Adepu, A.R., Bhogale, V.
The present investigation was focused on application of QbD approach to seethe effect of formulation variables on oraldisintegratingtablets containing antiemetic drug, Granisetron HCl. Risk assessment of critical material and process parameters are linked to criticalquality attributes (CQAs) of the product with respect to obtain target quality product profile (TQPP). Preliminary screening was done to characterize the effects of microcrystalline cellulose, crospovidone, croscarmellose sodium and magnesium stearate on drug release. The effects of critical parameters (concentration of two superdisintegrants crospovidone and croscarmellose sodium) were investigated by executing design of experimentation (DoE) using 3 level full factorial designs. A. The aim of this research work was to prepare orally disintegrate tablets of a model drug, Granisetron HCl by direct compression method that releasing not less than 99% of drug than that of commercial reference sample with respect to time. The prepared tablets were evaluated for their physicochemical properties and in vitro release. The relationship between the independent and dependent variables was found with linear prediction equation. The response and equation data was used to draw the contour plot, 3- Dplot, ANOVA design space.
Orally disintegrating tablets, Granisetron HCl, Superdisintegrants, 3 level full factorial design, Design space, Quality by design
Cite This Article
Adepu, A.R., Bhogale, V. (2016). Process Development, Evaluation and Controlling of Parameters during Formulation Development of Granisetron HCl as an ODT by QBD Concept, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(2), 189-201.