DISSOLUTION TECHNOLOGIES, cilt.2, sa.1, ss.1, 2023 (SCI-Expanded)
The objective of the current study was to develop orally disintegrating tablet (ODT)
formulations containing Melatonin drug. Mannitol in different particle sizes were also
used to study its effect on dissolution and tablet properties within the framework of
quality by design (QbD) approach and obtain the optimum formula. First, the quality
target product profile (QTPP) was identified, and critical quality attributes (CQAs) were
determined. Risk assessment was performed using the Failure Mode Effect Analysis
Method (FMEA) to define critical material attributes (CMAs) and critical process
parameters (CPPs). 34 formulations were prepared and tested within the framework of
quality by design. Box-Behnken design (BBD) with Response Surface Methodology
(RSM) was applied to assess the effect of independent factors on CQAs of ODTs.
Finally, the most suitable formulation in terms of tablet properties were determined with
Minitab™. Specification tests were applied to the optimum formula and it was checked
whether it met the required specifications. Based on the results, mannitol with a small
particle size provided a low disintegration time and a high dissolution rate. Therefore,
excipient selection according to the desires determined in QTPP is critical, even
between the same excipient types.