TY - JOUR T1 - Proper Accounting for Surface Area to Solution Volume Ratios in Exaggerated Extractions JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2016.007195 SP - pdajpst.2016.007195 AU - Dennis Jenke AU - Barrett Rabinow Y1 - 2017/01/01 UR - http://journal.pda.org/content/early/2017/02/13/pdajpst.2016.007195.abstract N2 - When drug products contact plastic manufacturing components, packaging systems and/or delivery devices, leachables from the plastics can accumulate in the drug product, potentially affecting its key quality attributes. Given practical issues associated with screening drug products for leachables, potential leachables are frequently surfaced as extractables revealed in extraction studies. To facilitate extractables discovery and identification and to shorten extraction times, extraction studies can be exaggerated and/or accelerated. One means of exaggerating an extraction is to increase the test article's extracted surface area to extraction solution volume (SA/V), as it is generally accepted that an extractable's concentration in an extract is proportional to SA/V in a 1 to 1 manner. However, as the relationship between an extractable's concentration and SA/V depends on the extractable's plastic/solvent partition coefficient (kp/l), the effect of SA/V on extractable's concentrations can be either under- or over-estimated if a 1 to 1 proportion is used. This manuscript presents the theoretical relationship between SA/L, concentration and kp/l, illustrates theory with a case study, and suggests proper exaggeration strategies. ER -