Assessment of Physicochemical Parameters and Contaminants in Herbal Dietary Supplements Used in the Treatment of Inflammatory Bowel Disease.

Autor: Amidžić Klarić D; Faculty of Pharmacy and Biochemistry, University of Zagreb, A. Kovačića 1, 10 000 Zagreb, Croatia., Kovačić J; Faculty of Pharmacy and Biochemistry, University of Zagreb, A. Kovačića 1, 10 000 Zagreb, Croatia., Jeličić ML; Faculty of Pharmacy and Biochemistry, University of Zagreb, A. Kovačića 1, 10 000 Zagreb, Croatia., Zubčić S; Agency for Medicinal Products and Medicinal Devices of Croatia, Ksaverska Cesta 4, 10 000 Zagreb, Croatia., Stankov V; Sample Control, Puškarićeva Ulica 18, 10 250 Lučko, Croatia., Gulan Čičak M; Faculty of Pharmacy and Biochemistry, University of Zagreb, A. Kovačića 1, 10 000 Zagreb, Croatia.; Sample Control, Puškarićeva Ulica 18, 10 250 Lučko, Croatia., Bučar B; Sample Control, Puškarićeva Ulica 18, 10 250 Lučko, Croatia., Klarić I; Public Health Brčko DC, R. Dž. Čauševića 1, 76000 Brčko DC, Bosnia and Hercegovina., Mornar A; Faculty of Pharmacy and Biochemistry, University of Zagreb, A. Kovačića 1, 10 000 Zagreb, Croatia.
Jazyk: angličtina
Zdroj: Pharmaceuticals (Basel, Switzerland) [Pharmaceuticals (Basel)] 2023 Jun 18; Vol. 16 (6). Date of Electronic Publication: 2023 Jun 18.
DOI: 10.3390/ph16060893
Abstrakt: Inflammatory bowel disease is a complex disorder characterized by chronic gastrointestinal inflammation. Thus, patients prefer to use herbal dietary supplements containing turmeric, Indian frankincense, green chiretta, and black pepper in an attempt to cope better with their chronic condition. The dietary supplements' dosage forms and herbal ingredients were assessed in terms of the products' physicochemical parameters (weight uniformity, friability, disintegration, rupture test, tablet's breaking force, and powder flowability) in view of the USP-NF requirements. In addition, contaminants such as organic solvents and ethylene oxide were evaluated using gas chromatography. Assessment of gluten via an Enzyme-Linked Immunosorbent Assay was also performed. Most of the products met USP requirements. The high average weight of one multicomponent tablet sample with a high breaking force value can explain the observed negative results of the disintegration test. A total of 26% of samples tested positive for gluten, but the most alarming fact is that the ethylene oxide levels found in two samples were up to 30 times higher than the EU limit. Accordingly, dietary supplement quality control is of fundamental importance.
Competing Interests: The authors declare no conflicts of interest.
Databáze: MEDLINE
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