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

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The objective of this investigation was to assess the compressibility properties of Pioglitazone Hydrochloride (PGZ) oral dispersible tablets utilizing a compaction simulator. Tablets were prepared via the direct compression method, incorporating varying particle sizes of PGZ in mannitol-based formulations that included Ludiflash® and its corresponding physical mixture. The formulations underwent compression at different compaction forces (5kN-20kN). Powder characteristics, such as hardness, friability, disintegration time, and dissolution rate, were evaluated. The results demonstrated favorable compressibility properties across all formulations. The compaction force and the choice of excipient significantly influenced formulation performance and drug release profiles. Utilizing Minitab 19™, an optimized formulation was determined, with all predicted outcomes falling within the expected range upon evaluations. In conclusion, the combined use of the compaction simulator and Minitab 19™ proved valuable in predicting the compressibility properties of PGZ and establishing a robust oral dispersible tablet. These findings suggest that adjusting critical process parameters (CPP) can effectively modify the compressibility properties of PGZ oral dispersible tablets. This insight not only contributes to understanding the compressibility behavior of PGZ oral dispersible tablets but also aids in the development of optimized tablet formulations.
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