113 Safety, tolerability and pharmacokinetics of novel liposomal ciprofloxacin formulations for inhalation in healthy volunteers (HV) and non-cystic fibrosis bronchiectasis (BE) patients

Abstract

Aim: To evaluate whether off label nebulised vancomycin (Vancocin®) injection can be delivered via Pari LC PlusTM and e-flow rapidTM nebulisers. Objectives: To measure particle size, proportion of drug remaining in the nebuliser, degradation of product and percentage of drug delivered. Method: Vancomycin 250mg (50mg/ml-500mg vial dissolved with 9.6ml water for injection) were nebulised via both nebuliser systems. Particle size distributions were measured using a HELOS KF particle sizer (Sympatec, Germany) at 4 representative flow rates for children and adults. The proportion of drug remaining and percentage delivered were calculated by measuring residual volume and concentration. Sample degradation was evaluated by HPLC. Results: Pari LC PlusTM − median particle sizes ranged from 1.75–2.18mm across the 4 flow rates; 61.6–73.9% of particles were between 1−5 mm in size. Of the nebulised dose, 81.2% was delivered with 18.8% remaining in the nebuliser. The residual concentration was 62.1mg/ml compared to 50mg/ml at initiation. There was no degradation after nebulisation. e-flow rapidTM − median particle sizes ranged from 3.33−3.6 mm across the 4 flow rates; 61.7−70% of particles were between 1−5 mm. Of the nebulised dose, 74% was delivered with 26% remaining in the nebuliser. The residual concentration was 48.8mg/ml compared with 50mg/ml initially. No degradation was seen. Conclusion: It is possible to nebulise vancomycin injection via both the Pari LC PlusTM and e-flow rapidTM nebulisers. The characteristics of the inhalation vary depending on the nebuliser used. It is not known if this is clinically significant.