By Prasad.VN Challapalli1, Manaud de Raspide2, Satish Kamath3, and Ram Kasina4
1 Pharmaceutical Development Services, Patheon Pharmaceuticals Inc. Cincinnati, OH USA
2 Actelion Pharmaceuticals, Ltd, Allschwil, Switzerland
3 GlaxoSmithKline, Parsippany, NJ, USA
4 McNeil Consumer Healthcare, Fort Washington, PA, USA
ABSTRACT
Roller compaction of low dose active pharmaceutical ingredients into solid dosages forms is quite challenging. Ribbon porosity, tensile strength, mean granule size and surface area are key quality attributes that can affect downstream processing and final product performance. These parameters were evaluated in the present study to establish a design space and operational conditions for roller compaction of a placebo tablet blend that closely mimics the formulation requirements of low dose pharmaceutical active ingredients. This study also helps to minimize the API need that often in limited supply during early stage of drug development.