386566 A Simple Process Transfer Method for Roller Compaction

Wednesday, November 19, 2014
Galleria Exhibit Hall (Hilton Atlanta)
Weixian Shi and Omar L. Sprockel, Commercial Oral Technology & Operations, Bristol-Myers Squibb, New Brunswick, NJ

A probability based process transfer method for roller compaction, from development scale to commercial scale, was found to accurately describe the mechanism of ribbon formation at both scales.  In this method, a statistical relationship between roller compaction parameters and ribbon attributes was first defined using a development Alexanderwerk WP120 roller compactor with an 18-run design of experiment. The statistical relationship was then adapted to a commercial Alexanderwerk WP200 roller compactor with one experimental run on the Alexanderwerk WP200. The experimental run served as a calibration of the statistical model parameters. The proposed transfer method was then confirmed by conducting a mapping study on the Alexanderwerk WP200 using a factorial DoE, which showed a match between the predictions and the verification experiments.  The study demonstrates the applicability of the roller compaction transfer method using the statistical model from the development scale calibrated with one experiment point at the commercial scale.

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See more of this Session: Poster Session: Pharmaceutical
See more of this Group/Topical: Food, Pharmaceutical & Bioengineering Division