Melbourn Scientific Applies Morphologi G3 to Pre-Formulation
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As part of an extension to its product development capabilities, Melbourn Scientific has become the first contract research organization in Europe to invest in the Morphologi G3, an automated image analysis system for particle characterization and foreign particulate contamination.
Derek Solomon, Laboratory Manager at Melbourn Scientific, a provider of contract analytical, formulation and drug development services, comments that particle morphology can impact the performance of the final product.
He said, “Subtle differences in particle size or shape can have significant effects on product performance including bioavailability, flowability, product stability, blending and tabletting efficiency. Even within well-controlled API production, additional processing steps such as crystallization, drying, milling, blending, filtering can all introduce variability into the product and have to be precisely controlled.”
“Therefore characterization of particle morphology is becoming increasingly important as companies seek detailed knowledge of particle behavior during processing. Morphologi G3 offers extra sensitivity and resolution than is available in traditional techniques and offers our clients the potential to identify, measure and monitor those process variables that are critical to product quality,” Solomon continued.
“We anticipate this new equipment will provide greater consistency in the descriptions and allow clients to better correlate morphology data against processing parameters such as flowability, active area or grinding efficiency.”
“By applying Quality By Design principles, companies can then control performance of particulate materials from development through to production,” he said.
Derek Solomon, Laboratory Manager at Melbourn Scientific, a provider of contract analytical, formulation and drug development services, comments that particle morphology can impact the performance of the final product.
He said, “Subtle differences in particle size or shape can have significant effects on product performance including bioavailability, flowability, product stability, blending and tabletting efficiency. Even within well-controlled API production, additional processing steps such as crystallization, drying, milling, blending, filtering can all introduce variability into the product and have to be precisely controlled.”
“Therefore characterization of particle morphology is becoming increasingly important as companies seek detailed knowledge of particle behavior during processing. Morphologi G3 offers extra sensitivity and resolution than is available in traditional techniques and offers our clients the potential to identify, measure and monitor those process variables that are critical to product quality,” Solomon continued.
“We anticipate this new equipment will provide greater consistency in the descriptions and allow clients to better correlate morphology data against processing parameters such as flowability, active area or grinding efficiency.”
“By applying Quality By Design principles, companies can then control performance of particulate materials from development through to production,” he said.
