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fast disintegrating tablet

A tablet and fast disintegrating technology is applied in the field of manufacturing fast disintegrating tablets to achieve the effect of improving breakage resistance

Active Publication Date: 2016-05-11
ASTELLAS PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] However, breakage of fast-disintegrating tablets (especially orally disintegrating tablets) in the distribution process is still a problem, and further improvement of technology is required

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0174] D-mannitol (Pearitol50C, Roquette Japan, the same unless otherwise specified below) 59.0w / w%, microcrystalline cellulose (MCCSANAQburst, PHARMATRANSSANAQAG manufacturing) 20.0w / w%, copovidone (KollidonVA64Fine, BASF Japan Manufacturing) 10.0w / w%, crospovidone (Kollidon CL, BASF Japan make) 10.0w / w% were mixed. Magnesium stearate (manufactured by ParteckLUBMST, Merck, the same unless otherwise specified below) 1.0w / w% was blended in this mixture, and a single-punch tablet press (Otokraf AGS-20kNG, manufactured by Shimadzu Corporation was used, The following is the same unless otherwise specified.) A tablet with a size of 180 mg per tablet (tablet diameter 8.5 mm) was prepared at a tableting pressure of about 1.0 kN / punch. The tablet hardness is 8N (n=1). Next, the tablet was treated with a pressure-resistant container (pressure-resistant sample cell) under the conditions of carbon dioxide pressure of 8.0 MPa and 45°C for 30 minutes, and then depressurized at a pressure r...

Embodiment 2

[0176] D-mannitol 54.0w / w%, microcrystalline cellulose (manufactured by MCCSANAQburst, PHARMATRANSSANAQAG) 20.0w / w%, copovidone (KollidonVA64Fine, made by BASF Japan) 15.0w / w%, crospovidone (KollidonCL) , BASF Japan made) 10.0w / w% for mixing. 1.0w / w% magnesium stearate was blended in the mixture, and a single-punch tablet press was used to form tablets each having a size of 180 mg (tablet diameter 8.5 mm) at a tableting pressure of about 1.0 kN / punch. The tablet hardness is 8N (n=1). Next, the tablet was treated with a pressure-resistant sample cell under the conditions of a carbon dioxide pressure of 8.0 MPa and 45°C for 30 minutes, and then the pressure was reduced at a reduced pressure rate of about 16 kPa / sec to obtain the rapidly disintegrating tablet of the present invention.

Embodiment 3

[0178] D-mannitol 97.0w / w% and copovidone (KollidonVA64Fine, BASF Japan make) 3.0w / w% were mixed. The mixture was made into 270 mg tablets (tablet diameter 9.0 mm) per tablet (tablet diameter 9.0 mm) using a single-punch tablet press at a tableting pressure of about 1.0 kN / punch, and the tablet hardness was 10N (n=3). Next, the tablet was treated with a pressure-resistant sample cell under the conditions of a carbon dioxide pressure of 6.0 MPa and 40°C for 30 minutes, and then the pressure was naturally reduced to obtain the rapidly disintegrating tablet of the present invention.

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Abstract

Provided are: a rapidly disintegrating tablet (in particular, an orally disintegrating tablet) containing drug-containing particles imparting a desired function based on the properties of the drug, which tablet still fully expresses the function even after a formulation step which might sometimes have an impact on the function thereof; and a method for producing the same. The rapidly disintegrating tablet is obtained by treating, with carbon dioxide in a super critical or subcritical state or with carbon dioxide liquid or gas, a drug and a material which is given the function of a binding agent by treatment with carbon dioxide in a super critical or subcritical state or with carbon dioxide liquid or gas.

Description

Technical field [0001] The present invention relates to a rapidly disintegrating tablet (especially an orally disintegrating tablet) having a porous structure by processing with carbon dioxide or liquid or gaseous carbon dioxide in a supercritical or subcritical state. In addition, the present invention relates to a method for producing a rapidly disintegrating tablet (especially an orally disintegrating tablet) having a porous structure by processing with carbon dioxide in a supercritical or subcritical state or liquid or gas carbon dioxide. Background technique [0002] In the provision of pharmaceutical preparations, in most cases, it is required to develop drug-containing particles that use the characteristics of drugs that are unstable to temperature or humidity, drugs that have a bitter taste, and drugs that require sustained-release properties to impart a certain function. Pharmaceutical preparations. [0003] Among pharmaceutical preparations, tablets are widely provided i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20
CPCA61K9/0056A61K9/2095
Inventor 小林正范伊藤佳孝真荣田笃柏原澄荣大竹胜人
Owner ASTELLAS PHARMA INC