Spraytec - Pharmaceutical spray applications
Already well-established for locally acting pharmaceuticals, Orally Inhaled and Nasal Drug Products (OINDPs) show great promise for the effective delivery of a variety of systemically-acting drug products. Patient acceptability, rapid absorption, gastro-intestinal tract avoidance, and the opportunity for product differentiation are just some of the driving factors.
For all OINDPs, particle size is a critical-to-quality attribute, directly influencing clinical efficacy. The correlation between particle size and in vivo deposition behavior makes particle size measurement essential for all inhaled products - in development, manufacture and QC. Spraytec meets this demand.
Spraytec is an advanced laser diffraction particle size analyzer designed specifically for spray droplet and dry powder aerosol measurements. A robust system with SOP-driven operation it offers:
- Rapid data acquisition: measurement rates in excess of 2.5 kHz allow real-time monitoring of particle size changes during a spray event.
- A broad dynamic range: accurate particle size measurement from 0.1 to 2000 micron covers the sub-10 micron range of primary interest for pulmonary delivery, nasal sprays and the characterization of poorly dispersed agglomerates.
- Concentration measurement: in combination with size data, enables the dynamic study of dispersion behavior.
A powerful tool for rapid screening and accelerated optimization of OINDPs, Spraytec perfectly complements techniques such as cascade impaction, adding detailed insight into dispersion and atomization behavior. Such information promotes an efficient, knowledge-led approach to device and formulation development, as advocated by QbD.
More information
Nasal Sprays: Spraytec users can fully characterize the output of nasal pump sprays, in line with FDA BA/BE guidance. Since laser diffraction data promote a greater understanding of the influence of device and formulation variables on product performance, Spraytec helps accelerate and optimize product development.
Inhaler Devices: Engineering DPI formulations that disperse to a respirable size is a tough challenge. Spraytec tracks particle size and concentration in real time, providing insight into the mechanics of dispersion to help identify successful formulation strategies.
Nebulizers: For nebulizers, Spraytec supports the characterization of both device and formulation, and enables the study of how patient inhalation influences product performance.
