錠剤粉砕によるβ-メチルジゴキシン散剤の付着性

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Beta-methyldigoxin (MD), a new semi-synthesized cardiac glycoside, has been widely used for treatment of congestive heart failure. Since any dosage form other than tablet form is not commercially available for MD, it has been necessary to prepare powder by pulverizing the tablet when dose adjustment is required. It has recently been suggested that the loss of content in digoxin powder is caused by adhesion to the wrapping papers. In the present study, we examined the content-uniformity and adhesiveness of MD in powder by pulverizing. In addition, we investigated the effect of magnesium stearate, a lubricant, on the adhesion of MD to wrapping paper. The content and content-uniformity of MD in powders were influenced by the numbers of tablet, namely, the amount of preparation. The extent of lost content and the variation in content-uniformity of MD increased with a decrease in the number of tablets. There was large adhesion of MD to wrapping papers. The percentage of MD lost by adhesion became exceedingly greater when the amount of powder per package became smaller. Furthermore, the percentage of MD lost in powder increased after dividing and packing by automatic machine, ranging from 17.1 to 37.3% of the initial value. When one package contained a small amount of powder, there was no remarkable effect of the lubricant on loss of MD after dividing and packing. This study confirms that attention should be given to prevent the possibility of MD content being lost in practical use.
日本医療薬学会の論文
1994-10-20

錠剤粉砕によるβ-メチルジゴキシン散剤の付着性

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