A Box Behnken Design Optimized Nano Vesicular Transdermal Patch for Allergies

The particle size of the niosomes was uniform and ranged from 18.9±0.14 μm (LN-15) to 48.5±1.02μm (LN-8). The zeta potential ranged from -53.8±0.14 mV (LN-8) to -85.3±0.02 mV (LN-1). The LRD content ranged from 88.29±3.05 (LN-3) to 95.61±3.88 (LN-16), while the EE% ranged from 84.17±1.64 (LN-4) to 93.85±3.48% (LN-16). The LRD discharge was least in LN-21 (88.26±2.64%) and efficient for LN-16 (98.58±2.31) (Table 3).

Figure 2:
(a) Optimized LNP (LN-16) 3D Surface plot of % LRD discharge response at y = pH 7.4; (b). Optimized LNP (LN-16) interaction diagram.

Figure 3:
Actual and expected values as linear correlation plots and the associated residual plots for various responses.

The physicochemical assets of the prepared patches were as per Table 4 indicating good appeal, uniform thickness/weight, flexibility that were confirmed by appreciable folding endurance and tensile strength.

The FTIR spectra revealed that the characteristic peaks and stretches present in the LRD are observed undisturbed even in the spectra of the formulation indicating the compatibility of LRD with the excipients used.

Figure 4:
In vitro discharge (%) of LNP vs. control at pH 6.

Visual inspection revealed the LNP to be homogenous, clean, and transparent with no lumps, clumps, or precipitates. LN can be used in dermatological operations without irritating the skin since its pH range is comparable to that of skin.

According to BBD research, cholesterol, span-40, span-60, and span-80 concentrations significantly affect in vitro LRD discharge. The model is suggested to be significant by the model’s F-value of 15.45. An F-value this large might happen to owe to noise only 0.01% of the time. Model terms are considered significant if their p-values are less than 0.05. B, D, and AB are important model terms in this situation. Model terms are not significant if the value is higher than 0.10. Model reduction may enhance the model if there are numerous unimportant model terms (except those necessary to support hierarchy). The signal-to-noise ratio is a measurement of model precision. An ideal ratio is > 4. A sufficient signal is indicated by the ratio of 14.019. To move around the design space, utilize this model.

The LNP when tested for in vitro LRD discharge for 42 hr. The LNP (LN-16) demonstrated a more controlled but gradually increasing discharge of LRD than the control patch (containing non Niosomal drug in the patch). LRD discharge from optimized LNP was studied for 42 hr using the linear regression equation Y = mx + b and r2 at pH 6, i.e., values for LRD, Y = 1.9329x + 18.408 and r2 = 0.8995 compared to the control (1.198x + 9.4167 and r2 = 0.9306) (Figure 4).

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