32 Full factorial design

The purpose of this study is to prepare Mouth dissolving tablets of Cinnarizine HCl and Domperidone Maleate by Direct compression method. In the present research study, Crosspovidone (CP) and Sodium Starch Glycolate (SSG) was taken as super disintegrant. Here the Cinnarizine HCl (H1 anti-histaminics) and Domperidone (anti-emetic) is taken as the model drug for the study and direct compression as a method for preparation of the Mouth Dissolving Tablet. These combination of drugs are ideal for the prevention of symptoms caused by vestibular disorders and vertigo/motion sickness, nausea, dizziness, headache, vomiting, sensation of fullness when there is a delay in gastric emptying. A 32 full factorial design was applied to investigate the combine effect of two formulation variable CP(X1) and SSG(X2). Here the concentration of both Superdisintegrants was taken as independent variable, X1 and X2 respectively. I.R. and DSC study revealed that all polymers and excipients used were compatible with the drugs. All the pre and post-compression evaluation parameters shows good results and all batches are within acceptable limits. Mouths feel test gives pleasant sensation on human subjects when tablets are put it on tongue. The effect of Disintegration time (Y1) and % Drug release (Y2) were investigated as dependent parameters. From optimization data results that, among all the formulation F6 Batch was best formulation. The optimized batch obtained from the factorial design was compared with the marketed products. The stability study of the optimized batch is also done at 40ºC and 75%RH.