To evaluate the quality and stability of limaprost-alfadex generics,we carried out a comparative study on 5 generics and 2 branded products.
The limaprost contents were higher in 2 of the generics than in the 2 branded products,and 1 generic had a higher level of 17S,10-dimethyl-trans -δ2-PGA1(11-deoxy congener),the major degradation product of limaprost,than the specification for the branded products (</=5.0%).To compare the stability of the tablets in the PTPs,they were removed from the aluminum pillow and stored under the conditions of 25°C and 57.5% relative humidity (RH),25°C and 75.0% RH and 40 °C and 75.0% RH.At 25°C and 57.5% RH,though the limaprost contents of the generics were similar to those of the branded products after 3 months,the 11-deoxy congener levels in 2 of the generics had increased to over 5.0%.Moreover,the percentage degradation of limaprost and 11-deoxy congener levels were particularly marked in some of the generics under the more humid conditions of 25°C and 75.0% RH and 40°C and 75.0% RH.On comparing the stability in cellophane paper at 25°C and 57.5% RH for 3 months,the limaprost content only remained above 90% in the branded products.These results indicate that the limaprost-alfadex generics could be less stable than the branded products in a PTP and one-dose package made of cellophane paper.Therefore,when deciding to use generics or not,it is necessary to evaluate them on the results of stability tests as well as those of bioequivalence and dissolution tests.
