Tablets & Capsules


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I 8 March 2014 Tablets & Capsules roller compaction Effect of roller compaction pressure on the blend and tablet properties of a formulation containing a poorly soluble drug E. E. Robles, P. M. Ved, N. Vora, T-Y. Kim, D. Cartwright, J. A. Williamson, N. Kanikkannan, and P. Skultety Xcelience This article describes a study of the effect of roll pressure on the blend characteristics and the tablet properties of an immediate- release formulation comprising a poorly soluble active pharma- ceutical ingredient (API). The results show that roll pressure has a significant effect on the dissolution of the tablets even when the tablet hardnesses are equal. These results suggest that roll pressure is a critical process parameter for poorly soluble APIs; that it needs to be optimized during the product development stage; and that it can be used as an in-process control during manufacture. nterest in using roller compaction to manufacture solid dosage forms has increased in recent years. It is a dry, continuous process that provides good control over final particle size and bulk density. The major advantage of roller compaction over wet granulation is that it requires no water or organic solvents. That is especially beneficial when working with APIs that are sensitive to heat and/or moisture. In operation, roller compaction densifies dry powders into a solid mass (compacted ribbon), which is then milled into granules of the desired size. The compaction process has several stages, including particle rearrange- c-Roblesart_8-17 copy_Masters 3/5/14 10:03 AM Page 8

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