Abstract
The purpose of this study was to examine differences in dissolution behavior between the original vancomycin hydrochloride injection preparation and 3 generics of it.The 4 injection preparations were dissolved in water for injection as described in the package inserts,or in normal saline,and their dissolution behavior was investigated after 15 seconds and 30 seconds.In addition,a kit formulation (Otsuka normal saline 2-Port) was used to investigate dissolution behavior when dissolution was performed either 2 or 3 times.
There were differences in dissolution rate between the 2 dissolution media with more than 90% of all the products dissolving within 15 seconds in water for injection and within 30 seconds in normal saline.In the case of performing dissolution twice with the kit formulation,the dissolution rate for all products was also more than 90%.
In conclusion,at least 15 seconds or 30 seconds,respectively,is required to dissolve more than 90% of the products in water for injection and normal saline.Also to dissolve more than 90% of the products in a kit formulation,dissolution must be performed at least twice.
