ABSTRACT
OBJECTIVE: The qualitative fit testing procedure would be challenging due to severe shortages, high cost, and unavailability of commercial fit test kits in the marketplaces during pandemics of respiratory infectious diseases. Assessment of alternatives for commercial fit test kits to be prepared for emergencies is critically required. This study aimed to investigate the feasibility of an alternative of the Accumed NF60 nebulizer for the OSHA-approved Allegro one. METHODS: Thirty-two participants were randomly allocated to six filtering facepiece respirators (FFRs). They were qualitatively fit tested by both manual Allegro and automated Accumed NF60 nebulizers. RESULTS: There was no statistically significant difference between the Allegro and Accumed NF60 nebulizers by passing rates. The odds for passing fit testing using the Accumed NF60 nebulizer was similar to that of the Allegro one [OR=1.0, 95% CI (0.58-1.74)]. CONCLUSIONS: The Accumed NF60 nebulizer could be used as a cost-benefit substitute for the standard fit test nebulizers in the pandemic situation where there is a shortage and difficulty of access. It is more convenient, decreases the time investment, and reduces the contact stress in the operators' hands as it does not require squeezing the nebulizer bulb frequently. The test solutions' preparation and fit testing procedures on many personnel are more straightforward, efficient, and hygienic than the Allegro one.
ABSTRACT
The recent Covid-19 pandemic has drawn attention to the amount of fugitive aerosol that is emitted by nebulizers. The novel I-neb Advance Adaptive Aerosol Delivery (AAD) System incorporates an improved AAD algorithm intended to reduce treatment times compared with earlier AAD devices. We conducted an in vitro test to determine the amount of fugitive aerosol that is emitted from the I-neb Advance (AAD) System. Three production equivalent investigational I-neb Advance nebulizers fitted with nonmetering chambers were filled with 1.7mL of 2mg/mL salbutamol solution. The delivered dose was collected on a filter during operation into a simulated breathing pattern (Tv=500mL, I:E=1:1, f 15 bpm). A second filter was fixed 1 cm away from the exhalation port of the nebulizer with an extraction flow of 60 L/min. Each nebulizer was run in triplicate. Salbutamol on filters was quantitated by high performance liquid chromatography. The delivered doses had low co-efficients of variation, intra-nebulizer=0.83 to 3% and inter-nebulizer=0.77%. The fugitive aerosol was lower than the limit of quantification of the assay (0.18% of fill) in 2/3 of the tests. Measurable exhaled doses were all below 0.3% of the fill volume. The improved AAD algorithm used in the I-neb Advance (AAD) System delivered precise, reproducible doses with minimal fugitive aerosol emissions into a simulated breathing pattern. The minimization of fugitive aerosol emissions demonstrated by AAD nebulizers likely has an added relevance to aerosol treatment following the emergence of the Covid-19 pandemic. Key Message: The novel I-neb Advance (AAD) System was shown to deliver reproducible doses of drug with minimal (<0.3% of the nominal dose) fugitive aerosol emissions. This observation could be important in clinical situations where there is a need to minimise escaping aerosol from nebuliser devices during use.
ABSTRACT
TYPE: TOPIC: Pharmacotherapeutics PURPOSE: The i-NEB-MiniTM is a jet nebulizer designed for controlled delivery of small (< 2 mL) volumes of potent drugs to the deep lung. The purpose of this study was to determine aerosol parameters and post nebulization drug activity of a novel formulation of recombinant Interferon Gamma (rIFNγ), a pluripotent molecule with Th1 helper cell activity. METHODS: rINFγ (200 μg/mL) was aerosolized using i-NEB-MiniTM driven by a portable compressor at 3.5 L/min. Two (2) mL was aerosolized into a Next Generation Impactor (NGI) using a 15 L/min vacuum. Aerosol parameters (MMAD, GSD, Total Respirable Dose) were determined using an HPLC assay (Vectura Ltd., UK). Bioactivity pre-/post-nebulization was determined using an HLADR assay (PBL Assay Sciences, Piscataway, NJ, USA). RESULTS: The MMAD, GSD and Total Respirable dose from a 200 μg/mL formulation (n=6) was 2.5 (± 0.2), 1.6 (± 0.4) and 123.7 (± 19.8) μg respectively. The bioactivity pre- and post-nebulization was consistent with the EP standard suggesting that nebulization did not affect biological activity of the protein. CONCLUSIONS: This study indicates that a clinically relevant and reproducible dose of rINFγ can be delivered with i-NEB-MiniTM. Bioactivity assay indicates that aerosol rINFγ retains protein integrity after nebulization. CLINICAL IMPLICATIONS: rINFγ is an immunomodulatory pleiotropic cytokine with potential for treatment of respiratory diseases such as Pulmonary Fibrosis, MDRTB, COPD and SARS-CoV-2. The results indicate that a clinically relevant dose of rINFγ can be aerosolized using the i-NEB-MiniTM jet nebulizer. DISCLOSURE: Stony Brook and New York University hold patents on the use of inhaled interferon licensed to InspiRx, Inc. Dr. Smaldone consults to InspiRx and is a member of the advisory board. Mr. Shukla and Dr. Toddywala are employees of InspiRx. KEYWORD: immunomodulation