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Film coating agent for solid preparation, and solid preparation using same

A technology of film coating agent and solid preparation, which is applied in the direction of pill delivery, sugar-coated pills, and medical preparations with non-active ingredients, etc. Ease of covering work and excellent disintegration properties

Active Publication Date: 2013-10-23
TORAY IND INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] It is known that many of the medicines are unstable to water vapor. If the medicine is left without packaging, the quality will deteriorate due to moisture absorption. Not only will it not be able to exert the expected efficacy, but it will also cause side effects to the patients who take it.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Add benzalkonium chloride to distilled water and dissolve it, then heat to about 70°C, add stearic acid therein and stir to make it uniformly dispersed. Thereafter, the obtained dispersion liquid was left to cool to room temperature, and HPMC (METOLOSE (registered trademark) TC-5R; Shin-Etsu Chemical) was added to dissolve it to obtain dispersion liquid I.

[0075] Add BT (Kunipia (registered trademark)-F; KUNIMINE industry, cation exchange capacity: 115 meq / 100g) to stirred distilled water, use a homogenizer (Polytron (registered trademark) model KR) to uniformly disperse it, and filter paper Suction filtration was performed, and the obtained filtrate (BT aqueous dispersion) was referred to as dispersion II.

[0076] Dispersion I and Dispersion II were mixed, gelled by electrostatic interaction, then crushed and stirred with a homogenizer, and filtered with filter paper to obtain a single-spray dispersion for film formation.

[0077] Spray the above-mentioned single-s...

Embodiment 2

[0080]Prepare dispersion liquid I and dispersion liquid II described in embodiment 1, spray dispersion liquid I once to the back side of polypropylene equilibrium tray, then spray dispersion liquid II once to the back side of same polypropylene equilibrium tray, immediately pass through the Dry with hot air. After repeating this operation several times, it was left to stand in an oven at 50° C. and dried overnight together with the equilibration tray. Thereafter, the film was peeled off from the equilibrium tray, and a film was formed by a double-spray film-forming method in which two kinds of dispersions were sprayed alternately (hereinafter abbreviated as "the film of Example 2").

Embodiment 3

[0082] Except changing the benzalkonium chloride in Example 1 to benzethonium chloride, the same operation as in Example 1 was performed to prepare a coating (hereinafter abbreviated as "the coating of Example 3").

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Abstract

An object of the present invention is to provide a film coating agent for a solid formulation, which has excellent water vapor barrier properties and is capable of stably maintaining the quality of medicinal ingredients even when the solid formulation has been stored unpacked for a long period of time. The present invention provides a film coating agent for a solid formulation, comprising a water-soluble cellulose derivative, swelling clay, a cationic surfactant, and a fatty acid, wherein the mass ratio of the above-described swelling clay to the above-described water-soluble cellulose derivative is 2:8 to 8:2, and the content of the above-described cationic surfactant is not less than 0.5 equivalents and not more than 3.0 equivalents relative to the cation exchange equivalent of the above-described swelling clay.

Description

technical field [0001] The present invention relates to a film coating agent (film coating) for solid preparations and a solid preparation using the coating agent. Background technique [0002] It is known that many medicines are unstable to water vapor. If the medicine is left without packaging, the quality will deteriorate due to moisture absorption. Not only will it not be able to exert the expected efficacy, but it will also cause side effects to patients who take it. Therefore, most of the commercially available medicines, especially solid preparations, are packaged with packaging materials such as PTP (press through pack) sheets, trying to prevent direct contact with water vapor. In recent years, a PTP sheet obtained by laminating polyvinylidene chloride excellent in water vapor barrier properties (moisture resistance) has been developed and put into practical use. [0003] As a method of improving the stability of the solid preparation itself against water vapor, the...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/38A61K9/14A61K9/16A61K9/28A61K9/36A61K9/50A61K47/02A61K47/12A61K47/18
CPCA61K9/2866A61K9/2813A61K47/38A61K9/14A61K9/16A61K9/28
Inventor 吉井良二林有纪藤崎由记
Owner TORAY IND INC