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Effect of Roller Compaction on Nisin Raw Material Lot-to-lot Variations

A. Habib 1) , Sevgi Takka 2) , and Adel Sakr

Industrial Pharmacy Program, College of Pharmacy, University of Cincinnati, Cincinnati, Ohio (USA)

Nisin is a peptide antimicrobial agent which has low and inconsistent bulk and tap densities, and very fine and inconsistent particle sizes. The raw material also exhibits poor flow properties and poor compressibility. Therefore, this study was performed to evaluate the effect of roller compaction in overcoming the raw material difficulties, flowability, and compressibility of nisin. The effect of single, double, and triple compaction, using a Freund TF-Mini roller compactor, was evaluated. It was found that although single pass roller compaction improved the raw material characteristics, at least three passes were necessary to produce acceptable flowability for compression and minimize raw material lot-to-lot variability. Roller compaction increased the bulk and tap densities of Nisin and decreased the percent of fines, angle of repose and Carr’s compressibility index. The number of roller compaction passes decreased the tablet capping. After three passes, excellent tablets were produced which could withstand the vigorous agitation in the Wurster fluid bed coating for colonic targeting.

Key wods Compactability · Lot-to-lot variability · Nisin · Peptide · Roller compaction

1) Present address: CIMA Labs Inc., Minneapolis, Minnesota (USA).

2) Present address: Gazi University, Faculty of Pharmacy, Pharmaceutical Technology Department, Ankara (Turkey).