Scale-up of a Pharmaceutical Roller Compaction Process Using a Joint-Y Partial Least Squares Model

Garcia-Munoz et al. [Garcia-Munoz, S.; Kourti, T.; MacGregor, J. F. Chemom. Intell. Lab. Syst. 2005, 79, 101–114] proposed a new latent variable regression methodology, joint-Y partial least squares (JYPLS), for product transfer between plants. In this paper, this method is used for product scale-up from a type of laboratory-scale roller compactor, a Fitzpatrick IR220, to a type of full-scale roller compactor, a Fitzpatrick IR520, in the pharmaceutical industry. A JYPLS model is first built with the data set collected from historical experiments on these two types of compactors. The JYPLS model relates API mass fraction, excipient mass factions, and roller compaction process measurements to ribbon properties. A constrained optimization is then formulated to invert the JYPLS model to find the key process settings of the Fitzpatrick IR520 to make the same quality of ribbon using the same raw materials formulation as the ribbon that had been produced on the Fitzpatrick IR220.