In Vitro Test Capabilities
IVRT and IVPT studies
In Vitro Release Tests (IVRT) and In Vitro Permeation tests (IVPT) using Franz-type diffusion Cells are critical to the development of both generic and branded topical and transdermal products. While IVRT studies are used to evaluate the release of the drug from the formulation, IVPT studies are used to evaluate the permeation of the drug through the human skin.
For generic products, FDA has issued product specific bioequivalence guidances for more than 75 products that require either IVRT studies or IVRT studies and IVPT studies. FDA has also issued general guidance on IVRT and IVPT methodologies which should be followed during development, validation and conducting bioequivalence. Healios has extensive expertise on conducting bioequivalence studies for generic products using both IVRT and IVPT studies.
IVRT and IVPT studies are an integral part of the development of novel topical & transdermal products, especially in selection if new chemical entities, dosage form selection and formulation development. Use of these in vitro techniques during product development saves significant time, resources, and cost. Healios has significant experience is conducting IVPT studies using different skin membranes including stratum corneum, epidermis, dermis and in the receiver phase.
