UV/VIS-imaging of white caffeine tablets for prediction of CQAs: API content, crushing strength, friability, disintegration time and dissolution profile.

Int J Pharm

Department of Organic Chemistry and Technology, Faculty of Chemical Technology and Biotechnology, Budapest University of Technology and Economics, Műegyetem rkp. 3, H-1111 Budapest, Hungary. Electronic address:

Published: September 2024

AI Article Synopsis

  • The paper demonstrates the use of UV/VIS imaging to assess key properties of tablet formulations made of white components, including crushing strength, friability, disintegration time, and dissolution profiles.
  • Images were taken using UV light for predicting API content and VIS light for other parameters, achieving a 5.6% error in API prediction and under 10% error in crushing strength assessments.
  • The study highlights the effectiveness of machine learning and artificial neural networks for classifying tablet samples and predicting dissolution profiles, showcasing the potential of machine vision for real-time quality control in pharmaceuticals.

Article Abstract

The paper provides a demonstration of how UV/VIS imaging can be employed to evaluate the crushing strength, friability, disintegration time and dissolution profile of tablets comprised of solely white components. The samples were produced using different levels of compression force and API content of anhydrous caffeine. Images were acquired from both sides of the samples using UV illumination for the API content prediction, while the other parameters were assessed using VIS illumination. Based on the color histograms of the UV images, API content was predicted with 5.6 % relative error. Textural analysis of the VIS images yielded crushing strength predictions under 10 % relative error. Regarding friability, three groups were established according to the weight loss of the samples. Likewise, the evaluation of disintegration time led to the identification of three groups: <10 s, 11-35 s, and over 36 s. Successful classification of the samples was achieved with machine learning algorithms. Finally, immediate release dissolution profiles were accurately predicted under 5 % of RMSE with an artificial neural network. The 50 ms exposition time during image acquisition and the resulting outcomes underscore the practicality of machine vision for real-time quality control in solid dosage forms, regardless of the color of the API.

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http://dx.doi.org/10.1016/j.ijpharm.2024.124565DOI Listing

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