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Drug products in the pharmaceutical industry are commonly prepared in the form of discrete multi-particulate units. Bead products are a vehicle used in the development of controlled release drugs and are prepared by coating an inert spherical core with multiple layers, including that of the active ingredient. Components in each applied layer can have a significant impact on how the drug will be released and porosity of the layers is a critical feature related to observed dissolution behaviour. However accurate and highly resolved measurement of the physical integrity of these layers is a significant challenge in the development of advanced multi-particulate dosage forms.
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The Problem
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Osteoporosis is a bone disease that affects 200 million people worldwide and contributes to 8.9 million fractures annually. The condition causes a loss of bone mass and structure which in turn leads to bones becoming weak and breaking, usually during a trip or fall. The disease is prevalent in people over 55, and in particular women, due to the loss of oestrogen hormone during the menopause. Osteoporosis is becoming increasingly prevalent in men who receive cancer therapies which supress testosterone levels. Bisphosphonates are a family of medicines which are commonly prescribed to treat osteoporosis. The most common types are alendronate and zoledronate which aim to strengthen osteoporotic bones by slowing down the activity of bone cells.
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The Problem
Malaria is one of the most prevalent parasitic diseases of humans and affects 216 million people worldwide. Many years of research have been dedicated to finding the most effective and affordable drugs to prevent infection, which have to date been very successful. Most recently the challenge has been the growth in resistance to existing treatments, which has driven further research into a new generation of anti-malarial drugs.
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The Problem
Medicinal products extracted from biological sources, called biopharmaceuticals or biologics, must be carefully produced to ensure that only high purity active material is generated. Biopharmaceutical manufacturing processes can have an impact on the amount of product-related variants in the final clinical material. Understanding and controlling amounts of these product-related variants is a major challenge in the development of biopharmaceutical products.
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The Problem
Drug products are manufactured to an extremely high standard to maintain product safety when taken by patients. Specifications used throughout the manufacturing process cover not only the drug itself, but also the level of potential impurities (chemical, solvent, or polymorph), which are set to limits that are monitored by regulatory bodies to uphold safety and product quality requirements. X-ray powder diffraction is a key analytical technique in the pharmaceutical industry for characterising drug compounds. This is used for throughout the development process to fingerprint compounds and quantify impurities.
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The Problem
Along with many pharmaceutical materials, sodium diclofenac, a commonly used painkiller, can crystallise in many different forms depending on the manufacturing and formulation conditions. Each crystalline form may have very different biological and physical properties including bioavailability, drug delivery mechanism and shelf-life. Full characterisation and optimisation of solid forms of an API is therefore critical.
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