Impact of Raman Mapping Area and Intra-Tablet Homogeneity on the Accuracy of Sustained-Release Tablet Dissolution Prediction
This exploratory study investigated the minimum required Raman mapping area for predicting sustained-release tablet dissolution profiles based on intra-tablet homogeneity. The aim was to minimize scanning time while achieving reliable dissolution profile predictions. To construct the sample set, we controlled the blending time to introduce variability in the homogeneity of the tablets. The dissolution prediction models were established using the partial least squares regression under different Raman mapping area.
The accuracy of the prediction results was evaluated according to the difference factor f1 and Intersection–Union two one-sided t-tests (IU TOST) methods, and the implications conveyed by the results were discussed. The results showed that the homogeneity of sustained-release tablets affects the minimum required mapping area, and the tablets with higher homogeneity show higher prediction accuracy when using the same mapping area to model the dissolution profiles of tablets.
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Materials
Stahera (Hunan, Changsha, China) supplied Sinomenine hydrochloride (Lot#: sta-20210523012) with a purity of at least 98%. Hydroxypropyl methyl cellulose (HPMC, Lot#: C11700890) sodium II with the grade of 15000 mPa.s was procured from Macklin (Shanghai, China). Yuanye (Shanghai, China) provided magnesium stearate (Mg-St, Lot#: J29O9R73388), pregelatinized starch (PGS, Lot#: Z10O11W126822), microcrystalline cellulose (MCC, Lot#: Z29M11W114313), and silicon dioxide.
Qi Zeng, Xin Gao, Long Wang, Guangpu Fang, Jiahe Qian, Hai Liu, Zheng Li, Wenlong Li, Impact of Raman Mapping Area and Intra-Tablet Homogeneity on the Accuracy of Sustained-Release Tablet Dissolution Prediction, European Journal of Pharmaceutics and Biopharmaceutics, 2023, ISSN 0939-6411, https://doi.org/10.1016/j.ejpb.2023.07.012.
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