ABSTRACT

Film coating, in the formal sense, is a process that has been utilized in the pharmaceutical industry for over half a century. In spite of its relative longevity, it remains a complex process in which all technical issues and their impact are not always fully appreciated with the result that potential problems continue to arise with all too frequent regularity. This chapter will focus on identifying the most common problems and adopting a sensible approach to their effective resolution. To the latter end, the importance of implementing the required tenets of QbD will be stressed.