(M1430-01-01) Drug Loading Efficiency of a Topical Anorectal Wipes: A Wipe Impregnation Study

Purpose: Impregnated wipes improve patient’s convenience and clinical adherence for drug applications to pressure sensitive indications such as hemorrhoids and are being pursued in the pharmaceutical research & development (R&D) to administer drugs and debridement for various other indications such as but not limited to Diabetic foot ulcers, bed sores etc. The advantages of using wipes for drug include ease of use, portability, and improved patient compliance. However, the loading capacity of the wipes is critical to their effectiveness. Establishing the drug loading efficiency of wipes is, therefore, a key critical quality attribute in the development of wipes. The purpose of this proof-of-concept study was to determine the maximum amount of a combination drug solution that can be impregnated on to a non-woven fabric wipes without any instabilities such as but not limited to dripping off, crystallization, soggy appearance, disintegration of fabric.

Methods: Drug substance solution was used to establish the saturation loading content of the wipes. Dipping, pipetting, and spraying techniques were used in R&D to impregnate the wipes. The drying time, cycling addition times, and application process, surface area of the wipe was considered as critical process parameters (CPPs) that might significantly affect the loading capacity of wipes. The weight of impregnated formulation, saturation loading, and % saturation loading was calculated for each addition step.

Results: The study demonstrated that the CPPs, i.e., drying time, cycling addition times, and application process do not play a significant role in controlling or limiting the saturation ability of the wipes with the formulation. The weight of the impregnated formulation ranged between 4.8 g and 6.05 g with no trend followed with respect to the number of additions or application process. Saturation loading was found to be between 5.5 and 6.5 with no trend followed with respect to the number of additions or application process with respective to surface area of the selected wipe. Percent saturation loading was found to range from 550% to 650% with no trend followed with respect to the number of additions or application process based on the surface area and weight of the wipe. The mean weight of impregnated formulation for dipping, pipetting, and spraying was 5.84 g, 5.90 g, and 5.81g, respectively. The mean saturation loading for dipping, pipetting, and spraying was 5.27%, 5.32%, and 5.23%, respectively. The wipes reached their saturation capacity at the addition step 4 at 45 min drying time.

Conclusion: The study findings provide valuable insights into the development of impregnated wipes. The study demonstrated the successful establishment of the saturation loading capacity of the wipes. The technique used to apply the formulation did not significantly affect the saturation loading capacity of the wipes but turns out the surface area, type of weaving (network density) and weightage of the wipe are additional identified key parameters in selection of a suitable fabric. These findings are useful in the development of a more efficient process for impregnating wipes with drug substances.

picture explaining the different techniques used

data summary

data summary depicted in graphs