A UV-Raman spectrometry method for quality control of anticancer preparations: Results after 18 months of implementation in hospital pharmacy.
Fiche publication
Date publication
février 2016
Journal
International journal of pharmaceutics
Auteurs
Membres identifiés du Cancéropôle Est :
Pr UBEAUD-SEQUIER Genevieve, Dr DORY Anne
Tous les auteurs :
Nardella F, Beck M, Collart-Dutilleul P, Becker G, Boulanger C, Perello L, Gairard-Dory A, Gourieux B, Ubeaud-Séquier G
Lien Pubmed
Résumé
In France, chemotherapy preparation units of hospital pharmacy compound cytotoxic infusion bags adapted to each patient. The narrow therapeutic index of these preparations led us to implement qualitative and quantitative control for patients' safety. To this aim, we calibrated an equipment combining UV-vis spectrometry and Raman spectroscopy (QC Prep+) and monitored 14 different molecule-solvent combinations over a 18 months period. This rapid and specific method allowed the qualitative and quantitative analysis of 1 mL sample tests in less than 2 min. On 5742 anticancer preparations, we obtained accepted results with more than 99.4% solvent identification, 99.6% drug identification and only 1.52% of preparations not matching quantitative specifications (±15% of theoretical concentration). This quantitative control enabled us to pinpoint some critical points of production for two of the most common preparations. We thus updated the procedures of reconstitution and preparation, increasing the quality of final product. UV-Raman spectrometry is thus an effective tool to control chemotherapy infusions and to improve good practices of preparation.
Mots clés
Antineoplastic Agents, analysis, Calibration, Drug Compounding, methods, France, Humans, Pharmacy Service, Hospital, Quality Control, Solvents, chemistry, Spectrophotometry, Ultraviolet, methods, Spectrum Analysis, Raman, methods, Time Factors
Référence
Int J Pharm. 2016 Feb 29;499(1-2):343-350