Malvern, UK, 14th February, 2018: The new Morphologi® range of automated static imaging systems for particle characterization from Malvern Panalytical—Morphologi 4 and Morphologi 4-ID—has been unveiled. Building on the success of their predecessors, the Morphologi G3 and Morphologi G3-ID, the new systems offer the pharmaceutical industry uniquely powerful tools for the rapid, automated component-specific measurement of particle size, shape and chemical identification. These instruments, winners of a 2018 iF design award, set new standards in measurement speed, image definition, and the range of material types that can be successfully analyzed.
Offering sharper and faster particle size and shape measurements, the Morphologi 4 adds value during chemical development and troubleshooting by generating a morphological profile that can be used to control the particle form to optimize yield, bioavailability, and processability. For QC in manufacturing, it is used to monitor critical process and material attributes, ensuring batch consistency, continual output, and identification of process deviation causes. The Morphologi 4-ID transforms the efficiency of deformulation and formulation development by delivering component-specific chemical identification of particles in the reference formulation. This can assist with establishing Q3 bioequivalence in vitro, and reduce the need for clinical endpoint studies.
The Morphologi 4 is a fully automated system for characterizing particles ranging in size from less than one micron up to a millimeter and beyond. Compared to its predecessor, it offers quicker measurement—a time saving of around 25 percent—while delivering simpler, more intuitive method development, and greater particle definition. A key feature is Sharp Edge, a new automated segmentation / thresholding algorithm that makes it easier to detect and define particles. Measurement sensitivity is further boosted by the 18 MP camera and by enclosure of the sample during imaging. These advances make it possible to accurately measure light-sensitive and low-contrast samples, such as particles in suspension, and deliver enhanced shape parameter sensitivity for all samples, enabling the user to detect subtle differences more easily.
The Morphologi 4-ID delivers Morphologically-Directed Raman Spectroscopy (MDRS®), integrating the static imaging capabilities of the Morphologi 4 with Raman spectroscopy in a single instrument, to enable the component-specific chemical identification of particles in a blend. Offering significantly faster spectral acquisition times than the previous model—a time reduction of up to 80 percent—it also allows acquisition conditions to be customized to a specific sample. This enhanced control, in combination with an extended spectral range, maximizes the range of materials that can be identified and/or differentiated within a blend. The instrument is fully automated and is designed to allow both particle characterization scientists with limited spectroscopy experience, and more experienced spectroscopists to gain in-depth understanding of their particulate samples.
Applications where the new Morphologi instruments add particular value are: characterization of the Reference Listed Drug (RLD) during deformulation in generic pharmaceutical development; determination of the morphological profile of the Active Pharmaceutical Ingredient (API) during chemical development; chemical identification and morphological characterization of formulation components during formulation development; batch-to-batch comparability; the identification of foreign particles and troubleshooting during manufacturing.
Deborah Huck-Jones, product manager for analytical imaging at Malvern Panalytical comments: “These latest additions to Malvern Panalytical’s range of advanced analytical characterization technologies deliver greater detail in faster measurement times than ever before. Their applications in both innovator and generic pharmaceutical development and manufacture support the critical goal of speed to market. A particular benefit of MDRS to generics formulators is its ability to help demonstrate Q3 bioequivalence by ensuring the required physicochemical attributes of particles in the test formulation match those of the reference formulation, thus reducing or eliminating the need for extended in vivo studies.”