Safety of Innovative Nanotechnology Oral Formulations Loaded with Bioactive Menopause Molecules: Influence of Genotoxicity and Biochemical Parameters on a Menopausal Rat Model.

Autor: Crișan S; Faculty of Pharmacy, 'Carol Davila' University of Medicine and Pharmacy, 6 Traian Vuia Street, 020945 Bucharest, Romania.; R&D Center, AC HELCOR, Victor Babes St., 430082 Baia Mare, Romania., Pop AL; Faculty of Pharmacy, 'Carol Davila' University of Medicine and Pharmacy, 6 Traian Vuia Street, 020945 Bucharest, Romania., Lacatusu I; Faculty of Applied Chemistry and Materials Science, The Polytechnic University of Bucharest, Polizu No 1, 011061 Bucharest, Romania., Badea N; Faculty of Applied Chemistry and Materials Science, The Polytechnic University of Bucharest, Polizu No 1, 011061 Bucharest, Romania., Mustaciosu C; Horia Hulubei National Institute for Physics and Nuclear Engineering IFIN-HH, 077125 Bucharest, Romania., Radu M; Horia Hulubei National Institute for Physics and Nuclear Engineering IFIN-HH, 077125 Bucharest, Romania., Varlas VN; Faculty of Medicine, 'Carol Davila' University of Medicine and Pharmacy, 37 Dionisie Lupu Street, 020021 Bucharest, Romania., Peneş ON; Faculty of Medicine, 'Carol Davila' University of Medicine and Pharmacy, 37 Dionisie Lupu Street, 020021 Bucharest, Romania., Ciobanu AM; Faculty of Pharmacy, 'Carol Davila' University of Medicine and Pharmacy, 6 Traian Vuia Street, 020945 Bucharest, Romania., Ghica M; Faculty of Pharmacy, 'Carol Davila' University of Medicine and Pharmacy, 6 Traian Vuia Street, 020945 Bucharest, Romania., Voicu SN; Department of Biochemistry and Molecular Biology, Faculty of Biology, University of Bucharest, 030018 Bucharest, Romania., Udeanu DI; Faculty of Pharmacy, 'Carol Davila' University of Medicine and Pharmacy, 6 Traian Vuia Street, 020945 Bucharest, Romania.
Jazyk: angličtina
Zdroj: Nutrients [Nutrients] 2023 Nov 29; Vol. 15 (23). Date of Electronic Publication: 2023 Nov 29.
DOI: 10.3390/nu15234951
Abstrakt: In recent years, nanoparticles have gained significant importance due to their unique properties, such as pharmacological, electrical, optical, and magnetic abilities, contributing to the growth of the science and technology sector. Particular naturally derived biomolecules with beneficial effects on menopause disorder have been the subject of studies of pharmaceutical formulation to obtain alternative pharmaceutical forms with increased bioavailability and without side effects, as in nanostructured lipid carriers (NLCs) loaded with such active ingredients. In the present study, one stage of a broader project, we have performed pharmacotoxicology studies for six combinatory innovative nanocapsule pharmaceutical forms containing active natural biomolecules before considering them as oral formulas for (1) in vitro toxicity studies on culture cells and (2) in vivo preclinical studies on a surgically induced menopause model of Wistar female rats, and the influence of the NLCs on key biochemical parameters: lipid profile (TG, Chol, HDL), glycemic markers (Gli), bone markers (Pac, Palc, Ca, phosphorus), renal markers (Crea, urea, URAC), inflammation (TNF), oxidative stress (GSH, MDA), and estrogen-progesterone hormonal profile. The micronucleus test did not reveal the genotoxicity of the tested compounds; the menopause model showed no significant safety concerns for the six tested formulas evaluated using the blood biochemical parameters; and the results showed the potential hypoglycemic, hypolipidemic, hypouricemic, and antioxidant potential of one of the tested formulas containing nano diosgenin and glycyrrhizic acid.
Databáze: MEDLINE