Development and Characterization of Self-Adhesive Polymeric Films with Antiallergic Effect.

This study aimed to design self-adhesive cutaneous films with an antiallergic effect using a Design of Experiments approach. The active pharmaceutical ingredient (API) was diphenhydramine hydrochloride (DPH). A full factorial experimental design with three factors and two levels was created. The factors were the polyvinyl alcohol (PVA) ratio, the polyacrylic acid (PAA) ratio, and the type of plasticizer. The responses evaluated were hardness, deformation at hardness, adhesive force, and in vitro DPH release profile. Eleven formulations were generated, prepared in two steps via solvent casting, and characterized in terms of mechanical and adhesive properties, as well as the in vitro DPH release profile. The PVA ratio had the most significant impact on the responses, followed by PEG 400 and PEG 4000. Four film formulations were investigated using Raman spectroscopy, which revealed that the API was distributed in both the base and adhesive layers. Consequently, an optimal formulation was prepared and characterized. Good mechanical properties (a hardness of 463.7 g and a deformation at hardness of 16.56 mm) and an increased adhesive force (76 g) were observed, while the DPH was released up to 68% over 12 h. In conclusion, a novel self-adhesive film was developed, which may enhance patients' adherence to local antiallergic treatment.