Inhalytix is a completely new software solution from Copley, the global leader in inhaler testing equipment, that brings a standardised approach to cascade impactor data analysis, efficiently converting raw data into performance-defining metrics for all inhaled products.
Cascade impactors determine aerodynamic particle size distribution (APSD), a critical quality attribute for inhaled drug delivery. Inhalytix is flexible, user configurable and suitable for all cascade impactors in routine use, for both standard and bespoke test set-ups and methods. It handles the entry, analysis and reporting of APSD data to company and regulatory standards, in accordance with draft USP Chapter <1603>, Ph.Eur. Chapter 2.9.18 and relevant US FDA guidance. The software also serves as a database for laboratory cascade impactor inventory enhancing data traceability and integrity.
Cascade impaction involves quantitative recovery and chemical analysis (typically by HPLC) of the size fractionated aerosol from an inhaled product to generate a drug specific APSD. The technique generates substantial quantities of data. Inhalytix is the successor to Copley’s highly regarded CITDAS software, built from the ground-up, drawing on the company’s established expertise in this area. It uses the same core calculation protocols but offers significantly enhanced functionality allowing customers to configure:
- Reports – choosing which metrics to include to ensure the consistent and informative delivery of results, to meet regulatory requirements.
- Equipment – selecting from a library of test equipment to handle standard and complex equipment configurations.
- Methods – to combine detailed product information with reporting and equipment configurations, and to define metrics such as stage groupings and fine particle dose.
Interactive routine analysis, with a defined method, proceeds via a simple three-step process: Prepare, Execute and Analyse. Data can be entered manually or imported and comparison tools simplify assessment of the results, especially when comparing test and reference products in the case of generics. Using the equipment database users can link mensuration data, which quantifies changes in the critical dimensions of an in-use impactor, to specific, serialised impactors. This capability enhances data traceability and makes it possible to use actual rather than nominal dimensions to calculate APSDs, with greater accuracy.
Inhalytix incorporates new metrics such as Impactor Sized Mass (ISM), Large Particle Mass (LPM), Small Particle Mass (SPM) and LPM/SPM ratio, amongst others and handles a broad array of impactors and components, including abbreviated impactors such as the Fast Screening Andersen (FSA). The software is 21 CFR Part 11 compliant with user access management and audit trails, and is also fully validated with a unique, built-in, auto-validation capability.
Available in various expandable, multi-user licence configurations, Inhalytix can be either server, cloud or individual computer-based, enabling access in and away from the lab.