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Coating material for solid medicine and solid medicine formed with same

A technology for solid preparations and coating agents, applied in the field of solid preparations, can solve the problems of unstable oxygen or water vapor, fatal medicines, etc., and achieve the effects of excellent disintegration, excellent moisture resistance, and easy coating operation.

Active Publication Date: 2014-12-03
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 medicines are unstable to oxygen or water vapor, and about 40% of them will change in some way if they are left without packaging, causing fatal problems in the quality of medicines

Method used

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  • Coating material for solid medicine and solid medicine formed with same
  • Coating material for solid medicine and solid medicine formed with same
  • Coating material for solid medicine and solid medicine formed with same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0060] The following examples are given to describe the present invention in detail, but the present invention is not limited to the following examples.

[0061] The dispersion state, oxygen transmission coefficient, and water vapor transmission rate of the swelling clay were measured using the film (film) obtained from the coating agent.

[0062] (Evaluation method of dispersion state of swelling clay)

[0063] The film was thinned using a gadolinium ion beam using a focused ion beam method (FB-2000A, Hitec Manifacchia & Sabis Co., Ltd.). The film formed into a thin film was observed using a transmission electron microscope (H-9000UHR; Hitec Manifacchia & Services Co., Ltd.), and the number of layers of the swelling clay was measured visually.

[0064] When the swelling clay is plane-oriented with respect to the cross section of the film (a cross section parallel to the surface of the film), a focused and clear microscopic image can be obtained, and a single layer (about 1 n...

reference example 1

[0075] (Reference Example 1) Preparation of Polyvinyl Alcohol Film

[0076] 42.5 parts by mass of water and 7.5 parts by mass of OPADRYIIHP (registered trademark) (Colorcon Nippon) were added, stirred and mixed to obtain a dispersion. Subsequently, this dispersion liquid was poured into a tray made of polypropylene with a flat bottom surface, and it was dried overnight in an oven at 50° C. in a horizontal state to obtain a film. The film is a polyvinyl alcohol (PVA) film. Hereinafter, polyvinyl alcohol is abbreviated as PVA.

reference example 2

[0077] (Reference Example 2) Preparation of Modified PVA Type Film

[0078] Add 45.0 parts by mass of water, 3.5 parts by mass of POVACOAT (registered trademark) (Nissin Chemical Co.), 1.0 parts by mass of titanium oxide, 0.5 parts by mass of talc, stir and mix to obtain a dispersion, using the same method as Reference Example 1 Method to obtain film. The film is a modified PVA-based film.

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Abstract

An object of the present invention is to provide a coating material for a solid formulation which is capable of stably retaining the effective ingredient in the solid formulation for a prolonged period even in unpacked condition in such a manner that the solid formulation can be used in a single-dose formulation. The present invention provides a coating material for a solid formulation which comprises a high hydrogen-bonding resin and a swelling clay and, when coated on a solid formulation and dried, forms a coating film in which the laminated structures of the aforementioned swelling clay are oriented planarly and dispersed in a network fashion.

Description

technical field [0001] The present invention relates to a coating agent for solid preparations and a solid preparation using the coating agent. Background technique [0002] It is known that many pharmaceuticals are unstable to oxygen or water vapor, and about 40% of them undergo some changes if they are left unpackaged, causing fatal problems in the quality of pharmaceuticals. Therefore, most of commercially available pharmaceuticals, especially solid preparations, are packaged in packaging materials such as PTP (press through pack) sheets to protect them from oxygen or water vapor. In recent years, a PTP sheet in which polyvinylidene chloride is laminated with excellent water vapor barrier properties (moisture resistance) and oxygen barrier properties has been developed and put into practical use. [0003] As a method for improving the stability of solid preparations to oxygen or water vapor, a method of sugar-coating a solid preparation or a method of film-coating a soli...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/32A61K9/34A61K47/14A61K47/46
CPCA61K9/2813A61K47/32A61K9/2826A61K9/284A61K47/02A61K9/28A61K47/14A61K47/46
Inventor 林有纪藤崎由记吉井良二
Owner TORAY IND INC
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