BackgroundOral and intravenous formulations of ciprofloxacin have established efficacy and safety profiles in respiratory infections. A dry powder for inhalation (DPI) that uses Novartis’ PulmoSphere™ technology has been developed to deliver high concentrations of ciprofloxacin to the lung with low systemic exposure using a portable and convenient passive dry powder inhaler (Novartis’ T-326 inhaler).ObjectivesThe primary objective was to investigate the safety and tolerability of ciprofloxacin DPI in healthy male subjects, with a secondary objective to investigate the pharmacokinetics of ciprofloxacin after ciprofloxacin DPI administration.MethodsThis was a phase I, single-dose, single-site, randomized, single-blind, placebo-controlled, crossover study conducted in the hospital setting. Subjects were followed up for safety for approximately 2 weeks. Six healthy male subjects, aged 27–42 years with no history of pulmonary disease, repeated bronchitis or respiratory allergies were enrolled. In randomized order and separated by a 1-week washout period, subjects inhaled a single dose of ciprofloxacin DPI 32.5 mg or placebo from the T-326 inhaler. Primary safety parameters included vital signs, electrocardiogram, laboratory tests, adverse events and lung function (total specific resistance, thoracic gas volume and forced expiratory volume in 1 s). Plasma concentration–time data were used to calculate pharmacokinetic parameters.ResultsCiprofloxacin DPI was well tolerated with no clinically relevant adverse effects on lung function. Estimates of lung deposition derived from physiology-based pharmacokinetic modelling suggest that approximately 40 % of the total dose of ciprofloxacin DPI reached the trachea/bronchi and alveolar space. Systemic ciprofloxacin was detected soon after inhalation [peak concentration in plasma (Cmax) 56.42 μg/L, median time to Cmax 0.625 h], but total systemic exposure was minimal (area under the plasma concentration–time curve 354.4 μg·h/L). Terminal elimination half-life (9.5 h), apparent total clearance from plasma after non-intravenous administration (91.7 L/h) and apparent volume of distribution (1,262 L) data suggest that elimination from the respiratory tract was prolonged.ConclusionsIn healthy subjects, ciprofloxacin DPI was well tolerated, delivered ciprofloxacin to the lungs and resulted in minimal systemic exposure, allowing further investigation of its clinical use for the management of specific, chronic infections in pulmonary diseases.
Iatrogenic dermatitis in times of COVID-19: a pandemic within a pandemic Editor The pandemic of the 21st century COVID-19 emerged in Wuhan, China, and swiftly became a global phenomenon. The frontline barriers for preventing spread are hand hygiene and personal protective equipment (PPE). The amplified hygiene practices and PPE as recommended have brought in its wake a second pandemica pandemic of dermatitis! 1 We reviewed the most prevalent types of iatrogenic skin damage among healthcare workers (HCWs), notably irritant, and allergic contact dermatitis (ACD) to PPE and hand hygiene
A total of 2089 faecal samples (956 buffaloes and 1133 cattle) were collected from 21 districts of five major agro-climatic zones of Punjab during April, 2013-May, 2014. An overall prevalence rate of 32.17 % (672/ 2089) was recorded for coccidiosis in dairy animals with a significantly higher (P \ 0.01) infection rate in buffaloes (35.46 %) in comparison to cattle (29.39 %). Quantitative analysis revealed oocyst per gram of faeces ranging from 200 to 10,000 (1083.72 ± 227.20) and 100 to 2400 (748.72 ± 81.38), in cattle and buffalo populations, respectively. The results of multivariate analysis showed that prevalence of coccidiosis in cattle population was associated with various risk factors viz. districts (P = 0.000; OR 2.749; 95 % CI 1.238-6.107), agro-climatic zones (P = 0.004; OR 2.707; 95 % CI 1.707-4.293) and seasons (P = 0.000; OR 1.106; 95 % CI 0.811-1.509). Similarly, in buffalo population an association with districts (P = 0.000; OR 2.163; 95 % CI 0.702-6.668), agro-climatic zones (P = 0.000; OR 1.237; 95 % CI 0.673-2.277) and seasons (P = 0.100; OR 1.382; 95 % CI 1.003-1.903) was recorded. The findings of the current study would provide a basis for evolving effective control strategy for the management of coccidiosis in dairy animals of the region.
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