Development and Characterization of Film Forming Gel for Analgesic and Wound Healing Activity

Abstract

Effective pain management and wound healing require patient-friendly drug delivery systems. Tramadol HCl, an opioid used for moderate to severe pain, is combined with Chitosan, a natural polymer known for its bioadhesive, antimicrobial, and wound-healing properties. Film-forming systems offer versatile applications in drug delivery. This study aims to develop and evaluate a Chitosan-based film-forming gel with Tramadol HCl to enhance drug availability, reduce dosing frequency, and minimize systemic side effects while promoting both analgesic and wound-healing effects. Tramadol HCl FFGs were prepared using Chitosan, film-forming polymers (HPMC, HEC, and MC), plasticizer, and solvent, optimized via a three-level full factorial design (3 independent and 3 dependent variables). Prepared FFG were characterized for pH, viscosity, spreadability, Drying time, drug content, in- vitro drug release and mechanical properties of the film. Design Expert Software facilitated statistical analysis. Optimized formulation was evaluated for physicochemical properties, in-vitro drug release, SEM, skin irritation, in-vivo pharmacodynamic and pharmacokinetic study. The optimum composition was found to be 0.95 % of Chitosan, 6.59 % of PVA and including HPMC E5 as polymer type. This formulation demonstrated a viscosity of 1460 cP, a drying time of 19 minutes, and a drug release of 76.85% within six hours. Developed formulation showed comparable analgesic, wound-healing activity and bioequivalence to a marketed formulation. Different FFG based on different polymer types were successfully developed and characterized. Above findings demonstrate that Chitosan-based Tramadol HCl film-forming gels proved to be an efficient dosage method for patient friendly topical drug delivery in pain management and wounds care.