MacroFLUX is a sophisticated analytical tool designed for the pharmaceutical industry to enhance drug formulation development and assess membrane permeability. It utilizes a system that combines dissolution testing with permeability assessment, providing a more comprehensive understanding of a drug's in vitro behavior to rank order potential in vivo drug behavior.
The MacroFLUX system integrates Rainbow Fiber Optic technology, which negates the need for manual sampling by allowing real-time UV concentration monitoring of active pharmaceutical ingredient (API) concentrations, in both donor and acceptor compartments of a special dissolution-permeation device where the compartments are separated by a biomimetic membrane. This allows assessment of dissolution in one vessel while also enabling assessment of permeability through the membrane into the other chamber. This feature is particularly beneficial in large-scale flux assays for oral solid dosage (OSD) forms, such as tablets and capsules.
One of the key advantages of the MacroFLUX apparatus is its robustness, ensuring consistent and reliable results across a range of pH conditions. This repeatability is crucial when studying the dissolution and permeability of various formulations of an API, as excipients can significantly affect their dissolution, solubility and permeability. The relationship between the flux measurements obtained from MacroFLUX and pharmacokinetic (PK) data in humans has been shown to be strong.
This correlation is invaluable for predicting the outcome of in vivo studies and for making informed decisions during the drug development process.
MacroFLUX is a valuable asset for drug product optimization, batch-to-batch comparability, and bioequivalence testing.
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