New Approach to Development and Manufacture of Enteric Compression Coatings

Sample Size Determination and Statistical Hypothesis Testing for Core Centration in Press Coated Tablets

“…A quality assessment process needs then to be established to guarantee that the centering of the core stays within certain specifications. Current methods used for evaluating core centration are either imprecise, where the core position is measured "by hand" [1,10], or expensive, where costly diagnostic equipment is required [3]. An option to obtain well-centered cores is to use onestep dry-coated tablets [3,11] but the technology is rather new and not implemented everywhere.…”