In vitro characterization and mouthfeel study of functionalized calcium carbonate in orally disintegrating tablets

Orally disintegrating tablets (ODT) are comfortable and safe drug delivery methods beneficial for all age groups of patients. ODTs are characterized by fast disintegration, high physical stability, taste masking and acceptable mouthfeel. In this work, the applicability of Functionalized Calcium Carbonate (FCC) to formulate ODTs with enhanced mouthfeel was elaborated and tested for acceptability on twenty healthy volunteers, using a 10-step visual analog scale Mechanical characteristics of the ODTs were examined using Heckel analysis, modified Heckel analysis and Leuenberger equation. Disintegration time was measured with the tensiometer method and analyzed for disintegration kinetics with a system of ODE. As a result, it was shown that the tablet was well accepted in healthy volunteers, disintegrated fast in vivo and correlates well with the mathematical model. Additionally, the compactibility and the physical stability were preserved yielding high porosity to absorb liquid necessary for disintegration. In vitro disintegration time was successfully linked to in vivo disintegration time. These findings lead to the conclusion that FCC is applicable to use in ODT dosage forms and mouthfeel was successfully enhanced to a pleasant result without losing the unique characteristics of FCC.

157