Research Projects

The current proposal aims to explore the new potential of nicotine, using carrier-linked formulation approaches for treating pemphigus vulgaris, an autoimmune disorder. This approach is based on the hypothesis proposed by physicians that there is an inverse relationship between cigarette smoking and the remission of pemphigus flares (Stanley and Amagai 2008). Pemphigus vulgaris (PV) is chronic autoimmune disorder that manifest as blistering conditions of the skin disease/mucous membranes and mediated by circulating pathogenic autoantibodies directly affecting keratinocyte cell surface proteins leading to acantholysis (KANWAR and DHAR 1995). Acantholysis indicates the loss of intercellular connection between the keratinocytes in the epidermal stratum spinosum that renders the intraepidermal clefts (Rehman, Huang, and Wan 2021). The disease first affects the oral mucosa, and later on, the other mucosal surfaces get involved, followed by the involvement of the skin. The study aims at developing a novel mucoadhesive formulation for continuous delivery of nicotine along with off-patent topical corticosteroids i.e., clobetasol propionate at the site of absorption. This approach will avoid serious side effects associated with oral corticosteroids and immunosuppressants, the mainstay therapy to treat pemphigus vulgaris and provide a 3-tier approach to manage the disease. Firstly, with use of nicotine (3-5 mg per application), secondly, with usage of phospholipid-based clobetasol propionate (0.05%) in microemulsion gel and thirdly, incorporation of silver nanoparticles (0.002%) in the hydrogel matrix will target the disease in a safer and effective manner. There have been clinical reports on use of topical corticosteroids for minor pemphigus, but after one month of therapy, the topical options failed. Later on, high doses of oral corticosteroids are prescribed (Dumas et al. 1999; Scully et al. 1999; Westerhof 1989). The formulation proposes to use nicotine in a dose of 3-5 mg per topical application, which will not be associated with the adverse effects of higher doses of nicotine (Ahluwalia, McNagny, and Clark 1998). This disease is reported to have a devastating effect on the life of the patients with 5-15% mortality (Didona et al. 2019). The nicotine used will be far less than that used in the transdermal nicotinic patches. The project has relevance due to its feedback on hypothesis from physicians, which can lead to product commercialisation after suitable scale-up and validation. The present proposal will result in a cheap, easily available, scientifically-sound and effective topical product for the management of pemphigus vulgaris. The proposal has the potential in resulting a product for this rare disease that can be a great boon for suffering patients.