Abstract
Condyloma acuminata is an infectious disease caused by the human papilloma virus (HPV) and one of the most common sexually transmitted infections. It is manifested as warts that frequently cause pain, pruritus, burning, and occasional bleeding. Treatment (physical, chemical, or surgical) can result in erosion, scars, or ulcers, implying inflammatory processes causing pain. In this work, a biocompatible topical hydrogel containing 2% ketorolac tromethamine was developed to manage the painful inflammatory processes occurring upon the removal of anogenital condylomas. The hydrogel was physically, mechanically, and morphologically characterized: it showed adequate characteristics for a topical formulation. Up to 73% of ketorolac in the gel can be released following a one-phase exponential model. Upon application on human skin and vaginal mucosa, ketorolac can permeate through both of these and it can be retained within both tissues, particularly on vaginal mucosa. Another advantage is that no systemic side effects should be expected after application of the gel. The hydrogel showed itself to be well tolerated in vivo when applied on humans, and it did not cause any visible irritation. Finally, ketorolac hydrogel showed 53% anti-inflammatory activity, suggesting that it is a stable and suitable formulation for the treatment of inflammatory processes, such as those occurring upon chemical or surgical removal of anogenital warts.
Highlights
An alginate-based hydrogel was extensively characterized in terms of morphology, pH, physical stability, and mechanical properties, showing adequate characteristics for a topical formulation
Drug release studies show that up to 73% of the total amount of ketorolac in the gel can be released in less than 6 h from the hydrogel following the one-phase exponential model
Permeation experiments under an infinite-dose approach were performed using human skin and vaginal mucosa, demonstrating that ketorolac contained in the hydrogel can permeate through both tissues successfully, showing almost 7 times faster permeation through vaginal mucosa (306.0 μg/h·cm2 ) than through human skin (50.92 μg/h·cm2 )
Summary
Considering the successful results in pain management after local injection in colon and vaginal surgeries, as previously described, topical ketorolac is proposed is proposed for intravaginal application, prevaginal applications and/or anal application in CA removal. Alginate-based gels show interesting mucoadhesive properties and a very good compatibility profile [16], having been extensively used in topical drug delivery systems with successful results In this this work, work, we we designed designed and and developed developed aa hydrogel hydrogel using using sodium sodium alginate alginate as as the the gelator and ketorolac ketorolactromethamine tromethamine(Figure (Figure1)1)asasa apotent potent non-steroidal antigelator polymer and non-steroidal anti-ininflammatory drug, a candidate local or post-treatment of inflammatory flammatory drug, as as a candidate forfor thethe local pre-preor post-treatment of inflammatory proprocesses derived from.
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