![]() ![]() Therefore, the die filling stage and factors affecting tablet weight variability (TWV) should be well understood to produce tablets that are acceptable for the market. Among these stages in the tableting process, die filling is a critical step because inconsistencies during it lead directly to variations in tablet weight, which then result in cracking, distortion, discrepancies in tablet thickness and tensile strength, and variability in the overall drug content of individual tablets. ![]() The process generally consists of three simple stages: die filling with powder, compaction of filled powder, and ejection of compacted power however, the powder dynamics during the tableting process have not yet been fully understood. Although tableting is a continuous process in the conventional batch process, areas to be elucidated still exist. Some researchers and companies have been trying to modify the conventional batch process to resemble a continuous process, which is significant in the wet granulation process, ,, ]. Research regarding the manufacturing of tablets has been in progress for many years, and continuous manufacturing has recently been attracting attention. Tablets are the most common solid dosage forms for oral delivery of therapeutic substances and are currently produced almost exclusively with high-speed rotary tablet presses, which are able to produce more than a million tablets per hour under optimal process conditions. The applied approach is useful for constructing a simple model to better understand the phenomenon (die filling in this case), and the constructed model can be expanded further by including blends manufactured by dry or wet granulation. The constructed model also predicted TWV well in the validation dataset. Bulk flow properties were evaluated, and a good prediction model was obtained by selecting five out of 14 bulk flow properties. To obtain blends with a wide range of properties, 27 powder blends were prepared by changing the active pharmaceutical ingredients (APIs), API loading in the formulation, and the grade of the lubricant. In this study, least absolute shrinkage and selection operator regression, a type of sparse modeling, was applied to select the critical flow properties from various ones, and TWV was predicted. With the progress in powder flow characterization, a wide variety of bulk flow properties can be obtained, and several studies have been conducted to predict tablet weight variability (TWV) from bulk flow properties by applying multivariate analysis however, there is still room for improvement in the selection of properties for predictive model construction. Die filling is a critical step in the pharmaceutical tableting process as it determines the uniformity in tablet weight, which affects the drug content uniformity and appearance of tablets. ![]()
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