A Bayesian Framework to Assess the Usability of Dry Powder Inhalers in a Cohort of Asthma Adolescents in Italy

The useability of DPIs (dry powder inhalers) depends on several factors that are influenced by the patients’ subjectivity and objectivity. The short-form global usability score (S-GUS), a specific tool for the quick ranking and comparison in real life of an inhaler’s usability, was used to investigate six of the most prescribed DPIs (Breezhaler, Diskus, Ellipta, Nexthaler, Spiromax, and Turbohaler) in consecutive asthma patients aged <18 years. A Bayesian indirect comparison (IC) was carried out to merge all pairwise comparisons between the six DPIs. Thirty-three subjects participated: eighteen tested Breezhaler, Spiromax, Nexthaler, and Ellipta simultaneously, while fifteen tested Breezhaler, Spiromax, Diskus, and Turbohaler. The estimates of the S-GUS, by the IC model, allowed us to rank the DPIs by their degree of usability: Ellipta, Diskus, and Spiromax were classified as “good to pretty good” (S-GUS > 15), while Spiromax, Turbohaler, and Breezhaler were classified as “insufficient” (S-GUS < 15). The multidomain assessment is recommended in asthma adolescents in order to approximate the effective usability of different DPIs as best as possible. The S-GUS proves particularly suitable in current clinical practice because of the short time required for its use in adolescents.

The Comparison of the Microbiological Characteristics of Wet Dough and Dry Powder Tarhana’s and Evaluation of Possible Health Risks

Tarhana is a traditional food produced by different traditional methods and the materials used in production are changing from a region to another region. The total yeast and molds, total mesophilic aerobic bacteria, Escherichia Coli and enterococci bacteria count of wet dough Kastamonu tarhana and dry powdered tarhana samples were investigated in this study. All microorganisms examined in our study were detected in one of the wet dough tarhana samples. The highest total yeast and molds, total mesophilic aerobic bacteria, Escherichia coli and enterococci bacteria counts were determined for the wet dough tarhana samples to be 2.2×106, 6.6×107, 1.2×106 and 1.9×106 cfu/g, respectively. No growth of microorganism capable of reproduction was observed in the powdered tarhana produced industrially. In addition, the Escherichia coli and enterococci bacteria were not detected for any of the dry powder tarhana samples. It was seen that the microbial load of the wet tarhana produced at home in Kastamonu was higher than the powdered tarhana. The reason for this situation was thought to be due to poor production and hygiene conditions. The presence of Escherichia coli and enterococci bacteria in samples indicates that there is possible fecal contamination of the raw materials used in wet dough tarhana production. Electron microscope images of molds obtained in our study are similar to molds producing mycotoxins. These results show that the wet dough tarhana have a greater risk for microorganism development and human health compared to dry powder tarhana.

Inhaled ciprofloxacin-loaded poly(2-ethyl-2-oxazoline) nanoparticles from dry powder inhaler formulation for the potential treatment of lower respiratory tract infections

Lower respiratory tract infections (LRTIs) are one of the fatal diseases of the lungs that have severe impacts on public health and the global economy. The currently available antibiotics administered orally for the treatment of LRTIs need high doses with frequent administration and cause dose-related adverse effects. To overcome this problem, we investigated the development of ciprofloxacin (CIP) loaded poly(2-ethyl-2-oxazoline) (PEtOx) nanoparticles (NPs) for potential pulmonary delivery from dry powder inhaler (DPI) formulations against LRTIs. NPs were prepared using a straightforward co-assembly reaction carried out by the intermolecular hydrogen bonding among PEtOx, tannic acid (TA), and CIP. The prepared NPs were characterized by scanning electron microscopy (SEM), dynamic light scattering (DLS), Fourier transform infrared spectroscopy (FTIR), powder X-ray diffraction analysis (PXRD), differential scanning calorimetry (DSC), and thermogravimetric analysis (TGA). The CIP was determined by validated HPLC and UV spectrophotometry methods. The CIP loading into the PEtOx was between 21–67% and increased loading was observed with the increasing concentration of CIP. The NP sizes of PEtOx with or without drug loading were between 196–350 nm and increased with increasing drug loading. The in vitro CIP release showed the maximum cumulative release of about 78% in 168 h with a burst release of 50% in the first 12 h. The kinetics of CIP release from NPs followed non-Fickian or anomalous transport thus suggesting the drug release was regulated by both diffusion and polymer degradation. The in vitro aerosolization study carried out using a Twin Stage Impinger (TSI) at 60 L/min air flow showed the fine particle fraction (FPF) between 34.4% and 40.8%. The FPF was increased with increased drug loading. The outcome of this study revealed the potential of the polymer PEtOx as a carrier for developing CIP-loaded PEtOx NPs as DPI formulation for pulmonary delivery against LRTIs.