Abstract
The properties of aerosols generated from salbutamol sulfate solution (1 mg/mL) using an air-jet nebulizer were evaluated using Next Generation Impactor (NGI), a full cascade impactor, and Fast Screening Impactor (FSI), an abbreviated impactor measurement (AIM). Both impactors were operated under the same experimental conditions. The samples were recovered and assayed using validated high performance liquid chromatography (HPLC). The study investigated AIM-Human Respiratory Tract (HRT) concept by comparing key parameters of aerosolization i.e. fine particle dose (FPD) and fine particle fraction (FPF) measured using FSI, with NGI as baseline. The results showed that FSI yielded different but comparable values for FPD and FPF, indicating that it is alternative impactor to NGI. Despite the fact that FSI could not replace NGI, it may be used as an alternative impactor for simple and rapid aerosol characterization of formulations in some pharmaceutical development and quality control processes.
Highlights
Aerodynamic Particle Size Distribution (APSD) is extensively recognized as a Critical Quality Attribute (CQA) in the in vitro characterization of orally-inhaled and nasal drug products (OINDP) (Nichols et al 2013; Fishler and Sznitman 2017; Roberts and Mitchell 2019)
The effectiveness of nebulizer delivery is usually dependent on two key parameters: fine particle dose (FPD) and fine particle fraction (FPF)
Determination of time taken to nebulize water to dryness and aerosol mass output Various volumes of high performance liquid chromatography (HPLC)-grade water i.e., 2, 2.5, 4 and 8 mL were put into an air-jet nebulizer reservoir which was connected to a PARI Boy air compressor (PARI Medical Ltd, Byfleet, UK) via a tube
Summary
Aerodynamic Particle Size Distribution (APSD) is extensively recognized as a Critical Quality Attribute (CQA) in the in vitro characterization of orally-inhaled and nasal drug products (OINDP) (Nichols et al 2013; Fishler and Sznitman 2017; Roberts and Mitchell 2019). Cascade impactors consist of a series of collection plates or cups in order of decreasing jet diameters with stage number (Kuhli et al 2009; Rissler et al 2009). They separate a formulation into various fractions based on inertial impaction which is a function of their aerodynamic diameters, which in turn, depend on size and particle density (Marple et al 2003; Mitchell and Nagel 2003; Nichols et al 2013; Roberts and Mitchell 2019)
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