(84c) Scale up of Dry Granulation from Pilot Scale to Commercial Manufacturing

Dry granulation (roller compaction) is a common processing technique used in the pharmaceutical industry to improve the flow of moisture sensitive drug substances. There are a number of manufacturers of this equipment. While the basic principle of roller compaction is the same for most equipment each device has its own unique operating attributes which differentiates it from another. These differences can present challenges when scaling up during development and technology transfer.

A case study is presented outlining the techniques used to transfer a roller compaction process from an Alexanderwerk WP120 in the development labs to a WP200 in a commercial manufacturing environment. Additionally techniques will be discussed which look at transferring from an Alexanderwerk to a Gerteis unit and subsequently scaling from a Gerteis Mini-Pactor to a Macro-Pactor. Ribbon density and particle size distribution of the granulation along with dissolution of the tablets produced were the primary outputs used to determine whether material manufactured on any unit was equivalent and/or appropriate.