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• W615519614 abstract "Improving the drug administration process by intravenous infusion means paying attention to flow-rate accuracy and guaranteeing that the entire prescribed dose is delivered. Now, when a drug is administered by gravity-fed infusion, flow-rate irregularity is principally due to an uncontrolled increase in infusion time. Moreover, the absence of a rinsing step after administration results in losing a fraction of the prescribed dose. In the field of oncology, the latest recommendations reinforce the constraint to rinse the infusion line after administration, by considering drug hazard for the nursing staff. This has led to the developing of a dedicated medical device whose objective is simply to respect these recommendations. However, the impact of infusion flow-rate and the benefits of line rinsing on the pharmacokinetic parameters of infused cancer drugs have never really been explored. This work aims to study the potential influence of these two infusion criteria on the pharmacokinetic parameters of drugs administered by infusion. It is based on the result of a mathematical model of gravity-fed infusion flow and on an application in clinical practice to determine the degree of involvement of the identified parameters on drug disposition. This work is divided into three parts. The objective of the first section is to place the medical device we have developed in an economic context and within the framework of the latest recommendations. Its impact on the two criteria cited above was studied through an in vitro experiment. This study demonstrates that the device itself does not modify gravity-fed infusion flow-rate but ensures that the totality of the prescribed dose is administered. The second part aims at presenting the different mathematical models concerning the impact of the infusion system on gravity-fed infusion flow-rate, according to the recipient in which the solution to be infused is conditioned: rigid vial, rigid bag, and flexible bag. In these models, two main variation factors were considered: pressure drop inside the recipient during infusion and infusion device creep. Three studies are described in the third section. In the first, the flow of gravity-fed infusion for a solution in a flexible bag was assessed to verify the corresponding mathematical model through experimentation. The results corroborate those of the theoretical model, i.e. the main factors causing flow-rate variation are pressure drop and creep. Secondly, the impact of the infusion technique on the pharmacokinetic parameters of two therapeutic molecules (amikacin and gemcitabine) was explored through two clinical studies. The amikacin study demonstrates that in the case of a considerable increase in infusion time during gravity-fed infusion, a significant reduction in maximal concentration may result. For a concentration-dependent antibiotic, treatment efficacy is known to depend on this parameter, which raises the question whether the amikacin infusion flow-rate with infusion pumps should not be systematically controlled to improve treatment efficacy. In the gemcitabine study, no significant difference was observed in the pharmacokinetic parameters for the three infusion techniques: infusion pump, gravity-fed infusion followed or not by a rinsing step. These contrasting results for amikacin and gemcitabine may be explained by factors such as different administration conditions and pharmacokinetic behaviour. Nonetheless, the results of the gemcitabine study confirm that the rinsing step, which is strongly recommended, does not alter the quality of care for patients receiving this drug. In conclusion, this work introduces an improved approach to the administration of drugs by infusion. To optimize this, medical devices for infusion should be assessed on suitable drug disposition criteria, and an evaluation made of their potential to modify the pharmacokinetic parameters of therapeutic drugs." @default.
• W615519614 created "2016-06-24" @default.
• W615519614 creator A5069183591 @default.
• W615519614 date "2010-10-13" @default.
• W615519614 modified "2023-09-22" @default.
• W615519614 title "Conceptualisation et optimisation des processus de mise à disposition de principes actifs : aspects mathématique, analytique et biopharmaceutique : application à la voie parentérale" @default.
• W615519614 hasPublicationYear "2010" @default.
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