Enhancing Tablet Dissolution Insights: A Comparative Study of Predictive ANN, PLS, and SVM Model With NIR Spectra

Le résumé fourni par la source

The pharmaceutical industry is making significant strides in enhancing process comprehension through the development of concepts like Quality by Design (QbD) and Process Analytical Technology (PAT). This shift has moved from traditional offline testing methods to real-time estimation of product quality. The dissolution characteristics of pharmaceutical tablets play a crucial role in maximizing the release of medications and their bioavailability. One factor that can affect dissolution is the blending procedure. Inadequate mixing can lead to patches of concentrated active components or excipients within the tablet, resulting in inconsistent dissolution behavior. A study investigated the impact of blending time and speed on the dissolution behavior of Amlodipine tablets using near-infrared (NIR) spectroscopy and multivariate modeling. NIR spectra were collected for Amlodipine tablets produced under various blending conditions using a 2-level central composite design. Dissolving profiles were analyzed using a USP dissolution device. Multivariate analysis techniques, including principal component analysis (PCA), partial least squares (PLS), Support Vector Machine (SVM), and Artificial Neural Networks (ANN), were applied to the collected NIR spectra. The findings demonstrated that blending speed and time had a significant influence on the dissolving properties of Amlodipine tablets. Blending at faster speeds and for shorter durations resulted in excessive shear and insufficient mixing, ultimately reduced drug release. The multivariate models constructed using ANN outperformed SVM and PLS in predicting dissolution profiles based on NIR spectra. This research highlights the effectiveness of NIR spectroscopy and multivariate modeling in optimizing tablet dissolution. These advancements enable continuous manufacturing of high-quality pharmaceutical products.

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