Effect of the Microstructure of Paracetamol Granules on Tablet Properties
Chemical Product Design and Engineering (CPD&E)
Chemical Product Design & Engineering - II (CPD&E - 2)
Keywords: Microstructure, Paracetamol, Granule, Product Design
Paracetamol Tablets are based on Paracetamol granules mixed with excipients. Typically these granules contain 90-96% Paracetamol and a binder, e.g. starch. The production process of these granules effects on the final tablet properties too. Most common is the granulation of Paracetamol in a fluidized bed. An alternative is a production process in a high-shear mixer. Research on the compressibility, the microstructure and the distribution of the binder was done using granules out of these production processes.
The microstructure of a granule produced in a high shear process shows a much more dense packing and a more homogeneous distribution of the binder (starch). The difference of the microstructure is confirmed by X-ray micro-tomography of fluidized bed and high-shear mixing granules. To distinguish between starch and Paracetamol the iodine-starch reaction was applied on the polished surface of embedded granules. Due to an image analysis the size and density distribution of the starch particles within the granules can be determined.
The effect of the granule structure on tablet strength was investigated using granules produced in a fluidized bed and in a high-shear mixing process. Plotting the strength of the tablets versus the compression force shows a significant higher strength of the tablets for granules produced in a high-shear process.
As a result it can be stated that the production process of Paracetamol granules effects on the resulting microstructure and the final properties of the tablets. Whether these findings can be transferred to other pharmaceutical products is subject to further research.
Presented Wednesday 19, 16:00 to 16:20, in session Chemical Product Design & Engineering - II (CPD&E - 2).
