Preparation, stabilisation, isolation and tableting of valsartan nanoparticles using a semi-continuous carrier particle mediated process

This work investigated the technical feasibility of preparing, stabilizing and isolating poorly water-soluble drug nanoparticles via a small-scale antisolvent precipitation process operating in semi-continuous mode. Specifically, novel was demonstrated for carrier particle mediated production, stabilization isolation valsartan into solid form using montmorillonite clay particles as carrier. The operated robustly full duration experiment (~16 min) steady-state conditions were reached after ~5 min. Nanoparticles (51 ± 1 nm) successfully prepared, stabilized isolated with help (MMT) or protamine functionalized (PA-MMT) dried by this route. dissolution profile nanocomposite solids similar to that produced corresponding laboratory scale batch mode process, indicating product quality (principally nanoscale size solid-state form) is retained during processing nanoparticles. Furthermore, tablets direct compression displayed comparable powdered material. PXRD, DSC, SSNMR studies indicate amorphous exhibited shelf-life stability equivalent > 10 months.