Frontage Global Drug Discovery Services (GDDS) offers a full spectrum of in vitro ADME assays for small molecule drug discovery and preclinical development. Our strong focus on lab operations, automation, and project management enables efficient delivery and unparalleled quality. We believe in a customer-centric approach providing real-time communication and reliable consultations to Sponsors.

EMLA Cream (lidocaine 2.5% and prilocaine 2.5%) is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine. It is a numbing cream that can be placed on the skin to provide pain relief, and used to numb an area before placing an IV, drawing blood, or giving injections. A typical stability study is conducted by the assay of API in the drug product, but the different product qualities may affect penetration. To evaluate penetration, in vitro human cadaver skin model using Franz diffusion cells is used to determine product equivalence. In this study, we evaluate the product equivalence at different stability time points between RLD and test products.

In this white paper, we show testing of two critical parameters for the method validation of Gyrolab: 1) carryover contamination and 2) after MRD (minimum required dilution) stability.