Due to aging population and increasing incidence of diseases, the pharmaceutical industry is forced to adapt and develop new products. Pharmaceutical market is dominated by oral drugs in the form of tablets and film-coated tablets. The film coating can be applied to the tablet core for a visual effect or functionality, such as e.g. easier swallowing, protection against oxygen, moisture, delayed release, etc..
Within the research we focused on products that have functional coating - an active ingredient for lowering cholesterol (active ingredient X-statin) with protection against oxygen and an active ingredient for reducing the amount of acid produced in the stomach (proton pump inhibitor or active ingredient Y-prazole) with gastroresistant coating. Defects of this type are classified as critical. Batches with damaged film coated tablets (FCT) were evaluated whereas defects were researched on how to eliminate them in later produced batches. For all batches, as an initial measure, we carried out a 100% automatic visual inspection, where it was not possible to completely remove all FCTs with a defect.
In case of active substance X, we found out that damaged edge of the core results as a defect in the film, as the coating suspension does not adhere to the damaged part. Due to its size, the core itself is exposed to greater mechanical forces during ejection from the matrix with the ejection tread, and during the coating itself. Worn tableting tool also contributed to occurrence of damaged core edges. With ordering a new tableting tool, changing its design, optimizing the recipe for tableting and coating, we managed to significantly reduce the incidence of damaged cores. FCT visual defects that we could not completely remove from batches were evaluated by performing accelerated stability, inspection of the packaging process, transverse and frontal SEM imaging, and tests of water sorption and ethanol passage through the coating. According to all the obtained results, we assessed that the coating damage is deep but does not affect the functionality of product with active ingredient X. The defect was classified as minor.
During investigation of defect of product with active ingredient Y, we found out that during the application of the first sub-coating, the tablets stick to each other due to an inadequate coating recipe. By changing the coating parameters, we managed to increase the dryness of the process and thereby eliminate the occurrence of inadequate FCTs. We performed a gastroresistance test and a stress test ("open dish") on batches where damaged FCTs could not be eliminated. Based on the obtained results, we found out that the coating defect has an impact on the coatings functionality, but it is not critical. The error was classified as major.
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