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The low drug loading in our formulations is also attributed to the small amount of drug (~2 mg) used in the preparation of the trial formulations.
Twenty trial formulations with independent variables, including PVP-CL 1 12.00%, PVP-K30 1–10.00%, starch-1500 2.5–12.5% and Avicel-PH102 2–19.25% were prepared by direct compression technique.
Biowaivers for Over-encapsulation of Clinical Trial Formulations: During the course of drug development, sponsors sometimes have to blind the formulations that they use in the clinical trials.
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Therefore, the clinical trial formulation was concluded to have almost no skin temperature reducing effect.
Changes in the pH levels appearing in the clinical trial formulation and control groups could be identified until after 4 weeks of use for the formulations (Fig. 3).
The above results indicate that, compared with existing products, the clinical trial formulation is effective for skin water retention because it prevents trans-epidermal water loss more effectively.
Although the temperature reduction effects of the clinical trial formulation were greater compared with the control group, the differences were small.
Therefore, it can be observed that the pruritus reducing effect of the clinical trial formulation was smaller compared with the control product.
As with skin water content, the effects were more remarkable in the clinical trial formulation group compared with the control group.
The SCORAD index values after treating the clinical trial formulation and positive control sample were estimated as ca. 20 at 2 weeks of the treatment, and at 4 weeks of the treatment they were decreased further down to 17.05 and 16.95 for the clinical trial formulation and the positive control groups, respectively, but the difference was not significant between two groups.
Compared with the control group, the group that used the clinical trial formulation had 15.23% higher water content after 2 weeks of use and 28.26% higher water content after 4 weeks of use.
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