Improved stability of OPALMON^[○!R] Tablets under Humid Conditions II : Stability in One-dose Package

The stability of OPALMON® tablets under humid conditions was improved in a previous study through the use of a better formulation. In the present study, we tested the improved formulation (improved OPALMON® tablets) for purity, content, disintegration time, and tablet hardness. The improved OPALMON® tablets contain a lyophilized form of limaprost alfadex and dextran with dextrin.The stability of the existing formulation of the OPALMON® tablets and improved OPALMON® tablets was compared under humid conditions either by placing tablets in a Petri dish or putting them in a one-dose package which consisted of glassine and cellophane paper. The percentage degradation of the improved OPALMON® tablets was approximately 20% of that of the existing formulation. In the one-dose package, the purity of the improved formulation met the acceptance criteria for four months at 25°C and 60% relative humidity (RH), and eight weeks at 25°C and 75% RH. In the one-dose package, the content and disintegration time of the improved formulation also met the acceptance criteria for four months at 25°C and 60% RH, and eight weeks at 25°C and 75% RH. However, there was a slight reduction in tablet hardness for the improved formulation after one month at 25°C and 60% RH, and one week at 25°C and 75% RH. On evaluating the strength of the tablets at the time of packaging through a packaging test using a fully automated tablet packer, there were no broken or chipped tablets in either the initial samples or samples with reduced hardness. We therefore concluded that the hardness of the improved OPALMON® tablets is satisfactory for our purposes.