Scientia Pharmaceutica

Biopharmaceuticals are medical drugs produced by means of biotechnology. In contrast with small-molecule (traditional) drugs, which are usually synthesized chemically, biopharmaceuticals are derived from biological sources, including tissues, cells, or microorganisms. Biopharmaceuticals comprise a wide extent of therapies, such as vaccines, monoclonal antibodies, cell therapies, recombinant proteins, and gene therapies, as well as biosimilars. These products are designed to become important treatment options for different diseases, including cancer, autoimmune pathological disorders, andinfectious diseases. The development of biopharmaceuticals often includes multifaceted processes, involving genetic engineering and cellular culture techniques, to guarantee efficacy and safety. Accordingly, biopharmaceuticals’ legislation is a key component for ensuring the highest quality of medical products, as well as protecting public health. As a rapidly developing area inside the pharmaceutical industry, biopharmaceuticals represent a significant advancing stage in modern medicine, offering targeted therapies that can improve patient outcomes. Accordingly, this paper seeks to provide current state-of-the-art didactic information, including better insight into various challenges related to biopharmaceuticals’ development, classification, medical use, legislation and ethics.

Docetaxel (DTX)-loaded polymeric nanoparticles composed of Eudragit RL and RS 100 were developed by solvent evaporation using D-α-tocopheryl polyethene glycol 1000 succinate as an emulsifier and optimised by Central Composite Design. The effects of homogenisation and sonication times on entrapment efficiency (%EE) and drug release (%DR) were statistically analysed across nine batches. Particle size (PS) ranged from 302 ± 1.0 to 502 ± 2.0 nm, and zeta potential (ZP) from 25.8 ± 2.5 to 42.9 ± 1.7 mV. %EE and %DR (pH 1.2 for 2 h, then pH 7.4 for 22 h, 40 mL medium at 37 ± 0.5 °C) ranged from 69.32 ± 3.77 to 92.71 ± 0.16% and 19.24 ± 3.03 to 49.17 ± 1.98%, respectively. Optimised DTX nanoparticles (DNPs) showed EE of 78.18 ± 0.56%, DR of 46.21 ± 1.41% at 24 h, PS of 357.9 ± 2.4 nm, and ZP of 42.9 ± 3.7 mV. Scanning electron microscopy revealed ~300 nm cuboidal particles with smooth surfaces. X-Ray Diffraction and Differential Scanning Colorimetry confirmed reduced drug crystallinity in DNPs. In vitro haemolysis assays showed ~11.5-fold lower haemolytic potential (p < 0.0001) versus DTX, confirming improved safety. Fluorescence microscopy indicated enhanced cellular uptake of DNPs in MDA-MB-231 cells, while cytotoxicity assays of DNPs showed a lower IC₅₀ (39.52 µM) compared to DTX (60.81 µM), demonstrating superior anticancer efficacy. Overall, DNPs represent a promising oral chemotherapy platform for breast cancer management.

Benign prostatic hyperplasia (BPH) and prostatitis are multifactorial urological disorders associated with chronic inflammation, oxidative stress, and androgenic imbalance. Dysphania ambrosioides (L.) Mosyakin & Clemants contains flavonoids and phenolic acids with well-recognised antioxidant and anti-inflammatory properties; however, its potential activity against the molecular targets of these prostatic disorders has not been systematically evaluated. A comparative quantitative analysis was performed using studies published between 2005 and 2025 that reported antioxidant activity (DPPH assay, IC₅₀ in µg/mL) of D. ambrosioides extracts. Metabolites from extracts with IC₅₀ values below the global mean (398.410 ± 81.810 µg/mL; n = 35) were selected for in silico prioritisation using OSIRIS, PASS, and ProTox 3.0, followed by molecular docking (CB-Dock2) against AR, 5AR2, COX-2, NLRP3, and α1A receptors. Luteolin and rosmarinic acid showed favourable binding energies (−9.5 to −7.7 kcal/mol) comparable in magnitude to reference drugs (finasteride −13.4, celecoxib −11.4, tamsulosin −7.3 kcal/mol). These metabolites, exhibited affinity for androgenic, inflammatory, and adrenergic targets, suggesting their potential to modulate key mechanisms underlying both BPH and prostatitis. This study integrates, for the first time, a quantitative assessment of antioxidant activity with a multitarget in silico analysis of D. ambrosioides, prioritising luteolin and rosmarinic acid as natural candidates with potential antioxidant, anti-inflammatory, and antiandrogenic properties relevant to prostatic health.