Melbourn Scientific (Cambridge, UK) has become the first CRO in the UK to routinely use the Malvern Instruments Spraytec particle size analyzer to support the development of inhaler, nebuliser and nasal spray systems. In addition, the two companies continue their collaborative work to better understand requirements for inhaler analysis.
Mark Hammond, Business Development Director for Melbourn Scientific, is clear that the Spraytec’s unique capabilities allow the company to provide a high degree of support for clients who are developing inhaled drugs, and to extend that support to nasal delivery applications.
“The Spraytec provides us with the capability to rapidly characterise respirable drug delivery systems,” said Mark Hammond. “This will help our clients in developing a better understanding of the operation of inhaler devices, and fits well with the current emphasis on QbD [Quality by Design]. Our ability to screen formulations provides the opportunity to highlight any issues associated with formulation or device development early on in the development process, and also reduces time spent using more traditional particle sizing techniques. For nasal sprays, the system permits developers to follow the recommendations made by the FDA in their draft Bioavailability and Bioequivalence guidance to industry”.
Spraytec uses laser diffraction to measure particle size distributions. Its ability to deliver real-time, high-speed measurements at an acquisition rate of up to 10 kHz enables the drug delivery profiles from different devices to be captured in exceptional detail. For use in regulated environments, full lifecycle documentation, following GAMP guidelines, provides complete design traceability; IQ/OQ documentation is provided for validation plans; and software provides technical compliance with the requirements of 21 CFR Part 11.