Effects of wet granulation process variables on the quantitative assay model of transmission Raman spectroscopy for pharmaceutical tablets
Transmission Raman spectroscopy (TRS) is a process analytical technology tool for nondestructive analysis of drug content in tablets. Although wet granulation is the most used tablet manufacturing method, most TRS studies have focused on tablets manufactured via direct compression. The effects of upstream process parameter variations, such as granulation, on the prediction performance of TRS quantitative models are unknown. We evaluated the effects of process parameter variations during granulation on the prediction performance of the TRS quantitative model. Tablets with a drug concentration of 1%w/w were used. We developed PLS calibration models for the drug concentration range of 70–130% label claims. Subsequently, we predicted the drug content of the tablets with different granulation parameters.
The results of our study demonstrate that the variation in the predicted recovery due to the variation in granulation parameters was practically acceptable. The calibration model showed a good prediction performance for tablets manufactured at different granulation scales and thicknesses. Therefore, we conclude that TRS quantitative models are robust to variations in upstream processes, such as granulation and downstream variations in tableting parameters. These results suggest that TRS is a versatile non-destructive quantitative analysis method that can be applied in tablet manufacturing.
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Acetaminophen (Mallinckrodt Inc., Saint Louis, MO, USA. Quality standard: JP (Japanese Pharmacopoeia). Purity: 100.0%) was used as the model drug. Mannitol (Pearlitol® 25C, Roquette Freres, Lestrem, France. Quality standards: JP, USP-NF (United States Pharmacopeia-National Formulary) and Ph.Eur. (European Pharmacopoeia)) and microcrystalline cellulose (CeolusTM PH-101, Asahi Kasei Corporation, Tokyo, Japan. Quality standards: JP, USP-NF, and Ph.Eur.) were fillers. Croscarmellose sodium.
Ryo Ohashi, Tatsuo Koide, Toshiro Fukami, Effects of wet granulation process variables on the quantitative assay model of transmission Raman spectroscopy for pharmaceutical tablets, European Journal of Pharmaceutics and Biopharmaceutics, 2023, ISSN 0939-6411, https://doi.org/10.1016/j.ejpb.2023.09.009.