Formulation and Process Development of Sane Khao Suk Capsules: From Thai Traditional Wisdom to WHO GMP Standard

Abstract

The Sane Khao Suk Pill is an ancient medicine composed of cannabis, nutmeg, mace, and wet tamarind. Its properties include aiding sleep, promoting appetite, and acting as a mild laxative. Originally, the medicine was in the form of a bolus, which is not popular today. This research aimed to develop the formula from the bolus into a more convenient and standardized capsule, adhering to the World Health Organization Good Manufacturing Practices (WHO GMP). The study explored three development methods: individual grinding, co-grinding, and wet granulation, to create a suitable dry powder for capsule filling. After initial tests, both separate and combined grinding methods proved unsuitable due to the stickiness of mace and the tendency of wet tamarind to revert after drying, which hindered the capsule-filling process. The most effective method identified was the wet granulation technique, which involved grinding all ingredients except the wet tamarind, mixing the powders with boiled wet tamarind water, and then performing granulation and drying for three hours. The resulting medicine was a fine, brown powder with a unique odor, successfully allowing for capsule filling. Quality evaluations showed that the final product complied with the Thai Herbal Pharmacopoeia 2020 specifications, demonstrating an average weight variation of 506.2±30.8 milligrams, average disintegration time of 10.30 minutes, and an average moisture content of 3.78±0.23%. The THC content was 12,319.09 milligrams per kilogram (mg/kg) and CBD 724.34 mg/kg. In conclusion, the most suitable method for producing Sane Khao Suk capsules is the preparation using wet granulation. The researchers had prepared standard operating procedures (SOPs) and quality assurance documentation that government hospitals could immediately utilize for manufacturing. Furthermore, they proposed further studies on the efficacy and safety of the Sane Khao Suk capsules in patients, to provide empirical data for their consideration in the National List of Essential Medicines.