Latent variable modeling to analyze the effects of process parameters on the dissolution of paracetamol tablet.
The dissolution is one of the critical quality attributes (CQAs) of oral solid dosage forms because it relates to the absorption of drug. In this paper, the influence of raw materials, granules and process parameters on the dissolution of paracetamol tablet was analyzed using latent variable modeling methods. The variability in raw materials and granules was understood based on the principle component analysis (PCA), respectively. A multi-block partial least squares (MBPLS) model was used to determine the critical factors affecting the dissolution. The results showed that the binder amount, the post granulation time, the API content in granule, the fill depth and the punch tip separation distance were the critical factors with variable importance in the projection (VIP) values larger than 1. The importance of each unit of the whole process was also ranked using the block importance in the projection (BIP) index. It was concluded that latent variable models (LVMs) were very useful tools to extract information from the available data and improve the understanding on dissolution behavior of paracetamol tablet. The obtained LVMs were also helpful to propose the process design space and to design control strategies in the further research.
a Research Center of TCM Information Engineering , Beijing University of Chinese Medicine , Beijing , P. R. China.
Fei
F
Sun
a Research Center of TCM Information Engineering , Beijing University of Chinese Medicine , Beijing , P. R. China.|b Beijing Key Laboratory of TCM Manufacturing Process Control and Quality Evaluation , Beijing Municipal Science & Technology Commission , Beijing , P. R. China.
Bing
B
Xu
a Research Center of TCM Information Engineering , Beijing University of Chinese Medicine , Beijing , P. R. China.
Yi
Y
Zhang
a Research Center of TCM Information Engineering , Beijing University of Chinese Medicine , Beijing , P. R. China.
Shengyun
S
Dai
a Research Center of TCM Information Engineering , Beijing University of Chinese Medicine , Beijing , P. R. China.|b Beijing Key Laboratory of TCM Manufacturing Process Control and Quality Evaluation , Beijing Municipal Science & Technology Commission , Beijing , P. R. China.
Xinyuan
X
Shi
a Research Center of TCM Information Engineering , Beijing University of Chinese Medicine , Beijing , P. R. China.|b Beijing Key Laboratory of TCM Manufacturing Process Control and Quality Evaluation , Beijing Municipal Science & Technology Commission , Beijing , P. R. China.
Yanjiang
Y
Qiao
D000082:Acetaminophen / Q000737:chemistry*; D004339:Drug Compounding; D016018:Least-Squares Analysis; D008956:Models, Chemical; D015999:Multivariate Analysis; D010316:Particle Size; D011208:Powders; D025341:Principal Component Analysis; D012995:Solubility; D013607:Tablets / Q000737:chemistry
D011208:Powders; D013607:Tablets; D000082:Acetaminophen
Paracetamol; dissolution; multi-block partial least squares; principle component analysis; quality by design
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