A chitosan-based spray for localized tranexamic acid delivery: Formulation development and enhanced hemostatic control

Objective(s): Topical tranexamic acid (TXA) can provide localized antifibrinolytic activity, but rapid drug clearance from bleeding surfaces may limit its effectiveness. Chitosan offers complementary hemostatic properties and may improve local drug retention due to its well-documented mucoadhesive properties. Although previous studies have explored TXA-loaded chitosan-based particulate hemostats, translating this concept into a sprayable, dose-reproducible, bio-adhesive topical delivery system remains insufficiently characterized.Materials and Methods: A chitosan-based TXA spray was developed as a translational topical delivery platform and characterized for appearance, pH, rheological behavior, spray pattern, dose uniformity, TXA content, and short-term stability. In vivo hemostatic efficacy was evaluated in a standardized rat tail-incision model. Animals received purified water, topical TXA, or the TXA-chitosan spray (n=۶/group). Time to hemostasis and blood loss were measured.Results: The optimized formulation showed a homogeneous appearance and a pH of ۶.۳۶±۰.۰۱. Apparent viscosity decreased from ۴۰.۵±۰.۳ to ۲۱.۸±۰.۲ mPa·s as rotational speed increased, indicating shear-thinning behavior. Spray delivery was highly reproducible, with ۱۱۸.۷±۰.۴ mg delivered per actuation and ۰.۳۴% relative standard deviation. TXA content remained ۹۸.۲% of the initial value after ۳۰ days at ۲۵±۲°C. Both TXA and TXA-chitosan significantly reduced bleeding time versus control (P≤۰.۰۰۵). Notably, the TXA-chitosan spray reduced blood loss to ۱۶.۳±۳.۹ mg versus ۳۳.۲±۵.۷ mg with TXA alone (P=۰.۰۲).Conclusion: The developed spray provides reproducible topical delivery and substantially enhanced blood-loss control compared with TXA alone, supporting its further development as a localized hemostatic platform.

کلیدواژه ها:

Chitosan ، Drug delivery systems ، Hemostatics ، Hemorrhage ، Tranexamic acid