Rapid Development of Robust, Large Dose, Direct Compression ODTs
Jan. 1, 2018, midnight
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The objective of this study is to provide insights into formulating resilient orally disintegrating tablets (ODTs) using Pharmaburst® 500, a widely employed ODT excipient platform from SPI Pharma. The focus is on comprehending the compressibility, compactability, and tabletability of formulations containing pediatric doses of taste-masked paracetamol (Actimask® 92M). The inclusion of such active doses results in tablet sizes approaching or surpassing the 500mg level outlined in the FDA Guideline, posing a common formulation challenge for this product type. The study examines the relationship between Disintegration Time (DT) and tablet robustness, assessed through Tensile Strength (TS) and Friability, especially when dealing with higher doses of a poorly compactible API like taste-masked paracetamol. The aim is to discern the impact of the excipient system alone on these parameters. Additionally, the porosity of the tablets is compared to values reported in other studies.