Presenting Inhalytix™: Solution for analysing and managing inhaler test data from Copley
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- Source: Copley
- Date: 22 Mar,2021
Inhalytix™ is a completely new software solution from Copley, the global leader in inhaler testing equipment, that brings a standardized 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 the 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 the 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.
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