2007 年 33 巻 12 号 p. 1013-1019
Recently,the use of generic drugs has been steadily increasing,and more medical institutions are dispensing single-dose packages to improve compliance among elderly patients.In view of this,we prepared single-dose packages for several generic products containing the laxative agent magnesium oxide and compared their stability with that of an original product when the packages were stored long-term under constant conditions.
We examined a total of four types of product-two plain tablets (ML and MM) and a film-coated tablet (KM) as the generic products,and subtle granules (SM) as the original product.They were evaluated with respect to appearance change as well as quantitative test,hardness test (SM excluded) disintegration test (SM excluded) and dissolution test results after storage for 90 days under three sets of constant conditions (25°C and 75% RH,30°C and 75% RH,40°C and 75% RH).
The appearance of the products did not change under any of the sets of conditions and the results of the quantitative test showed an average content of more than 96%.However,hardness increased under all of the storage conditions and there was a significant difference among the three product types in this regard.In the disintegration test,a delayed collapse was noted for all products except ML under each of the set of conditions.In the dissolution test,as compared with SM,the elution rate for KM was significantly lower,and it tended to be lower with ML and MM as well.
In our study,as we noted differences among the 4 types of product as regards physicochemical stability when packed in single dose packages,generic products must be carefully selected with regard to stability when adopting them for specific dispensing strategies.
