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In the pharmaceutical industry, dissolution testing is a very important tool in drug development and quality control. There is a need to establish the in vivo performance of products that contain probiotic agents for vaginal administration by developing in vitro methods of evaluation. In order to achieve a close in vitro–in vivo correlation for a tablet containing a probiotic agent for vaginal administration, the various parameters that must be considered when designing a dissolution apparatus include volume and composition of the dissolution medium, environmental conditions of the absorption site, and surface exposure of the tablet. The primary objective of the present investigation was the design of a dissolution apparatus that could simulate the vaginal environment for vaginal tablets containing a probiotic agent. The newly fabricated dissolution apparatus was found to be successful in minimizing the volume of the dissolution medium and in eliminating the risk of exposure of the vaginal formulation to agitation and sampling devices. Thus, the dissolution apparatus may prove to be of value for carrying out routine quality control tests.

Proposed Design of a Dissolution Apparatus for Vaginal Formulations Containing Probiotics