FORMULATION AND EVALUATION OF A TOPICAL GEL CONTAINING MINOXIDIL AND TOFACITINIB CITRATE FOR ALOPECIA AREATA

Abstract

Objective: The objective of the present study is to formulate and evaluate a topical gel containing Minoxidil and Tofacitinib citrate for alopecia areata. Methods: Six gels were formulated using the direct-dispersion method by using polymers in the ratio of Carbopol 934: HPMC and Carbopol 934: HPC in three different concentrations each. All the prepared gels were then characterized for its drug content, pH, Rheological measurement, Spreadibility, skin adhesion study, In vitro drug release, Ex-vivo skin permeation study and stability studies. Results: All the six formulations were evaluated for various parameters such as pH, viscosity, spreadibility, and drug content and in vitro drug release. The pH of all the formulations was in the range of 6.3-6.8 which was optimum for the skin. As the concentration of the polymer increased the viscosity also increased, F6 had the highest viscosity among all of 1082 cps. F5 had the highest spreadibility of 4.3±0.15 cm and the drug content of all ranged between 88-96% of Minoxidil and 86-97% for Tofacitinib citrate with F5 giving the best result drug release across a cellulose membrane for a period 8 h of 94.22±0.19% for Minoxidil and 93.62±0.49% for Tofacitinib citrate. Formulation F2 and F5 were subjected to skin adhesion studies by the use of wistar rat skin with F5 giving the highest bioadhesion of 108 g/cm2. Formulation F5 was selected as an optimized formulation among the six as it gave the best results for all the parameters. Then the optimized formulation was subjected to an ex-vivo permeation study for a period of 8 h and by using wistar rat skin as a permeation barrier and the drug release for Minoxidil and Tofacitinib citrate was found to be 71.94±0.78% and 69.49±0.47%. The stability study was carried out for two months at accelerated condition i.e., 40 °C±2 °C/75±5% RH proved that the formulated gel was Stable. Conclusion: The formulated topical gel containing Minoxidil and Tofacitinib citrate were found to be a promising approach for the treatment of alopecia areata.