Development of The Herbal Formulation of Trikatu Capsule

Abstract

This study aimed to develop a Trikatu capsule formulation, investigate suitable excipients for capsule production, and evaluate the stability of the formulation under accelerated conditions. The Trikatu formula consisted of black pepper, long pepper, and dried ginger in a 1:1:1 ratio. Each herbal powder exhibited fine, non-agglomerated characteristics, with yields of 92.10%, 91.39%, and 90.61%, respectively. The combined Trikatu powder appeared as a fine brown powder with a characteristic odor and pungent taste. Moisture content analysis, performed in triplicate, was within acceptable limits, with values of 1.667% for Trikatu, 2% for black pepper, 2% for long pepper, and 0.667% for dried ginger

Eight capsule formulations were evaluated, comprising four powder-based and four granule-based formulations. Physical property assessment indicated that Formulation 2 was the most suitable among the powder formulations, containing 9.5% spray-dried lactose and 0.5% magnesium stearate. Among the granule formulations, Formulation 7 containing 1.5% lactose, 5% corn starch, 0.5% PVP K90, 2.5% maltodextrin, and 0.5% magnesium stearate was identified as the most appropriate for capsule preparation

Quality control testing demonstrated that all capsule formulations showed normal physical characteristics. Weight variation complied with USP 41–NF 36 and the Thai Herbal Pharmacopoeia (2018). Disintegration testing showed complete disintegration within 15.48 minutes. Accelerated stability testing at 45°C and 75% relative humidity for 4 months revealed that Formulation 7, when stored in a tightly sealed container, maintained good stability and met the standards of USP 39, USP 41–NF 36, and the Thai Herbal Pharmacopoeia (2018)