Modeling of Pan Coating Processes: Prediction of Tablet Content Uniformity and Determination of Critical Process Parameters

Evaluation of critical process parameters for inter-tablet coating uniformity of active-coated GITS using Terahertz Pulsed Imaging

“…[22] described that the CV was reduced with the square root of the number of pan revolutions, which is the product of high drum rotation speeds and extended process times. [21] found that smaller tablet sizes are beneficial for coating uniformity. They confirm the results by [29] who found that the time that tablets spend in the spray zone throughout a single visit is shorter with smaller tablet size.…”

“…For the fit the squares of the distance were weighted using the reciprocal variance of the y-values of the respective data points. in the coating drum [22], a more uniform circulation time distribution [24] or a wider spray zone [21]. A contrasting effect was described by [23], who found that an underloading of the coating drum to only 67% capacity deteriorated coating uniformity.…”

“…Simulations investigating the influence of the spray pattern on the inter-tablet coating uniformity revealed that a wide spray zone is advantageous [21,22] as more tablets can receive coating at the same time. [16] showed that a low atomizing air pressure enlarges the mass variance of tablets and related this to an increase in droplet size and droplet size distribution.…”

“…They determine intertablet coating uniformity by (i) the weight variability of the coated and uncoated tablets [15,16] or the individual coating weights [17], (ii) the variability in tablet diameter or in layer thickness determined by NIR [18], and (iii) dyes or marker substances in the coating to quantify the amount of coating that is applied to the individual tablets [19,20]. Other approaches to investigate intertablet coating uniformity are based on computer simulations [21][22][23][24]. Up to now, no literature is available that has evaluated the use of TPI in the assessment of inter-tablet coating uniformity and the related CPP in pan coating processes.…”

An Overview of the Role of Mathematical Models in Implementation of Quality by Design Paradigm for Drug Development and Manufacture

“…The objective during scale-up is to keep the dimensionless numbers constant at various scales to ensure consistency of product quality at all scales. An example of a hybrid modeling approach is the model described by Chen et al [3]. This model is used for predicting active pharmaceutical ingredient content uniformity for a drug product in which the active is coated onto a core tablet.…”