Quality by Design Approach for Design, Development and Optimization of Orally Disintegrating Tablets of Montelukast Sodium

Abstract

Background:The goal of this research was to use the Quality by Design (QbD) approach to develop orally disintegrating tablets of Montelukast sodium, a leukotriene receptor antagonist used to treat asthma. Characterizing the reference product, defining the quality target product profile (QTPP), identifying critical quality attributes (CQAs), and performing initial testing are all parts of the QbD approach and relating the critical material attributes (CMAs) and critical process parameter (CPP) to drug product CQAs, as a result to develop the design space and defining control strategy. Method: Montelukast sodium tablets were designed using direct compression technique. Formulation were designed by using (DOE software v 13.2) 2 3 full factorial design in which three variables namely croscarmellose sodium (CCS), microcrystalline cellulose (MCC) and magnesium stearate were varied at two levels by considering one center point. Results:The disintegration time and in vitro dissolution were considered as responses and the prepared tablets have been evaluated for various quality control tests. Formulation F5 was considered as optimized as it showed minimum disintegration time and maximum drug release profile. Conclusion:The CMAs classified as high or medium risk in the initial risk assessment were mitigated to low risk based on the experimentation. Finally, a control strategy was defined giving better control over drug product development.

Central Composite Designed Fast Dissolving Tablets for Improved Solubility of the Loaded Drug Ondansetron Hydrochloride

“…The coefficient values of the polynomial equation were found to have a negative effect on wetting time when the concentrations of both disintegrates were at their highest, and a positive coefficient effect was found when the concentrations of the super disintegrate fluctuated randomly between the highest and lowest levels [ 26 , 27 ]. Figures 6 and 7 depict the findings.…”

“…The dispersion time was shown to be affected by the quantity of crospovidone and croscarmellose in the solution [ 28 ]. The percentage drug release (percent) was found to range from 90.25 ± 0.41 to 99.25 ± 0.36 within 30 minutes, and the polynomial equation producing the positive effect on percentage drug release indicates that, as the concentration of super disintegrates increase, the percentage drug release increases [ 27 , 29 ].…”