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Background: Signal strength for any drug event combination can be determined using disproportionality analysis. Vemurafenib is a BRAF inhibitor approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of metastatic melanoma. This study aims to identify the signal strength of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) associated with vemurafenib using disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS). Methods: Data were obtained from the public release of data in FAERS. Case/non-case method was adopted for the analysis of association between vemurafenib use and DRESS. The data mining algorithm used for the analysis was Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). A value of ROR-1.96SE>1, PRR≥2 were considered as positive signal strength. Results: A total of 7,171 reports for DRESS have been reported in the FDA database. Amongst which 125 reports were associated with vemurafenib. A cumulative ROR of 17.72 (95% CI 14.83; 21.18) and PRR of 17.46 (95% CI 14.65; 20.81) were observed. Combination treatment of vemurafenib with cobimetinib had higher number of reports (100) with ROR of 103.42 (84.13- 127.14) and PRR of 94.52 (78.26- 114.15). Four deaths were reported and the non-death serious reports included hospitalization, life-threatening, disability, and other serious events with 61, 11, 2 and 39 reports respectively. Conclusion: Positive signal strength was observed for vemurafenib associated DRESS. The signal strength was higher for vemurafenib in combination with cobimetinib than vemurafenib alone. Health care professionals should be cautious about encountering serious adverse events and should be reported to the regulatory authorities.

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Introduction: Mucoadhesive buccal films are most recently developed and preferred over buccal tablet because of the flexibility, better bioavailability, cost effectiveness, and good patient compliance it offers Objective: The study aimed to formulate mucoadhesive films of Clobetasol Propionate with reduced side effects, controlled release and better patient compliance, suitable for the management of oral lichen planus. Methods: Clobetasol Propionate Buccal Films were prepared by the incorporation of the Clobetasol Propionate along with polymers like Hydroxy Propyl Methyl Cellulose (HPMC) K4M, polyethylene glycol 400 and glycerol by solvent casting method. Results: The drug content of all the formulations was found to be 85.04% to 93.14%. The swelling index of all formulations of Clobetasol Propionate mucoadhesive buccal film was found to be 82% to 94.07%. Formulation F14 which contains Hydroxy Propyl Methyl Cellulose K4M (1%), and polyeth­ylene glycol 400 (1%) exhibited better results compared to other combination of polymers in different concentration. It showed swelling index of 94.07%. Drug content was found to be 91% and showed release of drug up to 95.05% in 12 hours. The optimised formula showed no significant changes on stability studies when stored at 40ºC/75% RH for three months. Conclusions: The application of mucoadhesive buccal film containing Clobetasol Propionate appeared to be effective, avoiding the side effects and the data obtained in the study suggested that buccal films can be successfully designed to give controlled drug delivery.