Novel algorithm elucidating the tablet dividing mechanism in scored tablets and its experimental verification

Abstract Scored tablets are produced to facilitate easy and uniform division of tablets. One of the most critical quality attributes of the scored tablet is its dividing uniformity. To clarify the tablet dividing mechanism, we proposed a novel algorithm on the basis of fracture and statistical mechanics. Powder formulations composed of microcrystalline cellulose, cornstarch, and lactose were prepared to realize tablets with different score line shapes. As a result, the probability of cracks in the tablet and the dividing uniformity were well estimated. The dividing uniformity was observed to be more sensitive to changes in the formulation factors rather than the shape of the score line. The proposed algorithm demonstrated that the variation in the crack initiation threshold originating from the formulation factors was more significant than that of the stress concentration on the basis of the shape of the score line.