Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

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

Version 1 : Received: 9 November 2023 / Approved: 10 November 2023 / Online: 10 November 2023 (10:20:01 CET)

How to cite: Ringe, S.; Kulkarni, S.; Sutar, A.; Kumar BV, S.; Shenoy, A. Enhancing Tablet Dissolution Insights: A Comparative Study of Predictive ANN, PLS, and SVM Model With NIR Spectra. Preprints 2023, 2023110692. https://doi.org/10.20944/preprints202311.0692.v1 Ringe, S.; Kulkarni, S.; Sutar, A.; Kumar BV, S.; Shenoy, A. Enhancing Tablet Dissolution Insights: A Comparative Study of Predictive ANN, PLS, and SVM Model With NIR Spectra. Preprints 2023, 2023110692. https://doi.org/10.20944/preprints202311.0692.v1

Abstract

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.

Keywords

chemometrics model; PAT; NIR; DoE; dissolution analysis; ANN; PLS; SVM

Subject

Medicine and Pharmacology, Pharmacy

Comments (0)

We encourage comments and feedback from a broad range of readers. See criteria for comments and our Diversity statement.

Leave a public comment
Send a private comment to the author(s)
* All users must log in before leaving a comment
Views 0
Downloads 0
Comments 0
Metrics 0


×
Alerts
Notify me about updates to this article or when a peer-reviewed version is published.
We use cookies on our website to ensure you get the best experience.
Read more about our cookies here.