Optimization of Process and Formulation Variables for Semha-Pinas Extract Effervescent Tablets Using the Box-Behnken Design.

Abstract

Semha-Pinas (SHPN) is a Thai traditional herbal formula used as an expectorant. Its traditional dosage form is pills, which are dispersed in water before use. The development of this recipe to effervescent tablets could enhance patient convenience with shortened the time needed to disintegrate the active ingredients. This work aimed to develop SHPN extract effervescent tablets based on process and formulation optimization using the Box-Behnken design. Four levels of three independent variables, including a compressional force, a quantity of effervescent base, and a quantity of fumed silica, were screened using the one factor at a time method. Three levels of each independent variable were included in the Box-Behnken design, including 1000 - 2000psi, 46 - 52%, and 1.67 - 3.33%, respectively. Four responses were monitored, including tablet thickness, hardness, disintegration time, and friability. In terms of design space, the results showed that the tablet hardness was not less than 5kP, disintegration time was not more than 5min, and friability was not more than 1% found when 2000psi compressional force was used. The optimal parameters were a compressional force of 2000psi, effervescent base of 50%, and fumed silica of 2.5%. This formulation had a tablet weight of 598.86 ± 0.05mg, a diameter of 12.68 ± 0.01mm, a thickness of 3.67 ± 0.01mm, a hardness of 5.57 ± 0.22 kP, a disintegration time of 1.68 ± 0.04min, and friability of 0.43 ± 0.02%. In conclusion, this work succeeded in developing SHPN extract effervescent tablets with desired properties that were easy to use. Furthermore, the time needed to disintegrate the active ingredients was decreased when compared with the traditional dosage form due to being easily dissolved in water.