ABSTRACT

Film coating of pharmaceutical dosage forms has evolved from its rudimentary origins

to become a sophisticated science that has contributed immeasurably to the advance-

ment of drug delivery. The earliest application of pharmaceutical coating has been

attributed to Rhazes (850-932 AD) who coated pills with the mucilage of psyllium

seeds to mask unpleasant taste (1). Other early coating systems involved the application

of gold and silver, talc, waxes, and gelatin to pills and tablets (2-4). These early coatings

were typically applied to substrates individually by supporting them with forceps or

mounting them on a needle and repeatedly dipping the articles into the coating fluid. The

origin of large scale film-coating of pharmaceuticals began with the adoption of sugar

coating from the candy industry which utilized the batch pan coating process. The first

sugar-coated pills were made available in the United States in 1842 (5) and shortly

thereafter were being manufactured in the United States in 1856 (6). Film coating with

polymers emerged in the 1950s as a more efficient alternative to sugar coating due to a

substantial reduction in drying time by the utilization of volatile organic solvents as the

dispersion media. In addition, film coating offered the benefit of less rigid coats which

reduced cracking and other coat defects and allowed for the successful coating of sub-

strates other than tablets, i.e., powders, granules, pellets, and capsules. Although film

coating with polymeric materials from organic solution offered many initial benefits,

ultimately these coating systems lost their favor due to flammability, toxicity, environ-

mental, and cost related issues. These problems regarding organic solvent-based film

coating led pharmaceutical manufacturers to re-evaluate aqueous-based coating systems.

By this time, coating equipment had substantially improved beyond the early pan coating

systems, and thus drying efficiency with aqueous coating systems was no longer a pro-

hibitive problem.