Applying Box-Behnken Design in Herbal Product Development: Semha-Pinas Plain Tablets

Abstract

Phlegm production is a common symptom of upper respiratory tract infections and some allergies. A traditional Thai herbal formula called Semha-Pinas offers an alternative treatment option for managing this symptom. This study aimed to optimize the formulation of Semha-Pinas plain tablets using the Box-Behnken design. Three factors were identified as potentially influencing tablet properties: compressional force, quantity of spray-dried lactose, and quantity of croscarmellose sodium. Initial screening with a one-factor-at-a-time approach helped narrow down the relevant ranges for each factor. Subsequently, the Box-Behnken design was employed with compressional forces ranging from 1,500 to 2,500 psi, spray-dried lactose quantities from 0 to 10%, and croscarmellose sodium quantities from 2 to 4%. Results showed that the optimal formulation, achieving a hardness of 5 to 8 kP, disintegration time of at least 0.5 minutes, and friability of not more than 0.4%, was found at 1,500 psi compressional force, 6% spray-dried lactose, and 3% croscarmellose sodium. This optimized formulation exhibited the following characteristics: tablet weight of 381.23 ± 0.80 mg, diameter of 9.66 ± 0.01 mm, thickness of 4.20 ± 0.04 mm, hardness of 7.50 ± 0.41 kP, disintegration time of 0.67 ± 0.07 minute, and friability of 0.22% ± 0.04%. Verification data confirmed the accuracy of the predictions, with all percent errors falling below 10%. In conclusion, this study successfully applied the Box-Behnken design to develop Semha-Pinas plain tablets that meet the relevant pharmacopoeial criteria.