466961 Application of Ehrfeld® Valve Assisted Micromixer for Generation of Micron Sized Particles of Poorly Water Soluble Drug Compounds
The current work investigates the application of Ehrfeld® valve assisted micromixer (VAMM) technology for generation of micronsized drug compounds which are poorly water soluble. The VAMM has emerged as a promising technology due to its unique construction which splits the fluid stream into multiple microchannels triggering impingement at multiple sites. In addition the unidirectional restrictor valve excludes reverse flow of fluid stream (therefore having an advantage over conventional T-mixers) and the passage of the thin fluid lamellae through the body of the micromixer ensures a well-mixed and highly supersaturated solution. First the mixing efficiency of the VAMM was characterized by developing an empirical correlation for mixing time (τmix) , followed by experimentation using a set of competitive parallel reactions (whose kinetics have been well studied) and establishing conversion of key reactant as a function of varying jet velocity. These values were then used, to estimate Damköhler number (Da) and τmix which enables a direct comparison of mixing efficiencies between VAMM and other well established micromixer systems .
Model Biopharmaceutical classification system (BCS) II compounds were identified and highly supersaturated solutions of same were subjected to anti-solvent crystallization process via VAMM in the presence of suitable stabilizer system . Similar crystallizations were also carried out in batch process, where the results clearly indicated the superior performance of VAMM in generation of fine particles when compared with the batch . In both the cases particles as small as d90 < 5µm were achieved, therefore establishing the Ehrfeld® Valve Assisted Micromixer as a feasible platform for precipitation of fine pharmaceutical compounds.
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IPDO communication number: IPDO IPM-00468
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