Solid preparation for coating agent, and film and coated solid preparation formed from same

A technology of solid preparation and coating agent, which can be used in sugar-coated pills, pill delivery, inorganic non-active ingredients, etc., and can solve the problems of unstable oxygen and water vapor.

Active Publication Date: 2017-02-22
TORAY IND INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] On the other hand, it is known that most medicines are unstable to oxygen and water vapor, and about 40% of them wi...

Method used

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  • Solid preparation for coating agent, and film and coated solid preparation formed from same
  • Solid preparation for coating agent, and film and coated solid preparation formed from same
  • Solid preparation for coating agent, and film and coated solid preparation formed from same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0071] Hereinafter, in order to demonstrate the excellent effects of the present invention, examples are used to illustrate, but the present invention is not limited thereby.

[0072] (Measurement of oral disintegration time)

[0073] Oral disintegration time was measured by 3 testers consisting of healthy adult males and females. The oral disintegration time of the core tablet was subtracted from the oral disintegration time of the orally disintegrable coated tablet, and the obtained time was calculated as the oral disintegration time of the coating.

[0074] (Cracks in the film under humidified conditions)

[0075] After storing at 40° C. and 75% RH for 1 day, the tablet was visually observed to evaluate whether or not the film was cracked.

[0076] (Measurement of Water Vapor Permeability Using Single Membrane)

[0077] The coating agent is repeatedly sprayed on the release film and dried to form a single film. The water vapor permeability is measured by partially modif...

reference example 1

[0089] (Reference Example 1) Production of Orally Disintegrating Tablets (Core Tablets)

[0090] 122.6225 parts by weight of mannitol (Pearitol (registered trademark); Roketto Japan Co., Ltd.) (hereinafter abbreviated as "parts", the same unless otherwise specified), 0.0025 parts of nafurphine hydrochloride, thiosulfuric acid 0.225 parts of sodium hydrate and 6.5 parts of crospovidone (Kollidon (registered trademark) CL; BASF Corporation) were put into a fluidized bed granulator (FLO-5; FLOINT INDUSTRIAL CO., LTD.) to produce granulated granules. Next, it was treated with Comil (197S; Powrek Co., Ltd.) to obtain sized pellets. 0.65 parts of magnesium stearate (Ohira Chemical Industry Co., Ltd.) was mixed with 129.35 parts of sized granules to obtain granules for tableting. The granules for tabletting were prepared into 130 mg 7 mmφSR tablets using a tablet press (Correct 19; Kikusui Seisakusho). The oral disintegration time of this tablet is 9 seconds.

reference example 2

[0091] (Reference Example 2) Production of hygroscopic orally disintegrating tablet (core tablet)

[0092] 26.3 parts of mannitol (Pearitol (registered trademark); Rocket Japan Co., Ltd.), 1.5 parts of hydroxypropyl cellulose (HPC-L; Nippon Soda Co., Ltd.), N-[(5R,6R,14S)-17-(cyclo 0.2 part of propylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-yl]phthalimide was charged into the fluidized bed granulator to produce granulated granules. Next, Comil is used for treatment to obtain sized granules. With 28 parts of sized granules, 94.2 parts of powdered sorbitol (NEOSORB (registered trademark); Rocket Japan Co., Ltd.) and 6.5 parts of crospovidone were mixed, and 1.3 parts of magnesium stearate were mixed to obtain granules for tableting. The granules for tabletting were formed into 130 mg of 7 mmφWR tablets using a tablet machine. The oral disintegration time of this tablet was 41 seconds.

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PUM

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Abstract

The purpose of the present invention is to provide a coating agent and a film that is formed from the coating agent that impart gas barrier properties to a solid preparation while still ensuring fast disintegrability. The purpose of the present invention is also to provide a coated solid preparation wherein gas barrier properties and fast disintegrability are maintained and wherein cracks do not occur in a film under humidified conditions. The present invention provides a coating agent for a solid preparation, the coating agent including lactose and an expansive clay and not including a water-soluble polymer, the weight of the expansive clay being 20%-50% of the solid component weight.

Description

technical field [0001] The present invention relates to a coating agent for solid preparations, a coating film formed therefrom, and a coated solid preparation. Background technique [0002] In recent years, orally disintegrating tablets that disintegrate rapidly in the oral cavity have been developed as dosage forms of pharmaceuticals that are convenient for patients with reduced swallowing function due to disease, aging, and decreased saliva secretion. [0003] As a coating of an orally disintegrating tablet, the following has been reported: a coating agent (coating agent) containing a water-soluble polymer is used to apply a coating to an orally disintegrating tablet having a hardness above a certain level. method (Patent Document 1); a method of applying a coating using a coating agent composed of a polyvinyl alcohol derivative and a specific water-soluble substance (Patent Document 2); and a specific carbohydrate and a water-insoluble inorganic compound or Coating of w...

Claims

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Application Information

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IPC IPC(8): A61K47/02A61K9/36A61K47/10A61K47/26
CPCA61K9/0056A61K9/2826A61K9/2813A61P1/02
Inventor 高木卓太田琴惠堀内保秀
Owner TORAY IND INC
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