Quality-by-Design Approach for Investigating the Efficacy of Tacrolimus and Hyaluronic Acid-Loaded Ethosomal Gel in Dermal Management of Psoriasis: In Vitro, Ex Vivo, and In Vivo Evaluation.

Psoriasis is an auto-immune condition with high keratinocyte hyperproliferation due to lower p53 and p22 levels. Tacrolimus, an immune suppressor, is considered one of the most effective drugs in suppressing psoriasis. Systematic administration of tacrolimus often leads to challenging side effects, namely increased infection risk, renal toxicity, neurological symptoms such as tremors and headaches, gastrointestinal disturbances, hypertension, skin-related problems, etc. To address this, a nanocarrier-based formulation of tacrolimus along with inclusion of hyaluronic acid was developed. The optimization and formulation of ethosomes via the ethanol injection technique were done based on the Box-Behnken experimental design. The results revealed hyaluronic acid-based tacrolimus ethosomes (HA-TAC-ETH) had nanometric vesicle size (315.7 ± 2.2 nm), polydispersity index (PDI) (0.472 ± 0.07), and high entrapment efficiency (88.3 ± 2.52%). The findings of drug release and skin permeation showed sustained drug release with increased dermal flux and enhancement ratio. The effectiveness of HA-TAC-ETH was confirmed in an imiquimod (5%)-prompted psoriasis model. The skin irritation score and Psoriasis Area and Severity Index (PASI) score indicated that HA-TAC-ETH gel has validated a decline in the entire factors (erythema, edema, and thickness) in the imiquimod-induced psoriasis model in contrast with TAC-ETH gel and TAC ointment. The fabricated HA-TAC-ETH opt gel proved to be safe and effective in in vivo studies and could be employed to treat psoriasis further.

Recent advancements in novel formulations of anti-psoriatic agents for effective delivery: clinical importance and patent survey.

Objectives An autoimmune-mediated dermatological ailment featuring recurrent episodes is acknowledged as psoriasis. Around the world, 2-3% of people suffer from this autoimmune skin condition. The primary goal of the current review is to analyse and determine the effectiveness of conventional and emerging nano technological strategies to alleviate psoriasis and discuss future perspectives. Evidence acquisition A thorough search of numerous electronic databases, including Science Direct, Scopus, Google Scholar, Clinical Trials, Google Patents, Research Gate, and PubMed, yielded all the data used in this review paper about the management of psoriasis via various anti-psoriatic agent and nanotechnology approaches. Keywords such as topical, liposomes, niosomes, micro needles, clinical trials, patents, pathogenesis, biosimilars, cytokines, and other pertinent words were investigated. Results Nano technological approaches are gaining prominence since they enable targeted delivery, rapid onset of action with limited systemic exposure. Researchers have investigated innovative, alternative therapeutic approaches that are both secure and efficient for treating psoriatic conditions. Further, the potential role of numerous psoriatic conventional therapies has been explored. The patents granted or in process to address psoriasis via topical route have been well explored. Modern nanotechnology has made it possible for pharmaceuticals to be delivered with improved physical, chemical, pharmacokinetic, and pharmacodynamic qualities. Despite extensive research complete cure for psoriasis is hampered. Conclusion Relying on the extensive literature review, it can be inferred that nanoparticles based novel delivery strategies have the possibility of enhancing the pharmacological activity and eliminating or resolving problems associated with this ailment. The different drug delivery systems available for the treatment of psoriasis along with the clinical trials in different stages, patents in process and granted, the commercialized status of therapeutic molecules, and the future of research in this area have been thoroughly reviewed.