Removal of bacterial growth inhibition of anticancer drugs by using complexation materials
| Autor: | Sylvie Crauste-Manciet, Aude Berroneau, Véronique Dubois, Guillaume Bouguéon, Maïté Sangnier |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
sterility testing
Sterility testing Pharmacy RM1-950 Bacterial growth Microbiological growth 030226 pharmacology & pharmacy 03 medical and health sciences batch production 0302 clinical medicine 030202 anesthesiology medicine Pharmacology (medical) 5-fluorouracil activated carbon Ion-exchange resin Pharmaceutical industry Pharmacology Chemistry microbiological growth Therapeutics. Pharmacology HD9665-9675 ion exchange resin Activated carbon medicine.drug Nuclear chemistry |
| Zdroj: | Pharmaceutical Technology in Hospital Pharmacy, Vol 5, Iss 1, Pp 1760-4 (2020) |
| ISSN: | 2365-2411 |
| Popis: | In the context of batch production of cytotoxic drugs in hospital pharmacies with the need of sterility testing, the objective was to validate the use of Rapid Microbiological Method (RMM), and to develop adequate neutralization method in case of inhibition of bacterial growth. The potential microbiological growth inhibitory effect of three anticancer drugs (5 fluorouracil, irinotecan and oxaliplatin) selected for batch production was assessed on BacT/ALERT® system. Among cytotoxic drugs, only 5FU exhibited inhibitory effect on microbiological growth using rapid microbiological method. To counteract this effect our purpose was to use neutralizing agents complexing the drug i. e. activated carbon or ion exchange resins. The microbiological bactericidal concentration of 5FU was very low (1.10–4 mg/mL) indicating the absolute need to neutralize the whole drug before sterility test. The complexation was validated by High Performance Liquid Chromatography control of the residual 5FU concentration in solution after the use of neutralizing agents. Only activated carbon was able to fully capture 5FU when previously diluted at 5 mg/mL. Conversely, the resins, in the condition of the study, were not able to fully capture 5FU whatever the dilution. The microbiological growth on BacT/ALERT® system after active carbon treatment was successfully confirmed with Staphylococcus aureus. Based on this validation results a method was then developed to routinely be able to perform sterility test of the batches produced and was confirmed on five microbiological species (i. e. S. aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, Aspergillus brasiliensis). Our work gives a new insight for considering sterility testing by rapid microbiological method even for drugs exhibiting inhibitory effect on microbiological growth. |
| Databáze: | OpenAIRE |
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