Development of a hybrid process analytical technol.. (PARTICLE-PRO)
Development of a hybrid process analytical technology to characterise the physical and chemical properties of particles
Start date: Dec 1, 2012,
End date: Nov 30, 2014
Particles and granules play a key role in process efficacy and final product quality for numerous industries including pharmaceuticals, food, nutritionals and cosmetics. Particle physics governs process variables such as flow, blending, granulation, compression and coating. These variables can have a significant effect on final product behaviour such as blend homogeneity, drug absorption rates, product robustness, etc. The identified key physical parameters include particle/granule size and shape. Similarly the chemistry variation within the products has a critical effect on product quality. The current method of determining the end-point of pharmaceutical processes such as granulation is a combination of off-line or in-line analysis of size and shape characteristics and of moisture content and end product analysis of active content uniformity. The size and shape characteristics are important as they can significantly impact on compression processes. The moisture content is important as it can impact on compression processes and product stability (negatively leading to hydration of the active ingredient). The active content uniformity is important to ensure that each patient receives the correct dosage quantity. The development of one hybrid technology that is capable of assessing these three characteristics in real time will significantly advance pharmaceutical manufacturing control and assure greater product control and patient safety.This project aims to develop a technology that is a hybrid of imaging-based physical characterization and NIR-Chemical Imaging technologies that will provide physical and chemical granule characterisation in-line in a manufacturing process. The benefits for the pharmaceutical sector are increased granulation process control, increased process quality, increased batch yields, reduced downtime, reduced investigations due to deviation investigations, reduced risk of non-supply of products, greater assurance for regulatory bodies.
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