Get your small molecule drug to market faster
Whether developing innovative new drug products or racing to be the first-to-file a complex generic product, the time, cost and risk associated with pharmaceutical drug product development is significant. Malvern Panalytical provides the physicochemical analysis tools and expertise to help mitigate these challenges, helping our customers speed products through the development workflow by supporting critical assessments of drug product attributes and behaviour.
Our technologies confirm the identity, activity, molecular conformation, morphological properties, solid form and stability of Active Pharmaceutical Ingredients (APIs) and excipients. We can then generate understanding of how these impact on and interact within a drug product formulation by characterizing formulation properties such as dispersion stability and rheology, providing insights into the behavior of specific components within a formulation during manufacturing and storage. Our solutions scale with the changing requirements of different stages in the development pipeline, ensuring workflow efficiencies are achieved throughout development and manufacture.
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Use our knowledge and technology to speed the discovery, development and manufacture of your drug product.
Determine component-specific particle size, shape, and chemical identity
Morphologically-Directed Raman Spectroscopy (MDRS®) provides particle size and shape analysis along with chemical identification to independently characterize components in a given formulation. This is useful for both innovator and generic drug products and finds a particular niche in deformulation studies, where MDRS is increasingly used to help establish Q3 bioequivalence in vitro. Morphologi products are also often used to check sample homogeneity and microstructure, and for root cause analysis studies for both product and process.
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XRPD for phase identification and purity analysis
X-ray powder diffraction (XRPD) is an important tool for distinguishing different crystalline forms to explore toxicity, efficacy and stability for solid-dose drugs. Detect the presence of very small amounts of crystalline or amorphous material. Assess stability during lyophilization, processing & storage.
Measure particle size and particle size distribution using laser diffraction
Laser diffraction is the industry ‘gold standard’ for determining particle size and particle size distribution in pharmaceutical formulations: from APIs to excipients, from oral solid dose analysis to droplet size. Whether liquid dispersions or dry powders, in the lab or on the processing line, we’ve got you covered. Adaptable for QA and continuous PAT monitoring.
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Characterize your sample’s particle size and stability, for safer, more effective drugs
The correct particle size and zeta potential can help ensure the production of effective therapeutics, delivered safely. Zetasizer systems are used to characterize the stability and quality of dispersions, emulsions and creams, reducing formulation time and speeding new products to market. Dynamic light scattering (DLS) and electrophoretic light scattering (ELS) allow fast determination of particle and molecular size, particle charge and particle concentration, in solutions and suspensions. Multi-Angle Dynamic Light Scattering (MADLS®) provides the highest resolution angle-independent size measurements, meaning no more worry about missing particles in your sample.
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XRF to detect and identify impurities and residual catalysts
X-ray fluorescence (XRF) allows the accurate testing of raw materials and final products while also detecting the presence of residual catalysts in the active pharmaceutical ingredient (API) and excipients. Helps to ensure compliance with USP<232> elemental impurities requirement.
Understand rheological properties
Rotational rheometers measure the rheological properties of topical formulations to ensure product quality and performance. They are also used for viscoelastic analysis of liquids and semi-solid formulations.
Analyze content, structure and purity
Chromatography systems and advanced detectors enable you to accurately determine formulation content and determine the molecular weight distributions of excipients, binders, and APIs.
MicroCal PEAQ-ITC for hit validation
Isothermal titration calorimetry (ITC) is widely used as a label-free analytical technique during drug discovery for assessing binding affinity. Measure thermodynamic binding parameters for interactions between small molecules and target.