Process for producing stable enteric sugar-coated tablet

A manufacturing method and enteric-coated technology, applied in the field of manufacturing enteric-concentrated sugar-coated tablets, can solve problems such as difficult methods

Inactive Publication Date: 2004-06-30
SS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, neither metho

Method used

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Examples

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Embodiment

[0021] Hereinafter, although an Example is given and this invention is demonstrated concretely, this invention is not limited to these.

reference example 1

[0022] Reference example 1 [Manufacturing of chip]

[0023] Using a punch with a diameter of 5.5 mm and 4.5R, chips (plain chips) having the compositions shown in Table 1 below were produced at 55 mg per chip. The tablet had a hardness of 2.8 kg and a disintegration time (test liquid: water) of 6 to 8 minutes.

[0024] 4.7 kg of the tablet was put into ventilated coating pan equipment (Hicoater HCT-48, manufactured by Freund Industrial Co.), and triethyl citrate The plasticizer solution of ester / glycerin fatty acid ester (35 / 20) is sprayed at a spray speed of 20g / min, and succinic acid acetate hydroxypropyl methylcellulose (trade name AS-MF) is sprinkled at 58g / min. Shin-Etsu Chemical Co., Ltd.) / talc (ratio 10 / 6) was uniformly mixed and dry-coated to obtain a 67 mg enteric-coated film tablet.

[0025] Table 1

[0026] Element

Embodiment 1

[0028] Using a ventilated coating pan (Hicoater-48 type, manufactured by Freund Industrial Co., Ltd.), 65% sucrose syrup was used to form a sucrose layer (film) of 5 mg per piece and a film thickness of 48 μm on the enteric film tablet obtained in Reference Example 1. Then use an aqueous suspension composed of 10% kaolin, 10% calcium carbonate, 5% talc, 5% titanium oxide, 4% gum arabic powder and 40% sucrose to form a smooth layer of 35 mg per tablet. Finally, 65% sucrose syrup added with tar pigment was used to form a coloring layer of 5 mg per tablet, which was glazed with wax to obtain enteric sugar-coated tablets.

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PUM

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Abstract

A process for producing a stable enteric sugar-coated tablet, characterized by coating an uncoated tablet with an enteric polymer, subsequently forming a 20 to 300 [mu]m-thick layer made of a water-soluble polymer and/or water-soluble saccharide, and then forming a sugar coating. Thus, an enteric sugar-coated tablet can be produced which is stable and in which the sugar coating neither discolors nor punctures nor cracks.

Description

technical field [0001] The present invention relates to a method for producing stable enteric-coated sugar-coated tablets, and more particularly to a method for producing enteric-concentrated sugar-coated tablets that prevent discoloration and breakage of the sugar-coated tablets over time. technical background [0002] The composition and formulation of the sugar-coated layer in sugar-coated tablets are various, and although the technical know-how is often unknown, according to "Coating of Pharmaceuticals" (Japan Federation of Industrial Technology) and "Lectures on the Basics of Pharmaceutical Development 18 "Preparation Engineering" (Diren Shuguan) is generally manufactured by sequentially forming a thin film layer, a bottom coating layer, a smooth layer on the chip, and then forming a dense sucrose layer to prevent water penetration, and finally polishing with wax. [0003] The sugar coating formation process generally includes the bottom coating process for giving the c...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/36A61K47/38
CPCA61K9/2826A61K9/28
Inventor 神户英芳小贯洋一金子哲男今森胜美
Owner SS PHARMA CO LTD
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