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Tablets & Capsules March 2014 17 target roll pressures. Overall, roll pressure had a signifi- cant effect on the dissolution of tablets, even though the hardness of the tablets remained the same, and the roll pressure range needs to be optimized and controlled. Conclusion In this study, the DT of the tablets increased linearly as the roll pressure increased for the target- and high- hardness tablets. The dissolution profile of the tablets compressed with a blend made with low roll pressure was faster at all three hardness levels. At the target hardness, the dissolution profile of tablets compressed with a blend made at low roll pressure was significantly faster com- pared to tablets compressed from blends made at the tar- get and high roll pressures. These results suggest that roll pressure is a critical process parameter for poorly soluble APIs and needs to be optimized during product develop- ment. Furthermore, roll pressure should be used as an in- process control parameter during product manufacture. T&C References 1. Miller, R.W. Roller compaction technology. In: Parikh, D.M., (Ed), Handbook of pharmaceutical granu- lation technology, Marcel Dekker, New York, pp. 102- 114, 1997. 2. Li, F., Meyer, R.F., and Chem, R. Understanding critical parameters in roller compaction process and development of a novel scaling method. Abstract #203, Milling and Blending, Fifth World Congress on Particle Technology, 2006. 3. Sheskey, P.J. and Dasbach, T. Evaluation of various polymers as dry binders in the preparation of an immedi- ate-release tablet formulation by roller compaction. Pharm Technol., 19, 98-112, 1995. 4. Dave, V.S., Fahmy, R.M., Bensley, D., and Hoag, S.W. Eudragit RS PO/RL PO as rate-controlling matrix- formers via roller compaction: Influence of formulation and process variables on functional attributes of granules and tablets. Drug Dev Ind Pharm, 38, 1240-1253, 2012. 5. Sheskey, P.J., Cabelka, T., Robb, R., and Boyce, B., Use of roller compaction in preparation of controlled- release hydrophilic tablets containing methylcellulose and hydroxypropylmethyl cellulose polymers. Pharm Technol, 18, 132-150, 1994. 6. Inghelbrecht, S. and Remon, J.P., Reducing dust and improving granule and tablet quality in the roller com- paction process. Int J Pharm., 171, 195-206, 1998. 7. Hancock, B.C., Colvin, J.T., Mullarney, M.P., and Zinchuk, A.V. The relative densities of pharmaceutical powders, blends, dry granulations and immediate release tablets. Pharm Technol, 64-80, April 2003. E. E. Robles is a scientist; P. M. Ved is a formulator III; N. Vora is a formulator II; T-Y. Kim is a team leader; D. Cartwright is a formulator III; J. A. Williamson is a team leader; N. Kanikkannan is a manager; and P. Skultety is vice president of pharmaceutical development services at Xcelience, 5415 West Laurel St, Tampa, FL 33607. Tel. 813 246 0404. Website: www.xcelience.com. Figure 4 Effect of tablet hardness on dissolution of tablets when blend is prepared at low roll pressure (2 MPa) Minutes % indomethacin release 100 90 80 70 60 50 5 10 20 30 45 60 75 Tablet, low hardness (7 kp) Tablet, target hardness (10 kp) Tablet, high hardness (13 kp) Figure 5 Effect of tablet hardness on dissolution of tablets when blend is prepared at target roll pressure (3.5 MPa) Minutes % indomethacin release 95 85 75 65 55 45 35 5 10 20 30 45 60 75 Tablet, low hardness (7 kp) Tablet, target hardness (10 kp) Tablet, high hardness (13 kp) Figure 6 Effect of tablet hardness on dissolution of tablets when blend is prepared at high roll pressure (5 MPa) Minutes % indomethacin release 95 85 75 65 55 45 35 5 10 20 30 45 60 75 Tablet, low hardness (7 kp) Tablet, target hardness (10 kp) Tablet, high hardness (13 kp) c-Roblesart_8-17 copy_Masters 3/5/14 10:04 AM Page 17