Tablet Scoring: Current Practice, Fundamentals, and Knowledge Gaps

Abstract

Oral solid dosage formulations and/or tablets have remained the preferred route of administration by both patients and health care practitioners. Oral tablets are easy to administer, they are non-invasive and cause less risk adversity. Because of the lack of commercially available tablet dose options, tablets are being split or partitioned by users. Tablet scoring refers to the breakage of a tablet to attain a desired efficacy dose and is an emerging concept in the pharmaceutical industry. The primary reason for the tablet scoring practice is to adjust the dose: dose tapering or dose titrating. Other reasons for tablet partitioning are to facilitate dose administration, particularly among the pediatric and the geriatric patient population, and to mitigating the high cost of prescription drugs. The scope of this review is to: (1) evaluate the advantages and inconveniences associated with tablet scoring/portioning, and (2) identify factors in the formulation and the manufacturing of tablets that influence tablet splitting. Whereas tablet partitioning has been a common practice, there is a lack of understanding regarding the fundamentals underpinning the performance of tablets with respect to splitting. Several factors can influence tablet partitioning: tablet size, shape, and thickness. A requirement has recently been set by the European Pharmacopoeia and the U.S. Food and Drug Administration for the uniformity of mass of subdivided tablets. For breaking ease, an in-vivo reference test and a routinely applicable in-vitro test need to be established.