Validation of Pharmaceutical Dextrose Monohydrate (DMH) Process Production at Pilot Scale

Pharmaceutical dextrose monohydrate (DMH) as one of the raw materials for drugs which is widely used in the manufacture of infusions and drug preparations, including BBO, which is entirely still imported. To achieve the independence of national pharmaceutical raw materials, it is important to study and develop the DMH pharmaceutical production process technology in Indonesia. In this research, the validation of the DMH pharmaceutical production process using food quality liquid glucose raw materials on a pilot-scale of 5 - 6 kg/product was carried out. The validation process has been carried out three times in all stages of the process, namely saccharification, carbon purification, resin purification, evaporation, crystallization, centrifugation, and drying. Several test parameters have been established at each stage of the process so that the repeatability of the production process and the quality of pharmaceutical DMH can be achieved. The results showed that each stage of the process played a role in improving the quality of dextrose. Product yield and weight loss of dextrose in the whole process were 50-52% and 9-10%, respectively. The results of testing the levels of dextrose (dextrose equivalent/DE), endotoxin content, pyrogen-free tests, and other parameters that have been carried out on pharmaceutical DMH products have met the quality requirements according to the Indonesian Pharmacopoeia Edition VI. In conclusion, the validation results show that the bench-scale pharmaceutical DMH production process technology is developed to produce pharmaceutical DMH products with process repeatability and good quality.