Background COVID-19 in Italy has led to the need to reorganize hospital protocols with a significant risk of interruption to cancer treatment programs. In this report, we will focus on a management model covering the two phases of the COVID-19 emergency, namely lockdown-phase I and post-lockdown-phase II. Methods The following steps were taken in the two phases: workload during visits and radiotherapy planning, use of dedicated routes, measures for triage areas, management of suspected and positive COVID-19 cases, personal protective equipment, hospital environments and intra-institutional meetings and tumor board management. Due to the guidelines set out by the Ministry of Health, oncological follow-up visits were interrupted during the lockdown-phase I; consequently, we set about contacting patients by telephone, with laboratory and instrumental exams being viewed via telematics. During the post-lockdown-phase II, the oncological follow-up clinic reopened, with two shifts operating daily. Results By comparing our radiotherapy activity from March 9 to May 4 2019 with the same period in 2020 during full phase I of the COVID-19 emergency, similar results were achieved. First radiotherapy visits, Simulation Computed Tomography and Linear Accelerator treatments amounted to 123, 137 and 151 in 2019 compared with 121, 135 and 170 in 2020 respectively. There were no cases of COVID-19 positivity recorded either in patients or in healthcare professionals, who were all negative to the swab tests performed. Conclusion During both phases of the COVID-19 emergency, the planned model used in our own experience guaranteed both continuity in radiotherapy treatments whilst neither reducing workload nor interrupting treatment and, as such, it ensured the safety of cancer patients, hospital environments and staff.

The study was conducted in order to assess the bioequivalence of two capsule formulations (test and reference) containing 20 mg of omeprazole (5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl) methyl]sulfinyl]-1H-benzimidazole, CAS 73590-58-6). Fifty healthy male and female volunteers were treated in a single-centre, randomised, repeated-dose (once daily for six consecutive days), open-label, two-way crossover study, with a washout period of at least 9 days between treatments. Plasma samples were collected up to 12 h post-dosing for the determination of omeprazole by HPLC with photodiode array detector (DAD). The evaluation of bioequivalence was based on the following pharmacokinetic parameters that were calculated by standard non-compartmental methods: area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUCt) and that extrapolated to infinity (AUC) and the maximumobserved concentration (Cmax). The 90% confidence interval around the ratios (test/reference) (obtained by analysis of variance, ANOVA) were 0.92-1.04 forCmax, 0.88-1.05 for AUCt, and 0.88-1.05 for AUC, i.e., within the predefined acceptable range for the conclusion of bioequivalence. The study indicated that the test and reference formulations containing 20 mg of omeprazole are bioequivalent in terms of both the rate and extent of bioavailability.

A fast, specific, accurate, precise and reproducible high-performance liquid chromatography (HPLC) method with diode-array detector (DAD) was developed and validated for the determination of ketoprofen (CAS 22071-15-4) in human plasma using flubiprofen (CAS 5104-49-4) as an internal standard. The chromatographic separation was achieved on an onyx monolithic C18 (100 x 4.6 mm) analytical column with an isocratic mobile phase consisting of acetonitrile/potassium dihydrogen phosphate (KH2PO4) 0.01 M, (40:60, v/v) adjusted to pH 3.5. The flow was set at 5 ml x min(-1) and the wavelength at 254 nm. The total analysis time was less than 5 min. The ratio of peak area of analyte to internal standard was used for quantification. The limit of detection was defined as the ketoprofen concentration that produced a signal-to noise ratio greater than 3. The lower limit of quantification (LLOQ) was 10 ng x m(-1). At this level, the relative standard deviation (RSD) was lower than 13%. The calibration curve was linear over the concentration range 1-500 ng x ml(-1) with a minimum detectable limit of 10 ng x ml(-1). The coefficients of variation for the inter-day and intra-day assay were found to be less than 11%. The present method was successfully applied to the routine analysis of human plasma samples collected from healthy volunteers after dermal application of two topical formulations containing ketoprofen in order to assess the relative bioavailability and to demonstrate that the systemic bioavailability of ketoprofen administered topically is low enough to ensure a low incidence of gastrointestinal adverse events.

Background: COVID-19 in Italy has led to a reorganization of hospital activities with risks of cancer treatments discontinuity. We report a management model in the two phases of the COVID-19 emergency, lockdown phase I and post-lockdown phase II.Methods: Actions were planned in the two phases: workloads of the visits and radiotherapy planning, dedicated routes, measures for triage areas, management of suspected and positive COVID-19 cases, personal protective equipment, environments andintra-institutional meetings and tumor boards management.Results: Comparing our radiotherapy activity in the period March 9- May 4, 2019 with the same period of 2020 in full phase I of the COVID-19 emergency, no changes were observed.First radiotherapy visits, Simulation Computed Tomography and Linear Accelerators treatments were 123, 137 and 151 in 2019 respect to 121, 135 and 170 in 2020.There were no cases of COVID-19 positivity recorded either in patients or in healthcare professionals who were all negative to the buffers performed.Conclusions: The model planned in our experience in both phases has guaranteed continuity of radiotherapy treatments without workload reduction nor treatment interruption ensuring safety of cancer patients, environments and staff.