usually molded into granules, tablets, etc. and then coated. The smaller the particle size, the easier it is to powder, and it is difficult to prevent the oozing of unpleasant taste. Although there is also a method of adding a flavo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/44A61K47/10A61K47/12A61K9/16A61K31/546A61K9/50
CPCA61K9/5089A61K31/546A61K9/1682A61P31/04A61K9/16A61K9/28
Inventor 田中宏本多刚北岛秀明
Owner SHIONOGI & CO LTD
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