Abstract

Background: Valerian root extract is used in traditional medicine to treat sleep disorders. According to previous studies, sedative effects are related to the presence of valerenic acid. Formulating orodispersible tablets (ODTs) is an effective and cost-benefit technique for accelerating drugs' therapeutic effects. This study aimed to formulate ODTs of valerian root extract and evaluate their properties.

Materials and Methods: Valerian root was extracted by percolation in 70% ethanol. The solubility of valerenic acid was investigated in various liquid carriers. The extract was uniformly dispersed in the selected carrier (Tween 80), then mixed with other excipients, and compressed into tablets. Fourteen formulations with different amounts of sodium starch glycolate (SSG, as a super disintegrant) and camphor (as a sublimating agent) were prepared. The physicochemical properties of the ODTs, drug release rates, and microbial limit tests (MLTs) were studied.

Results: Both SSG and camphor accelerated tablet disintegration rates and their composition showed a synergistic effect (P<0.05). The infrared spectroscopy revealed no chemical interaction between formulation components. The MLTs confirmed that a limited number of microbial colonies were grown in the liquid medium, and no pathogen growth occurred in the specific culture media.

Conclusion: The results revealed that Valerian ODT's physicochemical properties were significantly improved compared to conventional tablets. The technique can be utilized for other poorly watersoluble pharmaceuticals.

Keywords: Valerenic acid, orodispersible tablets, super disintegrant, sublimating agent, liquid-solid dispersion, drug release kinetics.

Graphical Abstract