Infections of the female reproductive tract are a major cause of morbidity and mortality in humans, requiring significant investment to sustain treatment and representing a major challenge to health. The increasing prevalence of bacterial resistance, and an almost complete absence of new antibiotic therapies for the past five decades, mean there is a desperate need for novel approaches to the treatment of bacterial infections. Within the present study, we demonstrate the effective ex vivo treatment of bacterial infection of the female reproductive tract using a controlled-release, liquid crystal-based platform. Liquid crystal encapsulation of ciprofloxacin significantly enhanced its bactericidal efficacy and reduced cell toxicity. Liquid crystal structures are low-cost, simple to manufacture and provide a sustained-release profile of encapsulated ciprofloxacin. Treatment of Escherichia coli infected reproductive tract epithelial cells and whole organ cultures with liquid crystal encapsulated ciprofloxacin proved to be an effective strategy for reducing bacterial load and reproductive tract inflammatory responses to infection. These data suggest that such an approach could provide an efficacious treatment modality for enhancing the effectiveness of current antibiotic therapies. Electronic supplementary material The online version of this article (10.1007/s10544-019-0385-x) contains supplementary material, which is available to authorized users.
Objectives Radiopharmaceuticals, since the discovery of the first medical application of radioactive isotope, have been essential therapeutics for the diagnosis and treatment of numerous diseases. Since the Directive 2001/83/EC entered in force, European regulatory authorities have established a harmonised framework to set quality requirements for the industrial production of radiopharmaceuticals. However, little is known about the harmonisation of extemporaneous preparation of radiopharmaceutical preparations (EPRPs) among European countries. In this context, this study aims to provide an overview of the national regulatory framework on the production of EPRPs of five European countries (i.e. UK, Spain, France, Germany and Italy). Methods Five different national regulatory frameworks were compared based on the results of a literature search on electronic databases (i.e. PubMed, Google scholar). Key findings Unlike industrially produced radiopharmaceuticals, the results highlighted that the regulatory framework on EPRPs is still not fully harmonised at the European level and many provisions are regulated by local national laws. Similarities and differences exist among the European countries, both regarding quality standards and educational courses the operators involved in the preparation of EPRPs have to attend. Conclusions The regulatory framework on the EPRPs is still not harmonised at the European level affecting the access to therapies of European citizens who are not equally guaranteed when an extemporaneous radiopharmaceutical has to be prepared to meet their needs.
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