PFR-Stimuli-PF2009 1595..1612

The practice of tablet splitting as a way to reduce prescription medication costs has become increasingly prevalent. The United States Pharmacopeial Convention (USPC) has no standards for the subdivision characteristics of scored tablets. Literature results show that many tablets on the US market exhibit unacceptable subdivision characteristics. The European Pharmacopoeia (EP) provides requirements for subdivision accuracy of scored tablets, if subdivision is indicated in order to comply with the product label. This Stimuli article provides a rationale for why standards should be included in USP to address the accuracy of subdivision, as well as to account for loss of mass upon subdivision. We propose that for accuracy of subdivision current EP standards be adopted, applicable only to any tablet that bears a score mark. For loss of mass, we propose an average of 3% of the intact tablet mass. From data reported in the literature we estimate that as many as half of the scored tablets on the US market would be in compliance with these standards. Generally, we do not advocate such standards be tested on a batch-to-batch basis but rather that the testing should be conducted as part of the development process before marketing approval. We also discuss a third, related, quality attribute: ease of subdivision. Although future research and discussion in this area are warranted, we believe that not only should scored tablets break into accurate partial doses with minimal loss of mass, but also that the tablets should be breakable by a representative sample of the population, including the elderly.