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

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.