Effect of process variables on roller-compacted ibuprofen tablets

The effect of roller compactor processing variables on the characteristics of ibuprofen tablets was investigated. A three-level factorial design was used for the investigation of the machine variables. The selected variables were the compaction roll pressure and a variable which combined both compaction roll and feed screw speed. A four-component formula containing ibuprofen, croscarmellose sodium. povidone and talc was used for the experimental batches. Three operators independently manufactured and tested twelve batches of ibuprofen tablets, each with a target weight of 210 mg and containing 200 mg active. Results of dissolution. disintegration. friability, hardness, thickness and weight are reported. Tablets from all experimental batches exceeded U.S.P. dissolution requirements. An interaction between roll pressure and the combined variable of roll and feed screw speed had a significant effect on dissolution. The machine variables studied did not have a statistically significant effect on tablet disintegration time or tablet crushing strength. The combined variable of roll speed and feed screw speed had a small but statistically significant effect on friability which was less than 1% for all batches. The variables studied had no statistically significant effect on tablet thickness or weight. Experimental tablets were compared to three commercial OTC brands of ibuprofen tablets with label claims of 200 mg and tablet weights ranging from 337 to 480 mg. The performance of the experimental tablets was comparable to the commercial brands.