Process Development, Evaluation and Controlling of Parameters during Formulation Development of Granisetron HCl as an ODT by QBD Concept

Author(s)

Adepu, A.R., Bhogale, V.

Author's Affiliation

Abstract

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.

Keywords

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.