PURPOSE:Formoterol fumarate inhalation solution (DEY, Napa, CA, USA) has recently been approved in the US for the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD). We compared the in vitro delivery characteristics of formoterol fumarate via the SideStream® Plus (SSP; Respironics, Inc., Parsippany, NJ, USA) and LC Plus® (LCP; Pari GmbH, Starnberg, Germany) jet nebulizers when run using wall air versus a portable compressor.
METHODS:Three each of SSP and LCP nebulizers were characterized for drug output and particle size in triplicate using both wall air and a MiniEliteÖ (Respironics, Inc.) compressor. Each nebulizer was filled with 2 mL of 20 μmg/2 mL formoterol fumarate and connected to a filter in line with a Harvard respirator (Harvard Apparatus, Harvard College, Holliston, MA, USA) set to generate a 500 mL, BPM= 25, I:E= 1:1 waveform. The nebulizers were run until 60 s after the onset of sputter, using either 4 L/min wall air or using a MiniElite compressor. Filters were eluted for assay by HPLC and nebulization time was recorded. Particle size was assessed using a laser particle sizer (Malvern® Mastersizer® S; Malvern Instruments Ltd, Malvern, UK.) and 2m L volume of drug.
RESULTS:Using wall air the results were: Filter dose SSP= 4.25 μg, LCP= 4.42 μg; MMAD SSP= 4.36 μm, LCP= 5.03 μm; FPF SSP= 58%, LCP= 50%. Nebulization times were 118 s for SSP and 145 s for LCP. Using the MiniElite compressor the results were: Filter dose SSP= 4.92 μg, LCP= 4.44 μg; MMAD SSP= 5.11 μm, LCP= 5.30 μm; FPF SSP= 49%, LCP= 47%. Nebulization times were 182 s for SSP and 162 s for LCP.
CONCLUSION:The two nebulizer brands had similar drug output and particle size characteristics when used with a formoterol fumarate inhalation solution run by either wall air or a compressor.
CLINICAL IMPLICATIONS:Formoterol fumarate inhalation solution can be nebulized with either of the two nebulizers tested using either wall air or the MicroElite portable compressor.
DISCLOSURE:Kurt Nikander, Employee All the authors are employees of Respironics, Inc.; No Product/Research Disclosure Information