Tablets are the most common dosage form for treatment in medicine. The aim of pharmaceutical industry is to simplify production and thus lower production prices by using direct tableting. To achieve this, the tablet mixture must have the appropriate properties: good flowability and compressibility. These properties are significantly influenced by the properties of the excipients used. Excipients can be pre-treated, e.g. by co-processing, thereby improving the physical properties important for tableting.
The purpose of the master's thesis was the preparation of a new co-processed excipient and its evaluation. We used two different co-processing methods: high shear granulation and roller compaction. The prepared materials were evaluated for flow properties, particle size distribution, morphology, compressibility and compactability. Based on these properties, the prepared materials were compared with the physical mixture Harke Plus Tab Prime and two reference co-processed excipients (Granfiller D and Hisorad). Flowability was evaluated by calculating the Carr index and Hausner ratio, compressibility and compactablity by performing Heckel analysis.
By co-processing, we managed to improve the flow properties of the Harke Plus Tab Prime, but at the same time we slightly worsened compaction properties (compressibility and compactability). Samples prepared by the roller compaction method achieved the best flowability but also the worst compressibility. Their particle size distribution was very broad and bimodal. Samples prepared by the high shear granulation method had a narrow unimodal particle size distribution and good flow properties. Compaction properties of materials prepared with high shear granulation were better compared to the samples prepared by roller compaction method, but worse than the Harke Plus Tab Prime. The best physical properties were achieved by the Harke HS#20 sample, whose flowability was better compared to the Harke Plus Tab Prime, and its compressibility and compatibility were slightly worse but comparable.
We found that in our case high shear granulation is a more suitable method of co-processing than roller compaction. By co-processing, we were able to improve some physical properties, especially flow properties. However, we need to reconsider the benefit of this additional process, as we have found that the physical mixture Harke Plus Tab Prime already has very good physical properties, suitable for direct tableting.
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