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Miniaturization sarpogrelate hydrochloride oral drug-giving preparation

A technology for sarpogrelate hydrochloride and preparations, which is applied in the field of sarpogrelate hydrochloride oral administration preparations, can solve the problems of increased size, difficulty in taking, increased dosage of additives, etc., and achieves good manufacturability, fast dissolution speed, and inhibition of hydrolysis. Effect

Active Publication Date: 2007-01-31
MITSUBISHI TANABE PHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the case of a drug with a large amount administered at one time, the amount of additives used for processing into a preparation also increases in proportion to the amount of the drug, and the size of the drug increases, making it difficult to take

Method used

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  • Miniaturization sarpogrelate hydrochloride oral drug-giving preparation
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  • Miniaturization sarpogrelate hydrochloride oral drug-giving preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] Example 1: Manufacture of miniaturized sargrelate hydrochloride oral preparation containing carboxymethylcellulose

[0084] (1) 56% by weight of sagrelorate hydrochloride, 19% by weight of crystalline cellulose, 14% by weight of carboxymethyl cellulose (manufactured by NICHIRIN CHEMICAL INDUSTRIES, LTD., NS-300) and 1% by weight of light anhydrous silicon Acid mix. Then, using a high-speed stirring granulator (manufactured by POWREX CORPORATION, a vertical granulator), granulate in an aqueous solution containing 1% by weight of citric acid and 2% by weight of hydroxypropylcellulose, and then dry to obtain granulated particles. 2.4% by weight of magnesium stearate was added to the granules, and compression molding (7.6 mm in diameter) was performed with a rotary tablet machine to obtain uncoated tablets.

[0085] (2) 3% by weight of hydroxypropylmethylcellulose (manufactured by Shin-Etsu Chemical, TC-5RG), 0.6% by weight of titanium oxide, 0.6% by weight of polyethylen...

Embodiment 2

[0092] Example 2: Manufacture of a miniaturized sagrelate hydrochloride oral preparation containing carmellose calcium

[0093] (1) 56% by weight of sagrelorate hydrochloride, 19% by weight of crystalline cellulose, 14% by weight of carmellose calcium (manufactured by NICHIRIN CHEMICAL INDUSTRIES, LTD, ECG505) and 1% by weight of light anhydrous silicic acid were mixed. Then, using a high-speed stirring granulator (manufactured by POWREX CORPORATION, a vertical granulator), granulate in an aqueous solution containing 1% by weight of citric acid and 2% by weight of hydroxypropylcellulose, and then dry to obtain granulated particles. 2.4% by weight of magnesium stearate was added to the granules, and compression molding (7.5 mm in diameter) was performed with a rotary tablet machine to obtain uncoated tablets.

[0094] (2) 3% by weight of hydroxypropylmethylcellulose (manufactured by Shin-Etsu Chemical, TC-5RG), 0.6% by weight of titanium oxide, 0.6% by weight of polyethylene g...

Embodiment 3

[0096] Embodiment 3: the manufacture (stirring granulation) of the miniaturized sarcogrelate hydrochloride oral administration preparation containing sodium carboxymethyl starch

[0097] (1) 56% by weight of sagrelorate hydrochloride, 23% by weight of crystalline cellulose, 10% by weight of sodium carboxymethyl starch (manufactured by DMV, Primogel), and 1% by weight of light anhydrous silicic acid were mixed. Then, using a high-speed stirring granulator (manufactured by POWREX CORPORATION, a vertical granulator), granulate in an aqueous solution containing 1% by weight of citric acid and 2% by weight of hydroxypropylcellulose, and then dry to obtain granulated particles. 2.4% by weight of magnesium stearate was added to the granules, and compression molding (7.5 mm in diameter) was performed with a rotary tablet machine to obtain uncoated tablets.

[0098] (2) 3% by weight of hydroxypropylmethylcellulose (manufactured by Shin-Etsu Chemical, TC-5RG), 0.6% by weight of titaniu...

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Abstract

Provided is an orally administrable preparation of hydrochloride sarpogrelate facilitating the administration by miniaturization. The miniaturized orally administrable preparation of the hydrochloride sarpogrelate has a high content of >=40% of the hydrochloride sarpogrelate per preparation, and exhibits good manufacturability by suppressing tablet trouble. The preparation also has a rapid elution rate from the preparation in the alimentary tract, and exhibits good preservation stability.

Description

[0001] TECHNICAL FIELD The present invention relates to an oral preparation of sargrelate hydrochloride, which can be easily administered by downsizing the oral preparation. Background technique [0002] Oral drug preparations are generally produced by adding additives such as excipients to the original drug, followed by granulation, further adding a lubricant, etc., and then tableting. However, in the case of a drug that is administered in a large amount at one time, the amount of additives for processing into a formulation also increases in proportion to the amount of the drug, and the size of the drug increases, making administration difficult. [0003] In the case of an oral preparation of sarcogrelate hydrochloride, the standard dosage per dose is 100 mg. A 100 mg tablet of sarcogrelate hydrochloride preparation (100 mg of Anplag (registered trademark) tablet manufactured by Mitsubishi Pharmaceutical Co., Ltd.) manufactured by conventional preparation technology contains ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/14A61K9/28A61K31/14A61K47/38A61K47/34
CPCA61K9/2054A61K31/225A61K47/38
Inventor 越智一树野村达雄
Owner MITSUBISHI TANABE PHARMA CORP
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