were studied. FEM results obtained for fully elastic and elasto-plastic tablets were 22 fairly similar, but they highlighted large differences in stress distributions depending 23 on the position of the breaking line. The stress values at failure were predicted to be 24 similar for tablets tested at an angle of 45° or above, whereas at lower test angles the 25 predicted breaking loads were up to 3 times larger. The stress distributions 26 suggested that not all breaking line angles would result in clean tensile failure. 27Practical results, however, did not confirm the differences in the predicted breaking 28 loads, but they confirmed differences in the way tablets broke. The results suggest 29 that it is not advisable to convert breaking loads obtained on scored tablets into tablet 30tensile strength values, and comparisons between different tablets or batches should 31 carefully consider the orientation of the breaking line with respect to the loading 32 plane, as the failure mechanisms appear to vary. Flat, round tablets usually have bevel-edges to reduce chipping of the tablet edges 38 during packaging, transport and handling, and very often they carry a breaking 39 ("score") line. The provision of a breaking line is an attempt to reduce the number of 40 tablet dosing strengths required to cover a range of dosing options for a drug. At the 41 same time, breaking lines might help patients who have swallowing difficulties and 42 provide some flexibility in the amount of drug taken in a single dose (van Santen et 43 al., 2002). However, as noted in the USP monograph on testing tablet breaking 44 forces (Method 1217, USP38/NF33, 2014) the presence of a breaking line might 45 influence the breaking forces recorded, and they hence advise that during the 46 standard diametral compression test the orientation of the breaking line should be 47 kept constant, either horizontally or vertically. However, in line with fracture 48 mechanics knowledge Newton et al. (1977) recommended that the breaking line 49 should be positioned perpendicular to the platen surfaces i.e. be parallel to the 50 direction of loading to increase the chance of tensile failure to occur along the 51 breaking line. As an alternative to the diametral compression test, Sovány et al. 52(2010) used a three-point bending test, whereby the breaking line was positioned 53 below the upper, slightly blunted loading edge, presumably facing downward (this is 54 not clearly specified in their paper). The advantage of a three-point bending test over 55 the diametral compression test is that the bending moment increases linearly from 56 zero at either support of the tablet to a maximum value at the mid-span location, and 57 assuming linear elastic behaviour, shear effects will not affect the maximum tensile 58 stress developing at the lower tablet surface (Stanley, 2001). Mazel et al. (2014) also 59 suggested that for pharmaceutical compacts the three-point bending test should be 60 preferred over the diametral compression test, because it reflects the ten...