ヒト二相性イソフェンインスリン水性懸濁製剤の含量均一性についてのバリデーション

抄録

We evaluated the validation of biphasic isophane insulin suspension (Humacart 3/7 and Penfill 30 R). The concentrations of total insulin, Zn, m-cresol and phenol in Humacart 3/7 and Penfill 30 R were consistent with the levels described in the interview form. To study the relationship between mixing (0, 5, 10 and 20 times) and the uniformity of the insulin suspension, Humacart 3/7 and Penfill 30 R were set into Penjector and Novopen, respectively. The total insulin concentrations of both insulin preparations varied between 50 and 170 U/ml without mixing, so mixing more than 10 times was necessary to equalize the insulin suspension. Total insulin concentrations through Penjector and Novopen decreased with increased leaving time after well mixing, thus these insulin preparations have to be injected as soon as possible after mixing. The differences in total insulin concentrations of Humacart 3/7 and Penfill 30 R after mixing were not significant, however the insulin concentrations of Humacart 3/7 filtered through a 0.45 μm membrane were higher than those of Penfill 30 R. The permeation rate of insulin in Humacart 3/7 using a permeation cell system was faster than that of Penfill 30 R. The differences in monomeric insulin concentration of the insulin preparations were not significant, however, the dimeric-hexameric insulin concentration in Humacart 3/7 was higher than that in Penfill 30 R. These results may indicate that the absorption of Humacart 3/7 is faster than that of Penfill 30 R in clinical use.