Efficiency of a New Mesh‐Type Nebulizer (NE‐SM1 NEPLUS) for Intrapulmonary Delivery of Ipratropium Bromide in Surgical Patients

Abstract

This study was aimed to evaluate the efficiency of a new mesh-type nebulizer for the intrapulmonary delivery of ipratropium bromide in surgical patients under mechanical ventilation. A total of 20 patients were randomly allocated to receive 0.5 mg ipratropium bromide using either a control (Pariboy SX, Pari, Co., Starnberg, Germany, n = 10) or test (NE-SM1 NEPLUS, KTMED INC., Seoul, Korea, n = 10) nebulizer during general anaesthesia. Ipratropium bromide was nebulized continuously for 20 min. in each group. Plasma concentrations of ipratropium bromide were obtained from blood samples at preset intervals. Non-compartmental analysis of ipratropium bromide was performed to compare the efficiency of pulmonary drug delivery in both nebulizers. Population pharmacokinetic analysis of ipratropium bromide was performed. Additionally, the noise level during the nebulizer operation and the aerosol particle size for each device were measured. The dose-normalized AUC last was 0.10 min/L for both nebulizers. The pharmacokinetics of nebulized ipratropium bromide can be described best by a one-compartment model with first-order absorption. The apparent volume of distribution and metabolic clearance were 1340 L and 6.78 L/min, respectively. Type of nebulizer was a significant covariate for absorption rate constant. The equivalent sound level and median aerosol particle diameter were 35.0 dB and 4.52 lm for the test nebulizer, and 60.2 dB and 3.85 lm for the control nebulizer, respectively. From the standpoint of the dose-normalized AUC last , a new vibrating mesh-type nebulizer shows similar performance in the intrapulmonary delivery of ipratropium bromide to that of a jet-type nebulizer in surgical patients.Pulmonary drug delivery is an effective route for bronchodilator administration to manage obstructive lung diseases, including asthma and chronic obstructive pulmonary disease. Nebulizers have been used to deliver bronchodilators to the lung in various clinical situations [1]. Nebulizers can be classified into two major types according to their operating principle, jet-and ultrasonic-type nebulizers [2]. For aerosol generation, jet nebulizers function via the Bernoulli principle and use high-speed velocity compressed gas, whereas ultrasonic nebulizers use a piezoelectric crystal that vibrates at a high frequency [2]. A class of advanced ultrasonic nebulizers that used ultrasonic vibrating mesh technology were launched around 2005. In these nebulizers, a mesh with 1000-7000 laser-drilled holes vibrates at the top of the liquid reservoir, and this technology is more effective than those with a vibrating piezoelectric element at the bottom of the liquid reservoir [3]. It is known that the type of nebulizer is an important factor for determining the efficiency of pulmonary drug delivery during mechanical ventilation [4]. Recently, a vibrating meshtype nebulizer (NE-SM1 NEPLUS, KTMED INC., Seoul, Korea) was commercialized and approved for the Korean market by the Korean Ministry of Food & Drug Safety. To the best of our...

Aerosol delivery during invasive mechanical ventilation: a systematic review

“…On one hand, greater postoperative efficacy of ultrasonic nebulizers compared to jet nebulizers was suggested in seven patients [ 23 ]. On the other hand, Lee et al [ 26 ] did not report higher efficacy for a recent vibrating-mesh nebulizer compared to a conventional jet nebulizer. However, the authors measured 46% ND in the T-piece of the vibrating-mesh nebulizer, which questioned its efficiency in generating aerosol particles [ 26 ].…”

“…On the other hand, Lee et al [ 26 ] did not report higher efficacy for a recent vibrating-mesh nebulizer compared to a conventional jet nebulizer. However, the authors measured 46% ND in the T-piece of the vibrating-mesh nebulizer, which questioned its efficiency in generating aerosol particles [ 26 ]. Combining a nebulizer with an inhalation chamber may significantly increase lung doses, as suggested by the scintigraphic study by Harvey et al [ 22 ] Actuating an MDI in an inhalation chamber placed at the Y-piece allowed a 1.5-fold to 4-fold increase in lung doses of bronchodilators [ 20 , 30 ].…”

Aerosol drug delivery to spontaneously-breathing preterm neonates: lessons learned

“…Aerosol particle size and drug output can be altered, to a certain extent, by modifying the flow of the driving gas [70]. However, in vibrating-membrane nebulizers a membrane with 1000-7000 laser-drilled holes vibrates at the top of the liquid reservoir thereby generating a mist of very fine droplets out through the holes [75].…”

Population pharmacokinetic analysis of ropivacaine extended‐release from a temperature‐responsive hydrogel in rats

“…However, the pharmacokinetics of the drug–hydrogel combination could not be explained by non‐compartmental analysis (NCA) 7 . Population analysis is an alternative approach that can be used to quantify the pharmacokinetic parameters associated with absorption 8 …”

“…7 Population analysis is an alternative approach that can be used to quantify the pharmacokinetic parameters associated with absorption. 8 The purpose of this study was to compare the pharmacokinetic parameters associated with absorption of 0.75% ropivacaine (Nacain Injection, Huons Co., Sungnam, Korea) and 0.75% ropivacaine incorporated into this temperature-responsive hydrogel-based drug delivery system (PF-72, TGel Bio, Inc., Seoul, Korea) in rats using population analysis, prior to its application in humans.…”