Development and evaluation of Sahasthara Thai medicine remedy in a film-forming spray for topical anti-inflammatory therapy

开发和评估用于局部抗炎治疗的成膜喷雾剂型的泰国萨哈斯塔拉草药疗法

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Abstract

BACKGROUND AND PURPOSE: The study aimed to develop a localized topical anti-inflammatory treatment using a Thai medicinal herbal remedy called "Sahasthara," known for its anti-inflammatory properties, to create a film-forming spray (FFS). EXPERIMENTAL APPROACH: This research evaluated and developed an FFS formulated with Sahasthara ethanolic extract (SHTe). Subsequently, the optimized formulation was investigated for in vitro anti-inflammatory activity, cell culture toxicity assessment, pharmacological effects, and stability studies. FINDINGS/RESULTS: An optimized formulation (F12) was identified, consisting of 1% w/w SHTe and PVP K90, glycerol, PEG 400, sesame oil, a eutectic blend, and ethanol. This clear, smooth surface, yellowish film releases 42.37%, 38.67%, and 68.93% at 8 h, corresponding to a flux of 20.94, 1.92, and 26.32 µg/cm2/h of piperine, plumbagin, and β-asarone, respectively. F12 was determined to have a viscosity, drying time, and spray angle of 20 cps, 4.57 min, and 66.0 degrees. In-vitro anti-inflammatory activity demonstrated nitric oxide (NO) inhibition with an IC50 of 9.18 µg/mL. No apparent toxicity was observed in a skin cell line. This formulation was developed to be physically stable after undergoing freeze-thaw cycles. Although thermodynamic stability studies under accelerated conditions revealed a minor decrease in piperine and β-asarone within the film, the results indicate no statistically significant changes in its anti-inflammatory activity. CONCLUSION AND IMPLICATIONS: SHTe FFS offers optimal spray ability, a high in-vitro drug release profile, potent inhibition of anti-inflammatory markers, and stability under accelerated conditions. These findings suggest that SHTe FFS can serve as an innovative topical anti-inflammatory treatment.

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