Roller Compaction Scale-Up

Bristol-Myers Squibb Company, New Brunswick, New Jersey, U.S.A. Abhay Gupta 

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Analytical Division, Rockville, Maryland, U.S.A. 

Industrial and Physical Pharmacy, Purdue University, West Lafayette, Indiana, U.S.A. 

---

In the aforementioned chapter in the First Edition Reference 1,1 mentioned, There is no such thing as a standard approach to solve compactor scale-up or compactor equipment changes in the pharmaceutical production process (1). At that time of the publication, it appeared that was very much the case history of roller compaction scale-up in the pharmaceutical industry. This understanding was based on the fact that there were no pharmaceutical industrial journal articles published at the time on the subject. On the other hand, it was also true that considerations, approaches, and examples presented in that chapter were experienced by others and were not all-inclusive. 

The following roller compaction scale-up examples illustrate technology strategies that identify equipment design features, process parameters, and evaluations defining roller compaction scale-up processes. 

Roller Compaction Scale-Up Using Near Infrared (NIR)... 

Table 6 Roller compaction scale-up trial using scale-up factors...

Miller, R.W., A. Gupta, and K.R. Morris, Roller compaction scale-up. Drugs. Pharm. Sci., 157(Pharmaceutical Process Scale-Up (2nd ed.)) 237-266 (2006). 

---