Determination Of Tensile Strength Of Shaped Tablets

During early drug product development, methods for characterization of mechanical attributes are developed for flat, round tablets. However, there is a lack of understanding on how to compute the tensile strength of shaped tablets, which makes determination of the tabletability and compressibility impossible. Existing models for biconvex, round and capsule shaped tablets were analyzed. In addition, a finite element method simulation was developed to compute the tensile strength of oval tablets. It was found that the model by Shang et al. (2013) for biconvex tablets is consistent over a wide range of dimensions including flat, round tablet. A hybrid model was proposed for capsule shaped tablets based on models by Shang et al. and Pitt et al. (2013). However, models developed for capsule shaped tablets may under predict or over predict the tensile strength of oval tablets. Therefore, tensile strength of oval tablets must be separately evaluated for each tablet.(c) 2021 Elsevier B.V. All rights reserved.