Compressibility behavior of pioglitazone hydrochloride in mannitol-based formulations: An investigation using compaction simulator and QbD approach.

This study aimed to investigate the compressibility properties of Pioglitazone Hydrochloride (PGZ) oral dispersible tablets using a compaction simulator. The tablets were prepared and formulated by direct compression method with varying particle sizes of PGZ in mannitol-based formulations, containing Ludiflash® and its corresponding physical mixture. All formulations were compressed at different compaction forces (5kN-20kN). Powders were evaluated for their tablet properties, such as hardness, friability, disintegration time and dissolution rate. Results showed that all formulations exhibited good compressibility properties. The compaction force and choice of excipient played a vital role in formulation performance and drug release profile. With the use of Minitab 19 an optimized formulation was derived and all predicted outputs was seen to be within range after evaluations. In conclusion, the combined use of the compaction simulator and Minitab 19 were found to be useful tools in predicting the compressibility properties of PGZ and therefore developing a robust oral dispersible tablet. These findings suggest that the compressibility properties of PGZ oral dispersible tablets can be effectively modified by adjusting the critical process parameters (CPP). Hence, providing valuable insights into the compressibility behavior of PGZ oral dispersible tablets and also aiding in the development of optimized tablet formulations.