Figure 3 – uploaded by Masarat Begum

See full PDF downloadDownload figure

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 — Figure 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

Related Figures (16)

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. 1: Comparative dissolution profile of A, to A,

Fig. 2: Comparative dissolution profile of A, to A9

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.

Figure 3 – uploaded by Masarat Begum

Related Figures (16)

Connect with 287M+ leading minds in your field