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Abishek Kathuria is technical manager at Evonik Pharma Polymers.
There are various theories about how to scale up a solid dosage coating operation in a pan coater. This article provides a basic process understanding and scale-up theory based on first principles.
The coating process indicated in Figure 1 is an operation that comprises multiple, simultaneous ongoing exchange processes. These processes include:
Figure 1: Pan-coating process.
However, there are certain losses, such as heat loss to the metal body and the environment, that cannot be characterised easily. An approximate mass and energy balance for the operation can be calculated as below.
Equilibrium state at coating process
As with any theoretical analysis, there are assumptions built into the model described above. For example:
These steps can be used to measure process efficiency and efficiency of the inlet air heat capacity. These actions are beneficial because the process scientist may realise that only a small fraction of heat–mass uptake capacity is being utilised. It may or may not be possible to change this. As long as the total process reconciliation is acceptable (e.g., within 2%), the process efficiency can be calculated as a ratio of tablet weight gain to the weight of solids sprayed. As the process is scaled up, the increased bed depth will generally improve coating efficiency, thus providing better opportunity for process air to exchange heat with the tablets.
Similarly, spray gun positioning, relative to the bed and to the inlet air plenum, will affect the drying process of spray droplets. In general, the greatest impact depends upon the distance of the spray gun from the bed, atomisation/fan air pressures and nozzle type/diameter.
Various articles on scale-up principles have been published (1–3). The following are basic scale-up principles that can be applied easily in practice:
The general principles described above underpin the tablet coating process and can support successful scale-up.
Abhishek Kathuria is technical manager at Evonik Pharma Polymers.
1. R. Turton and X.X. Cheng, Powder Technology, 150, 78–85 (2005).
2. S.C. Porter, "Scale-up of film coating", Pharmaceutical Process Scale-Up, M. Levin, Ed., (Marcel Dekker Inc, New York, USA, 2000), pp. 259–310.
3. G.B. Tatterson, Scaleup and Design of Industrial Mixing Processes (McGraw Hill, New York, USA, 1994.