Diffusion testing measures the rate that an active pharmaceutical ingredient is released from a semisolid preparation, providing the quality control analyst with critical performance data. 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.” This device consists of a small-volume, water-jacketed cell that contains a chamber for drug application, a membrane through which the drug may permeate, and a receptor media chamber from which samples may be extracted 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. In newer systems the receptor media is heated directly, 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 legacy manual diffusion testing systems consist of six cells, a cell drive, a speed control, a media replace beaker, a circulating bath, and a manual sampling syringe. The analyst removes samples using the syringe and replaces the medium after each sample is removed. Hanson’s new Phoenix™ line of diffusion cell testers operate without a circulating bath, making the system more portable with a smaller footprint.
Phoenix™ Dry Heat Systems
The new Phoenix™ family of dry‐heat systems makes diffusion‐cell testing faster, easier, and more economical. The Phoenix DB‐6 manual sampling system offers six‐cell manual sampling in a compact footprint with an advanced touch screen display. The Phoenix RDS Robotic Diffusion Station delivers fully automated sampling, collection, and media replace with the ability to run up to 24 cells at once from a single computer workstation. Both systems rely on the outstanding performance of the new Phoenix™ Dry Heat diffusion cell, made from precision borosilicate glass, with mixer inserts engineered to produce instant homogenization of receptor media.
LEGACY DIFFUSION TEST SYSTEMS
The Hanson 6-Cell Manual Diffusion Test System is a startup vertical diffusion cell test system ideal for manual use and sampling and is adaptable for later addition of the Vision Microette autosampler. The Vision Microette diffusion test system automates sampling from groups of six Hanson Vertical Diffusion Cells (VDCs) for extensive unattended tests and handles surfactants, saline, and hydroalcoholic receptor solutions.
Hanson Research worked with EMD Millipore to develop a special dosage wafer for the Hanson VDC that accommodates the Strat-M® membrane from EMD Millipore.