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The paper entitled “Mucoadhesive Budesonide Formulation for the Treatment of Eosinophilic Esophagitis Pharmaceutics 2020, 12, 211” discusses the physicochemical and technological characterization of a formulation to treat eosinophilic esophagitis [...]

Background Flecainide acetate (FlecAc) is an antiarrhythmic drug, effective in children and fetal tachyarrhythmias. FlecAc is commercially available as 50 mg–150 mg oral tablets or intravenous injectable solutions, approved only for use in adults. For paediatric use, an extemporaneous preparation has to be compounded, using the pure active principle or, when this is lacking, the ground tablet. Few examples of extemporaneous FlecAc preparations are reported in the literature, normally at a dose of 20 mg/mL. Nevertheless, in the case of neonates and infants, a lower concentration is useful. Purpose The aim of this work was to compound FlecAc oral liquids (2 mg/mL) using pure powder (API) or ground commercial tablets (GCT) and to evaluate the chemical stability of the active principle. Material and methods Oral solutions were compounded using either a preserved simple syrup (PSS) with the addition of a suspending phase or a ready-to-use commercial suspending vehicle, ORA-Plus ORA-Sweet (OPOS), to be stored at 4°C or 25°C, respectively. Four types of aqueous solutions were compounded following hospital standard operating procedures. In three different pharmacies, seven hospital pharmacists compounded a total of 28 preparations (n=28): 1) PSS-API, 2) PSS-GCT, 3) OPOS-API and 4) OPOS-GCT. The samples were stored at 4°C (PSS), 25°C (OPOS) and 40°C (both) for 42 days. The FlecAc content was determined using a stability indicating the high-performance liquid chromatography method. Results At time t=0, the mean FlecAc content of all samples was 1.82±0.10 mg/mL, against a labelled content of 2.00 mg/mL. A significant difference in FlecAc content was observed only in the case of GCT preparations (OPOS-GCT: 1.87±0.07 mg/mL; PSS-GCT: 1.79±0.15 mg/mL, p=0.03). Based on these results, duration and method of stirring were further investigated and improved in a second batch, which showed a higher mean content and reduced variability (1.92±0.06 mg/mL). FlecAc was stable over the entire period. Conclusion FlecAc is completely solubilised in the proposed vehicles and stable for 42 days. A suspending agent is therefore necessary only to mask the excipients of the tablet, if not completely solubilised. Normally suggested storage in a refrigerator when PSS is compounded should be carefully considered, because of the influence of the reduced temperature on FlecAc solubility. References and/or acknowledgements No conflict of interest.

INTRODUCTION:Hepatitis C virus (HCV) infection is one of the main causes of chronic liver disease worldwide. The goal of HCV therapy is to eradicate the infection, which results in eliminating detectable circulating HCV after cessation of treatment, to prevent complications.METHODS:A prospective analysis was undertaken in the primary referral center in Turin. Throughout the use of questionnaries submitted to healthcare professionals, clinical and economic data from three different care pathways of HCV treatment were collected and processed. Costs were measured up to 8, 12, and 24-weeks treatment and based on time-driven activity-based costing (ABC) of the two main HCV treatments, Sovaldi and Harvoni. For the ABC analysis, three types of care pathways were considered, based on patient's clinical history resources used: patients treated for 8, 12, and 24 weeks. Gastroenterologists, pharmacists, administrative personel, and storemen were involved in the project. The aim of the analysis was to evaluate the organizational impact of the three different strategies for the treatment of HCV infection with Harvoni or Sovaldi and to estimate the differential cost.RESULTS:The data indicates that shortening treatment from 24 to 12 weeks and from 24 to 8 weeks leads to a saving of EUR192 and EUR766 for both treatment strategies. When drug costs are also taken into account, the reduction of treatment with shortening treatment from 12 to 8 weeks leads to a saving of EUR15,252.77, a reduction of EUR60,691.07 from 24 to 8 weeks for Harvoni treatment. The reduction of treatment with shortening from 24 to 12 weeks for Sovaldi leads to a saving of EUR37,668.30. The paths of 8 and 12 weeks are those associated with fewer resources in terms of professional's time, costs relating to laboratory tests, and cost of drugs.CONCLUSIONS:The reduction of the amount of time spent by healthcare professionals in the 12 weeks and in the 8 weeks strategies allows a reallocation of the resources employed.