Application of Quality by Design Principles to Study the Effect of Coprocessed Materials in the Preparation of Mirtazapine Orodispersible Tablets.

Manal Kamal Darwish

Abstract


The aim of this study was to determine the effect of two coprocessed materials in presence and absence of superdisintegrant (kyron T314) in the preparation of mirtazapine orodispersible tablets. Mirtazapine solubility was increased by complexation with kleptose forming an inclusion complex in a ratio 1:1. Quality by Design (QbD) was incorporated to determine the material attributes and the critical quality attributes (CQAs). Box behnken design was applied to study the effect of three independent variables X1: amount of lufiflash, X2: amount of pearlitol flash and X3: % of kyron T314 on two responses, Y1: dissolution after 1 minute and Y2: disintegration time. All formulated ODTs showed disintegration time less than 35 seconds and all formulations showed a notable increase in dissolution rate. Design space was determined from the overlay plot of different variables, X1 and X2 and X3 at two levels of the superdisintegrant. The one with maximum predicted dissolution rate and minimum predicted disintegration time was a formulation containing ludiflash (X1)= 9.25 mg, pearlitol flash (X2= 50 mg) and kyron T314= 3%. This formulation (Test ODT) was prepared and was subjected to in vivo study. Mirtazapine in human plasma was determined by LC-MS/MS and different pharmacokinetic parameters was determined for both test ODT and conventional oral tablet (Remeron). The pharmacokinetic parameters indicated that the two formulations are bioequivalence.


Keywords


mirtazapine; Box-Behnken; ludiflash; pearlitol flash; kleptose HPB

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