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Quick disintegration tablet and method of producing the same

A manufacturing method and technology for rapidly disintegrating tablets, applied in the field of rapidly disintegrating tablets and their manufacturing, can solve the problems of tablet adhesion, tablet fragility, melting and the like, and achieve the effects of sufficient tablet strength, easy taking and high strength.

Inactive Publication Date: 2008-01-30
EISIA R&D MANAGEMENT CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the tablet described in Patent Document 2, since sugar is used as a cross-linking agent, when stored under high humidity, the sugar melts, and the tablet may become fragile and adhesion between tablets may occur. And other issues

Method used

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  • Quick disintegration tablet and method of producing the same
  • Quick disintegration tablet and method of producing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0100] Using a mechanical mixer (manufactured by Okada Seiko Co., Ltd.), 115.36 g of crystalline cellulose (trade name: ABISEL PH301, manufactured by Asahi Kasei Industries, Ltd., hereinafter referred to as "ABISEL PH301") and 173.04 g of mannose were mixed as the above-mentioned additive at 800 rpm. Alcohol (trade name: Parteck M200, manufactured by Merck) and 11.6 g of aminoalkyl methacrylate copolymer E (trade name: オイドラギッッド (registered trademark) EPO, Dagusa Co., Ltd.) as the above-mentioned acrylic copolymer for 3 minutes. Using the Kikusui small high-speed rotary tablet press (VIRGO 0512SS2AZ)-external lubricant spray system (ELS-P1 type I) to target the weight of the obtained mixture at 180 mg, under the conditions of compression molding pressure 2.0kN, 2.5kN, 2.9kN , respectively compression molding the above mixture. At this time, a die ring and a punch having an inner diameter of 8 mm were used, and magnesium stearate was used as an external lubricant to obtain a com...

Embodiment 2

[0107] 0.35 g of amlodipine besylate (manufactured by Dr. Reddy's Company) as the above-mentioned drug, and 6.9 g of crystalline cellulose as the above-mentioned additive (trade name: Abicel PH101, manufactured by Asahi Kasei Industries, Ltd., hereinafter) were thoroughly mixed using a polyethylene bag. called "ABISEL PH101"), 10.4 g of mannitol (manufactured by Towa Chemical Industry Co., Ltd.), and 0.35 g of aminoalkyl methacrylate copolymer E (trade name: オイドラギッド (registered trademark) EPO , Dagusa Company) to obtain the mixture. Next, the resulting mixture was compression-molded using Shimadzu Autograph AGS-1000D under a compression molding pressure of 2.9 kN to obtain a compression-molded product with a weight of 180 mg and a diameter of 8 mm. For compression molding, apply magnesium stearate (NOF Co., Ltd.) to the ring and punch.

[0108] The compression-molded product was kept warm in a constant temperature bath (80° C. holding temperature) for 10 hours, and then left ...

Embodiment 3

[0119] 0.054 g of amlodipine besylate (manufactured by Dr. Reddy's Company) as the above-mentioned drug, 1.13 g of Abicel PH101 (manufactured by Asahi Kasei Industries, Ltd.) and 1.70 g of mannitol (manufactured by Towa Kasei Kogyo Co., Ltd.) and 0.114 g of aminoalkyl methacrylate copolymer E (trade name: オイドラギッド (registered trademark) EPO, Dagusa Corporation) as the above-mentioned acrylic copolymer to obtain a mixture.

[0120] Next, the obtained mixture was compression-molded using Shimadzu Autograph AGS-1000D under a compression molding pressure of 2.9 kN to obtain a compression-molded product with a weight of 180 mg and a diameter of 8 mm. For compression molding, apply magnesium stearate (NOF Co., Ltd.) to the ring and punch.

[0121] The compression-molded product was kept warm in a constant temperature bath (80° C. holding temperature) for 10 hours, and then left to cool to room temperature to obtain the above-mentioned rapidly disintegrating tablet (orally rapidly dis...

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Abstract

It is intended to provide a method of producing a quick disintegration tablet by which desired quick disintegration properties can be established and a quick disintegration tablet having a sufficient tablet strength can be produced, and which is usable over a wide scope and has a high efficiency; and a quick disintegration tablet produced by the production method as described above which can be easily taken even by a patient having a lowered swallowing ability and has such a high strength as not being broken during distribution, storage and formulation procedures with the use of, for example, an automatic packaging machine. These objects can be achieved by providing a method of producing a quick disintegration tablet which comprises: (1) the step of blending an active ingredient, an acrylic copolymer and at least one pharmacologically acceptable additive; (2) the step of compressing and molding the mixture obtained in the above step (1); and (3) the step of maintaining the compression-molded article obtained in the above step (2) under temperature conditions of 50 to 100C for a definite period of time; and a quick disintegration tablet which is produced by the method of producing a quick disintegration tablet as described above.

Description

technical field [0001] The present invention relates to a rapidly disintegrating tablet and a manufacturing method thereof, in particular to a rapidly disintegrating tablet with high tablet strength and a manufacturing method thereof. Background technique [0002] Tablets are frequently used as pharmaceutical dosage forms due to their convenience and ease of administration. Tablets are required to be protected from damage or wear during distribution because they have a certain shape. Therefore, in order to ensure the strength of the tablet, it is necessary to consider the disintegration of the tablet after ingestion and the dissolution property of the drug. In recent years, tablets that are easily disintegrated in the oral cavity, developed as a dosage form that children or elderly people with reduced swallowing function can easily take without water, are also required to have the same strength as ordinary tablets. In addition, these tablets are not only required to have a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/32
CPCA61K9/0056A61K9/2095
Inventor 铃木智雄
Owner EISIA R&D MANAGEMENT CO LTD
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