Principal Component Analysis for Pharmaceutical Process and Product Characterization:Case Study From Immediate and Controlled Release Tablet Manufacturing

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As an important data analysis technique for reducing dimensionality of complex process data , Principal Component Analysis (PCA) has been widely used in pharmaceutical PAT applications. The objectives of this work were to utilize PCA for: (1) differentiating physical and chemical characteristics of pharmaceutical solid dosage forms; and (2) establishing link among formulation parameters , manufacturing process variables , and pharmaceutical product quality attributes of controlled release dosage form. Immediate-release and controlled-release theophylline tablets were manufactured and subjected to NIR diffuse reflectance spectroscopy analysis. The raw or preprocessed NIR spectral datasets grouped with either constant tablet hardness , or constant formulation chemistry , or constant core tablet API strength were subjected to PCA. It was determined that the first and second principal components track tablet hardness and chemical composition for immediate release tablets , respectively. For the film-coated controlled release tablets , process trajectory for the film-coating process demonstrated an information-critical coating thickness. The controlled-release tablets were subjected to dissolution testing. A link between coating film thickness and drug dissolution rate was identified via integration of PCA and mass-transfer kinetics analysis of coated tablet dissolution process. Therefore , the possibility of using PCA to separate the physical and chemical information embedded with the NIR spectra of tablets , and to depict link among pharmaceutical formulation parameters , processing variables , and performance characteristics of tablets was demonstrated.

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