H-AN-008 Diffusion Method Transfer Guide from Microette to Phoenix™ System Request

Summary
Diffusion or permeation testing measures the release or permeation rate of an active pharmaceutical ingredient (API) diffuse from the semisolid preparation; it is very good quality control tool to measure the critical performance data of semisolid formulation. Diffusion testing using diffusion cells has become the industry standard due to the pioneering work of Dr. T. J. Franz who developed the “Franz cell.” Franz Cells are a widely used methodology to evaluate in vitro drug permeation or in vitro drug release. This device consists of a small-volume, water-jacketed cell (receptor compartment) and donor compartment that contains a chamber for drug application, a membrane to be placed between donor and receptor compartment, through which the drug may diffuse into the receptor chamber, and from receptor chamber samples may be extracted at a desired time point and analyzed for drug release. Later developments include non-water-jacketed, dry-heat cells such as Teledyne Hanson’s Phoenix™ line of diffusion testers.

A traditional diffusion testing system typically has a group of six cells for simultaneous testing of six specimens. A magnetic cell drive controls the mixing of each cell receptor chamber throughout the test, and a circulating bath provides heated water to the jacketed cells to maintain a constant temperature. With innovation in our newer systems the receptor media is heated directly to achieve precise temperature, also known as a dry-heat cell. Samples are taken from the receptor chamber, and the same amount of media is then replaced to maintain a constant media-membrane interface.

Sampling of the receptor medium can be performed manually or automatically. Teledyne Hanson’s manual diffusion testing systems consist of six cells, a cell drive, a speed control, and a manual sampling syringe. The analyst removes samples using the syringe and replaces the medium after each sample is removed. The automated system provides automated sampling, collection, and media replace.

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