A Parenteral Drug Scale-Up

Department of Pharmaceutical Technology, Shire US Manufacturing, Owings Mill, 

The basic principles employed in the preparation of parenteral products do not vary from those widely used in other sterile and non-sterile liquid preparations. However, it is imperative that all calculations are made in an accurate and most precise manner. Therefore, an issue of a parenteral solution scale-up essentially becomes a liquid scale-up task, which requires a high degree of accuracy. A practical yet scientifically sound means of performing this scale-up analysis of liquid parenteral systems is presented below. The approach is based on the scale of agitation method. For singlephase liquid systems, the primary scale-up criterion is equal liquid motion when comparing pilot-size batches to a larger production-size batches. 

One of the most important processes involved in the scale-up of liquid parenteral preparations is mixing (1). For liquids, mixing can be defined as a 

---