A Review on Tablet Scoring: Background, History and Current Regulatory Considerations

Abstract

Tablet splitting or breaking of tablets into multiple strengths has been a common practice across the world. Splitting of tablet offers various advantages such as dose flexibility and ease of swallowing in different population including geriatric and pediatric patients (wide patient acceptance) and cost saving on medications (economic advantage) The tablet products that are meant to be split and approved by the Food and Drug Administration (FDA) will have a scored line indicating the split location to ensure patient can adjust the dose by splitting and such splitting information will be included in the patient package insert. Having a consistent scored reduces difficulty in dose related problems especially when using products made by different manufacturers such as Generic compared to Reference Listed Drugs (RLD). Physical characteristics such as shape, size and tablet score may affect tablet splitability. Currently, various regulatory bodies (FDA, USP, and EP) provide consistent and useful information to the pharmaceutical industry. In this review, authors have compiled information from currently available resources on tablet scoring.