Due to an ageing population and co-morbidity the pharmaceutical industry needs to constantly adapt and develop new pharmaceutical products, including fixed-dose combination products. Most of the oral medications are in a form of a tablet, with film-coated tablets being the most common ones. During the tablet film coating we apply a thin polymer coat to the tablet core, which can have an impact on the functionality of the final product, or it can be applied for aesthetic reason. Either way, we must ensure an even application of the coating due to the quality assurance, as the even appearance of coated tablets is one of the important attributes of the quality of film-coated tablets. If there is an active ingredient included in the tablet coating, the requirement of uniformity of dosage units must also be met for the active substance in the coating. From this point of view, it is important to use an optimized tablet core coating process. To avoid possible mistakes when producing batches of film-coated tablets and nonachievement of the required batch quality, we need to carefully study the properties of the tablet coating process. Improper planning of the film coating process can result in high variability in the amount of coating between tablets of the final product. In order to avoid high variability of coating amount, it is necessary to evaluate the efficiency of the coating process, determine critical process parameters, and understand their impact on the quality of the coated tablet.
The purpose of the master's thesis is to evaluate the effectiveness of the pilot scale tablet pan coater in terms of uniformity of the amount of coating between tablets. Based on tactically selected values of process variables of the coating process and rigorous evaluation of the uniformity of tablet content, we set up predictive models of the dependence of the amount of coating RSD on the critical variable of the coating process, i.e. of the total number of drum revolutions. It turned out that the evaluated pilot version of the tablet coater is effective in achieving the desired degree of uniformity of content or the amount of coating between the tablets. With the help of the set model for individual drum filling, we can predict what can be expected realistically in terms of the best results of uniformity of the coating under selected coating conditions, also taking into account the formulation design and limitations of process equipment, e.g. the minimum and maximum dispersion flow that can supply the spray nozzle. By performing the experimental work, we demonstrated the applicability of the experimental predictive models of the coating amount variability in evaluating the performance of the pilot scale tablet coater.
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