Tablet Formulation and Stability Test of Thai Traditional Remedy for Muscle Pain Treatment called Sahasthara

Abstract

A Thai Traditional remedy called Sahasthara (SHT) is normally used to treat muscles pain and arthritis in the National drug list of herbal medicinal products A.D. 2011 of Thailand. Its formula consists of twenty one plants. Its ethanolic extract of SHT exhibited anti-inflammatory activity via inhibition of NO production with IC50 as 2.06 µg/ml. Piperine was isolated from its extract and also tested by inhibitory effect on NO production. It showed higher anti-inflammatory than indomethacin as positive control (IC50 as 11.48 and 20.32 µg/ml). The tablet form of the ethanolic extract of SHT remedy was developed and tested product stability under accelerated condition. Preformulation of SHT extract was investigated under various storage conditions; moisture, acid-base, temperatures and oxidation environments. The results exhibited that SHT extract was stable in base, high temperature but unstable in acid and oxidation environments. A direct compression method was used in developing the tablets. The suitable excipients were microcrystalline cellulose (Avicel® PH 102), croscarmellose sodium (Ac-Di-Sol®), Hydrophilic fumed silica (Aerosil®) and magnesium stearate. The physical properties of tablets were evaluated and accepted following by the USP25 requirements. The results of stability test of its tablet was investigated by using HPLC and found that piperine as a main compound was remained as 88.94% at day 120. These results concluded that its tablet was stable and shelf life more than 2 years.