Study of leachable compounds in hospital pharmacy-compounded prefilled syringes, infusion bags and vials.
Details
Serval ID
serval:BIB_ECDC35D70135
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Study of leachable compounds in hospital pharmacy-compounded prefilled syringes, infusion bags and vials.
Journal
Journal of pharmaceutical sciences
ISSN
1520-6017 (Electronic)
ISSN-L
0022-3549
Publication state
Published
Issued date
11/2024
Peer-reviewed
Oui
Volume
113
Number
11
Pages
3227-3237
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Publication Status: ppublish
Abstract
Hospital pharmacy compoundings are crucial for maintaining patient care. They are time- and cost-effective in hospital pharmacy settings because they prevent waste, preparation errors, dosage errors, microbial contamination and breakage due to handling. Unfortunately, the drawbacks of hospital pharmacy compounding include the selection of inappropriate medical devices (MDs) for long-term storage, which could directly impact patients. In this study, three important hospital pharmaceutical compoundings, vancomycin in prefilled syringes (PFSs) made of polypropylene (PP) material, paediatric parenteral nutrition (PN) in ethylene vinyl acetate (EVA) bags and diluted insulin in cyclic olefin copolymer (COC) vials, were selected for leachate study and risk assessment. These compounds were studied via a semiquantitative screening approach by means of an ultrahigh-performance liquid chromatography coupled to high-resolution mass spectrometry (UHPLC-HRMS) with postcolumn infusion and an in-house built database. 17 leachable compounds for the PFS, 25 for the PN, and 10 for the vial were identified, and their concentrations were estimated for toxicological assessments. In conclusion, all MDs used in hospital pharmacy compoundings were observed suitable thanks to risk assessments. However, suitable MDs recommended for long-term storage would remain with polymers like COC, for higher safety when exposed to frail and vulnerable patients like neonates and infants.
Keywords
Syringes, Drug Packaging, Pharmacy Service, Hospital, Drug Compounding/methods, Chromatography, High Pressure Liquid/methods, Humans, Insulin/chemistry, Insulin/administration & dosage, Polyvinyls/chemistry, Polypropylenes/chemistry, Drug Contamination/prevention & control, Drug Storage, Hospital pharmacy compounding, Insulin vial, Leachable compounds, Parenteral nutrition, Prefilled syringes, UHPLC-HRMS
Pubmed
Open Access
Yes
Create date
30/08/2024 14:23
Last modification date
20/11/2024 7:29