Evaluation of Bilayer Tablet Machines—A Case Study |
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Authors: | Shun Por Li Marshall G. Karth Kenneth M. Feld Louis C. Di Paolo Chandrashekar M. Pendharkar Robert O. Williams |
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Affiliation: | a Rhone-Poulenc Rorer Pharmaceuticals Inc., Pharmaceutical Technology and Engineering, Fort Washington, PAb Central Research, Rhone-Poulenc Rorer Pharmaceuticals Inc, Collegeville, PAc Affinity Pharmaceutics, Fort Washington, PAd Johnson & Johnson Merck Consumer Pharmaceuticals Co., Fort Washington, PA |
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Abstract: | Four bilayer tablet compression machines were evaluated for their suitability for compression of a specific bilayer tablet formulation. Tablet machines evaluated were: Manesty (Model No. BB4), Manesty (Model No. Rotappress), Fette (Model No. P3102) and Kilian (Model No. 51AST-ZS) tablet presses. The tablet delamination tendency was the primary acceptance criteria for the evaluation of tablet press performance. The compression force on layer I was found to be the major factor influencing tablet delamination. It was found that the Kilian press was best suited for the compression of the model bilayer tablet formulation. The Kilian press is equipped with a special sampling device for layer I which allows additional compression force to be applied on layer I only at the time of weight sampling. The sampling device then returns to the original set points after sampling is completed. This feature maintains the compression force on layer I to a minimum during routine compression. Data indicated that the compression force on layer I and the compression zone in the die cavity of layer II were two factors needing to be controlled in order to yield bilayer tablets with acceptable physical characteristics. |
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