Quality by Design (QbD) for the pharmaceutical industry includes the design, development and production control of products and production processes from the beginning to the end of the product development phase for ensuring the consistent quality of a pharmaceutical product. The QbD is a systematic scientific approach aimed at meeting the needs of the patient in the desired and targeted quality and aiming to produce the same quality pharmaceutical product in this direction. Process Analytical Technology, which is assessed in that regard, is part of a design quality approach that is used to design, analyze, and control real-time measurements of quality and performance criteria for raw and processed materials to achieve the desired final product. This scientific and systematic approach to pharmaceutical product development, which is also acknowledged and supported by the health authorities, serves to the changing and developing pharmaceutical sector.
In this study, silver nanoparticle (AgNP) synthesis was carried out using Onosma sericeum Willd aqueous extract for the first time, with a simple, economical, and green method without the need for any other organic solvent or external reducing or stabilizing agent. A variety of AgNPs, all of different particle sizes, were synthesized by controlling the silver ion concentration, extract volume, temperature, and pH. It was determined that the optimum conditions for AgNP synthesis were 1mM AgNO3, pH 8, 25 ˚C, 20 g / 200 mL extract, silver nitrate and extract ratio 5: 1 (v / v). The AgNPs were defined using UV-vis spectroscopy, field emission scanning electron microscopy (FESEM), energy dispersive X-ray analysis (EDAX), transmission electron microscopy (TEM), and X-ray diffraction (XRD). The particle size distribution and zeta potential measurements of the AgNPs were measured using the dynamic light scattering (DLS) technique. It was determined that the AgNPs with a particle size of less than 10 nm showed a higher catalytic effect in the reduction of 2-nitrobenzenamine. It was also found that these nanoparticles had a cytotoxic effect on the MCF-7 breast cancer cell line 2 depending on dosage and time. The resulting IC50 values were between 76.63 µg/mL and 169.77 µg/mL. Furthermore, the biosynthesized AgNPs showed effective antibacterial activity against the Acinetobacter baumannii bacteria. The results of the study showed that synthesized AgNPs can have a promising role in biomedical and nanobiotechnology applications.
The aboveground and root parts of Onosma mutabilis were extracted using subcritical water and the process was optimized with response surface methodology. The composition of the extracts was determined by chromatographic methods and compared to that of conventional maceration of the plant. The optimum total phenolic contents for the aboveground part and the roots were 193.9 and 174.4 μg/g, respectively. These results were achieved at a subcritical water temperature of 150 °C, an extraction time of 180 min, and a water/plant ratio of 0.1, for both parts of the plant. Principal component analysis revealed that the roots contained mainly phenols, ketones, and diols, with the aboveground part mostly alkenes and pyrazines, whereas the extract from maceration contained mainly terpenes, esters, furans, and organic acids. The quantification of selected phenolic substances showed that subcritical water extraction compared favorably to maceration, especially with respect to pyrocatechol (1062 as compared to 10.2 μg/g) and epicatechin (1109 as compared to 23.4 μg/g). Furthermore, the roots of the plant contained twice as much of these two phenolics compared to the aboveground part. Subcritical water extraction of O. mutabilis is an environmentally friendly method that can extract selected phenolics at higher concentrations compared to maceration.
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