オザグレルナトリウ厶注射薬の後発医薬品に関する品質評価

抄録

We studied the quality and stability of generic sodium ozagrel solution products for injection. Through the use of inspection apparatus, we noted exfoliation of the surface layer of glass ampoules filled with sodium ozagrel solution drug products for injection. Also, foreign insoluble matter, such as oil droplets, which was assumed to be silicone that had been applied to the internal surface of syringe barrels, was observed in pre-filled syringe products. In a stability study performed under accelerated conditions (40°C/75% RH) the generic sodium ozagrel solutions yielded a degradation product that was not detected in the lyophilized original product. The degradation product content of some of the generic products was over 16 mg/mL of sodium ozagrel, exceeding the specification for the original lyophilized product. These results indicate that some of the generic products are inferior in quality and stability to the original lyophilized drug.