The Division of Product Quality Research (DPQR) conducts research on assessing the quality and safety of drug products. One of the on-going research activities is to conduct research on assessing the performance, quality and safety of transdermal and topical drug products. These studies are critical in assessing the quality of transdermal and topical drug delivery systems. To support this function, DPQR is requesting the acquisition of one (1) Automated Dry Heat Diffusion System with 24 vertical cells (or equivalent). This Automated Dry Heat Diffusion System will be used to perform diffusion studies that are approximately 96 hours and with large number of samples and repetitions to check the drug release and permeation across synthetic and biological barriers. This Automated Dry Heat Diffusion System and these diffusion studies will provide valuable information regarding safety, performance, and quality of transdermal and drug products and support CDER’s mission critical missions.
The Automated Dry Heat Diffusion System with 24 vertical cells is used for studying the in vitro drug release and diffusion across various synthetic and biological barriers. This diffusion system has a heated donor and receiver compartments of the vertical diffusion cells with an automated mechanism to continuously collect and replace aliquot and whole media samples from all diffusion cells. This automated mechanism should also eliminate and expel any air bubbles that may be formed below the diffusion barrier during dosing and sampling throughout the study duration. This Automated Dry Heat Diffusion System is also equipped with sensors for direct measurement and control of donor and receiver chambers and barrier temperatures throughout the study duration.
