Control of chemotherapy preparations: gravimetry in process versus FIA - application to 5FU
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The gravimetric control is based on the weight of pharmaceuticals and medical devices for each step of the preparation of chemotherapies. A scale inside the isolator linked with interactive manufacturing procedures allows a computer-assisted gravimetric system. In this study, we compare the gravimetric method to the dosage method by flow injection analysis (FIA) on 5-fluorouracile (5FU) preparations.
5-FU is prepared in 5% GLUCOSE (n = 50). We compare the accuracy of the two methods: gravimetry (A&D scale) and FIA (Merck Hitachi HPLC) versus theoretical values of adjusted concentrations based on supplier databases (volume and weight). The results are analyzed according to specific quantitative statistic tests at a risk of 5%.
The average deviation with the gravimetric method is 4% versus 11% for the FIA method. The deviations with the theoretical adjusted concentrations are not statistically significant with the gravimetric method (p<0.01). On the contrary, deviations with the FIA method are statistically significant (p=0.02). The differences between the results obtained by the gravimetric method and the FIA method are not statistically significant (p<0.01). The deviations can be explained by the lack of precision of the two methods, of the medical devices, of the operators, of the volumes and drug concentrations. Each method shows bias such as the lack of homogenization and the sampling method for FIA; FIA or scale inaccuracy and the turbulent air flow of the isolator for the gravimetric method.
The gravimetric method can be applied to the whole production. It could be a choice method for the chemotherapy control. This study can be extended to other cytotoxic drugs.