Granulation process analysis technologies and potential applications in traditional Chinese medicine

Abstract

Pharmaceutical production is changing from batch production to continuous production, during which granulation is one of the most important unit operations. The quality of mass-produced products is traditionally guaranteed by conducting off-line testing, which cannot meet the demand of continuous production for real-time monitoring of critical process parameters and critical quality attributes (CQAs) of the pharmaceutical granulation technology. Since the U.S. Food and Drug Administration proposed process analytical technology (PAT) in 2004, many PAT tools have been developed to monitor the granulation process and provide information regarding the granulation operation conditions and endpoint determination. In this article, we review the recent research and application of two PAT modes in the granulation process, namely, single CQA and multi-CQA PAT, with the aim to provide references for comprehensively improving the technological level of the pharmaceutical granulation process. Furthermore, the potential applications in traditional Chinese Medicine are discussed.

Granulates Based on Bio and Industrial Waste and Biochar in a Sustainable Economy

“…Dry granulation uses mechanical pressure to encourage the agglomeration of dry powder particles, whereas wet granulation combines raw material powder with granulation solution to generate wet matter and enhance agglomeration. This process mainly uses roller compaction granulation instead of wet granulation which uses fluidized-bed, high-shear, or twin-screw granulation [10].…”

Comparative pharmacokinetics of six components in normal and rheumatoid arthritis rats after intragastrical administration of Qianghuo Shengshi Decoction granules by LC-MS/MS

“…However, it also has shortcomings, such as short shelf life, inconvenient storage and transportation, and poor compliance for the patient, which limits the application of QSD and obstructs its modern development ( Lin, 2019 ). With the rapid development of modern TCM, granules have become one of the prominent dosage forms in TCM treatment circles, as they bring great convenience to patients to compensate for the decoction's disadvantages ( Cui et al, 2022 , Zhang et al, 2022a , Zhang et al, 2022b ). So far, numerous studies have been conducted on the clinical application of QSD, but related reports on the quality control and new formulation development are still lacking.…”