Vacuum drum drying – A novel solvent-evaporation based technology to manufacture amorphous solid dispersions in comparison to spray drying and hot melt extrusion
نویسندگان
چکیده
In this study, a novel solvent-evaporation based technology to manufacture amorphous solid dispersions (ASDs) called vacuum drum drying (VDD) was assessed in comparison the conventional technologies hot-melt extrusion (HME) and spray (SD). Ritonavir (15%w/w) embedded copovidone/sorbitan monolaurate used investigate impact on ASD quality, material properties in-vitro dissolution. All ASDs met critical quality criteria: absence of drug substance related crystallinity, residual solvents below ICH limit (SD, VDD) degradation products within specification limits. Clear differences such as particle morphology size distribution, powder densities flowability were observed. Overall, milled extrudate showed superior terms downstream processability. The VDD intermediate performed slightly better electrostatic behavior compared dried while showing comparably unfavorable densities. However, dissolution data suggested no significant difference between prepared by HME, SD, thus, change bioavailability is expected. conclusion, might be viable alternative - especially for thermosensitive shear-sensitive compounds with potential process formulations high loads viscosities exhibiting higher throughputs at lower footprint.
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ژورنال
عنوان ژورنال: International Journal of Pharmaceutics
سال: 2021
ISSN: ['0378-5173', '1873-3476']
DOI: https://doi.org/10.1016/j.ijpharm.2021.120233