Optimized Roflumilast Ethosomal Gel for Enhanced Transdermal Therapy in Atopic Dermatitis: An In Vitro Study.
Mehmood Yasir Y, Rizvi Syeda Momena SM, Javed Atika A, Siddique Rida R et al.
This study evaluated a transdermal drug delivery system using roflumilast (RT)-loaded ethosomal gel for the topical treatment of inflammatory skin disorders. RT-loaded ethosomes were prepared using the cold method and incorporated into a topical gel. Eight formulations were developed and optimized using a Design of Experiments approach to investigate the effects of formulation variables on drug entrapment and performance. Among them, RT-5 was selected as the optimized formulation and evaluated for physicochemical properties, stability, microbiological quality, drug release, and transdermal permeation. RT-5 exhibited suitable topical characteristics, including a pH of 5.3-5.5, viscosity of 90-91 cP, and good spreadability. In vitro diffusion studies at pH 5.5 showed 25.5% ± 3% drug release within the first hour compared with 5.2% ± 2% from the commercial cream. Moreover, RT-5 achieved cumulative drug penetration of 99.34% after 12 h, demonstrating enhanced transdermal delivery. Stability studies showed that the formulation maintained acceptable pH, viscosity, consistency, and appearance for 6 months under recommended storage conditions and at least 3 months under accelerated conditions. Microbiological testing revealed no detectable bacterial growth. The outcome of this work showed that RT-5 demonstrated satisfactory stability, quality, and improved transdermal delivery of roflumilast.