21 February 2012; Nottingham, UK: Copley Scientific has added a new, freely available download to its extensive library on the company website. ‘Calculating particle size distribution metrics for inhaled product characterization’ is a recently published paper authored by Mark Copley, Sales Director of Copley Scientific, and David Lewis from 3DI Solutions. It provides a review of the data processing techniques used to generate relevant aerodynamic particle size distribution (APSD) metrics for orally inhaled products (OIPs). A valuable reference for anyone working in the development and QC of this important class of pharmaceuticals, the paper can be downloaded Here.
Particle size is critical for OIPs because of its influence on the efficiency of drug delivery. The authors discuss this need for particle size data and how to efficiently derive key metrics from the substantial amount of data produced when using cascade impaction. Cascade impaction is the mandatory technique for measuring APSD measurement in all OIPs.
Cascade impaction involves size fractionation of a delivered dose. This enables the generation of an APSD specifically for the active pharmaceutical ingredient, rather than the entire formulation. Each sample is separated into around 7 or 8 fractions, each of which is analyzed by HPLC. Processing the resulting data to produce meaningful metrics is essential but can be complicated and potentially time-consuming.
Beginning with an introduction to cascade impaction ‘Calculating particle size distribution metrics for inhaled product characterization’ focuses on the calculation of mass median aerodynamic diameter (MMAD), comparing the different data regression techniques that can be applied in its determination. The simplicity, effectiveness and validity of direct linear interpolation is emphasised and, there is more general discussion of current efforts towards streamlined data analysis. Download this and other articles and white papers Here.
About Copley Scientific
Copley Scientific is recognised as the world’s leading manufacturer and supplier of inhaler test equipment and is a major provider of testing systems for other pharmaceutical dosage forms. The company is also active in detergent testing, air sampling and aerosol characterisation.
Copley Scientific’s pharmaceutical product range includes test equipment for: delivered dose uniformity and aerodynamic particle size measurement of metered-dose inhalers, dry powder inhalers, nebulizers and nasal sprays; as well as tablets (dissolution, disintegration, friability and hardness) capsules, powders, suppositories and transdermals.
Copley Scientific has offices in the UK and Switzerland. The company works in partnership with aerosol particle science experts MSP Corporation in North America, and also distributes MSP Corporation’s air sampling and aerosol characterisation products throughout Europe.
Serving the pharmaceutical and associated industries, Copley Scientific offers an extensive range of equipment for research, development and quality control, as well as full validation and aftersales services. This broad range of products is supplied and supported worldwide through a network of specialist distributors. www.copleyscientific.com