Figure 1 Comparative dissolution profile of A, to A,
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SSG: Sodium starch glycollate, CP: Crospovidone Table 2: Coded values for X1 and X2 SSG: Sodium starch glycollate, CP: Crospovidone Table 3: Formulation using 3? full factorial designs Table 1: 3? Full factorial design layout Table 6: Dissolution data of formulation A1 to A9% drug release in 900 ml 6.8 phosphate buffer 50 rpm, 37°C+0.1°C, USP Type II *Whether long-term stability studies are performed at 25 °C + 2 °C/60% RH + 5% RH or 30 °C + 2 °C/65% RH + 5% RH or 30 °C + 2 °C/75% RH + 5% RH is determined by the climatic condition under which the API is intended to be stored (see Appendix 1). Testing at a more severe long-term condition can be an alternative to testing condition, i.e. 25 °C/60% RH or 30 °C/65% RH. **Tf 30 °C + 2 °C/65% RH + 5% RH or 30 °C + 2 °C/75% RH + 5% RH is the long-term condition there is no intermediate condition. Table 4: ICH guide lines for stability study *The values represent mean+standard deviation, n=5 Table 5: Optimization of prepared batches SSG: Sodium starch glycollate, CP: Crospovidone Table 7: Response data for 3? Full factorial optimization design Fig. 2: Comparative dissolution profile of A, to A9 Fig. 4: Diagrammatic representation of (a) contour plot and (b) 3D view of effect of A and B on friability Fig. 3: Diagrammatic representation of (a) contour plot and (b) 3D view of effect of A and B on disintegration time The response DT and friability were evaluated and found within limits. The values of response predicted from the model analysis shown in Table 10. The close resemblance between the observed and the predicted response value assessed the robustness of prediction. These values indicate the validity of the generated model. Fig. 6: Comparisons of release profile of stability batch at accelerated stability study Developed ODT gave satisfactory results for various physicochemical evaluations such as hardness, friability, weight variation, drug content, and in vitro DT and in vitro dissolution profiles. DT and % friability of ODT depends on the concentration of superdisintegrants. The DT and % friability of all the formulation varied from 8141.37 to 1840.92 s and 0.87+1.95 to 0.70+1.43. Combination of superdisintegrants is used to derive the satisfactory result. The concentration of superdisintegrants was optimized using 3? full factorial design with the help of design expert 8.0.7.1 version software, in that two independent factors were a concentration of CP (2-4%) and concentration of SSG (4—6%). Three different levels were coded as (-1, 0, +1). From the polynomial equation and contour plots, the best-optimized batch found. Checkpoint batch was prepared for model validation. The close resemblance between the observed and the predicted response value assessed the robustness of prediction. These values indicate the validity of the generated model. SD: Standard deviation Table 8: Regression output of R1 for 3? full factorial design SD: Standard deviation SSG: Sodium starch glycollate, CP: Crospovidone Table 9: Formulation of checkpoint batch - C Table 11: Stability study evaluation data Table 10: Validation of mathematical model
