Chapter 33 – Development.pdfVIP

C H A P T E R 33 33 Development, Optimization, and Scale-up of Process Parameters: Pan Coating Stuart Porter, Gary Sackett and Lirong Liu 33.1 INTRODUCTION 33.1.2 Evolution of Pharmaceutical Coating Technologies In the modern pharmaceutical industry, film-coating is generally referred to as a process by which a thin Application of coatings to medicinal products can continuous layer of solid is applied onto the surface be traced back by more than a century. However, of a dosage form or its intermediate. The purpose of a uniform and consistent film-coating process that film-coating includes aesthetic enhancement, increase meets the minimum requirements imposed by today’s of shelf life, taste masking, moderating the release pro- regulatory requirements has only been available for file of active pharmaceutical ingredient API , trade- the past few decades. marking, and protection of intellectual property … etc. Sugar-coating in a smooth bowl-shaped container, The thickness of the film is generally less than a originally with an external heat source, probably rep- hundred microns. The composition of the film may resents one of the earliest processes used as a phar- include a mixture of inert excipients, as well as an API. maceutical coating process. Film-coating emerged as an alternative to the sugar-coating process to reduce process time, and minimize exposure to high tem- 33.1.1 Theory of Film-coating perature and excessive moisture. The evolution in design of equipment has progressed from an open Film-coatings can be applied by different meth- system to one that is completely enclosed, and self- ods, such as spraying a liquid, dipping into a liquid, contained. Liquid delivery and air handling sy