| Summary: | Direct compression is the most efficient formulation process for tablet dosage form. Excipient for direct compression can be made by co-processing with spray drying method. The aim of the study is to investigate the effect of spray dryed co-processing to the physical properties of mixture microcrystalline cellulose PH 102 and Povidone® K 30 with simplex lattice design as well as to determine the optimum proportions. Furthermore, this co-processed excipient was used as additive in the manufacture of paracetamol tablets.
The research was carried out by spray drying process to microcrystalline cellulose PH 102 and Povidone® K 30 at various proportions of mixture using simplex lattice design model. The optimum proportion was determined by examining flow and compactibility properties which expressed as compressibility index (CI) and hardness. The optimum co-processed excipient was used as direct compression excipient of 500 mg paracetamol tablet
The test results showed that the flow properties was fluctuated while the compactibility increased in the addition of Povidone® K 30 proportion. Optimum proportion was achieved in 71% microcrystalline cellulose PH 102 and 29% Povidone® K 30 with theoretical predictions of CI and hardness were 20.77% and 8.20 kg respectively. The test result verified that the real co-processed excipient were 16.22 ± 0.39% for CI and 7.61 ± 0.12 kg for hardness, differ significantly for both parameter from the theoretical prediction (p < 0,05). The optimum co-processed excipient produced paracetamol tablets which fulfill all of the test parameters including hardness, friability, disintegration time, and dissolution.
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