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Orally disintegrating tablet comprising fat-soluble substance

A technology for fat-soluble drugs and fast-disintegrating tablets, which is applied to medical preparations containing active ingredients, drug combinations, drug delivery, etc., can solve the problems of insufficient hardness and prolonged disintegration time, and achieve short disintegration time, No drug leakage, the effect of preventing leakage

Inactive Publication Date: 2009-01-07
EISIA R&D MANAGEMENT CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when a fat-soluble drug is used as the main ingredient in the above-mentioned tablet, since the drug oozes out during tablet compression and adheres to the upper punch or lower punch of the tablet press, sufficient hardness cannot be obtained, or the disintegration time is prolonged. So it can't actually be used as an orally disintegrating tablet

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] After dissolving 72 g of polyvinyl alcohol (Gohsenol, Nippon Synthetic Chemicals) in 720 g of purified water, 300 g of teprenone and 1.5 g of tocopherol were added and emulsified using a universal homogenizer (POLYTRON Kobayashi). This emulsion and 300 g of hydrous silica (SYLYSIA 350, Fuji Silicon Chemical) were put into a stirring mixer (10L high-speed mixer, KAWATA Corporation) and granulated. The granulated product was dried with a fluidized bed dryer (cast coater FLO-5, Freund Sangyo), and sized with a Power Mill (Showa Giken) to obtain adsorption granules.

[0069] Put 340g of this adsorption particle into a stirring mixer (10L high-speed mixer, KAWATA Co., Ltd.), add 220g of 9% methylcellulose aqueous solution, purified water, and 25g of hydrous silica, and coat it on the particle .

[0070] Add 0.7g menthol fragrance (Menthol CoatonAL21717, Ogawa fragrance), 2g magnesium stearate (Taihei Chemical Industry), 320g crystalline cellulose (Avicel PH101, Asahi Kasei ...

Embodiment 2

[0072] Put 500g of calcium silicate (Fluorite R, TOKUYAMA) into a stirring mixer (25L vertical mixer, POWREX Co., Ltd.), add 1010g of teprenone and 2g of tocopherol to it, and add purified water after absorbing it Granulation. This was dried with a fluidized bed dryer (cast coater FLO-5, FREUND Industry), and sized with a power mill to obtain adsorbed granules.

[0073] 150g adsorption particles, 336g mannitol (Pearlitol DC400, ROQUETTE Japan), 512g crystalline cellulose (Avicel PH101, Asahi Kasei Industry), 80g corn starch, 50g calcium silicate, 3.2g sodium stearyl fumarate (Kimura Industry) Mix, and use a rotary tablet press to compress at a punching pressure of 650 kg to obtain a tablet of 566 mg per tablet.

Embodiment 3

[0075] Add 1000g of calcium silicate into a stirring mixer, add 1000g of teprenone and 2g of tocopherol into it for adsorption, then add purified water to granulate. This was dried with a fluidized bed dryer (cast coater FLO-5, FREUND Industry), and sized with a power mill to obtain adsorbed granules.

[0076] 300g of this adsorption granule, 504g of mannitol (Pearlitol DC500, ROQUETTE Japan), 768g of crystalline cellulose (AvicelPH102, Asahi Kasei Industries), 120g of cornstarch, and 4.8g of sodium stearyl fumarate were mixed, and a rotary tablet press was used to Press 550kg to compress the tablet to obtain a tablet of 566mg per tablet.

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Abstract

Disclosed is an orally disintegrating tablet which comprises a high dose of a fat-soluble substance, can be produced by a dry tableting process, and can be disintegrated in an oral cavity rapidly. Also disclosed is a process for production of the tablet. The tablet can be produced by preparing a granule comprising a porous substance and a fat-soluble substance adsorbed onto the porous substance, mixing the granule with a sugar alcohol, crystalline cellulose and a lubricant homogeneously, and shaping the mixture into a tablet.

Description

technical field [0001] The present invention relates to an orally disintegrating tablet containing fat-soluble drugs, especially oily drugs. More specifically, the present invention relates to an orally rapidly disintegrating tablet formulated with a high content of fat-soluble drug. Background technique [0002] Orally rapidly disintegrating tablets are tablets that disintegrate rapidly under the action of saliva in the oral cavity, and are easy to take for the elderly or young children who have poor swallowing ability. And there is an advantage that it can be taken anytime and anywhere because it does not require water when taking it. [0003] Various studies have been conducted on orally rapidly disintegrating tablets, and there have been many reports. For example, it is known to add a drug suspended in an aqueous solution of hydrolyzed gelatin to a cylindrical aluminum mold cooled with liquid nitrogen, freeze it, and produce an orally disintegrating tablet under reduce...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/26A61K31/07A61K31/121A61K31/122A61K31/355A61K31/59A61K47/04A61K47/10A61K47/26A61K47/38
CPCA61K9/16A61K31/59A61K31/355A61K31/07A61K9/2018A61K9/2077A61K9/0056A61K31/122A61K31/121A61K9/2054A61P43/00A61K9/20A61K47/26A61K47/38
Inventor 高见典茂柳乐慎介冈田康志大肋孝行西岛玲子
Owner EISIA R&D MANAGEMENT CO LTD
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