DEVELOPMENT, OPTIMIZATION AND SCALE UP OF AN INNOVATIVE TOPICAL CREAM FORMULATION OF TERIFLUNOMIDE FOR THE TREATMENT OF ATOPIC DERMATITIS

Abstract

The skin, as the largest organ of the body, plays a crucial role in protection and appearance. Its health has been a primary focus of scientific exploration, with the goal of offering better treatment and aesthetic products. Skin diseases such as atopic dermatitis (AD), psoriasis, acne, vitiligo, and skin cancers significantly impact individuals' quality of life, influencing their socioeconomic and psychological well-being. Atopic dermatitis, a common inflammatory skin condition, affects 15-20% of children and 1-3% of adults. It often appears before the age of 5, with environmental and lifestyle changes being major contributing factors, alongside genetic mutations like those affecting the filaggrin gene. AD typically manifests as pruritus, erythema, and dermatitic plaques, with different presentations depending on age. Treatments include emollients, moisturizers, topical corticosteroids, calcineurin inhibitors, and newer options like Janus Kinase inhibitors (JAKi) and phosphodiesterase-4 inhibitors (PDE4i). However, there remains a significant need for more effective treatment options. Considering the need of new treatment options, a topical teriflunomide cream was developed, by repurposing the teriflunomide drug substance which was approved for multiple sclerosis as 7mg and 14mg tablets, for AD treatment. The formulation was optimized, scaled up, and tested for stability according to ICH guidelines, with further safety and efficacy studies planned.