A UV-Raman spectrometry method for quality control of anticancer preparations: Results after 18 months of implementation in hospital pharmacy

Nardella, Flore; Beck, M.; Collart-Dutilleul, P; Becker, Guillaume; Boulanger, Coralie; Perello, Laurent; Gairard-Dory, A.; Gourieux, B.; Ubeaud-Séquier, Geneviève

doi:10.1016/j.ijpharm.2016.01.002

Cited by 24 publications

(17 citation statements)

References 34 publications

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“…This weakness was evoked by Bazin et al in their comparison of the various analytical tools available for the control of chemotherapy [6]. This observation correlates with our conformity results which are less good than those observed in adults [16,21]. The majority of our NC can be attributed to the lack of analytical sensitivity in low concentration areas.…”

Section: Discussionsupporting

confidence: 70%

“…Yet, the majority of controls matched the ± 10% range (Figure 4). 86.2% of controls were between 0% and ± 10% (Figure 4) against 93.0% for Nardella et al [16] and 95.4% for Dziopa et al [21]. The detailed results showed that the number of controls between ]-15%; -10%] and ]+10%; + 15%] is more important for etoposide, methotrexate, vincristine, and vindesine.…”

Section: Discussionmentioning

confidence: 89%

“…We have set, as many units and authors [11,16,21], the validation criteria to ± 15%. Yet, the majority of controls matched the ± 10% range (Figure 4).…”

Section: Discussionmentioning

confidence: 99%

“…However, this method has some inconvenient like technical and time constraints which can be a limiting factor for the integration of an analytical control in real time. Other techniques were developed to allow faster controls: high-performance thin layer chromatography (HPTLC) [12], automaton coupling ultraviolet (UV) and Fourier-Transformed Infrared spectroscopy (UV/vis-FTIR) (Multispec ® ) [13,14] or Raman spectroscopy (UV-Raman) (QCPrep ® ) [15][16][17][18]. HPTLC concept is interesting because it allows significant time savings by successfully analyzing more than 20 samples in one run.…”

Section: Introductionmentioning

confidence: 99%

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Analytical Control of Pediatric Chemotherapy Preparations with a UV-Raman Automaton: Results After 18 Months of Implementation and Development of A Suitable Method for Low Volume Preparations

Chouquet

Benoît

Morand

2017

Pharmaceutical Technology in Hospital Pharmacy

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AbstractBackgroundIn France, control of chemotherapy preparations is highly recommended. Analytical control is a method of choice for identifying and quantifying drugs. Pediatric preparations, which often contain small quantities of drugs and are made in low final volumes were until then not analytically controlled. After the development and validation of a new sampling and assaying method for low volume chemotherapy preparations with an UV/Raman automaton (QCPrep +), the quality control results of the preparations intended for the patients were analyzed over a period of eighteen monthsMethodsThe results were studied by type of preparation (low and high volume), per molecule, manipulator, and conformity rates dispersion.ResultsOver the period, 7,548 controls were carried out, representing 87.7% of our production. 75.5% of these controls concerned low-volume preparations (<50mL). The overall conformity rate was 94.4%. The lowest conformity rates were found for vinca alkaloids, methotrexate and some rarely manipulated drugs (cisplatin, decitabine, epirubicin). The study of the results dispersion showed non-conformities increasing with low concentrations, specific to pediatrics. These results show the limits of analytical control for pediatric preparations. The low analytical sensitivity encountered for certain concentrations and drugs requires a complementary quality control tool, like camera or video. However this new analytical method allows us to improve the safety of the injectable chemotherapy circuit.ConclusionYoung patients can benefit from the same level of safety and quality as adult patients. Some critical points could be highlighted: the homogenization of the preparations, the analytical sensitivity of some drugs and human factors. This data allow us to focus our work on staff training, improving our calibration ranges and on the development of complementary control tools.

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Section: Discussionsupporting

confidence: 70%

Section: Discussionmentioning

confidence: 89%

“…We have set, as many units and authors [11,16,21], the validation criteria to ± 15%. Yet, the majority of controls matched the ± 10% range (Figure 4).…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Analytical Control of Pediatric Chemotherapy Preparations with a UV-Raman Automaton: Results After 18 Months of Implementation and Development of A Suitable Method for Low Volume Preparations

Chouquet

Benoît

Morand

2017

Pharmaceutical Technology in Hospital Pharmacy

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“…Ultraviolet spectrometry can be performed alone (Druglog ® distributed by Pharmed) or associated to Fourrier Transformed Infrared Spectrometry (FTIR) which was called Multispec ® or to Raman spectrometry (QC Prep + ® , Icônes Services, France) [7]. Ultraviolet detection was also used in quality controls by High Pressure Liquid Chromatography (HPLC) coupled to a diode array detector (DAD) [8].…”

mentioning

confidence: 99%

Centrally Prepared Cytotoxic Drugs: What Is the Purpose of Their Quality Control?

Lagarce

2017

Pharmaceutical Technology in Hospital Pharmacy

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AbstractTo assess the quality of centrally prepared cytotoxics a global approach is being implemented by pharmacists. A risk analysis is performed, and then many in-process controls are proposed. The aseptic process and the material are also fully validated. Moreover the skills of pharmacy technicians are being checked and monitored over time. This short opinion paper discusses the place of in-process quality control within the quality system applied to cytotoxic preparations. It also discusses the pros and cons of analytical control of the final product versus continuous control of each preparation step by eye witness or an electronic device such as a camcorder. Finally the relevancy of controls is discussed in function of different cases and of the human and material resources available in the pharmaceutical technology cytotoxic unit.

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Flow Injection Analysis With UV Detection Versus Raman Spectroscopy for the Quantitative Analysis of Remdesivir

Berge,

Siboni,

Mequinion

et al. 2024

J Raman Spectroscopy

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The quality and the security of preparations in hospital centres are essential to guarantee the patient's safety. The development of fast and efficient analytical methods is required to control the finished product before use. In this context, the study aimed to compare the performance and interchangeability of two spectral analytical methods: the flow injection analysis (FIA) with UV detection and the Raman spectroscopy for the quality control of preparation before use to quantify the remdesivir as a SARS‐CoV‐2 drug. A quantitative study of remdesivir was performed using clinically relevant concentration solutions ranging from 0.25 to 1.625 mg.mL−1 in 0.9% NaCl. Samples were analysed by FIA‐UV at 245 nm and by a handheld Raman spectroscopy at 785 nm. Quantitative models were developed using a calibration set (n = 45 samples) and optimized using a validation set (n = 27). An external validation test set (n = 58) was used to compare the two methods by a Bland–Altman plot. Partial least square regression was used to analyse Raman spectra, while univariate analysis was performed at 245 nm for FIA‐UV. The regression coefficient was higher than 0.990 for both methods, and the root mean square error of prediction was 0.031 mg.mL−1 for Raman spectroscopy. The Bland–Altman plot confirmed the interchangeability of the two methods and the potential of Raman spectroscopy to control remdesivir during clinical preparation in the hospital.

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A UV-Raman spectrometry method for quality control of anticancer preparations: Results after 18 months of implementation in hospital pharmacy

Cited by 24 publications

References 34 publications

Analytical Control of Pediatric Chemotherapy Preparations with a UV-Raman Automaton: Results After 18 Months of Implementation and Development of A Suitable Method for Low Volume Preparations

Analytical Control of Pediatric Chemotherapy Preparations with a UV-Raman Automaton: Results After 18 Months of Implementation and Development of A Suitable Method for Low Volume Preparations

Centrally Prepared Cytotoxic Drugs: What Is the Purpose of Their Quality Control?

Flow Injection Analysis With UV Detection Versus Raman Spectroscopy for the Quantitative Analysis of Remdesivir

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