Optimization of Semha-Pinas Extract Orodispersible Tablets Using Response Surface Methodology

Abstract

The original dosage form of the Semha-Pinas herbal formula, an expectorant in Thai traditional medicine, is in a pill form. However, it is inconvenient to use because it must be powdered and dissolved in hot water or juice of Citrus x aurantium L. before use. The development of a new dosage form presents a challenging prospect. This work aimed to develop Semha-Pinas extract orodispersible tablets based on the response surface methodology using the Box-Behnken design. Firstly, Semha-Pinas extract was tested for its safety in HepG2 cells. The safe extract was further developed as orodispersible tablets. Four levels of three factors — compressional force (500–2,000 psi), the quantity of microcrystalline cellulose (0–15%), and the quantity of croscarmellose sodium and sodium starch glycolate (0:8–6:2%) — were screened using the one factor at a time technique. The Box-Behnken design has three levels for each factor: 1,000–2,000 psi, 5–15%, and 2:6–6:2%, respectively. Tablet thickness, hardness, friability, and disintegration time were the four responses that were monitored. The results indicated the safety of the Semha-Pinas extract, even at a concentration of 5 mg/mL. The optimal orodispersible tablet formulation had a compressional force of 1,500 psi, microcrystalline cellulose of 10%, and croscarmellose sodium to sodium starch glycolate of 4:4%. In summary, this study successfully fabricated Semha-Pinas extract orodispersible tablets using response surface methodology, achieving the desired property of fast disintegration. Moreover, these findings can serve as a valuable reference for pilot scale and industrial scale production.