Silk fibroin hydrogel containing Sesbania sesban L. extract for rheumatoid arthritis treatment.

PURPOSE: Rheumatoid arthritis, a chronic and progressive inflammation condition in the joints, has significantly reduced the patient quality of life and life expectancy. Crucially, there is no complete therapy for this disease, and the current treatments possess numerous side effects. Thus, novel therapeutic approach is necessary. To that end, this study developed novel silk fibroin in-situ hydrogel containing Sesbania sesban L. extract, a plant with high anti-inflammatory actions that are beneficial for rheumatoid arthritis treatments. METHODS: The hydrogels were manufactured using simple method of spontaneous gelation at different temperature. The gel properties of morphology, gelation time, viscosity, gel strength, stability, drug loading capacity, drug release rate, and in-vitro anti-inflammatory activity were investigated with appropriate methods. RESULTS: The optimal formulation had highly porous structure, with a gelation time of 0.5 h at room temperature and bodily temperature of 37 °C, a viscosity of 2530 ± 50 cP, a gel strength of 1880.14 ± 35.10 g, and a physical stability of >6 months. Moreover, the hydrogel contained the Sesbania sesban L. leaf extract with a total phenolic content of 92.8 ± 8.30 mg GAE/g, and sustained the release rate for >20 days, followed the Higuchi model. Regarding the in-vitro activities, all formulations were nontoxic to the RAW 264.7 cell line and demonstrated comparable anti-inflammatory activity to the free extract, in terms of the NO reduction levels. CONCLUSION: Conclusively, the systems possessed potential properties to be further investigated to become a prospective rheumatoid arthritis treatment.

Development and Pre-clinical Study of Anti-Allergic Cream Containing Dexamethasone and Chlorpheniramine.

OBJECTIVES: In this study, we aimed to develop and optimize an anti-allergic cream containing dexamethasone and chlorpheniramine using the design of experiments (DoE) method. The optimized product was investigated for its physicochemical properties and in vivo therapeutic effects in rabbits. MATERIALS AND METHODS: The creams were formulated using the simple mixing process, which was optimized by the Design Expert software. The products were then evaluated the properties such as pH, skin diffusion profile, short-term stability, qualitative, and assay, using the newly validated UV-Vis spectrophotoscopy quantitative method. In vivo efficacy tests in rabbits of the best products were compared with the marketed Phenergan® (promethazine 2%). RESULTS: The UV-Vis method used to simultaneously determine the amount of both dexamethasone and chlorpheniramine was successfully developed and validated. Using the DoE method, it was clear that the release profile of dexamethasone depended on the amount of sodium lauryl sulfate, propylene glycol, and DMSO. In contrast, only DMSO affected the release pattern of chlorpheniramine. The best formulation was optimized by the software. The product showed acceptable parameters in pH (5.7±0.1), short-term stability over 10 days, and skin diffusion profiles of 20.47±1.25% and 4.92±0.42% after 40 min for dexamethasone and chlorpheniramine, respectively. In addition, the product demonstrated no observable inflammatory response in the experimental animals. Also, it illustrated 2-fold better anti-allergic efficacy than the marketed product (i.e., 27.2 compared with 43.4 min in the recovery time). CONCLUSION: We were successful in developing and optimizing an anti-allergic cream containing dexamethasone and chlorpheniramine. The best product satisfied all required parameters. Interestingly, our product showed higher efficacy than Phenergan®. These results can be a background for further clinical trials.