Dissolution and membrane permeation simultaneous measurement system 'Macro/Bio FLUX'
Pion MacroFLUX, BioFLUX
Dissolution and membrane permeability can be evaluated simultaneously in the final dosage form! It is also used for predicting biological equivalence tests!
This is a system that combines the Pion Corporation's Rainbow with the dedicated Macro FLUX (Bio FLUX) module and the corresponding dissolution tester. By using two probes from the Rainbow, it is possible to measure dissolution on the donor side of the dissolution tester's vessel and absorption on the acceptor side of the dedicated chamber. Unlike µFLUX, this system allows testing in the final dosage forms such as tablets and capsules. The difference between MacroFLUX and BioFLUX lies in the testing volume. MacroFLUX uses a 1,000 mL vessel, while BioFLUX aims for testing with a volume closer to that of a living organism, using a 500 mL vessel.
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basic information
* Evaluation of Drug-Drug Interactions After the start of the trial, there are many instances of tests where FaSSIF or FeSSIF is dripped in to shift the pH after a certain period of time. By conducting tests under varying conditions, such as from the normal gastric acid pH and from low gastric acid pH, there is also evidence of verification of drug-drug interactions. * Evaluation of Food Effect By changing the test solution used on the donor side to FaSSIF or FeSSIF, it is possible to verify the Food Effect. * Comparison of Brand-name and Generic Products Tests are conducted under the same conditions as the target brand-name product, and there is evidence that the results have been used for predicting bioavailability (BA). * In China, there are cases where Macro/BioFLUX data has been utilized for exemptions from human bioequivalence testing (bio waivers).
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Physio-Machina Co., Ltd. is a company that primarily sells products such as formulation development equipment and dissolution testers, conducts validation and calibration of peripheral devices, and engages in the import and export of software and various equipment. Additionally, it actively provides translation and interpretation of technical documents and seminars, as well as support for the creation of SOPs and conducts training sessions.