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.

A number of the abuse-deterrent formulations in development and available on the market utilize hard-to-crush tablet technologies. Frontage possesses wide experience in running studies with controlled substances. Frontage provided full support in developing the protocol, revising study methodology, developing full package for IRB submission, including Informed Consent Form.

This study is aimed at developing a Nanoemulsion formulation of a poorly water-soluble and thermally, oxidatively, and photolytically unstable active pharmaceutical ingredient (API) for ophthalmic application, specifically for the reduction of intraocular pressure (IOP) and to provide neuroprotection.