CRITICAL QUALITY RISK ANALYSIS OF PROCESS PARAMETERS OF FLUID BED COATING TECHNOLOGY
The fluidized bed coating (FBC) is a complex process in pharmaceutical formulation engineering since there are a number of parameters that can affect it. In order to develop a robust pharmaceutical manufacturing process, it is important to determine all the critical process parameters (CPP) affecting critical quality attribute of the final product. There are many problems with a fluid bed coating process that produced inconsistent results. Many of the coating parameters interacted with each other, so conventional one factor at a time (OFAT) experiments were unable to resolve the issue. Design of experiments examines all of the variables simultaneously so it enabled us to identify the optimum values for the factors much more quickly. Main objective of this study is to provide a sophisticated robust and rugged FBC for the preparation of Ciprofloxacin Pellets with desired quality and performance (i.e. dissolution)