分包散剤の重量変動の薬物血中濃度推移に及ぼす影響

概要

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Effects of weight variation of powders divided by an automatic packaging machine for dispensing on time-course of simulated blood drug levels were studied. Digoxin and phenytoin (powdered form with excipients) and sodium valproate (fine granules) as model drugs were packaged by the machine. To simulate weight variation of packaging, normal random deviates were also used. In case of valproic acid, relatively large variation of the levels to the weight variation was observed, and this phenomenon may be caused by rapid absorption and elimination of drug. However, relatively small variations of that in digoxin and phenytoin were observed, and these phenomena may be caused by slow or saturated elimination of drug. The concept of regression and correlation was applied to the relationship between weight variation and variated blood drug levels as the technique in order to quantify the response. Observed values of the regression and correlation coefficients were 0.08 and 0.18 in phenytoin, 0.15 and 0.56 in digoxin, and 0.52 and 0.88 in valproic acid, respectively. The degrees of effect of weight variation on the variation of blood drug levels resulted from the pharmacokinetic properties of drugs, and the regression and correlation coefficients may be able to use as a decision marker to decide tolerance limits of weight variation of powders in dispensing.
日本医療薬学会の論文
1988-08-20