In this paper, the response surface methodology (RSM) was proposed for studying the synergistic extraction of chromium(III) ions by double-carrier supported liquid membrane (DCSLM) with organophosphorus carriers (D2EHPA/Cyanex272). At first, the optimization method of “one-factor-at-a-time” was adopted for determination of the best conditions for Cr(III) extraction by SLM with only one carrier (D2EHPA). The optimum/threshold D2EHPA concentration in the membrane phase increased linearly with initial concentration of Cr(III) ions in the feed phase. After the addition the second carrier (Cyanex272), the synergistic effect was observed. The largest percentage of extraction and the shorter time was obtained. The optimization of the synergistic extraction in DCSLM system by RSM using Box–Behnken design (BBD) for three variables (concentration and proportions of the carriers, initial concentration of Cr(III), and time of the process) was studied. The statistical model was verified with the analysis of variance (ANOVA) for the response surface quadratic model. The reduced quadratic model showed that the predicted values were in agreement with those obtained experimentally, as well as the fact that the concentrations and proportions of the carriers had a significant influence on the response. The developed model was considered to be verified and can be used to predict the optimal condition for the chromium ions extraction.
Supercritical carbon dioxide extraction was used to extract carotenoids from dry paprika Capsicum annuum. Studies regarding the effect of process parameters, including pressure (25–45 MPa), temperature (40–60 °C), and time (10–110 min), were carried out using response surface methodology. It was found that under optimal conditions (pressure of 45 MPa, temperature of 50 °C, and time of 74 min), the extract yield was 10.05%, and the total content of carotenoids in the extract was 4.21%, in good agreement with the predicted values (10.24% and 4.24%, respectively). Composition analysis showed that paprika extract mainly consisted of linoleic acid. There was no significant difference between the fatty acid content of the extracts obtained by SC-CO2 extraction and n-hexane Soxhlet extraction. For functional purposes, the effect of storage conditions and time on the quality of paprika extract was also specified.
1 December 2024 in Expert Review of Pharmacoeconomics & Outcomes Research
The new European Medical Device Regulation has raised the bar for the clinical evaluation of medical devices to gain marketing authorization by Notified Bodies (NBs) regarding certificates of conformity in Europe. Restrictions applied for High-risk medical devices (HRMD) may require further evidence generation. Some other jurisdictions apply similar schemes that may be useful to the European Union. This systematic review focused on extracting lessons from similar schemes worldwide to the European context. A systematic review of peer-reviewed and gray literature was performed based on 'Device approval' and 'conditional approval' keywords. Databases such as Medline, Embase, and WoS retrieved documents assessed with the AMSTAR-2 checklist. A descriptive and narrative analysis was conducted detailed in CRD42023431233 - PROSPERO. We obtained eight documents where conditional approvals for High-risk medical devices in the United States of America, China, and Canada were subject to generate further evidence. In Europe, NBs impose restrictions or limitations to certificates of conformity instead. Further development of policies, supporting access to HRMD subject to further evidence generation, would help Europe in further defining the appropriate situations for the application of determined regulatory routes, to enhance access to HRMD with promising evidence and further evidence development. PROSPERO (CRD42023431233).