Abstract
In this work, Class 2 and Class 3 solvents contained in two corticosteroids, flunisolide (Fluni) and fluticasone propionate (Fluti), were reduced to a few ppm by supercritical CO2 extraction. The process was carried out at pressures from 80 to 200 bar, temperatures of 40 °C and 80 °C, and at a fixed CO2 flow rate of 0.7 kg/h. The results demonstrated that CO2 density is the key parameter influencing the extraction kinetics and the solvent final residue. In particular, in the range investigated, optimal pressure and temperature conditions for the extraction of residual organic solvents were found working at 200 bar and 40 °C, which corresponds to a CO2 density of 0.840 g/cm3. Operating in this way, total organic solvent residues were reduced from 13,671 ppm and 326 ppm to 12 ppm and 10 ppm for Fluni and Fluti, respectively.
Highlights
Extraction of Organic Solvents fromOrganic solvents are classified according to their dangerousness into three groups, in which Class 3 solvents are the lowest risk category [1,2]
According to the scientific literature, all solvents considered in this work are soluble in supercritical CO2 (SC-CO2) at mild pressure and temperature [25,26,27,28,29,30]
active pharmaceutical ingredients (APIs) instead have to show either zero or very reduced solubility in SC-CO2 to avoid their co-extraction during processing
Summary
Extraction of Organic Solvents fromOrganic solvents are classified according to their dangerousness into three groups, in which Class 3 solvents are the lowest risk category [1,2]. The pharmaceutical industry is among the largest users of organic solvents, since, to produce active pharmaceutical ingredients (APIs), several processing steps are performed [3]. SCCO2 is appealing since is low-cost, inert, and non-toxic It has been successfully adopted for the production of micro- and nanoparticles [7,8,9] and porous 3-D devices [10,11,12], for the extraction of active compounds from various vegetable matrices [13,14,15], and for cleaning [16]. Once extracted from a solid matrix, organic solvents can be completely separated from CO2 by a simple depressurization step; this is a key characteristic of processing delicate active molecules
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