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Molecular Profiles Introduces new Nanoscale Predictive Analytical Screening Solution for APIs

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Molecular Profiles announces the latest addition to its nanoscale analytical services offering, nanoPASS™ (nanoscale Predictive Analytical Screening Solution). This new service platform is a comprehensive suite of analytical techniques designed to optimize solid state selection of APIs and provide further insight into the formulation of APIs and excipients.

Processing of drug substance and excipients can have a significant effect on surface properties and subsequent stability/bioavailability of the active. To decide on the best formulation option, full understanding of bulk and surface physicochemical properties is required.

Enabling technologies allow empirical observations such as batch-to-batch variation, cohesive tendency and powder flow to be correlated to actual physicochemical properties.

The nanoPASS™ suite has been equipped with an extended range of analytical techniques, including nanoscale determination of materials, mechanical and cohesive properties, chemical spectroscopy, physical properties (XRPD and thermal techniques), high-resolution spatial mapping and imaging of chemical, physical, thermal and material properties.

The solid state characterization capabilities of the service platform enable users to compare bulk and surface properties of drug substance, excipients, granules and aggregates providing them with a detailed physicochemical profile.

The nanoPASS™ service platform requires only small amounts of sample to provide dependable material characterization. An example of the power of the analytical benefits afforded by nanoPASS™ is the pre-formulation screening of the physical properties of single formulated particles using Atomic Force Microscopy (AFM), which provides deep insight into the pharmaceutical function of developmental products.

“The introduction of this novel service platform further demonstrates our dedication to providing a high quality and reliable extension to the R&D capabilities within pharmaceutical companies,” comments Dr. Nikin Patel, CEO, Molecular Profiles. “Our team of specialized, experienced scientists will be building upon this platform to develop an extended range of service offerings intended to provide our customers with even more clarity and choice.”