(166a) Reducing Powder Lubrication in an Encapsulation Process for Improved Dissolution Performance
AIChE Annual Meeting
2014
2014 AIChE Annual Meeting
Pharmaceutical Discovery, Development and Manufacturing Forum
Application of Quality By Design in Drug Product Process Development I
Monday, November 17, 2014 - 3:15pm to 3:40pm
Lubrication of pharmaceutical formulations aids manufacturing by reducing friction and adhesion between the powder and the processing equipment as well as helping to increase the bulk density of the powder for improved flowability. However, if the extent of lubrication becomes too great, adverse effects – including reduced tensile strength of compacts and slowed disintegration/dissolution of dosage forms – can be observed. In this work, a case study is presented where an approach to resolve slow capsule dissolution is described. This approach entails (1) an engineering analysis to identify the root cause and propose alternative equipment design solutions and (2) a process modeling effort using the discrete element method (DEM) to assess the performance of these alternatives in silico. Results and outcomes to be described.