ABSTRACT

I. INTRODUCTION The scale-up of a liquid-dispersed pharmaceutical product from the laboratory beaker to the pilot plant and then to the production facility is a major undertaking, where early intelligent decisions can yield significant economic benefits and also prevent major headaches and delays. There are many types and variations of mixing, dispersion, emulsification, and size-reduction equipment that can be used to prepare these dispersed systems. By selecting a given type of equipment, certain operating techniques are made possible as a result of the individual capabilities of that equipment. Since it is essential that the product manufactured on a large scale be exactly the same as that made in the laboratory and in the pilot plant, it is important to select laboratory equipment that can be effectively scaled up without production limitations. In this chapter we assume that a product has been successfully produced on a small scale in a laboratory. Given this promising start, the next decision-how to make the product and with which type of equipment-will bear heavily on the chances of the product being produced at the lowest cost, with the best reproducibility, and with the least chance of production delays.