Newly designed punch for scored tablets: Evaluation by an expert system based on quality by design

Abstract

Scored tablets enable modulation of the drug dose and intake by elderly, pediatric and dysphagic patients. However, they are known to involve difficulties in splitting, problems of mass uniformity of portions and loss of mass on breaking. A new punch designed for manufacturing of convex-faced cylindrical easy-breakable tablets (EBTs) was proposed. The upper punch exhibited a pronounced cross ridge and two curvatures, the peripheral one having lower radius, to allow a section of small area to be split and better exploitation of the applied force. Punches of 8 mm in diameter were used for manufacturing of orally disintegrating tablets (ODTs), and four of the most common co-processed ODT excipients were employed to explore the versatility of the investigated punch. For this purpose, an expert system was constructed based on 10 selected critical quality attributes, namely bulk density, compressibility index and cohesion index of the powder formulations as well as mass uniformity, crushing strength, friability, breakability index, disintegration time, wetting time and percentage water uptake of the tablets. Experimental data relevant to these parameters were normalized to radius values in a 0–10 range, 5 being the minimum acceptable. By connecting such normalized values, radar diagrams were drawn. The relevant area and shape along with the calculated indices of overall quality pointed out suitability and robust performance of the EBT punch used for ODT manufacturing.