Quality of dorzolamide hydrochloride and timolol maleate containing eye drops distributed online

Autor: Sára Merczel, Róbert György Vida, Tamás Tasi, András Fittler, Lajos Botz
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Saudi Pharmaceutical Journal, Vol 31, Iss 6, Pp 921-928 (2023)
Druh dokumentu: article
ISSN: 1319-0164
DOI: 10.1016/j.jsps.2023.04.018
Popis: Patient safety risks associated with the online purchase of medications, especially in case of ophthalmic preparations, are significant. Our study aimed to carry out quality assessment of dorzolamide hydrochloride (DZA) and timolol maleate (TIM) eye drops preserved with benzalkonium chloride (BAC) via online test purchases.Three samples were purchased online, while control preparations were acquired through authorized national drug supply chain. Our method was based on the International Pharmaceutical Federation (FIP) Inspection Checklist and integrated the evaluation of packaging and labelling. Sterility was established according to the European Pharmacopoeia (Ph. Eur.), while qualitative and quantitative quality was assessed with high-performance liquid chromatographic (HPLC) analysis.Several signs of falsification were recognized upon visual inspection of the online samples. All the products were clear, colourless, slightly viscous solutions. They were free from visible contaminants. The samples were sterile as no evidence of microbial growth was found. A quick and inexpensive HPLC analysis, optimized by the authors showed that active ingredients and the preservative deviated significantly (p
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